Information and Resources

House Passes FDA Drug Safety Bill

July 11, 2007 -- The FDA would have to step up its monitoring of drug safety under a bill passed by the House Wednesday.

The bill, which was approved overwhelmingly, gives the FDA new authority to require safety studies of drugs already being sold to U.S. consumers. It also forces the agency to keep closer tabs on drugs deemed riskier because of their side effects or because they're widely used.

Rep. John Dingell, D-Mich., the bill's main sponsor, says the bill's safety provisions had "the goal of reducing the likelihood of another Vioxx situation."

Vioxx was the blockbuster pain drug that was pulled from the market in 2004 after years of sales to U.S. patients. The move was made after the FDA determined that Vioxx and similar drugs more than doubled the risk of heart attacks and stroke.

Lawmakers approved a key change that compels regulators to conduct annual studies of riskier drugs for the first several years they're on the market. Another would give the agency the right to order drug companies to change their warning labels if new safety concerns arise. Under current law drug labels are often a topic of negotiation between drugmakers and the FDA.

Some lawmakers who supported the legislation expressed concerns that it did not go far enough to enforce drug safety. Rep. Henry Waxman, D-Calif., who has conducted detailed investigations into the FDA's safety practices, says he wanted to include stiffer monetary penalties for companies that violate their agreements with the agency.

"By and large, it's a good bill," Waxman tells WebMD.

Direct-to-Consumer Ads

The bill also stiffens fines for false direct-to-consumer drug advertisements. Such ads, which often urge viewers to ask their doctors about a prescription product, have received blame for what some researchers see as overprescribing of drugs.

Drug promotions would also have to include a toll-free telephone number and web site address for consumers to report medication reactions.

User Fees

The reforms were tacked onto a larger bill reauthorizing a new round of drug industry "user fees." The law lets manufacturers pay about $400 million every year directly into the FDA to fund drug reviews and safety monitoring.

In return, companies are guaranteed faster rulings on their drugs awaiting approval.

The bill passed by a wide 403-16 margin. But it will still have to be joined with a similar bill passed by the Senate before it can become law. The bill must be on President Bush's desk before Sept. 30, when the current FDA user-fee program expires.