Healthy Skepticism Library item: 11534

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Publication type: news

Bridges A.
Congress OKs drug safety bill
Associated Press 2007 Sep 20
http://news.yahoo.com/s/ap/20070921/ap_on_go_co/drug_safety

Full text:

WASHINGTON – Congress sent President Bush legislation Thursday giving the Food and Drug Administration new powers to ensure the safety of prescription drugs.

The Senate passed the FDA bill by voice vote Thursday, a day after the House approved it by an overwhelming margin. Bush is expected to sign the bill.

Broadly, the bill renews for five years two programs to collect fees from drug and medical device manufacturers to defray the FDA’s expense in reviewing products seeking agency approval. The FDA had warned if the fees programs were not renewed by Friday, it would be forced to begin sending layoff notices to nearly 2,000 of its employees. That now appears unlikely.

Legislators used the bill as a vehicle to add to the FDA’s powers to police drug safety – a response to the withdrawal of the painkiller Vioxx three years ago.

“This bill will meet the challenges of protecting American consumers and patients and usher in a new era of drug safety,” said Sen. Mike Enzi, R-Wyo.

While the FDA’s focus traditionally has been on the approval of new drugs, its handling of emerging problems with Vioxx and other drugs already on the market has earned it sharp criticism in recent years.

The bill would give the FDA the power both to require drug companies to further study the safety of medicines if needed and to mandate new label warnings, when problems do appear. The FDA would be able to fine companies to ensure compliance with those two new authorities. The legislation also would require companies to publicly release results of all clinical trials that show how well their drugs performed, although the level of disclosure remains to be determined.

The FDA also would gain the ability to fine drug companies for not completing follow-up studies on their drugs after they’ve won government approval. Those studies now often remain undone, often leaving important safety questions unanswered.

“This important bill should give every American greater peace of mind every single day – every time we eat, take our medicine or see our doctor,” said Sen. Edward M. Kennedy, D-Mass.

The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in fees next year.

The legislation also would force the FDA to further step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive. The manufacturers of certain new drugs would have to draft for each a so-called “Risk Evaluation and Mitigation Strategy” that can include medication guides distributed with each prescription to ensure the medicine’s safe use.

On food, the bill calls for the setting up of a registry to log incidents where adulterated food could pose a health risk. It also would require the FDA to set pet food ingredient and processing standards – a provision born of the massive dog and cat food recalls of earlier this year.

FDA Commissioner Andrew C. von Eschenbach said in a statement that the agency was pleased Congress had approved the bill, which he said reauthorized programs that were “vitally important to the agency and its continued ability to protect and promote the public health.”

The trade association representing the drug industry, the Pharmaceutical Research and Manufacturers of America, called passage of the bill “a crucial step to make our nation’s drug safety system – which already is the best in the world – even better.”