- The Washington Times - Friday, September 21, 2007

The Food and Drug Administration gets a failing grade from the American public.

Half of respondents in a national survey rate the agency’s performance as poor, according to a report by the American University’s Center for Congressional and Presidential Studies.

“At a time when Congress is reviewing and debating legislation to strengthen the safety of prescription medicines and overhaul the FDA, this survey validates that drug safety is a real concern for the American public,” said James Thurber, the center’s director.

But Congress this week moved to beef up the FDA’s authority and ability to make our drugs safer. Almost three years ago to the day Vioxx was pulled off the market, House and Senate lawmakers agreed on a compromise drug safety bill that will increase the amount of money pharmaceutical companies pay the FDA to determine a drug’s safety and eventually give it the green light for consumer consumption.

Fees paid by drug manufactures to the FDA would increase to nearly $420 million for the next fiscal year, up from at least $305 million in the current year.

The House passed the bill on Wednesday, and the Senate passed it last night by voice vote.

Following the agency’s handling of Vioxx, the Merck & Co. painkiller withdrawn in 2004 after being linked to heart attacks and strokes, and Avandia, GlaxoSmithKline PLC’s diabetes pill linked in some studies to a risk of heart attacks, the legislation is a major step forward.

It has been said that the FDA focuses too heavily on data gathered during clinical trials, before the drug enters the market. The legislation addresses that concern by forcing the agency to more closely monitor side effects of drugs after they have been approved.

And, under current law, the agency can only request that drug makers conduct added studies after drugs are sold. The bill gives the FDA authority to require drug companies to rewrite drug labels warning doctors of new safety problems, to conduct new studies of drugs already on the market and limit distribution if needed.

“Congress is about to give the president legislation that should end the secrecy and foot-dragging when it comes to letting consumers know about unsafe medicines,” said Jim Guest, president of Consumers Union.

The legislation also requires the FDA to use databases to find side effects that occur after medications are on the market. In addition, results of clinical trials would have to be disclosed, which supporters of the legislation said would make it harder for drug makers to withhold results that show dangers.

“One of the biggest consumer victories in this legislation is that it will be harder for drug companies to fudge the results of their clinical trials,” said Bill Vaughn, a policy analyst with Consumers Union.

The powerful pharmaceutical lobby, known as the Pharmaceutical Research and Manufacturers Association, also praised the passage of the legislation.

“The legislation will enable FDA to hire additional employees to review broadcast advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated,” said PhRMA President Billy Tauzin.

c Health Care runs on Fridays. Contact Gregory Lopes at 202/636-4892 or gregorylopes@washingtontimes.com.

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