House Passes Bill to Bolster Drug Safety

Both houses of the U.S. Congress have passed bills demanding stronger federal oversight of drug safety.

Legislation passed Wednesday by the U.S. House of Representatives significantly bolsters the Food and Drug Administration’s resources and authority in ensuring the safety of drugs, The Los Angeles Times reported.

The legislation was prompted by federal investigations into the arthritis drug Vioxx. The medication was withdrawn in 2004 because of evidence that it caused heart attack and stroke. It had been on the market for five years.

Investigators found holes in the FDA drug approval process, including understaffing and a lack of post-market surveillance.

The drug safety provision is part of a bill that reauthorizes the collection of fees from drug manufacturers to finance the agency’s drug approval process.

The language in the House bill appears stronger than similar legislation passed by the Senate, the Times said.

Both bills direct the agency to establish a computerized system to watch for possible health risks after drugs reach the market and to require that manufacturers include possible risks in drug packaging.

A compromise bill is expected before Congress’s August recess, the Times said.