 |
 |
 |
|
 |
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA | FDA Centennial
The FDA has issued Warning Letters to a number of firms marketing unapproved alternative hormone therapies. The dietary supplements and hormone creams being sold are, in fact, unapproved new drugs that have not been found safe and effective to treat or prevent certain serious or life-threatening diseases or conditions. These alternative therapies are often promoted as "natural" or "safer" treatments that can be used in place of approved hormone therapies.
In the Warning Letters, the FDA advises the firms that under the Federal Food, Drug, and Cosmetic Act, a product is considered to be a drug if it claims to diagnose, cure, mitigate, treat, or prevent disease, or for products other than foods and dietary supplements, if it claims to affect the structure or function of the body. The letters further state that the FDA considers these products to be "new drugs" that require FDA approval before marketing.
To view the individual Warning Letters, visit www.fda.gov/bbs/topics/news/2005/NEW01260.html. The FDA also advises marketers that advertising claims are governed by the Federal Trade Commission. More information on such claims can be found at: www.ftc.gov/opa/2005/11/hormone.htm
In response to the emerging threat of an Avian flu pandemic, the FDA has announced the formation of a Rapid Response Team to ensure that antiviral drugs are available to Americans if needed. Pandemic influenza is an extreme, acute outbreak of flu. Avian influenza is an infection caused by bird flu viruses.
The Rapid Response Team will help ensure an adequate supply of Tamiflu (oseltamivir) and other anti-influenza drugs in the event of an outbreak of Avian flu in the United States. "Using the Rapid Response Team approach, we believe we could review a complete drug application in six to eight weeks," says Acting FDA Commissioner Andrew von Eschenbach, M.D.
In partnership with the U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention, the National Institutes of Health, and industry, the Rapid Response Team also will address roadblocks to manufacturing and will support the design and conduct of clinical studies to test potential treatments for Avian flu. In the event of a pandemic, new medications could be made available under Emergency Use Authorization. And the team will facilitate the development and availability of safe and effective vaccines that could help protect Americans against a future pandemic.
As the threat of pandemic flu continues, the FDA anticipates an increase in the sale of counterfeit or fraudulent treatments. The agency is not aware of any counterfeit Tamiflu cases in the United States at this time. But there are initiatives in place to deter counterfeiters and others who sell fraudulent or phony products for Avian flu.
Mexico, the United States, and Canada have joined together to combat weight-loss fraud. Under a Trilateral Cooperation Charter agreement signed in 2003, six agencies--two from each of the three countries--recently announced that they have taken more than 700 compliance actions against companies that promote bogus weight-loss products. These products mislead the public, endanger public health, provide false hope, and defraud citizens of billions of dollars.
The FDA and the Federal Trade Commission (FTC) are the two agencies representing the United States in this effort. "False and misleading claims can have significant health consequences for those who use these products that do not produce the desired results," says Murray Lumpkin, M.D., the FDA's deputy commissioner for International and Special Programs. "International cooperation is the key to fighting weight-loss scams that target all consumers, regardless of geographic borders," said Lydia Parnes, director of the FTC's Bureau of Consumer Protection.
According to the World Health Organization, more than 60 percent of U.S. and Mexican citizens and more than 50 percent of Canadians are overweight or obese. Obesity and overweight are major contributors to chronic disease and disability.
Compliance actions taken include prosecutions, recalls, seizures, import refusals, warnings, and other enforcement programs against false and misleading weight-loss advertising and labeling. These actions are complemented by a comprehensive education and public outreach program to help consumers, industry, and advertisers to identify which types of claims are deceptive and misleading.
The three countries remind consumers that the only way to lose weight is to follow a sensible, well-balanced diet that lowers caloric intake and to increase physical activity. While certain prescription products have been found to be safe and effective in promoting weight loss, the best proven method remains sensible diet and exercise.
The FDA has approved the first West Nile Virus (WNV) blood test to screen donors of blood, organs, cells, and tissues. The new test will help protect those who receive blood and other such products against WNV infection. As of early December 2005, 30 cases have been documented, including nine who died.
The Procleix WNV Assay, made by Gen-Probe Inc., and marketed by Chiron Corp., detects viral genetic material (ribonucleic acid, or RNA). An urgent effort to develop such a blood test began after it was discovered in 2002 that WNV could be transmitted in blood.
WNV is typically transmitted to humans by mosquitoes when they extract blood. It was first detected in the United States in 1999, and has recurred each year for seven consecutive years, causing close to 20,000 human cases of disease and at least 762 deaths since 2002. It is estimated that between 1 million and 2 million people in the United States have been infected with WNV.
In December 2005, the FDA launched a new Web-based system for the Voluntary Cosmetic Registration Program (VCRP). Cosmetic firms can now register their establishments and file their cosmetic formulations with the FDA electronically.
From information maintained in the VCRP database, the FDA can estimate the extent and use of a cosmetic ingredient in the event the agency has to develop safety messages to alert manufacturers and the public. The VCRP helps the agency in its mission to protect consumers and helps cosmetic manufacturers and distributors make informed decisions.
The new electronic system is designed to streamline the process, which should encourage greater participation by the cosmetics industry. Visit www.cfsan.fda.gov/~dms/cos-regn.html to learn more and to register.
An updated label for the Ortho Evra contraceptive patch warns that the patch exposes women to higher levels of estrogen than most birth control pills approved by the FDA.
Ortho Evra is the only skin patch approved for birth control. It is a weekly prescription patch that releases an estrogen hormone and a progestin hormone through the skin into the blood stream.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical daily birth control pill. However, the maximal blood level of estrogen is about 25 percent lower with Ortho Evra than with typical birth control pills.
Higher levels of estrogen may put some women at increased risk for blood clots. It is not known whether women using Ortho Evra have a higher risk of these serious side effects than women taking the typical 35-microgram estrogen pills.
The FDA advises women to talk to their health care provider about whether the patch is the right method of birth control for them.
The FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho–McNeil Pharmaceutical Inc. in Bridgewater, N.J., is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills.
Go to www.fda.gov/cder/drug/infopage/orthoevra/default.htm for more information.
The FDA has approved a new drug to treat adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed after at least two chemotherapy regimens. Arranon (nelarabine) is the first drug to treat this limited population of patients.
Arranon is a cancer chemotherapy drug that kills cancer cells by blocking the ability of cells to reproduce.
The FDA approved Arranon under the accelerated approval program, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of a product's effectiveness. Arranon also received Orphan Drug Designation, which is granted to products that treat rare diseases--those that affect fewer than 200,000 people in the United States.
The safety and effectiveness of Arranon were demonstrated in two clinical studies, one conducted in children and the other in adults. Both studies enrolled individuals with relapsed or refractory T-ALL/T-LBL, and all patients received Arranon. Among the 39 children treated, 23 percent had a complete disappearance of their cancer, which lasted from 3.3 to 9.3 weeks. Of the 28 adults treated, the rate of complete disappearance was 21 percent and lasted from four to more than 195 weeks.
Common side effects reported with Arranon treatment are fatigue, nausea, vomiting, and diarrhea.
Arranon will be distributed and marketed by GlaxoSmithKline (GSK) of Research Triangle Park, N.C.
The FDA has announced the approval of Exjade (deferasirox) for treating chronic iron overload due to multiple blood transfusions. Exjade is the first orally administered medication to be approved for this use. Treatment for iron overload, which can damage the heart and liver, had previously required daily prolonged drug infusions lasting eight to 12 hours.
In clinical studies lasting 48 weeks, Exjade demonstrated reduction in liver iron concentration in adults and children receiving red blood cell transfusions on an ongoing basis. "This oral therapy will allow greater patient compliance and will potentially reduce the complications of iron overload," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research.
Exjade was approved in November 2005 under the FDA's accelerated approval program, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of the product's effectiveness. Companies are required to do further studies to verify the clinical benefits.
Exjade also received Orphan Drug Designation, which is granted to products that treat diseases affecting fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive U.S. marketing to the first sponsor that obtains marketing approval for a designated orphan drug.
Common side effects of Exjade in clinical studies included nausea and abdominal pain. Elevations in blood tests that measure kidney and liver functions were also noted. Less common side effects included hearing and visual disturbances and rashes.
Exjade is manufactured by Novartis Pharmaceutical Corp. in Stein, Switzerland.
The FDA is warning companies that manufacture, market, or distribute products made from cherries or other fruits to stop making unproven health claims both on the product labels and on their Web sites. Such claims make the product a drug, as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The companies cited are marketing dried fruit, fruit juice, and juice concentrate for treating or preventing a variety of diseases, including cancer, heart disease, and arthritis.
The Warning Letters state that if the firms fail to take prompt corrective measures, they may face FDA enforcement action without further notice. This action could include seizure of the products, injunctions against the manufacturers and distributors of such products, and criminal actions against those responsible for causing violations of the FD&C Act.
Copies of the Warning Letters are available at: www.cfsan.fda.gov/~dms/cos-regn.html
The Food and Drug Administration has announced that whole grain barley and barley-containing products are allowed to claim that they reduce the risk of coronary heart disease (CHD).
CHD is the cause of almost 500,000 deaths annually. Risk factors for CHD include high total cholesterol levels and high levels of low-density lipoprotein (LDL) cholesterol. Scientific evidence shows that adding barley to one's diet can contribute to lowering serum cholesterol.
Consumers can expect to see whole barley and dry milled barley products such as flakes, grits, flour, meal, and barley meal bearing the health claim. An example of the health claim that may be used is:
"Soluble fiber from foods such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect."
"Promoting health by helping people get better nutrition information about the foods they eat is among FDA's top priorities, because the choices that Americans make about their diet have a great impact on their well-being," says FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D.
The FDA is authorizing food manufacturers to immediately use the health claim for barley and the reduced risk of CHD through the issuance of an interim final rule. To qualify for the health claim, the barley-containing foods must provide at least 0.75 gram of soluble fiber per serving of the food.
The FDA will accept public comments on the interim final rule, published in the Federal Register on Dec. 23, 2005, for 75 days. Comments may be submitted to Docket No. 2004P-0512 at the Federal eRulemaking Portal.