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The Institute of Medicine (IOM), a leading organization that advises the U.S. government on the most critical issues in medicine and public health, has elected FDA Commissioner Mark B. McClellan, M.D., Ph.D., and Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D., as members of the institute. In the past, FDA scientists have been elected to the prestigious IOM, a component of the National Academy of Sciences, but never both the commissioner and the deputy commissioner.
"I applaud Mark and Les for receiving this honor," says Tommy G. Thompson, Secretary of Health and Human Services. "Every day at the FDA, they show real leadership in developing and implementing creative new ways to better protect and promote the health of Americans. The Institute of Medicine will benefit from their experience and expertise in science and public health."
New IOM members are chosen worldwide on the basis of their distinguished professional achievement in a field related to medicine and health, and on their involvement in health care, disease prevention, education and research. They contribute to IOM's reports and research projects without pay.
"Both Les and I are honored to become IOM members, and we will do our part to support the IOM's unique public health mission," McClellan said of the IOM appointment, announced in October 2003. "And at FDA, we're pleased to be part of an organization that is recognized around the world for using the best and latest science to protect and advance the health of the public."
Following reports of suicidal thoughts and suicide attempts, the FDA issued a public health advisory in October 2003 concerning children with major depressive disorder (MDD) who have taken various antidepressant drugs.
The FDA has completed a preliminary review of reports for eight antidepressant drugs:
Although Luvox was reviewed, the drug is not approved as an antidepressant in the United States.
According to the FDA, the data don't clearly establish an association between the use of these drugs and increased suicidal thoughts or actions in children. But at this point, it is not possible to rule out an increased risk of these adverse events for these drugs. In June 2003, the FDA recommended that Paxil not be used in children and adolescents for the treatment of MDD.
The FDA recognizes that MDD is a serious condition for which there are few treatment options. In addition to using non-medication treatment approaches, doctors must often make choices among drugs that are available for treating adult MDD. Prozac is the only drug labeled for use in pediatric MDD.
The FDA has scheduled a meeting on Feb. 2, 2004, of its Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to discuss data and regulatory actions on this topic.
Antidepressants in adults and children should be used with caution, and antidepressants should not be discontinued before consulting with a physician. The public health advisory can be found at www.fda.gov/cder/drug/advisory/mdd.htm.
The FDA is using a new electronic registration system for food facilities, developing improved tests to detect food contamination, strengthening security at borders, and pursuing an abundance of research projects to bolster the safety and security of America's food supply.
An electronic registration system for food facilities went "live" in October 2003, enabling 400,000 facilities worldwide to register online quickly and easily. The system helps facilities comply with an interim final rule that requires all domestic and foreign food facilities to register with the FDA by Dec. 12, 2003. As a result, the FDA will have, for the first time, an official roster of food facilities that will allow timely notification and response in the event of a food safety threat.
The FDA is also developing more rapid, easier, and less costly tests to detect biological, chemical and radiological threat agents in foods. According to a report to Congress issued by the agency in October 2003, the FDA currently has more than 90 different active research projects involving test and sampling methodology development. This agency-wide effort involves many FDA scientific experts and partners in academia, private industry, other government agencies and trade associations.
Another interim final rule, effective Dec. 12, 2003, requires that the FDA be provided prior notice of shipments of human and animal food being imported or offered for import into the United States. The FDA is working closely with the Bureau of Customs and Border Protection (CBP) to ensure that the new regulations and their enforcement promote a coordinated strategy for border protection. CBP employees are serving on the FDA's behalf at ports where the FDA may not currently have staff and augment FDA staff in the enforcement of the agency's prior notice regulation.
The FDA's report to Congress is available on the Web at www.fda.gov/oc/bioterrorism/bioact.html.
The FDA has approved the first drug for the treatment of people with moderate-to-severe Alzheimer's disease. The new drug, Namenda (memantine), is thought to work by blocking the action of glutamate, a brain chemical that may be overactive in people with Alzheimer's. Other drugs on the market, approved to treat mild-to-moderate Alzheimer's, are believed to work by inhibiting cholinesterase, an enzyme that breaks down acetylcholine, a chemical used by nerves to communicate with each other.
Researchers conducted two studies of 250 and 400 people who took Namenda over a six-month period. A third study of 166 people was conducted for three months. In the largest study, patients took Namenda along with Aricept (donepezil), a drug already approved for the treatment of Alzheimer's disease. In the two other studies, patients were taking Namenda alone. In all three studies, people taking Namenda experienced less deterioration compared with patients treated with an inactive substance (placebo).
Alzheimer's disease, which affects about 4.5 million Americans, is a degenerative condition affecting memory, judgment and the ability to reason. Although Namenda helps treat the symptoms of Alzheimer's disease in some people, there is no evidence that it changes the underlying nature of the disease.
The most frequently reported side effects from Namenda in the studies were dizziness, headache, and constipation. These side effects occurred in fewer than 10 percent of those taking the drug.
Namenda is marketed by Forest Laboratories Inc. of Jersey City, N.J.
Cialis (tadalafil), approved by the FDA in November 2003, is the third oral medication approved to treat impotence in men. Cialis is different than the other approved products in that it stays in the body longer. It relaxes muscles in the penis and increases blood flow into the penis, which produces an erection.
Cialis was evaluated in clinical trials involving more than 4,000 men with impotence. In two of the trials, men had impotence associated with diabetes or following radical prostatectomy for prostate cancer.
Cialis should not be used by those who are being treated with nitrates such as nitroglycerin tablets or patches. The drug also should not be used with most alpha blockers, medicines used to treat benign prostatic hyperplasia and high blood pressure. The combination of Cialis with alpha blockers may significantly lower blood pressure and lead to fainting or even death.
Men who use Cialis should inform their doctors because some drugs affect the metabolism of Cialis. The drug should not be taken by men for whom sexual activity is inadvisable because of an underlying heart condition. Before taking Cialis, men should tell their doctors about any heart problems they have experienced. Use of the drug is not recommended for those who have suffered a heart attack or stroke within the last six months. Cialis also is not recommended for those who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, or an eye condition called retinitis pigmentosa.
The most common side effects for Cialis include headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. A small number of men also reported abnormal vision.
Before taking Cialis, men are advised to undergo a thorough medical history and physical examination to identify appropriate treatment for their impotence.
Cialis is manufactured for Lilly ICOS LLC by Eli Lilly and Company, Indianapolis.
Estrasorb (estradiol topical emulsion) is the latest estrogen therapy product approved by the FDA to treat menopausal hot flashes.
Estrasorb, made by Novavax of Columbia, Md., is absorbed through the skin into the bloodstream after the lotion is applied to the legs, thighs, or calves on a daily basis. Women should not apply sunscreen at the same time as applying Estrasorb because this may affect the amount of estradiol actually absorbed.
In January 2003, the FDA advised women and their doctors that menopausal hormone therapy--estrogen and estrogen with progestins--may be associated with an increased risk of heart disease, heart attacks, strokes, and breast cancer. This was based on the findings of the Women's Health Initiative study conducted by the National Institutes of Health (NIH).
To help women make decisions about whether to take hormone therapy, the FDA and the NIH initiated a nationwide information campaign to raise awareness about the recent findings. As a result, a menopause and hormone therapy fact sheet was developed, as well as a purse guide that women can use to discuss their options with a health professional. These materials can be found on the FDA Web site at www.fda.gov/womens/menopause/.
Based on the latest evidence, the FDA believes that estrogen and estrogen with progestin products, including Estrasorb, provide valuable therapy for many postmenopausal women, particularly those with hot flashes. The agency reminds women, however, that these treatments also have important risks, and that they should be used in the lowest dose and for the shortest time required to provide relief. Label warnings and cautions for Estrasorb are similar to other menopausal hormone therapy products.
Tetrahydrogestrinone (THG), a substance taken by athletes to improve their performance, is considered to be an unapproved drug by the FDA, and cannot be legally marketed.
The FDA is warning consumers that little is known about the safety of this substance, its structure, and relationship to better-known products. The agency says that its use may pose considerable risks to health. The FDA is concerned about the marketing and use of this unapproved product and is working with other federal law enforcement agencies to aggressively "engage, enforce, and prosecute" those firms or people who manufacture, distribute, or market THG.
While in some cases THG is being represented as a dietary supplement, the FDA says that in fact the substance does not meet the definition of a dietary supplement. Rather, it is a purely synthetic "designer" steroid derived by simple chemical modification from another anabolic steroid that is explicitly banned by the United States Anti-Doping Agency, an independent body that monitors and enforces drug use restrictions in athletic competitions. THG is closely and structurally related to two other synthetic anabolic steroids, gestrinone and trenbolone. Anabolic steroids, which build muscle mass, can have serious long-term health consequences in men, women, and children.
THG cannot be legally marketed without FDA approval under the agency's rigorous approval standards, meant to ensure that drugs sold to American consumers are safe and effective.
The FDA has released new guidance that outlines a comprehensive approach to preventing the antimicrobial resistance that may result from the use of antimicrobial drugs in animals.
Antimicrobial drugs, such as antibiotics, are medicines often used to treat bacterial infections in both humans and animals. Their use has been one of the great advances in modern medicine--helping to prevent many of the illnesses that were leading causes of death for most of human history. When bacteria develop resistance, human and animal health is at risk because the medicines that we depend on to treat infections become ineffective.
The guidance provides a risk assessment process for animal drug sponsors to determine the likelihood that an antimicrobial drug used to treat an animal may cause an antimicrobial resistance problem in humans who consume meat or other products from that animal. This process can help prevent antimicrobial drugs with a high risk of causing antimicrobial resistance problems in humans from being improperly used in food-producing animals. Food-producing animals include cows, pigs, chickens, turkeys, sheep, and fish.
If the assessments show that the risks are significant, the FDA could deny the application to market the drug, which would prevent the use of the drug in food-producing animals, or the FDA could approve the drug, but place conditions on its use to ensure it would not pose a human health risk.
For more information, see www.fda.gov/oc/antimicrobial/questions.html.
The FDA says that raw or lightly cooked green onions (scallions) are associated with an outbreak of hepatitis A, a liver disease, in Pennsylvania and three other states. In an attempt to determine the source of the green onions and how they became contaminated, the FDA has been working closely with the CDC and the states so that the problem can be corrected.
Hepatitis A develops within six weeks of an exposure. It is usually mild and characterized by jaundice (yellow skin), fatigue, abdominal pain, loss of appetite, nausea, diarrhea, and fever. Hepatitis A can occasionally be severe, especially in people with liver disease.
The first outbreak of hepatitis A associated with the onions occurred in September 2003 in Tennessee, North Carolina and Georgia restaurants. Another outbreak of hepatitis A among patrons of a single restaurant in Pennsylvania occurred during late October and early November.
The FDA is advising consumers to:
The FDA has alerted inspectors at the Mexican border to detain any raw green onions from a small number of implicated firms. Mexican officials have been very responsive during the outbreak investigation and are investigating practices at these firms to determine what might have caused the contamination.
Regulations being developed under the Bioterrorism Act of 2002 give the agency new authority to help improve its ability to contain and prevent outbreaks of foodborne illness. These new regulations and increased presence at the border will help enhance the agency's food safety and security measures.
President Bush has signed legislation that provides user fees to the FDA for animal drug reviews. Known as the Animal Drug User Fee Act (ADUFA), the law, passed in November 2003, establishes a funding system for the new animal drug review process that is similar to that established for the human drug review process more than a decade ago.
The fees collected for these services will be directed toward the FDA's Center for Veterinary Medicine (CVM) and will be used to provide additional resources for its animal drug review program. The goal is to achieve shorter, more predictable review times by increasing the review staff at CVM and by building better management systems. As a result, the FDA anticipates substantial savings to the industry in regulatory review and developmental expenses without compromising the agency's high standards for safe and effective products.
The FDA is authorized to collect $5 million in fees in fiscal year 2004, which began Oct. 1, 2003; $8 million in fiscal year 2005; and $10 million in fiscal years 2006 through 2008. The law provides for specific waivers or reductions of fees, including for small businesses and where the fees would present a significant barrier to innovation.
"The resources provided by this law will help CVM scientists keep pace with the rapid advances in science and medicine that drive the quality of health care for our animals," says CVM Director Stephen Sundlof, D.V.M., Ph.D. "We view this legislation as a vital component in our commitment to promote and protect public and animal health."
Several test kits to detect peanut proteins in breakfast cereal, cookies, ice cream, and milk chocolate have been designated as "performance tested methods" by the Association of Official Analytical Chemists International (AOAC), working in collaboration with the FDA. The AOAC validates and approves analytical methods used in foods and agriculture. The FDA relies on methods validated by the AOAC in its enforcement programs.
The approved test kits provide quick and reliable methods for the food industry to more readily detect the presence of peanuts in food not labeled as containing peanuts, and can more effectively prevent these products from reaching consumers.
Peanuts can cause severe and, in some cases, fatal allergic reactions in some people.
The approved kits are: Biokits Peanut Assay, developed by Tepnel BioSystems Ltd. of Flintshire, UK; RIDASCREEN FAST Peanut, developed by R-Biopharm AG of Darmstadt, Germany; and Veratox for Peanut Allergen, developed by Neogen Corp. of Lansing, Mich.
The likely users of these kits are organizations that have laboratory facilities, such as research and industrial food operations and regulatory agencies. For example, use of these tests can assist organizations in rapidly determining whether their food processing operations are adequate to prevent the inclusion of peanut products in foods that do not declare peanuts as an ingredient. The tests also can determine whether food processing plant cleanup operations are sufficient to avoid cross-contamination.
The FDA has informed physicians about adverse events associated with the Cordis Corp.'s Cypher Sirolimus-eluting Coronary Stent, a cylindrical metal mesh designed to keep arteries from reclogging after angioplasty procedures. The stent slowly releases the drug sirolimus, which is intended to reduce the rate of re-blockage that occurs with other stents. The FDA approved the Cypher stent in April 2003.
The agency has received more than 360 reports of clotting (thrombosis) occurring after the device was implanted. In more than 70 of these reports, use of the device was associated with death. In the remainder, the device was associated with injury requiring medical or surgical intervention. To date, it appears that the rate of thrombosis is within the expected rate for any stent.
The FDA also has received more than 70 reports--including some deaths--that Cordis considers to be related to hypersensitivity reactions. In most cases, hypersensitivity was minor, but there were some severe reactions. Symptoms in these reports include pain, rash, respiratory changes, hives, itching, fever, and blood pressure changes. Though some of the reported reactions remain unexplained, many are believed to be related to standard drug therapy associated with the procedure.
Hundreds of thousands of patients have been treated successfully with the Cypher stent, and the FDA considers it a safe and effective product when used according to the labeling. The agency will continue to monitor adverse events for the Cypher stent, as it does with all medical devices.
People who have received the Cypher stent should continue to follow their regularly scheduled doctor appointments. People who have experienced an adverse event related to the Cypher stent, and their physicians, are encouraged to report the incident to the FDA. Reports can be made online by following the instructions at www.fda.gov/medwatch/how.htm; by telephone at (800) FDA-1088; by fax at (800) FDA-0178; or by mail at: MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
The information for physicians can be found on the FDA Web site at www.fda.gov/cdrh/safety/cypher.html.
The FDA has undertaken a process to assess the safety of food products derived from cloned animals and the risks to animals involved in cloning.
The process began two years ago, when the FDA commissioned the National Academy of Sciences (NAS) to consider scientific information on animal biotechnology. The NAS concluded that although food from animal clones posed only a low level of food safety concern, it would be prudent to have more data in order to minimize further safety concerns.
The FDA decided that before it could address any policy issues on animal cloning, it needed to conduct a risk assessment, followed by development of risk management options, in an open and transparent process.
Cloning is a process that allows livestock breeders and others to replicate their best animals, which are then used for breeding stock. Cloning can also be used to expand populations of endangered species.
The FDA previewed a risk assessment on animal cloning in November 2003 at a public Veterinary Medicine Advisory Committee meeting held in Rockville, Md.
The draft risk assessment builds on findings of the NAS and indicates that food products derived from animal clones and their offspring are likely to be as safe to eat as food from their non-clone counterparts, based on all the evidence available. These scientific findings also showed that healthy adult clones are virtually indistinguishable from their conventional counterparts.
Pending a final decision on cloned animals, the agency will continue to request that producers withhold from the market animal clones, their progeny, or products derived from them, with the full expectation that firms will comply with this request as they have willingly done in the past.
Following the close of a public comment period on the risk assessment, the FDA will review the comments in preparing a final risk assessment and draft risk management options.
In November 2003, the FDA issued draft guidance that encourages drug and biologic developers to conduct pharmacogenomic tests during drug development. Pharmacogenomics deals with the small genetic differences that help explain why some people respond positively to a drug, while others may not respond or may experience side effects.
Genetic differences also can predict variations in drug metabolism--how quickly or slowly a drug is eliminated from the body. The promise of pharmacogenomics lies in its potential ability to individualize therapy by predicting which people have a greater chance of benefit or risk. This ultimately helps maximize drug safety and effectiveness.
"Using genomic testing to guide drug therapy will constitute a significant shift from the current practice of population-based treatment toward 'fine-tuning' individual therapy," says Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.
Scientific understanding of pharmacogenomics is most advanced in the area of drug metabolism. But the FDA anticipates rapid evolution of other uses. For example, experts hope that pharmacogenomic testing will help identify cancers that have a high probability of responding to a particular medication or regimen.
The document, "Draft Guidance for Industry: Pharmacogenomic Data Submissions," is available on this Web site.