FDA Alert News February 2007

FDA Alert News February 2007 - Food and drug administration press release and news alerts for february 2007

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FDA Alert News February 2007
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Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA) in the U.S. Department of Veterans Affairs (VA) announced today that they have signed a memorandum of understanding (MOU) to share information and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices (medical products). This partnership is part of the ongoing drug and medical product safety initiatives detailed in a report released today by theFDA.

The goals of the collaboration are to explore ways to enhance postmarket medical product safety data collection and risk communication through more robust interagency activities. It will promote efficient use of tools and expertise for medical product risk identification, validation and analysis. Additionally, this effort will help build infrastructure and processes that meet the commonneeds for evaluating the safety, efficacy and use of medical products.

"Patient safety is our primary concern," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "This collaboration will benefit VHA, FDA and all Americans by enhancing our ability to fully understand the life cycle of a product. It will also better enable us to identify new risks and more fully understand known risks caused by specific medical products as well as to better communicate that information to health care practitioners and patients."

"This truly is a natural partnership," said Michael Kussman, M.D., Acting Under Secretary for Health for VHA. "VHA offers enrolled veterans the largest integrated health care system in the nation and leads the way in many areas of health care quality and safety. We are eager to continue to work with FDA to accomplish our shared mission of protecting public health."

By strengthening the process for postmarketing safety, VHA and FDA are continuing to improve the safe and effective use of medical products by using the best management approaches, the best information technology and the best quality systems and review processes.

All personal health information exchanged under the agreement will be protected in accordance with federal law.

For a copy of the MOU, visit: www.fda.gov/oc/mous/domestic/225-07-4300.html.

FDA Reinforces Commitment to Drug Safety

The U.S. Food and Drug Administration (FDA) today outlined a comprehensive commitment to the safety of drugs and other medical products. The FDA report, which also responds to a set of recommendations made by the Institute of Medicine (IOM) in 2006, details a series of initial steps that aim to ensurethat FDA's safety programs are the best possible.

"Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology and the health care system," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health."

In 2005, the FDA asked the IOM for its assessment of the U.S. drug safety system. In September 2006, the IOM released a report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, that included substantive recommendations on how the FDA can improve its drug safety efforts.

The agency carefully considered recent IOM recommendations, along with advice from other experts, for making needed advances in the system. FDA agrees with the IOM that FDA's mission requires the agency "to balance expeditious access to drugs with concerns for safety" (IOM, Sept. 2006).

FDA believes that concrete steps should be taken. The FDA plans to strengthen the drug safety system with a number of actions in support of three key efforts:

In addition, a number of the recently proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), if adopted by Congress, will respond to some of the IOM recommendations. This will provide significant increased resources for drug safety and added flexibility to FDA in the use of fee funding to address the entire drug life cycle.

The FDA's ongoing effort for drug safety constitutes a comprehensive approach to the IOM's suggestions. It includes 18 actions that were initiated recently as a result of FDA's own assessment of the drug safety system, eight items that are part of the proposed recommendations for the reauthorization of the PDUFA and 15 new items.

For more information, please visit www.fda.gov forthe following:

FDA Statement on Effectiveness of Newer Birth Control Pills

Recent wire service stories about today's meeting of the FDA Reproductive Health Drugs Advisory Committee have created misperceptions about the effectivenessof newer generation hormonal contraceptives.

The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago. In fact, the newer generation products are highly effective in preventing pregnancy.

The stories also mistakenly state that FDA called the meeting to discuss the need for higher standards of efficacy for the newer products.

In fact, as published in the Federal Register Notice announcing this meeting, the purpose of this two-day meeting is to discuss clinical trial designs that reflect the diversity of users of hormonal contraceptives, expectations for efficacy and safety, and user acceptability of the newer generation products, including cycle control.

FDA Commissioner Announces Important Personnel Changes

U.S. Food and Drug Administration (FDA) Commissioner Dr. Andrew C. von Eschenbach is pleased to announce two new personnel changes at the Agency; the creation of the Office of the Chief Medical Officer which will be overseen by Deputy Commissioner Dr. Janet Woodcock and the appointment of John R. Dyer, MPH, as the agency's Deputy Commissioner for Operations and the Chief Operating Officer (COO).

As the Deputy Commissioner and the Chief Medical Officer, Dr. Woodcock will oversee scientific and planning-related operations for FDA. In this capacity, Dr. Woodcock shares responsibility and collaboration with the Commissioner of FDA in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agency's scientific and medical regulatory activities in order to achieve the mission of FDA.

"FDA is a science-based agency and science-led Agency; science provides the foundation for our regulatory decisions and the work we do on a daily basis to promote and protect the nations' health," said Dr. von Eschenbach. "Creation of this office, and position, will better ensure we achieve this mission with the highest scientific quality and effectiveness needed."

Dr. Woodcock most recently served as the Deputy Commissioner for Operations. An internist and rheumatologist, Dr. Woodcock was previously the Director of the FDA's Center for Drug Evaluation and Research (CDER) and also has significant experience working in the Center for Biologics Evaluation and Research (CBER). Dr. Woodcock started her FDA career in 1986.

Mr. Dyer will be a part of the senior management of the agency that supports the Commissioner in advancing his priority initiatives. Specifically, Mr. Dyer will concentrate on strengthening the management, business processes, and information technology of the agency. In addition, Mr. Dyer will work with the other Deputy Commissioners and the Chief of Staff to provide management leadership and oversight to FDA.

"Management and oversight of FDA's administrative processes are crucial to ensuring this agency is able to carry out its diverse and complex public health mandate," said Dr. von Eschenbach. "With almost 24 percent of the products in the marketplace regulated by FDA it is imperative we apply and incorporate modern management tools and techniques to our regulatory decisions. Mr. Dyer's deep experience in management is ideally suited to meet the emerging challenges and opportunities involved in protecting and promoting the health of the American public in the 21st century."

Mr. Dyer most recently served as the Chief Operating Officer for the Centers for Medicare & Medicaid Services (CMS), a federal agency within the Department of Health and Human Services that is responsible for providing health insurance benefits to the elderly, disabled, and indigent through the Medicare and Medicaid programs. In that capacity, he led the implementation of the Medicare Modernization Act (MMA) and was responsible for the overall day to day operations of the agency. Specifically as COO, he helped develop the program policies and regulations, and stood up the business and systems operations of the prescription drug program in time for the congressionally mandated start of open enrollment on Oct 15, 2005 and start of the drug prescription benefits on January 1, 2006.

Prior to CMS, from 2001-2003, Mr. Dyer worked in the private sector for information technology and executive leadership companies. He was involved in entrepreneurial ventures in agriculture, real estate, and industrial enterprises in Latin America from 2003-2004.

In his federal career from 1972 to 2000, Mr. Dyer held increasingly responsible executive positions with the Social Security Administration (SSA), including the Chief Information Officer and Principal Deputy Commissioner where he assisted the agency by leading the effort to automate and modernize systems and improve the level of customer service. Other federal positions include the Director for Budget and Management at CMS (then the Health Care Financing Administration) from 1984-1998 and Commerce Branch Chief at the Office of Management and Budget in the Executive Office of the President. While at OMB, Mr. Dyer had budget and policy review of wide-ranging research and development programs ranging from mental health to ocean and atmospheric related.

Mr. Dyer has been the recipient of many awards during his federal career including the Presidential Award for Distinguished Executive. He holds a Masters Degree in Public Health from the University of Michigan and obtained his undergraduate Bachelor of Arts in Sociology from Notre Dame.

FDA Issues Draft Guidance on License Applications for Certain Placental/Umbilical Cord Blood Products

The Food and Drug Administration (FDA) today issued a draft guidance recommending a streamlined path to licensure for establishments that manufacture cord bloodfor certain medical conditions.

Placental/umbilical cord blood is a rich source of precursor cells capable of differentiating into mature blood cells. These precursor cells are known as hematopoietic stem/progenitor cells and can be used to replenish the bone marrow in patients with blood-based malignancies such as leukemia.

The draft guidance describes FDA's regulatory approach to the regulation of cord blood hematopoietic stem/progenitor cells that are:

"Cord blood hematopoietic stem/progenitor cells offer the potential for tremendous therapeutic benefit," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research (CBER).  "In this draft guidance, FDA provides recommendations on a streamlined path tolicensure for these promising products that also ensures their safety and effectiveness."

FDA first proposed a new regulatory framework for human cells, tissues and cellular and tissue-based products (HCT/P), including cord blood, in 1997.  This tiered approach, fully implemented in May of 2005, requires that establishments register with FDA and list their products, ensure quality control by adhering  to the agency's current good tissue practices and follow the agency's rules on donor eligibility. Under this framework, cord blood hematopoietic stem/progenitor cells from unrelated donors are regulated as both HCT/P and as biologic drugs subject to licensure.

In 1998, when cord blood transplants were still relatively uncommon, FDA sought input from scientists and industry to develop product standards, establishment controls, and processing controls that would clear the way for biologics license applications ensuring the safety and effectiveness of placental/umbilical cord blood from unrelated donors that is used to replenish a patient's bone marrow. To provide a scientific basis for the proposed standards, FDA requested the submission of clinical and non-clinical laboratory data to a public site created for this purpose.

In 2003, the agency convened its Biological Response Modifiers Advisory Committee to discuss the current clinical data, safety and effectiveness issues surrounding placental/umbilical cord blood transplantation, and possible quality measures. At that time, cord blood was being used in increasing numbers, and members of the interested public voiced their opinion that licensure of cord blood products would increase confidence in the safety and effectiveness of these products.

FDA has since determined that cord blood hematopoietic stem/progenitor cells are safe and effective for certain indications based on the data submitted to the public docket and the large body of published literature.

Therefore, the new draft guidance offers cord blood banks a less burdensome path to licensure. Rather than having to submit their own clinical data, they may cite existing data in the docket.

The draft guidance also provides manufacturers with recommendations on the content and format of information to be submitted with an application, discusses the manufacture of cord blood hematopoietic stem/progenitor cells and elaborates on how to comply with applicable regulatory requirements.

FDA is accepting public comment for 90 days from the date of publication in the Federal Register. Electronic comments may be sent to www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number (2006D-0514).

For a copy of the guidance, visit: http://www.fda.gov/cber/gdlns/cordbld.pdf

GE OEC Medical Systems Signs Consent Decree with FDA;Agrees to Correct Manufacturing Deficiencies

The U.S. Food and Drug Administration (FDA) today announced that GE OEC Medical Systems, Inc., its parent company, the General Electric Company doing business as GE Healthcare, and two of their top executives have signed a consent decree of permanent injunction related to X-ray surgical imaging systems manufactured by GE OEC Medical Systems. The consent decree prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, Utah, and Lawrence, Massachusetts, until the devices and facilities have been shown to be in compliance with FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices.

The decree was filed today in the U.S. District Court for the District of Utah and is subject to court approval.

The X-ray surgical imaging systems subject to the decree are manufactured and designed at GE OEC Medical Systems' facilities in Salt Lake City, Utah, and Lawrence, Massachusetts, and include the 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV System, and ENTrak 2500 NAV System, as well as their components and accessories. These are radiological image processing and image-intensified fluoroscopic X-ray systems that are used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care, emergency room procedures, and other imaging applications.

“These devices are used on thousands of patients, and their dependability and accuracy are critical for the successful outcomes of important medical procedures,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “When FDA's August 2006 inspection found ongoing CGMP deficiencies at the Utah facility, GE voluntarily stopped distributing devices from that facility and is working with FDA to ensure that necessary corrective actions are fully implemented."

FDA's most recent inspection of the Utah facility, conducted between July 31 and August 29, 2006, revealed CGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions. FDA previously inspected the Utah facility between November 15 and December 1, 2004. Following that inspection, FDA issued a Warning Letter on March 31, 2005, citing violations of the CGMP requirements. The government brought this enforcement action when FDA's 2006 inspections showed inadequate responses to FDA’s requests for corrections in the 2005 Warning Letter.

Under the terms of the consent decree, signed by Joseph M. Hogan, Senior Vice President, GE Company and President and Chief Executive Officer, GE Healthcare, and Peter McCabe, President and Chief Executive Officer of GE OEC Medical Systems and GE Healthcare Surgery, the companies have agreed to take necessary measures to ensure that the X-ray surgical imaging systems manufactured and designed at the Utah and Massachusetts facilities comply with CGMP requirements, as well as FDA regulations for reporting adverse events and malfunctions and device corrections and removals.

The decree also requires that the companies hire an independent expert to conduct inspections of GE OEC Medical Systems facilities in Utah and Massachusetts and certify to FDA that corrections have been made. Manufacturing and distribution can resume at the Utah and Massachusetts facilities once FDA is satisfied that those facilities are in compliance with the law. An outside expert also will conduct yearly audit inspections for four years to assure that the facilities remain in compliance and will submit his/her findings to FDA. FDA may order the companies to stop manufacturing and distributing the X-ray imaging systems if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act or FDA regulations.

Under the consent decree, the companies are also required to submit to FDA a corrective action plan for bringing into compliance with the Act the 9900 Elite C-Arm Systems, the 9900 Elite NAV C-Arm Systems, and the 9800 C-Arm Systems that are currently in use in the U.S. by physicians, hospitals, and other facilities. GE OEC Medical Systems also has voluntarily initiated product recalls on several models of its X-ray surgical imaging systems. Copies of the recall notices are available on the company's website at http://www.gehealthcare.com/usen/xr/surgery/oec_info.html.

The consent decree allows the companies to continue to provide routine service maintenance, replacement parts, and accessories for the GE OEC X-ray surgical imaging systems that are already employed in U.S. hospitals and other health care facilities.

FDA and States Closer to Identifying Source of E. coli ContaminationAssociated with Illnesses at Taco John's Restaurants

The Food and Drug Administration (FDA) today announced that it has moved closer to identifying the source of illness for the Taco John E. coli outbreak. FDA and the state of California, working in conjunction with state health officials in Minnesota, Iowa, and Wisconsin, have DNA-matched the strain of E. coli O157:H7 bacteria associated with the outbreak with two environmental samples gatheredfrom dairy farms near a lettuce growing area in California's Central Valley.

The investigation is ongoing, including obtaining additional samples, to determine if and how material from the dairy farms may have contaminated the lettuce growing area.

FDA has no indication that any lettuce currently on the market, including iceberg lettuce, is connected with any consumer illnesses. This outbreak is not connected to any previous outbreak.

The outbreak sickened approximately 81 individuals in November and December of 2006. Illnesses were reported in Minnesota (33), Iowa (47), and Wisconsin (1). Twenty-six people were hospitalized, and two suffered hemolytic uremic syndrome, a serious complication of E. coli O157:H7 infection that can cause permanent kidney damage and death. No deaths have been associated with the outbreak. No new cases of illness are being reported and the outbreak is now considered over.

Taco John's is headquartered in Cheyenne, Wyoming, and has franchises in more than 25 states; however, the outbreak was associated only with Taco John's restaurants located in Iowa and Minnesota.

Epidemiological studies by Minnesota and Iowa health officials had previously identified shredded iceberg lettuce served in the restaurants as the likely vehicle of transmission in the outbreak. FDA was able to focus on specific lettuce growing regions based on the traceback from records obtained from the lettuce processor. The recent DNA match provides a clue as to one possible source of the contamination for the lettuce, although others may exist.  It has yet to be determined how the E. coli contaminated the lettuce. The traceback investigation is ongoing and will hopefully yield further insight into how this contamination occurred.

In the wake of recent outbreaks of consumer illness connected with fresh produce, FDA will accelerate its efforts to address produce safety, including consideration of new regulations, if appropriate, to reduce risk of contamination by pathogens.

In the near future, FDA plans to announce public meetings specifically to involve all stakeholders in identifying and initiating measures that will improve the safety of fresh produce marketed in U.S. commerce.

FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard

The U.S. Food and Drug Administration is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy orBSE.

This is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle. These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.

The proposed rule would cover drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines) and medical devices intended for use in humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

"These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE," said Andrew von Eschenbach, M.D., Commissioner Food and Drugs. "This proposed rule adds one more safeguard that will reduce the risk of transmission even further."

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

To ensure that companies comply with these prohibitions, FDA proposes to require that records be kept to demonstrate that any cattle material used as an ingredient in these medical products or as part of their manufacturing process meet the rule’s requirements.

Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks of mad cow disease in Europe and a disease in humans called variant Creutzfeldt-Jakob (vCJD) disease. Both disorders, which are thought to be caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years. Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; however the specific products associated with this transmission are unknown.

About 200 cases of vCJD have been identified worldwide, including three cases in the U.S. However, there is no evidence that those three patients contracted the BSE agent in the U.S.

FDA and USDA’s efforts to help protect the public from vCJD have included several other significant steps such as the FDA’s 1997 ruminant feed regulation, which forbids the use of certain mammalian-origin proteins in ruminant feed. Also, a 2005 interim final rule bans the use of certain high-risk cattle material in food, dietary supplements and cosmetics.

FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program

The Food and Drug Administration (FDA) today proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. To achieve these public health benefits, the agency proposes to recommend, as part of the reauthorization of the program, that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line.

The user fee program, which was first authorized by the Prescription Drug Use Fee Act (PDUFA) in November 1992, adds industry's funds to the agency's appropriations to help FDA's human drug review program achieve demanding performance goals. Over the years, the PDUFA programs, which have to be reauthorized by Congress every five years, have enabled the agency to dramatically reduce its review times for drugs and biological medications while increasing scientific consultations, clarifying issues involving drug development, and increasing oversight of postmarket safety.

"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process," said HHS Secretary Mike Leavitt. "I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals."

"In the last 14 years, three consecutive user fee programs -- PDUFA I, II and III -- have brought enormous public health gains to our and, indeed, the world's consumers, by helping FDA make increasingly complex medications available to patients faster than was ever possible before without sacrificing quality," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Our proposed recommendations for PDUFA IV aim to top these accomplishments by achieving, above all, an impressive expansion and modernization of our drug safety system, and adding resources to enhance information technology initiatives."

To develop the proposal, FDA held a public meeting and other consultations with stakeholders, including organizations representing health care professionals, consumers, patient advocates, and regulated industry. These stakeholders urged the FDA to seek additional appropriated funds to strengthen its ongoing drug safety program. In addition, consumer groups favored the adoption of user fees to increase FDA's capacity for review of direct-to-consumer TV ads.

Based on these consultations and an analysis of its commitments and anticipated means, FDA proposes to recommend using the $87.4 million user fee increase for significant program enhancements. PDUFA IV is the mechanism for placing the drug review process on a sound financial footing. The following are the key components of the proposal:

Program enhancements: $37.9 million
The biggest recommended increase, of $29.3 million, would provide a major boost for FDA activities to ensure the safety of medications after they are on the market. The increased funds would be available for FDA drug safety activities for marketed medications throughout as long as they remain on the market and would increase FDA's drug safety capacity for surveillance including hiring an additional 82 employees to perform postmarket safety work. To that end, FDA also recommends elimination of a statutory provision under which PDUFA fees may be used to assess safety issues only during the first three years after the product's approval. The agency would also use the added resources to adopt new scientific approaches and improve the utility of existing tools for the detection and prevention of adverse events, for example obtaining access to the best available databases to better analyze drug safety signals.

Other enhancement proposals call for:

In addition, the FDA proposes to recommend creating a separate new user fee program to collect new fees from companies that seek FDA advisory reviews of their direct-to-consumer television advertisements. FDA anticipates that these fees will be $6.2 million in the first year and support 27 additional staff to carry out this review function.

Financial baseline: $49.4 million

Since the user fees collected have not kept up with the increasing costs of the program, FDA proposes to request several increases in user fees to stabilize PDUFA IV's financial base line, to be divided as follows:

FDA's PDUFA proposals will be presented to the public at a public meeting on February 16, 2007. After all public comments are evaluated and any appropriate changes made, final proposals will be submitted to Congress. PDUFA reauthorization would go into effect only after enacted by Congress and signed by the President.

For more information, The Federal Register Notice is available at http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2007&mn=1&dy=16".

FDA's PDUFA proposals will be presented to the public at a public meeting on February 16, 2007. After all public comments are evaluated and any appropriate changes made, final proposals will be submitted to Congress.

To submit electronic comments on the documents, visit the FDA Dockets page. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Feb. 23, 2007 and should include the docket number 2007N-0005.

FDA Updates Health Claim for Calcium and Osteoporosis

The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule would allow manufacturers to include new information on their food and supplement labeling and to eliminate certain other information, described below.

“This is important information for all citizens,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Nutrition. “All persons lose bone with age, and the loss can influence an individual's risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one’s risk.”

Today’s action is part of FDA’s continued commitment to helping consumers make informed and healthy food choices, and responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, The Coca-Cola Company.

The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act of 1990 for the relationship between calcium intake and osteoporosis. The proposal would amend this existing health claim by allowing for claims of a reduced risk of osteoporosis with the consumption of both calcium and vitamin D.

The proposed rule also would eliminate certain requirements that were a part of the required claim language in the existing calcium and osteoporosis health claim. However, FDA is not changing its conclusion that there is still significant scientific agreement to support claims for calcium intake and reduced risk of osteoporosis.

“Osteoporosis is a significant public health problem, especially for women,” said Kathleen Uhl, MD, assistant commissioner of FDA’s Office of Women’s Health. “This new labeling should assist consumers to select foods - and women especially since women do the majority of food shopping in the US - that provide adequate calcium and Vitamin D intake and hopefully prevent the occurrence of osteoporosis in themselves and their family members.”

FDA’s decision to amend the existing health claim is based on the agency’s review of the publicly available scientific evidence, which included the 2004 Surgeon General’s report on Bone Health and Osteoporosis and the 2000 NIH Consensus Statement on Osteoporosis, Prevention, Diagnosis and Therapy.

Specifically, FDA is proposing to change the calcium and osteoporosis health claim to:

Shorten the claim language by:

Comments may be submitted electronically to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA (click on the Docket Search link on the left side and put in the docket number 2004P-0464) or in writing to the Division of Dockets Management, 5630 Fishers Lane, room 1061, Rockville, MD 20852. Please reference the docket number when submitting comments.

FDA Approves the First Drug for Obese Dogs

The Food and Drug Administration (FDA) today is announcing the approval of Slentrol (dirlotapide), a prescription drug for the management of obesity in dogs. Slentrol reduces appetite and fat absorption to produce weight loss. A veterinarian will determine whether the dog should be treated, based on the dog's weight and general health.

"This is a welcome addition to animal therapies, because dog obesity appears to be increasing," said Stephen Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Veterinarians are well aware that overweight pets are at a higher risk of developing various health problems, from cardiovascular conditions to diabetes to joint problems."

Veterinarians generally define a dog that weighs 20 percent more than its ideal weight as obese. Surveys have found that approximately 5 percent of dogs in the United States are obese, and another 20-30 percent are overweight.

Slentrol is a new chemical entity, called a selective microsomal triglyceride transfer protein inhibitor, which blocks the assembly and release of lipoproteins into the bloodstream. The mechanism for producing weight loss is not completely understood, but seems to result from reduced fat absorption and a satiety signal from lipid-filled cells lining the intestine.

The drug is given to the dog in varying amounts over the course of the treatment. The dog is given an initial dose for the first 14 days. After that, the veterinarian will assess the dog's progress at monthly intervals, adjusting the dose depending on the dog's weight loss. After the dog has achieved the goal weight, the drug's manufacturer recommends continued use of the drug during a three-month period, while the veterinarian and dog owner establish the optimal level of food intake and physical activity needed to maintain the dog's weight.

Adverse reactions associated with treatment with Slentrol include vomiting, loose stools, diarrhea, lethargy and loss of appetite.

To discourage human use, the label of Slentrol includes the standard warning, "Not for use in humans. Keep this and all drugs out of reach of children," and cites adverse reactions associated with human use, including abdominal distention, abdominal pain, diarrhea, flatulence, headache, nausea and vomiting.

Slentrol is manufactured by Pfizer Inc., New York, N.Y.

For more information on Slentrol, please see www.fda.gov/OHRMS/DOCKETS/98fr/2006-141-260-fois001.pdf and www.fda.gov/OHRMS/DOCKETS/98fr/E6-22542.htm .

FDA Issues Draft Documents on the Safety of Animal Clones

The U.S. Food and Drug Administration (FDA) today issued three documents on the safety of animal cloning -- a draft risk assessment; a proposed riskmanagement plan; and a draft guidance for industry.

Draft risk assessment

The draft risk assessment finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They agreed with the methods FDA used to evaluate the data and the conclusions set out in thedocument.

The draft risk assessment presents an overview of assisted reproductive methods widely used in animal agriculture, the extensive scientific information available on animal health and food consumption risks, and draws science-based conclusions. These conclusions agree with those of the National Academies of Sciences, released in a 2002 report. Due to limited data on sheep clones, in the draft guidance FDA recommends that sheep clones not be used for human food.

"Based on FDA's analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Cloning poses no unique risks to animal health when compared to other assisted reproductive technologies currently in use in U.S. agriculture."

An animal clone is a genetic copy of a donor animal, similar to identical twins but born at different times. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence.

Proposed risk management plan

The proposed risk management plan addresses risks to animal health and potential remaining uncertainties associated with feed and food from animal clones and their offspring.

The proposed plan outlines measures that FDA might take to address the risks that cloning poses to animals involved in the cloning process. These risks all have been observed in other assisted reproductive technologies currently in use in common agricultural practices.

One such measure could be that the agency would work with scientific and professional societies with expertise in animal health and reproduction to develop a set of care standards for animals involved in the cloning process. Although the agency does not have authority to address the ethics of animal cloning, the proposed risk management plan does state that FDA plans to continue to provide scientific expertise to interested parties working on these issues.

"Because the release of the draft risk assessment and proposed risk management plan marks the beginning of our interaction with the public on these issues, we are continuing to ask producers of clones and livestock breeders to voluntarily refrain from introducing food products from these animals into commerce so that we will have the opportunity to consider the public's comments and to issue any final documents as warranted," said Sundlof.

Draft guidance for industry

The draft guidance for industry addresses the use of food and feed products derived from clones and their offspring. The guidance is directed at clone producers, livestock breeders, and farmers and ranchers purchasing clones. It provides the agency's current thinking on use of clones and their offspring in human food or animal feed.

In the draft guidance, FDA does not recommend any special measures relating to human food use of offspring of clones of any species. Because of their cost and rarity, clones will be used as are any other elite breeding stock -- to pass on naturally-occurring, desirable traits such as disease resistance and higher quality meat to production herds. Because clones will be used primarily for breeding, almost all of the food that comes from the cloning process is expected to be from sexually-reproduced offspring and descendents of clones, and not the clones themselves.

FDA is seeking comments from the public on the three documents for the next 90 days. To submit electronic comments on the three documents, visit http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Apr. 2, 2007 and should include the docket number 2003N-0573.

For more information, visit http://www.fda.gov/cvm/CloneRiskAssessment.htm.

FDA's Dr. Kessler to Chair Global Task Force for Harmonization of Medical Device Practices

The U.S. Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) is pleased to announce that Dr. Larry Kessler, a senior FDA scientist and manager, will chair the Global Harmonization Task Force (GHTF) for the next eighteen months. Dr. Kessler, director of the Office of Science and Engineering Laboratories (OSEL) in FDA's Center for Devices and Radiological Health (CDRH), assumed the chair of the forum of medical deviceregulators and trade associations on Dec, 22, 2006.

"We're very proud of the opportunity for HHS/FDA to chair this initiative for the next eighteen months," said Andrew von Eschenbach, M.D., commissioner, Food and Drugs. "I have full confidence in Dr. Kessler to fulfill his responsibilities as chair of this global initiative to help harmonize medical device regulatory practices and to help drive further technological progress in the medical device industry."

GHTF is a voluntary group of representatives of national medical device regulatory authorities and trade associations of medical device manufacturers. The founding members came from the United States, Europe, Canada, Japan and Australia. The main goals of GHTF are to advance the safety, effectiveness, performance and quality of medical devices; encourage technological innovation; foster international trade; and serve as a forum for exchange of information that can be of help to countries that are developing their own regulatory systems. Since its founding in 1992, GHTF has promoted the convergence of global regulatory practices by issuing almost 40 harmonized guidances, now widely followed by many countries.

Dr. Kessler has contributed to these accomplishments as the chair in 1996-2001 of a GHTF Study Group that reviewed the programs for the post-marketing surveillance of medical devices in the founding countries, and which established a mechanism for regulators to exchange significant post-market device information about adverse events, called the National Competent Authority Reporting program. This Study Group also set a standard for a unified, world-wide system of reporting adverse events associated with medical devices by producing major documents on what defines an adverse event, and what, when and how to report it.

Dr. Kessler joined FDA in 1995 after a decade with the National Cancer Institute, part of the HHS' National Institutes of Health, where he served for nine years as the chief of the Applied Research Branch. His first position at FDA was as director of CDRH's Office of Surveillance and Biometrics, a role in which he guided the implementation of the agency's Medical Device Reporting regulation; developed a program for reducing the burden of repetitive reporting; and began testing a sentinel system for the reporting of adverse events by user facilities. He also helped develop a new program to encourage the application of a variety of new Bayesian statistical methods for the review process for medical devices, which has sped up the development and approval of some innovative technologies.

From September 2001 through August 2002, Dr. Kessler was a visiting scientist at the Fred Hutchinson Cancer Research Center in Seattle, Washington, where he conducted research on colorectal and lung cancer, examined trends in prostate cancer, and worked on the National Emphysema Treatment Trial. Since September, 2002, Dr. Kessler has directed OSEL, which plays a crucial role in identifying key scientific questions and solutions concerning the safety and effectiveness of medical devices.

Dr. Kessler has written more than 100 peer-reviewed journal articles, mostly on the application of quantitative methods and problems in surveillance and public health. He graduated magna cum laude in mathematics from Boston University, and received his Doctor of Science degree from the Johns Hopkins University, School of Hygiene and Public Health.

FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution

The Food and Drug Administration today approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The approval is an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, Ondansetron was the 20th highest-selling brand-name drug in the United States in 2005, with sales totaling $839,256,543 as reported in the onlinemagazine Drug Topics.

"This approval will result in significant savings for the American public," said Gary J. Buehler, director, Office of Generic Drugs. "Generic drugs are safe and effective alternatives to brand name drugs and undergo a thorough scientific and regulatory review."

The economic benefits of FDA's generic drug approval program are significant because generic drug products, which are used to fill over 50 percent of all prescriptions, frequently cost a fraction of the price of the brand-name drugs. Such savings are likely to increase as more competitors enter the market. (See http://www.fda.gov/cder/ogd/generic_competition.htm).

The Office of Generic Drugs reviews and takes action on generic drug applications as expeditiously as possible. The same thorough and rigorously scientific review standards of safety, efficacy and quality are applied to generic drug applications as are applied to new drug applications. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm

Ondansetron Hydrochloride Tablets (4 mg, 8 mg, 16 mg and 24 mg) are manufactured by Dr. Reddy Laboratories, Ltd., Bridgewater, NJ 08807.

Ondansetron Orally Disintegrating Tablets (4 mg, 8 mg, 16 mg and 24 mg) are manufactured by Kali Laboratories, Inc., Somerset, NJ 08873

Ondansetron Hydrochloride Oral Solution (4mg (base)/5 mL) is manufactured by Roxane Laboratories, Inc., Columbus, OH 43228

For additional information related to FDA's Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

Randall Lutter Appointed Acting Deputy Commissioner for Policy

Dr. Andrew von Eschenbach, Commissioner of Food and Drugs (FDA), today announced that Randall Lutter, Ph.D., will serve as Acting Deputy Commissioner for Policy. Lutter will be replacing Dr. Scott Gottlieb who recently announced his resignation, effective late January 2007.

In this role, Lutter will provide guidance and input on all agency matters and serve as lead advisor to the Commissioner on agency policy.

“Randy has played a key role in the development and implementation of many of the agency’s highest priority initiatives,” said Dr. von Eschenbach. “The leadership he has shown in his current position as Associate Commissioner for Policy and Planning will ensure not only a smooth transition but also continued success in carrying out this agency’s mission.”

Lutter joined FDA in 2003 as Chief Economist in the Office of Planning and has most recently served as the Associate Commissioner of Policy and Planning where he coordinated the agency’s regulatory and administrative policies aimed at protecting and advancing the health of the public. In this capacity he has also served as a lead advocate for Administration, Department, and FDA policies and programs before the Congress and to the public, especially with respect to health risks associated with importation of drugs and challenges controlling counterfeit drugs.

Before joining FDA Lutter was a resident scholar with the American Enterprise Institute and fellow with the AEI-Brookings Joint Center for Regulatory Studies. From 1991 to 1997 he served at the Office of Management and Budget in the Office of Information and Regulatory Affairs and from 1997 to 1998 he was senior economist for regulation and the environment at the President’s Council of Economic Advisers.

Lutter is a graduate of Cornell University where he earned a Ph.D. and M.A. in Economics.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate. The product is approved for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD) in whom the hormone desmopressin is either ineffective or contraindicated. It is not approved for patients with severe vWD (Type 3) who are undergoing major surgery. The disease is the most common inherited bleeding disorder, affecting about one percent ofthe U.S. population.

Alphanate is the first biologic product approved for treatment of surgical and invasive procedures in patients with vWD. Alphanate is already approved for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.

"This approval is an important advance for patients and their surgeons, providing them access to a proven preventive therapy that can make needed surgery possible and safer," said Jesse L. Goodman, M.D., MPH, director of FDA's Center for Biologics Evaluation and Research.

Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most affected people, the disease is mild, and treatment usually is not required to stop bleeding. However, about 2,000 people in the U.S. each year suffer from moderate and severe forms of the disease in which bleeding can be excessive if not treated.

Successful management of surgery or invasive procedures in mildly, moderately and severely affected individuals routinely requires correction of the bleeding defect. In the absence of correction of the bleeding defect, patients may suffer from prolonged bleeding and delayed wound healing.

Alphanate is purified from pooled human plasma from carefully screened and tested U.S. donors, and contains the clotting proteins deficient or defective in vWD, which are Factor VIII (also know as Antihemophilic factor) and von Willebrand factor. Alphanate undergoes two separate steps for viral inactivation to reduce the risk for transfusion-transmitted viruses. However, the potential risk for the transmission of blood-borne viruses, and theoretically variant CJD, while very low, cannot be totally eliminated.

In clinical studies with Alphanate, 120 major, moderate and minor surgical procedures were performed in 76 patients. Based on predefined criteria for efficacy, more than 90 percent of patients had favorable outcomes. In these clinical studies, 15.8 percent of subjects and 5.7 percent of infusions were accompanied by adverse reactions, most commonly itching, pharyngitis, paresthesia (a sensation of numbness and tingling on the skin) and headache, swelling of the face, and rash and chills.

Alphanate is manufactured by Grifols Biologicals, Inc., Los Angeles, Calif.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, is requesting nearly $2.1 billion to protect and promote public health as part of the President's fiscal year (FY) 2008 budget—more than a 5 percent increase over the budget submitted to Congresslast year.

The FY 2008 request, which covers the period of Oct. 1, 2007 through Sept. 30, 2008, includes $1.64 billion in budget authority and nearly $444 million in industry user fees. The budget proposal includes significant increases to strengthen food safety, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes significant increases to cover higher infrastructure expenses and cost of living adjustments for FDA employees to support the agency's highly trained and specialized public health workforce. These investments will accelerate the availability of new and innovative medical products and help ensure the safety of the food supply.

"As the FDA enters its second century of service, our focus will continue on critical public health initiatives, including ensuring the safety of the food we eat and the safety and effectiveness of the medicines we take," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The President's budget provides FDA with a sound approach for meeting its public health mandate and priorities for the American people."

The following are FDA's key proposed budget increases:

For more information on the President's FY 2008 budget for FDA, visit: http://www.fda.gov/oc/oms/ofm/budget/documentation.htm.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today cleared for marketing a test that determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer. It is the first cleared moleculartest that profiles genetic activity.

The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient's body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.

The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients' odds of the cancer spreading.

MammaPrint was developed by Agendia, a laboratory located in Amsterdam, Netherlands, where the product has been on the market since 2005.

"Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "MammaPrint results will provide patients and physicians with more information about the prospects for the outcome of the disease. This information will support treatment decisions.

Agendia compared the genetic profiles of a large number of women suffering from breast cancer and identified a set of 70 genes whose activity confers information about the likelihood of tumor recurrence. The MammaPrint test measures the level of activity of each of these genes in a sample of a woman's surgically removed breast cancer tumor, then uses a specific formula, known as an algorithm, to produce a score that determines whether the patient is deemed low risk or high risk for spread of the cancer to another site. The result may help a doctor in planning appropriate follow-up for a patient when used with other clinical information and laboratory tests.

The MammaPrint is the first cleared in vitro diagnostic multivariate index assay (IVDMIA) device. Several months ago, FDA issued a draft guidance document concerning the need for these complex molecular tests to meet pre-market review and post-market device requirements even when the tests are developed and used by a single laboratory. Although FDA regulates diagnostic tests sold to laboratories, hospitals and physicians, it uses discretion when regulating tests developed and performed by single laboratories.

On February 8, FDA will hold a public meeting to discuss its draft guidance document describing its regulatory approach to this type of test.

"There have been rapid advances in microarrays and other pioneering diagnostics, and a corresponding increase in the use and impact of these complex tests. This has prompted FDA to take a closer look at the potential risks as well as the benefits associated with such tests when they are developed and used in laboratories," remarked Steven Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation. "This test clearance takes into account the development of these innovative technologies and ensures public health by carefully evaluating their performance."

Prior to clearance, FDA requested evidence that the MammaPrint had been properly validated for its intended use. Agendia submitted data from a study using tumor samples and clinical data from 302 patients at five European centers. These studies confirmed that the test was useful in predicting time to distant metastasis in women who are under age 61 and in the two earliest stages of the disease (Stage I and Stage II) and who have tumor size equal to or less than five centimeters and no evidence that the cancer has spread to nearby lymph nodes (lymph node negative). FDA plans to publish a special controls guidance document within the next 60 days describing types of data that shouldsupport claims for genetic profiling for breast cancer prognosis.

According to the American Cancer Society, an estimated 178,480 new cases of invasive breast cancer will be diagnosed among women in the United States this year and over 40,000 women are expected to die from the disease.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults.  Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version.  OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli and is indicated for use in adults ages 18 years and older along with a reduced-calorie,low-fat diet, and exercise program. 

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, Deputy Director for FDA's Center for Drug Evaluation and Research.  "OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

OTC orlistat is not for people who have problems absorbing food or for those who are not overweight. Orlistat helps produce weight loss by decreasing the intestinal absorption of fat.  The 60 mg capsule can be taken up to three times a day with each fat-containing meal.  Because of the possible loss of certain nutrients, it is recommended that people using orlistat should also take a multivitamin at bedtime. 

The most common side effect of the product is a change in bowel habits, which may include loose stools.  Eating a low fat diet will reduce the likelihood of this side effect.  Also, people who have had an organ transplant should not take OTC orlistat because of possible drug interactions.  In addition, anyone taking blood thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat. 

FDA approved OTC orlistat based on the review of the sponsor's safety data and after submitting the product for the consideration by an FDA advisorycommittee in January 2006. The committee voted in favor of OTC approval. 

Custom Ultrasonics Signs Consent Decree

The Food and Drug Administration (FDA) announces that Custom Ultrasonics, Inc., (CUI) has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures. The consent decree was signed by Judge Timothy J. Savage and entered on January 25, 2007 in the U.S. District Court for the Eastern District of Pennsylvania.

The company's actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections. The FDA is not aware of any adverse events. An endoscope, which is a tube inserted into the body, enables doctors to visualize internal organs. Endoscopes are used in many areas of the body, including the digestive tract, the respiratory tract and the urinary tract.

FDA advises health care providers using these products to discontinue using them if another option is available and to contact the firm for more information. Other options include using an alternative device or following appropriate protocols to manually wash and disinfect the device. If no alternative is available then health care providers should carefully weigh the risks and benefits of using these products.

In addition to Custom Ultrasonics, Inc., the complaint names as defendant, Frank J. Weber, President and Chief Executive Officer of Custom Ultrasonics, Inc.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today cleared for U.S. marketing a vascular shunt, a medical device that can help save the arms and legs of soldiers critically injured in combat as well as individuals in other trauma settings and emergency situations. The Temporary Limb Salvage Shunt (TLSS), made by Vascutek Ltd. (Renfrew, Scotland), was reviewed by FDA in lessthan one week because of the critical need for such a device.

"This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. "This device has been used successfully by other countries, and is particularly important to serve our men and women in the Armed Forces who are seriously injured in combat."

The device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb. It can be implanted on the battlefield and other remote areas to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb until the patient can be transported to a surgical facility.

The TLSS is a tube formed from two layers of plastic. The device has several features that optimize its use in a trauma situation, including a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; beveled ends that facilitate quick and effective placement of the device within the severed blood vessel; graduated markings that provide visual confirmation of proper device placement; and extra reinforcement in the center of the device so it can be cut to a shorter length if needed.

To facilitate this accelerated review process, the device manufacturer worked in close collaboration with FDA's Division of Cardiovascular Devices after discussion of the need for the device with the U.S. Air Force. There are currently no other devices specifically available for treating injuries of this nature.

Cardinal Health 303, Inc. Signs Consent Decree with FDA, Agrees to Correct Manufacturing Deficiencies

The U.S. Food & Drug Administration (FDA) today announced that Cardinal Health 303 Inc. (Cardinal 303), formerly known as Alaris Medical Systems, Inc., and three of its top executives, have signed a consent decree for condemnation and permanent injunction related to their Signature Edition (SE) infusion pumps. The infusion pumps have a design defect referred to as "key bounce" which may cause the pump to recognize a single key stroke as a double key stroke. The "key bounce" problem poses a risk to public health due to a potential over-infusionof medications.

Cardinal 303 has agreed to stop manufacturing and distributing all models of the SE infusion pumps until Cardinal 303 corrects manufacturing deficiencies and until the devices are made in compliance with the current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for medical devices.

Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients.  They are used in situations where medication must be administered intravenously or through other routes, in a continuous or intermittent manner, for a prolonged period of time.

Under the terms of the consent decree, the company has agreed to take necessary measures to ensure compliance with the CGMP requirements and the QS regulation by all of its facilities that design, manufacture, process, pack, label, hold, or distribute SE infusion pumps.  The decree was signed by Dwight Winstead, Cardinal 303's President and Chief Operating Officer, David L. Schlotterbeck, the company's Chairman and Chief Executive Officer, and William H. Murphy, the company’s Senior Vice President of Quality and Regulatory Affairs. The decree also requires the company to retain an independent expert consultant to conduct inspections of its SE infusion pump facilities and certify to FDA that corrections have been made.  FDA will continue to monitor these activities through its own inspections.

Under the consent decree, FDA will allow Cardinal 303 to continue to service and repair SE infusion pumps that were already in the hands of customers before entry of the decree.  The company is also required to submit to FDA an acceptable detailed corrective action plan to bring the SE infusion pumps currently in use in the United States into compliance with the Federal Food, Drug, and Cosmetic Act.

The decree was entered in the United States District Court for the Southern District of California on February 8, 2007.

On August 25, 2006, the U.S. Marshals seized several lots of Cardinal 303's SE Gold infusion pumps located at the company's manufacturing facility in San Diego, California.  The seizure was intended to ensure that the infusion pumps are not distributed unless the problem is corrected.  Cardinal 303 voluntarily suspended production, sales, repair, and installation of SE infusion pumps following the seizure. 

On August 15, 2006, the company also voluntarily initiated a field corrective action for all SE infusion pumps, which consisted of sending letters and warning labels to its customers concerning the "key bounce" problem.  The FDA has classified this action as a Class I recall (a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death).  A copy of the company's letter to customers is available on the company's website at www.cardinalhealth.com/alaris. 

FDA previously issued warning letters to the company,  outlining deviations from the CGMP requirements and QS regulation.  The company was given opportunities to correct the violations, but failed to take appropriate actions. 

After corrective actions under the decree are completed and Cardinal 303 has been allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its SE infusion pump facilities at least once a year for no less than four years.  Results of these audit inspections will be reported directly to FDA.  If Cardinal 303 fails to comply with any provision of the decree, or violates the Act or FDA regulations, FDA may order the firm to again cease manufacturing and distributing, recall the products, or take other action.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis -- from the drug's label. The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild tomoderate severity (acquired outside of hospitals or long-term care facilities).

In addition, the agency has worked with the company, Sanofi Aventis, to update the product labeling with a "boxed warning," FDA's strongest form of warning. The warning states that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.

FDA also worked with the manufacturer to develop a Patient Medication Guide -- that informs patients about the risk of the drug and how to use it safely. The Medication Guide (an FDA-approved patient information sheet) will be provided to patients with each prescription.

"Today's action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research.

Other labeling changes included in today's action are a strengthened warning section regarding specific drug-related adverse events including visual disturbances and loss of consciousness. Warnings for hepatic toxicity (rare but severe symptoms of liver disease) were strengthened in June 2006.

The joint advisory committee, which met on December 14 and 15, 2006, advised that the available data including data acquired since the initial approval of Ketek support a conclusion that the benefits of Ketek outweigh the risks in patients with community acquired pneumonia, but not for patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis. They also recommended a boxed warning as well as Medication Guide for the drug. The joint panel consisted of FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees.

The antibiotic Ketek was originally approved in 2004 and is manufactured by Sanofi Aventis.

For additional information, visit: http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm

FDA Clears First of Its Kind Suture Made Using DNA Technology

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing in the U.S. the TephaFLEX Absorbable Suture—the first absorbable polymer suture made from material isolated from bacteria modified by recombinantDNA technology.

Recombinant DNA technology uses living organisms to create chemicals thatmay be more difficult to produce under standard industrial methods.

"The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. "This approach could have broader applications for medical devices that use this novel manufacturingtechnology."

FDA based its decision on the company's laboratory and animal testing that examined chemical composition, biological safety and mechanical performance of the polymeric suture. The company provided data to show that the suture could be manufactured in a consistent and safe manner.

FDA reviewed safety and effectiveness information for the device under the de novo petition process. De novo petitions were added under the Food and Drug Administration Modernization Act of 1997 to find a way for novel but less risky products to get to market. As a result of its review, FDA determined that products of this type will be regulated as class II (moderate-risk) devices.

The device is contraindicated in patients allergic to the cells or the growth media used to produce the absorbable polymeric material.

Doctors use sutures in patients to hold soft tissue together while the tissue heals from a deep cut or surgical incision. Absorbable sutures are made of materials that break down in the body after a short period of time.

TephaFLEX Absorbable Suture is manufactured by Tepha, Inc., of Cambridge, Mass.

FDA's regulation of all medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II) or high-risk (class III) categories. The FDA regulatory program for medical devices is comprehensive and includes requirements for registration and listing of products, premarket evaluation, high-quality production using good manufacturing practices and post-market reporting of adverse events.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) is warning consumers not to eat certain jars of Peter Pan peanut butter or Great Value peanut butter due to risk of contamination with Salmonella Tennessee (a bacterium that causes foodborne illness).  The affected jars of Peter Pan and Great Value peanut butter have a product code located on the lid of the jar that begins with the number "2111."   Both the Peter Pan and Great Value brands are manufactured in a single facility in Georgia by ConAgra.  Great Value peanut butter made by other manufacturers is not affected.

If consumers have any of this Peter Pan or Great Value brand peanut butter in their home that has been purchased since May 2006, they should discard it.

Symptoms of foodborne illness caused by Salmonella include fever, diarrhea and abdominal cramps.  In persons with poor underlying health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.  Individuals who have recently eaten Peter Pan and Great Value brand peanut butter beginning with product code 2111 and have experienced any of these symptoms should contact their doctor or health care provider immediately.  Any such illnesses should be reported to state or local health authorities.

FDA's warning is based on a just-completed epidemiological study by the Centers for Disease Control and Prevention (CDC), the states and local health agencies, which links 288 cases of foodborne illness in 39 states to consumption of varying types of Peter Pan peanut butter.  This report was provided to FDA on February 13.

The outbreak appears to be ongoing and the first consumer may have become ill in August 2006.  The cause of foodborne illnesses can be difficult to identify.  As a result of extensive epidemiological testing and recent case control studies, CDC was recently able to identify Peter Pan peanut butter as the likely cause of illness.  Great Value brand peanut butter beginning with product code 2111 is manufactured in the same plant as Peter Pan peanut butter and, thus, is believed to be at similar risk of contamination.

ConAgra is recalling all Peter Pan and Great Value peanut butter beginning with product code 2111 that already was distributed.  The company also is destroying all affected products in their possession.  The company will cease production until the exact cause of contamination can be identified and eliminated.  ConAgra will advise consumers to destroy any Peter Pan and Great Value brand peanut butter beginning with product code 2111 in their possession.  To assist in this endeavor, FDA has sent investigators to ConAgra's processing plant in Sylvester, Georgia where the products are made to review records, collect product samples and conduct tests for Salmonella Tennessee.

FDA will provide regular updates as more information becomes available.

Consumers who have questions should contact ConAgra at 866-344-6970. 

Update on Salmonella Outbreak and Peter Pan Peanut Butter and Great Value Peanut Butter

On February 14, 2007, FDA advised consumers not to eat any Peter Pan peanut butter purchased since May 2006 and not to eat Great Value peanut butter with a product code beginning with "2111" purchased since May 2006 because of risk of contamination with Salmonella Tennessee. Salmonella is a bacterium that causes foodborne illness, and “Tennessee” is a type of Salmonella. All Peter Pan peanut butter purchased since May 2006 is affected; only those jars of Great Value peanut butter purchased since May 2006 with a product code beginning with "2111” are affected. Although Great Value peanut butter with the specified product code has not been linked by CDC to the cases of Salmonella Tennessee infection, the product is manufactured in the same plant as Peter Pan peanut butter and, thus, is believed to be at similar risk of contamination. Great Value peanut butter made by manufacturers other than ConAgra is not affected.

Number of Cases and State Locations:

The Centers for Disease Control and Prevention (CDC) has identified 290 people from 39 states who have gotten sick from Salmonella Tennessee, the Salmonella type associated with this outbreak. Forty six (46) patients are known to have been hospitalized and there have been no reported deaths.

The 39 states with reported illness are: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia.

Advice to Consumers:

FDA continues to advise consumers not to eat any Peter Pan peanut butter purchased since May 2006. FDA also continues to advise consumers not to eat any Great Value peanut butter purchased since May 2006 with product codes beginning with the numbers “2111” on the jar lid. All such products should be thrown out. If consumers cannot find a number on the jar lid or are unsure, the safest thing to do is to discard the product.

Individuals who have recently eaten the affected Peter Pan and Great Value peanut butter and who have experienced any symptoms of Salmonella infection should contact their health care provider immediately. Symptoms include fever, diarrhea and abdominal cramps.  For persons in poor health or with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

Anyone who has a jar of the affected peanut butter and who has become ill also should report that they have a jar to state or local health authorities. Individuals who have eaten the affected peanut butter within the last week and who do not feel sick most likely will not get sick. However, persons who begin to have any of the symptoms outlined above should see a health care professional.  

FDA Actions To-Date:

On February 13, 2007, FDA was notified by CDC and state health departments of data showing an outbreak of Salmonella Tennessee infection in people who reported having eaten certain jars of Peter Pan peanut butter. Since that time, FDA has been conducting an active investigation of Peter Pan and Great Value peanut butter made by ConAgra in the same facility.

On February 13, FDA contacted ConAgra officials. On February 14, ConAgra agreed to initiate a product recall.

On February 14, FDA took the following actions:

Next Steps:

Recall Status and For More Information:

ConAgra is recalling all Peter Pan peanut butter and all Great Value peanut butter beginning with product code 2111 that already was distributed. The company also is destroying all affected products in its possession. The company has stopped production and is working to identify the cause of the contamination. ConAgra has advised consumers to destroy all Peter Pan peanut butter and any Great Value peanut butter beginning with product code 2111.

For more information see: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01563.html (press releases) and http://www.cfsan.fda.gov/~dms/pnutbuqa.html (questions and answers).

FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet

The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminaryanalysis, contains haloperidol, a powerful anti-psychotic drug.

Reports show several consumers in the United States have sought emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product. Haloperidol can cause muscle stiffness and spasms, agitation, and sedation.

Therefore, the agency is reissuing its warning to consumers about the possible dangers of buying prescription drugs online. FDA urges consumers to review the FDA Web site for information before buying medication over the Internet.

FDA laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia. FDA learned about these mislabeled and potentially dangerous products after their recipients complained to a U.S. pharmaceutical manufacturer.

The origin of these tablets is unknown but the packages were postmarked in Greece. Photographs of the tablets in question and the shipping packages can be seen at http://www.fda.gov/bbs/topics/news/photos/haloperidol.html. If the tablets received from an Internet seller resemble those in the photos and haloperidol was not specifically ordered, do not take these tablets. Instead, consumers should notify their health care provider and report the suspected products to FDA by submitting a product quality problem report at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate informationwhen it is available.

Taking medication that contains an active ingredient other than what was prescribed by a qualified health care professional is generally unsafe. FDA continuouslywarns U.S. consumers of the possible dangers of buying prescription drugs onlineand urges them to review the FDA Web site for additional information prior tomaking purchases of medication over the Internet (http://www.fda.gov/buyonline/).

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated withthe medicines, and to advise them of precautions that can be taken.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., MPH, Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

The draft Patient Medication Guides for each product can be found at http://www.fda.gov/cder/drug/infopage/ADHD/default.htm.For more information please visit www.fda.gov.

FDA Proposes to Strengthen Label Warning for Xolair

Today the Food and Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab, marketed as Xolair. The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a Medication Guide for patientsto strengthen the existing warning for anaphylaxis.

Xolair was approved in 2003 to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen (pollen, grass or dust) and whose symptoms are inadequately controlled with inhaled steroids. In clinical trials, Xolair decreased the rate of asthma exacerbations, which were defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of baseline inhaled corticosteroid dose.

Anaphylaxis was reported following administration of Xolair in clinical trials and was therefore, discussed in the initial product labeling. The cases were reported at a frequency of approximately one in a thousand patients (0.1%). Due to the nature of continued reports in the post-marketing experience, including their life-threatening potential, frequency, and the possibility for the delayed onset of anaphylaxis, FDA has now requested that Genentech, Inc., add the boxed warning and strengthen the existing warning. As the agency gains experience and collects data about a marketed product the determination may be made to strengthen the product label to ensure that consumers are aware of newly identified significant risks.

The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given. Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection. Following administration of Xolair, patients should also carry and know how to initiate emergency self-treatment for anaphylaxis.

For further information and a copy of the health care professional sheet, go to http://www.fda.gov/cder/drug/infopage/omalizumab/default.htm.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn's disease, a chronicinflammatory disease of the intestines, which affects an estimated one millionAmericans. Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced inlarge quantities in a manufacturing plant). The product acts to reduceexcessive levels of human tumor necrosis factor (TNF) alpha, which plays an importantrole in abnormal inflammatory and immune responses. The labeling includesa boxed warning about potential serious adverse events.

Crohn's disease is a chronic, incurable, inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and in some cases, abnormal connections (fistulas) leading from the intestine to the skin.

"Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade (infliximab) therapy," said Dr. Douglas Throckmorton, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval provides patients and their health care providers with a new treatmentoption.

The product has been studied in 1,478 patients with Crohn's disease in four clinical trials comparing the drug to a placebo (contains no active ingredient) and two longer term extension studies.

The labeling of Humira includes a boxed warning, the strongest type of label warning, that use of this product has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis. Before initiating Humira treatment, patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection. Other serious adverse events reported by Humira users include lymphoma, a type of cancer. The most frequent adverse events included upper respiratory infections, sinusitis, and nausea.

Humira requires subcutaneous injections (under the skin) to initiate treatment for Crohn's disease, and maintenance treatment is administered as one injection every other week.

Humira was previously approved for the treatment of three autoimmune diseases: rheumatoid arthritis, a chronic inflammation of the joints; psoriatic arthritis, which causes joint swelling and scaly skin; and ankylosing spondylitis, a systemic rheumatic disease that affects the spine and sacroiliac joints. Humira is manufactured by Abbott Laboratories, Abbott Park, Ill.

FDA Clears Baxter's Modified Infusion Pump

The U.S. Food and Drug Administration (FDA) has cleared for marketing a modified Colleague Volumetric Infusion Pump which addresses many of the problems thatprompted a series of Class I recalls and a product seizure in 2005.

Confusing display screens, software defects, swollen batteries and other defects could have resulted in the pumps either shutting down or under- or over-delivering critical medication and fluids to patients and were associated with serious injuries and deaths.

In June 2006, the manufacturer, Baxter Healthcare Corporation signed a consent decree with FDA detailing the steps that must be taken before the Colleague pump would meet appropriate regulatory requirements and could be sold again. The agreement resolved a court action by FDA that began with the October 2005 product seizure.

"The clearance of the Colleague pump is an example of FDA's efforts to protect the public throughout a product's life cycle," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "FDA works with companies to ensure products are safe and effective at every step of the process whether it be pre-market development, product evaluation or after the device is actually on the market."

The Colleague device was one of the most commonly used volumetric pumps in the U.S. when FDA asked U.S. marshals to seize all pumps stored in Baxter Healthcare's northern Illinois warehouses in October 2005. However, hospitals and clinics were allowed to continue to use pumps already in their possession, guided by instructions provided by Baxter Healthcare.

Baxter Healthcare's pre-market submission for the modified pump included:

FDA will continue working with Baxter Healthcare to ensure that infusion pumps are safe and effective for their intended use. FDA is committed to assuring that the company fully addresses the issues identified in the consent decree. Pumps seized by the government are not in distribution at this time. Baxter Healthcare is located in Deerfield, Ill.

Holmes By-Products, Inc. Enters Consent Decree with FDA

The U.S. Food & Drug Administration (FDA) today announced that Holmes By-Products, Inc., Millersburg, Ohio, a renderer of bovine and poultry materials, and two of its officers, have entered a consent decree of permanent injunction due to significant violations of FDA's Ruminant Feed Ban (21 C.F.R. § 589.2000), discovered after consecutive inspections. The ruminant feed ban is an important safeguard against the establishment and proliferation of bovine spongiformencephalopathy (BSE), otherwise known as mad cow disease, in the United States.

The defendants have agreed to come into compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations through a combination of one or more of the following, as required by FDA's Ruminant Feed Ban:

  1. labeling products with the statement "Do not feed to cattle or other ruminants"
  2. maintaining separate lines of equipment for producing various products; and/or
  3. sufficiently cleaning existing equipment between uses.

Further, the consent decree provides for FDA to require a recall or shutdown in the event of future violations.

The consent decree was entered by Judge James S. Gwin in the U.S. District Court for the Northern District of Ohio on February 26, 2007.

To prevent the outbreak and spread of BSE, FDA published a regulation in 1997 prohibiting the use of most mammalian protein in the manufacture of animal feeds given to ruminant animals, including cattle, sheep, goats, deer and elk. Holmes By-Products, Inc. used common equipment to manufacture mammalian meat and bone meal and poultry by-product meal products without using a clean-out process adequate to avoid and prevent co-mingling and cross-contamination. Although these are significant violations of the feed ban regulations, no evidence was found indicating that this poultry by-product meal had actually been fed to cattle or other ruminants.

FDA reminds those businesses and individuals involved in the production, distribution and use of animal feeds and feed ingredients that if they are producing or using feed products for ruminants, and feed for other species that contains prohibited mammalian proteins, they must provide for adequate measures to avoid co-mingling or cross-contamination of these two types of products. Further, feed products that contain or may contain mammalian proteins prohibited from use in ruminant feed must be labeled with the caution statement "Do not feed to cattle or other ruminants."

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) today announced the approval of two formulations of Cerenia (maropitant citrate), a new class of drug that is effective against certain causes of vomiting in dogs.  Cerenia Tablets are indicated for the prevention of acute vomiting and vomiting due to motion sickness, and Cerenia Injectable Solution is approved for the prevention and treatment ofacute vomiting. 

Cerenia is the first product approved for: the prevention of vomiting due to motion sickness and the prevention and treatment of acute vomiting in dogs.  Both products are available only by order of a veterinarian.

Motion sickness affects many dogs, who can become ill as early as five minutes after the start of a trip.  In addition, dogs undergoing chemotherapy or suffering from a parvoviral infection, kidney disease, pancreatitis, or other disease, can suffer from acute vomiting that can cause electrolyte abnormalities, weakness, dehydration, and possibly death.  Dogs frequently must be hospitalized and treated with intravenous (IV) fluids to address problems from severe vomiting.

"This approval is good news for many dog owners whose dogs suffer from motion sickness and for whom even a small journey can trigger vomiting," said Stephen Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "But it is even more important for cases in which vomiting -- whatever its cause -- can be a serious health hazard."

In one of the studies supporting the approval of Cerenia, the drug was tested on dogs with cancer undergoing chemotherapeutic treatment with cisplatin, an agent that induces strong vomiting. In these trials, Cerenia was 95 percent effective in preventing vomiting from cisplatin.

Cerenia is manufactured by Pfizer, Inc. New York, N.Y.



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Saturday July 19, 2008