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A new vaccine called Fluarix is approved to immunize adults 18 years old and older against influenza virus. Influenza is commonly called the flu.
"The FDA's approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," says Health and Human Services Secretary Mike Leavitt. "Having more manufacturers of influenza vaccine licensed in the U.S. and having more vaccine dosages is critical to public health and I applaud FDA for taking such quick action ... ."
The approval of Fluarix, which contains inactivated virus, breaks new ground in that it is the first vaccine approved using FDA's accelerated approval process. This process allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an endpoint that is reasonably likely to predict clinical benefit.
In this case, the manufacturer demonstrated that after vaccination with Fluarix, adults made levels of protective antibodies in the blood that the FDA believes are likely to be effective in preventing flu. GlaxoSmithKline (GSK), the manufacturer of Fluarix, will do further clinical studies to verify the clinical benefit of the vaccine.
The FDA based accelerated approval of Fluarix on thorough evaluation of safety and effectiveness data from four clinical studies involving about 1,200 adults. Other data from post-marketing reports in other countries where Fluarix is already approved were also reviewed.
Andrew C. von Eschenbach, M.D., was named acting commissioner of the Food and Drug Administration after former Commissioner Lester M. Crawford, Ph.D., D.V.M., announced his retirement in September. Before his appointment, von Eschenbach was the director of the National Cancer Institute (NCI).
A nationally recognized urologic surgeon, von Eschenbach's distinguished career as a key leader in the fight against cancer spans nearly three decades. Before accepting the appointment to lead the NCI in January 2002, von Eschenbach served as executive vice president and chief academic officer of the University of Texas M.D. Anderson Cancer Center in Houston, leading a faculty of nearly 1,000 cancer researchers and clinicians.
At M.D. Anderson, he also served as vice president for academic affairs and held the distinguished Roy M. and Phyllis Gough Huffington Clinical Research Distinguished Chair in urologic oncology.
In addition to other honors received, von Eschenbach was instrumental in fostering integrated research programs in the biology, epidemiology, prevention, and treatment of prostate cancer, as founding director of the Prostate Cancer Research Program at M.D. Anderson.
"I look forward to bringing my experience on the discovery side of medicine to the delivery side of medicine, making sure patients get the drugs and treatments they need as quickly and safely as possible," he said.
Because of potential conflicts of interest involving both the NCI and the FDA, von Eschenbach has agreed not to participate in certain FDA matters in which the NCI is also involved, unless specifically requested to do so.
In another personnel change, the agency announced that Steven Galson, M.D., M.P.H., will lead the more than 2,200 employees of the FDA's Center for Drug Evaluation and Research.
Galson, a rear admiral in the Commissioned Corps of the U.S. Public Health Service, has served as deputy director of CDER and as acting director. Before his arrival at the FDA in 2001, Galson was the director of the Office of Science Coordination and Policy and the Office of Prevention, Pesticides and Toxic Substances at the Environmental Protection Agency.
Protecting the U.S. food supply from terrorist threats is the focus of a new collaboration among federal government agencies, states, and private industry. The FDA, the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and the FBI compose the federal partners in this Strategic Partnership Program Agroterrorism Initiative.
"Ensuring the safety of our nation's food supply is a top priority for President Bush and USDA," says Agriculture Secretary Mike Johanns. "This partnership demonstrates our commitment as government and the private sector work together to protect our agricultural commodities from terrorism. We look forward to working with our partners." Over the next year, teams of federal and state officials will travel to all 50 states to meet with all sectors of the food chain. Together, the federal, state, and private-industry partners will discuss security issues from farm-to-table and will consider ways to better protect our food supply.
This effort is the second major joint initiative for the federal partners. In May 2005, the FBI, with the support of the FDA, DHS, and USDA, hosted the first-ever International Symposium for Agrosecurity in Kansas City, Mo.
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The FDA has approved a strengthened distribution program for isotretinoin (Accutane) and its generics, a drug that should not be taken by women who are pregnant or who might become pregnant. Isotretinoin is highly effective for treating severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy.
The iPLEDGE program requires registration by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use isotretinoin. Wholesalers and pharmacies must also comply with the program requirements in order to distribute and dispense the drug.
In addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form and obtaining counseling about the risks and requirements for safe use of the drug. Women of childbearing age must comply with required pregnancy testing.
A Public Health Advisory has been issued by the FDA to alert physicians to reports of suicidal thinking in children and adolescents associated with Strattera (atomoxetine). Strattera is approved to treat attention-deficit hyperactivity disorder (ADHD).
The FDA is advising health care providers, parents, and other caregivers to closely monitor children and adolescents being treated with Strattera. Patients should be monitored for worsening symptoms including agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior. Special attention should be paid to symptoms during the first few months of therapy or when the drug dose is increased or decreased. Caregivers and those taking Strattera who have concerns or questions about these symptoms should contact their health care provider.
The FDA also has directed the manufacturer of Strattera, Eli Lilly and Co. of Indianapolis, to develop a Medication Guide for patients and caregivers. The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of the drug.
Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, describes the FDA's action as "another example of the agency acting swiftly to alert the public to significant drug safety information needed to use a drug in a safe manner."
An analysis of the manufacturer's clinical trials database, which included 1,350 people receiving Strattera and 851 receiving a placebo, showed that 0.4 percent of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo. There was one suicide attempt by a patient who received Strattera among the approximately 2,200 children in the trials.
Strattera has been on the market since 2002 and has been used in more than 2 million patients. It is currently approved in the United States to treat ADHD in children, adolescents, and adults. Strattera has not been studied in children younger than 6 years.
A child-friendly version of the MyPyramid Food Guidance System has been released by the U.S. Department of Agriculture (USDA). MyPyramid for Kids, designed for children ages 6 to 11, provides age-appropriate information about the 2005 "Dietary Guidelines for Americans" and the MyPyramid Food Guidance System released earlier this year.
"This is a fun approach to addressing the very serious problem of childhood obesity," says Agriculture Secretary Mike Johanns, who unveiled MyPyramid for Kids at an Alexandria, Va., elementary school. "We know that MyPyramid captured America's attention and our hope is that MyPyramid for Kids will inspire the same level of interest and help to improve the health of America's kids."
The MyPyramid for Kids slogan for children is "Eat Right. Exercise. Have Fun." Through an interactive game, lesson plans, colorful posters and flyers, worksheets, and valuable tips for families, MyPyramid for Kids encourages children, teachers, and parents to work together to make healthier food choices and be active every day.
The interactive computer game, called MyPyramid Blast Off, involves a rocket that needs fuel to blast off. The game reinforces the key concepts of MyPyramid for Kids by challenging children to select a healthy variety of foods and physical activities to fuel their rockets.
The FDA and the Centers for Disease Control and Prevention (CDC) have alerted consumers and health care providers to five reports of Guillain-Barré Syndrome (GBS) following administration of Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135), manufactured by Sanofi Pasteur. It is not known whether these cases were caused by the vaccine or were coincidental. The FDA and the CDC are sharing this information with the public and are actively investigating the situation because it is potentially serious.
GBS is a neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. This syndrome typically causes increasing weakness in the legs and arms that can be severe and requires hospitalization.
The five cases of GBS reported after administration of Menactra occurred in individuals living in New Jersey, New York, Ohio, and Pennsylvania. All of the five were 17 or 18 years old and developed weakness or abnormal sensations in the arms or legs, two to four weeks after vaccination. All individuals are reported to be recovering or to have recovered. More than 2.5 million doses of Menactra vaccine have been distributed nationwide. The rate of GBS based on the number of cases reported after administration of Menactra is similar to what might have been expected to occur by coincidence, that is, even without vaccination. However, the timing of the events is a concern. Also, vaccine adverse events are not always reported to the FDA, so there may be additional cases which the agencies are not aware of.
Studies conducted by Sanofi Pasteur of more than 7,000 recipients of Menactra showed no GBS cases. The CDC conducted a rapid study using available health care organization databases and found that no cases of GBS have been reported to date among 110,000 Menactra recipients.
Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis, which affects about 1 in 100,000 people annually. Ten percent to 14 percent of cases are fatal, and between 11 percent and 19 percent of survivors may have permanent disability.
According to Jesse Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research, there were no immediate changes in recommendations for vaccination. People should continue to follow their doctors' recommendations. The FDA and the CDC are not able to determine whether any or all the cases were due to vaccination. The current information is considered to be preliminary, and the two agencies are continuing to evaluate the situation.
Because this matter is potentially serious, the FDA and the CDC are asking anyone with knowledge of possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS). Individuals can report to VAERS on the Web at www.vaers.hhs.gov or by phone at (800) 822-7967.
The FDA announced new measures in October 2005 to further help protect consumers against the agent thought to cause bovine spongiform encephalopathy (BSE), also called mad cow disease. The agency has proposed amending its animal feed regulations to prohibit from use in the food or feed of all animals certain high-risk cattle materials that potentially can carry the BSE-infectious agent. All the proposed prohibitions, except for those related to tallow, have already applied to cattle feed since 1997.
"These additional measures ... will make an already small risk even smaller by further strengthening the effective measures already in place to protect American consumers from BSE," says Acting FDA Commissioner Andrew von Eschenbach, M.D.
The high-risk cattle materials prohibited in the new proposed rule include:
The proposed regulation builds on a series of firewalls that include the FDA's 1997 feed regulation, which prohibits the use of certain mammalian-origin proteins in ruminant feed (e.g., for cattle and sheep) but allows these materials to be used in feed for non-ruminant species. The removal of high-risk materials from all animal feed--including pet food--will protect against the transmission of the agent of BSE.
Comments on the proposed regulation may be submitted at www.fda.gov/ohrms/dockets/98fr/cv048.pdf by Dec. 20, 2005.
See www.fda.gov/oc/opacom/hottopics/bse.html for more information about the FDA's work on BSE and links to related sites.