Improved drug safety legislation passes

Last Thursday, Congress passed legislation overhauling how the FDA monitors pharmaceutical companies, giving it new power to protect the public. President Bush is expected to sign the legislation.

Under the new law, the FDA can require pharmaceutical companies to closely monitor the use of newly approved medicines for signs of harm, much as they must do while testing the drugs to win approval. The FDA can mine large patient databases kept by Medicare, the Veterans Affairs Department and private health insurers for early warning signs.

In addition, the FDA has the authority to order quick changes to drug labels to warn of safety concerns and to review television ads before airing. Companies will be required to post results from drug trials publicly, whatever the results.

"It means this history of never showing studies that show safety problems will end," said Dr. Steven E. Nissen, a Cleveland Clinic heart specialist whose identification of heart problems caused by the diabetes drug Avandia sparked criticism of the FDA's drug-safety program this year.

Why is this important? Well, as it turns out, the old system isn't so hot:

The 422-page bill plugs holes in the government's drug-safety system that were exposed when Vioxx was linked to deaths in 2004. Beforehand, most of the FDA's muscle rested in its power to decide whether a drug worked safely enough to go on the market. But the agency had far less power to restrict use of medicines later found to be dangerous.

Instead, the FDA was forced to depend on doctors and drug makers to report side effects, a poor approach to quickly detect dangers. The FDA had to ask drug companies to recall medicines that appeared dangerous, and many simply ignored the agency's orders to study drug performance after receiving approvals.

This basically translates to a) patients taking drugs before the FDA has had time to determine if there are serious long term side effects, as well as b) patients actually not filling their prescriptions because of low confidence in their safety. Naturally this kind of legislation can't address the key issue of drugs ordered from overseas being filled with poison, but come on, you can only expect so much. At any rate, it's nice to see that when presented with evidence of, you know, the entire population being at serious risk over the course of many many years that Congress can, uh, spring into action.