30 novembre, 2006 18:38
Congress Weighs FDA Drug Safety Reforms
By Lisa Richwine
WASHINGTON (Reuters) Nov 17 - Congress must give the U.S. Food and Drug Administration more authority and funding so it can restore its reputation and better protect patients from harmful drugs, witnesses told a Senate hearing on Thursday.
Consumer and patient groups joined a leading cardiologist in urging quick action on legislation to give the FDA more power to require new warnings on medicines or post-approval studies. Witnesses also called for a boost to the FDA budget.
"The absence of that would leave the agency starved for resources... with unclear authority in terms of being able to deal with the industry," said Sheila Burke, co-chair of an Institute of Medicine panel that urged major reforms to improve the FDA's oversight of medicines after they reach the market.
Drug safety concerns intensified after Merck & Co Inc. pulled arthritis pill Vioxx from the market in September 2004 when a study showed prolonged use doubled heart attack and stroke risk.
Others told the Senate Health, Education, Labor and Pensions Committee they generally supported the bill by Senators Mike Enzi of Wyoming and Edward Kennedy of Massachusetts as a starting point but saw room for strengthening it.
Enzi is the committee's outgoing Republican chairman, and Democrat Kennedy is set to take control in January. Congress is expected to consider drug safety measures next year, possibly when they renew the fees drugmakers pay for product reviews.
Cleveland Clinic cardiologist Steve Nissen said Congress needed to act in order for the FDA to rebuild public trust.
After Vioxx and other safety controversies, "the American people no longer trust the FDA to protect their health," said Nissen, who has served on FDA advisory panels.
A Johnson & Johnson representative said the company supported creation of risk management plans for new medicines but hoped the most severe approaches, such as distribution limits, would be reserved for rare cases.
"We urge the committee to very carefully weigh issues of patient access," said Dr. Adrian Thomas, vice president of benefit-risk management at Johnson & Johnson Pharmaceutical Research & Development.
FDA officials have refrained from taking a position on the Enzi-Kennedy bill but say they are considering the Institute of Medicine suggestions, many of which are similar to ideas in the legislation. An FDA task force is due to report in December on its review of the IOM report, agency officials said.
"FDA has done considerable work over the past two years to improve our approach to drug safety, and we are committed to taking additional steps," FDA spokeswoman Kristen Neese said.
Earlier this week, FDA Deputy Commissioner Scott Gottlieb said the agency could improve drug safety by strengthening existing tools rather than simply gaining new powers.
Resource Centers
http://www.medscape.com/resource/patientsafety
