Congress Moves To Increase Spending On Drug Safety

Wednesday, July 11th 2007, 6:48 am
By: News On 6

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. The drug was withdrawn voluntarily in 2004 after research showed it doubled the risk of heart attacks and strokes.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.