Healthy Skepticism Library item: 10974

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Publication type: news

Drug Safety Spending May Be Increased
Associated Press 2007 Jul 11
http://biz.yahoo.com/ap/070711/drug_safety.html?.v=1

Full text:

Congress Moves to Increase Drug Safety Spending to $400 Million

WASHINGTON (AP) — Congress is moving to give federal health officials more money to monitor prescription drug safety, part of an effort to avoid another Vioxx debacle.
The House was expected to approve legislation Wednesday that would give the Food and Drug Administration nearly $400 million, collected as fees from the drug industry, to spend on drug safety over the next five years. The Senate has already approved similar legislation.

Both bills also would give the agency more power to require drug companies to do follow-up studies on certain medicines. The House version would require the FDA to periodically review the safety of those drugs as well. It also seeks stricter limits on experts with conflicts of interest from advising the FDA, and would require drug ads to include a toll-free number and Web address for consumers to report side effects.

The FDA was criticized for being too slow to respond once serious problems were linked to the painkiller Vioxx, made by Merck & Co. The drug was withdrawn voluntarily in 2004 after research showed it doubled the risk of heart attacks and strokes.

The legislation’s underlying purpose is to renew, through 2012, a program that has the drug industry pay fees to the agency to defray the cost of reviewing new medicines. In the wake of the Vioxx withdrawal and subsequent problems with other drugs, lawmakers seized on the legislation to overhaul how the FDA handles the safety of the drugs it regulates.

Once the legislation is approved, the House and Senate will have to resolve differences between the versions.