Healthy Skepticism Library item: 10886

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Publication type: news

Richwine L.
Bill on Drug Safety, FDA Funding Clears U.S. House
Reuters 2007 Jul 12
http://www.medscape.com/viewarticle/559672?src=mp

Full text:

The U.S. House of Representatives voted on Wednesday to give the Food and Drug Administration more power over drugmakers as part of an effort to better protect the public from dangerous medicines.

The measure must be merged with a competing version that passed the Senate in May before it can go to President George W. Bush to sign into law.

The FDA could require post-approval studies of new prescription drugs or order additional warnings under the legislation, which passed the House in a 403-16 vote.

Companies that fail to follow FDA directives could face fines as high as $50 million. Running a false or misleading advertisement to consumers could draw fines of $250,000.

“This legislation strikes the proper balance between new drug safety regulations and measures, and ensuring consumers have the access to innovative prescription pharmaceuticals without undue delay,” said Rep. John Dingell, a Michigan Democrat and chairman of the House Energy and Commerce Committee.

The new authority for the FDA was among provisions meant to improve the government’s drug safety oversight, increase transparency of company clinical trials and raise the fees that manufacturers pay to help speed reviews of medicines and medical devices.

Lawmakers crafted the legislation in response to complaints about the FDA’s handling of serious side effects seen after drugs hit the market. The agency was criticized as slow to act on signs of problems with Merck & Co. Inc.‘s arthritis pill Vioxx, which the company withdrew in 2004, and other medicines.

Pharmaceutical companies and the FDA had proposed $393 million in fees for each of the next five years to speed agency reviews and help fund safety monitoring after approval.

Under the House bill, companies would pay an extra $225 million over five years specifically for post-approval checks.

The Senate bill differs from the House plan in part by capping fines at $2 million and setting lower drugmaker fees.

Lawmakers are expected to work out differences between the House and Senate versions before the current fees expire in September.

The drug industry has generally supported the bill. Pharmaceutical companies strongly favor extending the fees they pay the FDA because they help cut product review times.