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Healthy Skepticism Library item: 11534

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

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.”

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909