FDA Alert News January 2007

FDA Alert News January 2007 - Food and drug administration January 2007 press release and news alerts

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FDA Alert News January 2007
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Food and Drug Administration

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three documents on the safety of animal cloning -- a draft risk assessment; a proposed riskmanagement plan; and a draft guidance for industry.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 Due to limited data on sheep clones, in the draft guidance FDA recommends that sheep clones not be used for human food.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.

FDA Approves Novel Device That Prevents or Reduces Brain Damage in Infants

The Food and Drug Administration (FDA) today approved a first-of-a-kind medical device for the treatment of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE), a potentially fatal injury to the brain caused by low levels of oxygen.  The Olympic Cool-Cap system is designed to prevent or reduce damage to the brains of these patients by keeping the head cool while the body is maintained at a slightly below-normal temperature.  The Cool-Cap is manufactured by OlympicMedical Corporation, a subsidiary of Natus Medical Incorporated of San Carlos, Calif.

“This approval brings new hope to parents of the approximately 5,000-9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy,” said Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health.  “Until now, there has been no effective treatment for these infants other than supportive care.  Up to 20 percent of them died, and 25 percent suffered permanent disability because of neurological deficits.”

The Olympic Cool-Cap treats the patient by maintaining a steady flow of water at a selected cool temperature through a cap covering the infant’s head. The system, which consists of a cooling unit, a control unit, temperature probes and a water-filled cap, was found safe and effective in a study with 234 infants with moderate to severe HIE.  At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group compared with the control group.

As conditions of the approval, Olympic Medical Corporation will set up a patient registry to collect information on device usage and to track treatment outcomes; organize a training and certification process for all operators of the device; and restrict use of the device to patients who meet the eligibility criteria defined by the original study.

FDA Approves Treatment for Children and Teens With Mildly to Moderately Active Ulcerative Colitis

The Food and Drug Administration (FDA) today approved Colazal (balsalazide disodium) for the treatment of mildly to moderately active ulcerative colitis in patients 5 to 17 years of age. The condition is a type of inflammatory bowel disease which causes inflammation of the colon and rectum and affects about 5 per 100,000 pediatric patients in the United States each year. Pediatric use of Colazal was granted orphan drug status under FDA's Orphan Drug program, which provides financial incentives for firms that develop therapiesfor diseases affecting fewer than 200,000 patients a year.

"Ulcerative colitis is a debilitating and frequently painful disease for which there has been no satisfactory pediatric treatment," said Dr. Douglas C. Throckmorton, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval is another example of the great benefits that the Orphan Drug program provides for patient populations that are too small to justify the large investment in new drug development."

Colazal had been previously approved for use in adult patients with mildly to moderately active ulcerative colitis. The drug's safety and effectiveness in children 5 to 17 years of age with mildly to moderately active ulcerative colitis was demonstrated in a multicenter study in 68 patients who were randomized to receive either 6.75 grams or 2.25 grams of Colazal per day for a total of 8 weeks of treatment. In this study, 45% of the children on the higher dose and 37% on the lower dose showed clinical improvement in rectal bleeding and the appearance of the gastrointestinal mucosa.

The most common adverse events associated with the use of Colazal were headache, and symptoms referrable to the gastrointestinal tract, such as abdominal pain, vomiting and diarrhea. The overall rate of drug-related adverse events was higher in the low-dose group as compared to the high-dose group. This may have been due to the lower efficacy seen in the low-dose group.

Colazal is manufactured by Salix Pharmaceuticals, Inc., Morrisville, NC.

FDA Reminds Consumers to Practice Egg Safety this Holiday Season

The U. S. Food and Drug Administration (FDA) reminds consumers to pay special attention to the handling of eggs and preparation of foods that contain eggs during this holiday season. Some holiday favorites, such as cookie dough, homemade eggnog, and some types of stuffing, may contain eggs that are raw or undercooked. Eggs sometimes contain a bacteria called Salmonella enteriditis (SE), which can cause illness if eggs are not handled and cooked properly. An FDA national survey of consumer food safety practices, the 2006 FDA/FSIS Food Safety Survey, found that cookie dough is one of the major sources of raw egg in the American diet, and that only three percent of respondents always use a food thermometer when they cook baked egg dishes such as stuffing.

To avoid egg-related illness from holiday foods:

An estimated 118,000 illnesses per year are caused by consumption of eggs contaminated with SE. To help consumers avoid these illnesses, FDA requires the following statement on packages of fresh eggs that have not been treated to destroy Salmonella:

Safe Handling Instructions: To prevent illness from bacteria, keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.

Following these instructions is important for everyone, but especially for those most vulnerable to foodborne illness—young children; the elderly; persons with weakened immune systems due to conditions such as AIDS, cancer or diabetes, or treatments such as chemotherapy for cancer; persons with weakened immune systems due to steroid use; and persons with immune suppression after organ transplantation.

Find more information about holiday food safety at www.cfsan.fda.gov or call 1-888-SAFEFOOD.

FDA Approves New Drug for Schizophrenia

The Food and Drug Administration (FDA) today approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia. Paliperidone is a new molecular entity, which means this medication contains an active substance that has never before been approved for marketing in any form in the United States. Paliperidone is the principal active metabolite of risperidone,a marketed drug for treating schizophrenia.

"Schizophrenia can be a devastating illness requiring lifelong medication and professional counseling," said Douglas Throckmorton, MD, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval adds to the treatment options for patients with this condition."

Schizophrenia is a chronic, disabling mental disorder that affects more than two million Americans. Symptoms include hallucinations, delusions, disordered thinking, movement disorders, social withdrawal and cognitive deficits (e.g., difficulty with perception, memory or abstract thinking that interferes with one's ability to learn; impaired judgment, inattentiveness, impulsiveness or impairment of speech and language).

The effectiveness of Invega in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled trials conducted in North America, Europe and Asia. The 1665 participating adults were evaluated for the full array of signs and symptoms of schizophrenia. In the three studies using doses ranging from three milligrams (mg) to 15 mg a day, the effectiveness of Invega at relieving symptoms of schizophrenia was superior to the placebo treatment. The recommended dose range for Invega is three mg to 12 mg a day.

Among the commonly reported adverse events were restlessness, extrapyramidal symptoms (movement disorders), rapid heart beat and sleepiness. Invega is a member of a class of drugs called atypical antipsychotics that have an increased rate of death compared with placebo in elderly patients with dementia-related psychosis. Invega is not approved for dementia-related psychosis.

The effectiveness of Invega has not been evaluated in placebo-controlled trials for longer than six weeks, and patients who use the drug for extended periods should be periodically reevaluated by a physician.

Invega is manufactured by ALZA Corp. in Mountain View, CA. for Janssen, L.P. in Titusville, NJ.

FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers

The Food and Drug Administration (FDA) today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches, and muscleaches.

To help ensure safe use of OTC products, and to provide consumers with the labeling necessary for them to make more informed medical decisions, FDA is proposing the following label changes:

For Products Containing Acetaminophen

For Products Containing NSAIDs

The new labeling would be required for all OTC drug products that contain only an IAAA ingredient, as well as for products that contain an IAAA ingredient with other ingredients, such as cold symptom relievers. Consumers may also be taking IAAA ingredients in their prescription medications, which makes it important to alert them of the contents of their OTC medications, so they do not take too much of an IAAA ingredient.

FDA based its proposal for labeling changes on previous Advisory Committee discussions, recommendations, and public comments (see http://www.fda.gov/ohrms/dockets/ac/cder02.htm#NonprescriptionDrugs) and a review of the scientific literature.

A number of manufacturers of OTC internal analgesic drug products already have voluntarily implemented labeling changes to identify these potential safetyconcerns.

Comments on the current proposal, to be published in the December 26, 2006 Federal Register may be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to: (http://www.fda.gov/ohrms/dockets/default.htm ).

FDA Warns of Safety Concern Regarding Rituxan in New Patient Population

The Food and Drug Administration (FDA) is alerting health care professionals and patients treated with Rituxan (rituximab) to reports of an emerging risk of a serious side effect in patients receiving or who have used Rituxan. FDA recently learned that two patients who were treated with Rituxan for systemic lupus erythematosus (SLE) developed progressive multifocal leukoencephalopathy (PML), a fatal viral infection of the central nervous system. This side effect has been reported in patients as late as 12 months after their lastdose of Rituxan.

SLE is not an approved indication for Rituxan. Rituxan is approved only for the treatment of patients with non-Hodgkin's lymphoma and patients with rheumatoid arthritis whose disease no longer responds to other common treatments.

"Rituxan is used in both approved and off-label settings, and therefore it is very important for prescribers as well as patients to be aware of these new reports of the risk of PML," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research. "Patients who are being treated or have been treated with Rituxan who experience any major changes in vision, balance, or coordination, or who experience confusion, should promptly call their doctor."

Rituxan, which has been marketed since 1997, acts on the body's immune system by decreasing certain types of white blood cells. This makes the drug effective in treating lymphoma and rheumatoid arthritis, but it also increases the body's susceptibility to infection. The Rituxan label was updated in February 2006 to include postmarketing reports of cases of serious viral illnesses, including PML, in patients with lymphoma who received Rituxan. There have been 23 confirmed cases of PML in patients with lymphoid malignancies either during or after completion of treatment with Rituxan. The majority of these patients also had received other drugs known to affect the immune system.

Additionally, cases of PML have occurred in patients who have not received Rituxan. Most reports have been in patients with a compromised immune system, either due to medical conditions (lymphoma or blood cancers, HIV infection and congenital immunodeficiency syndromes) or medical treatments (cancer chemotherapy and immunosuppressive medications in organ transplant recipients). There also have been literature reports of PML in patients with SLE who did not receive Rituxan, but had received other immunosuppressive drugs. Currently FDA is working with Genentech, the drug's sponsor, to add this recent information on PML to the drug label.

Health care professionals should report any serious adverse events possibly associated with the use of Rituxan to FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Rituxan is manufactured by Genentech, Inc. of South San Francisco, Calif.

FDA Approves Drug to Treat Cyanide Poisoning

The Food and Drug Administration (FDA) today approved Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning.  The approval, which is based on evidence of the drug's effectiveness when tested in animals, improves the nation's ability to respond to emergencies, including a potential attack by terrorists.

"Cyanide is a potent poison and one of the substances that could be used in a chemical attack," said Steven Galson, M.D., MPH, Director of FDA's Center for Drug Evaluation andResearch.  "Today's approval is yet another measure to counter thethreat of terrorism, which is a critical component of FDA's public health mission."

Cyanokit received a priority review and was approved under the Animal Efficacy Rule, which  allows use of animal data for evidence of a drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans. 

In a controlled study in cyanide-poisoned adult dogs, the use of Cyanokit reduced whole blood cyanide concentration by approximately 55% by the end of the infusion, and significantly improved survival of the Cyanokit-treated dogs compared with dogs receiving placebo.

The safety, metabolism and excretion of Cyanokit were evaluated in 136 healthy adult humans.  At the proposed starting dose of 5 grams, the drug was found to be generally well tolerated with side effects that were mild to moderate.  The drug exits the body unchanged in the urine.  In the presence of cyanide, Cyanokit's active drug takes up the cyanide and becomes a form of vitamin B12.

The most frequently reported adverse reactions in the trial were red urine, skin redness (both from the drug's coloration itself), a temporary increase in blood pressure, headache, nausea and injection site reactions.  Allergic reactions were observed in a small number of individuals but were relatively mild and responded quickly to treatment.

Cyanokit is manufactured for EMD Pharmaceuticals, Inc by Merck Sante s.a.s. in Semoy, France and packaged by Dey Laboratories of Napa, California.

More information about FDA's efforts to counteract bioterrorism is available on FDA's website at http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html.

Celebrex Approved to Treat Juvenile Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) today approved Celebrex (celecoxib) for a new use – the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older. Today's approval follows the November 29 meeting of FDA's Arthritis Advisory Committee, in which the committee voted 15 to 1 in favor of approval of this product.

JRA is an autoimmune disease that affects approximately 30,000 to 60,000 children in the United States. The disease is associated with joint swelling, pain, decreased range of motion and abnormalities of growth and development. In some cases, systemic complications may occur including uveitis, a chronic inflammation of the eye. In severe, uncontrolled cases, permanent disability may occur due to progressive joint damage.

“JRA is often a devastating disease,” said Steven Galson, M.D.,MPH, Director of FDA’s Center for Drug Evaluation and Research. “Whilethere are other medicines approved for the treatment of this disorder, for somechildren they may have limited effectiveness or cause intolerable side effects.Celebrex will be a needed additional treatment option for children.”

A 24-week study of Celebrex involving 242 patients between the ages of two and 17 years demonstrated its effectiveness in treating JRA. The most commonly reported side effects were cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea and vomiting.

Celebrex has not been studied in patients under the age of two years, in patients who weigh less than 22 pounds, or in patients showing signs of having “systemic onset JRA”, a more serious type of JRA associated with high fever and rash. Celebrex should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions, including abnormal clotting tests, which can be associated with the clinical condition known as disseminated intravascular coagulation (DIC). DIC is a serious condition in which the body's blood clotting mechanisms are activated throughout the body instead of being localized to an area of injury.

Safety and efficacy were not studied beyond six months, and experience with adults suggests the possibility of longer term cardiovascular problems. As part of the approval of Celebrex, the drug's manufacturer has agreed to conduct two Phase 4 postmarketing studies: a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.

Celebrex, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), was originally approved in l998 for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis in adults. Celebrex is manufactured by Pfizer Inc. of New York, NY.

For more information on Celebrex and COX-2 drugs, please see http://www.fda.gov/cder/drug/infopage/COX2/default.htm

FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations

The U.S. Food and Drug Administration (FDA) today approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations.  Trasylol is given to patients before heart surgery to reduce bleeding and the need for blood transfusions.  Trasylol is marketed by Bayer Pharmaceuticals Corporation, Leverkusen, Germany.

"The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label," said Steven Galson, M.D., MPH, Director of FDA's Center for Drug Evaluation andResearch.

The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery (a procedure used to improve blood flow to the heart) when patients undergo cardiopulmonary bypass (a procedure that allows a machine to take over the heart's functions when it is stopped during surgery).  The changes also include a warning that Trasylol increases the possible risk for kidney damage, and suggest ways to manage and reduce the patient's risk for hypersensitivity (exaggerated immune) reactions.

The labeling changes follow an FDA-conducted review of safety information that FDA became aware of after the product was introduced to the market.  FDA began this safety review of Trasylol in January 2006.  The review was triggered by the results of two published research studies.  One study reported an increase in the possibility of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other drugs.  The other study reported an increase in the possibility of kidney damage compared to other drugs, but did not show an increased risk of heart attack or stroke.  On February 8, 2006, FDA issued a Public Health Advisory regarding these new findings with Trasylol.  On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol.  At that meeting, the committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes.  The labeling changes for Trasylol are based upon the recommendations of that advisory committee.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006.  The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.  The FDA review of this additional Trasylol safety information is continuing and it may result in other actions, including additional changes to the labeling.  For additional information about Trasylol, see www.fda.gov/cder/drug/infopage/aprotinin/default.htm.

FDA Updates its Nationwide Alert on Counterfeit One Touch Blood Glucose Test Strips

The U.S. Food and Drug Administration (FDA) is providing an update to its notifications on October 13, and October 23, 2006, alerting the public to counterfeit blood glucose test strips being sold in the US for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today’s update includes an additional lot number that is being distributed, along with a description of how to identify the new lot.

FDA has classified the current situation as a Class I recall because some of the counterfeit products have significant deviations in performance. The counterfeit test strips potentially could give incorrect blood glucose values-- either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.

The products of concern are counterfeit – they are not marketed or distributed by Lifescan, and Lifescan is not responsible for conducting the recall. Rather, firms that are distributing the counterfeit product are responsible for conducting the recall using corrective actions developed by Lifescan, with input from FDA. FDA continues to work with Lifescan and the distributors to ensure that counterfeit products are removed from the market.

The counterfeit test strips are:

LifeScan, Inc. alerted FDA of the new lot of counterfeit test strips. The FDA continues to investigate the matter, including whether there have been any adverse events associated with this counterfeit product.

Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact LifeScan, Inc. at 1-866-621-4855. Consumers who have discarded the outer box or do not know the lot number of their test strips should stop using those test strips and replace them.

The counterfeit test strips were distributed to pharmacies and stores nationwide by various distributors.

How to Identify

For complete information on how to identify the counterfeit test strips, please check LifeScan’s web site at www.lifescan.com/company/about/press/counterfeit/.

The following characteristics may help to identify the counterfeit test strips:

Counterfeit One Touch Basic/Profile Test Strips, lot numbers 272894A, 2619932, and 2606340

Counterfeit One Touch Basic/Profile Test Strips, lot numbers 2615211 and (227078A (new lot))

Counterfeit One Touch Ultra Test Strips, lot numbers 2691191 and 2691261

On October 13, 2006 (later updated October 26, 2006), LifeScan alerted the public via a press release and notified pharmacists, distributors, and wholesalers through a letter. The firm advised customers to contact their original source of supply for restitution. For more information, visit www.Lifescan.org.

On October 13, 2006 (later updated October 23, 2006), FDA alerted its Counterfeit Alert Network partners, a coalition of healthcare professional, consumer and trade associations, who have agreed to further disseminate this important information in a timely and effective manner. For more information about this and other counterfeit products, visit www.fda.gov/counterfeit/.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Food and Drug Administration

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 .

Food and Drug Administration

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.

Food and Drug Administration

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.

Food and Drug Administration

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

Food and Drug Administration

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.

Food and Drug Administration

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.



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