Bill on FDA drug safety sent to Bush

? 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 today, 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. It 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.

The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in fees next year.