Healthy Skepticism Library item: 11533

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Publication type: news

Congress finally passes bill to give FDA sweeping powers
Pharma Times 2007 Sep 21
http://www.pharmatimes.com/WorldNews/ViewArticle.aspx?id=11798

Full text:

The US Congress has given approval to legislation that is designed to transform the US Food and Drug Administration by increasing its funding and expanding its powers.

The Senate passed the bill without objection yesterday evening, a day after the House of Representatives had overwhelmingly cleared it with a 405 to seven vote. The bill now goes to President Bush who is expected to sign it without any further discussion.

The legislation includes the passage of the Prescription Drug User Fee Act (PDUFA) reauthorisation legislation, which was due to expire on September 30 but the FDA had warned that if the fees programmes were not renewed by today (September 21), it would be forced to begin sending layoff notices to nearly 2,000 of its employees. The need to renew said act resulted in Congress proposing other measures that will give the FDA new powers.

For example, the bill gives the agency the authority to require pharmaceutical firms to change drug labels warning doctors of new safety problems, to conduct new studies of treatments already on the market and to limit distribution if needed. It also grants the FDA the authority to fine firms if they do not complete post-marketing studies.

The new laws are also designed to force the FDA to step up its active surveillance regarding safety and create a new programme to review advertising practices. FDA Commissioner Andrew von Eschenbach said he was pleased Congress had approved the bill, as it has reauthorised programmes that were “vitally important to the agency and its continued ability to protect and promote the public health.”

Senator Edward Kennedy, one of the main authors of the bill, noted that “this ought to be reassuring for every family about the safety of their prescription drugs,” and give “every American greater peace of mind every single day – every time we eat, take our medicine or see our doctor.” The industry trade association, the Pharmaceutical Research and Manufacturers of America, called the bill “a crucial step to make our nation’s drug safety system – which already is the best in the world – even better.”