Senators offer drug safety options

WASHINGTON, D.C.-After months of negotiations, Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) unveiled their long-anticipated bill to improve FDA oversight of drug safety. By including something for everybody-registration and results disclosure of clinical trails, limits on advisory committee conflicts of interest, support for Critical Path research-the legislation (S. 3807) puts down a marker for Congressional action on drug safety next year.

Unlike earlier legislation sponsored by Sens. Charles Grassley and Chris Dodd, the bill does not establish a separate FDA drug safety office, and it does not give FDA specific authority to mandate post-marketing studies. Instead, the measure sponsored by these leaders of the Senate's Health, Education, Labor and Pensions (HELP) Committee clarifies FDA authority to require risk management plans and to levy fines for non-compliance.

The centerpiece of the bill requires manufacturers to develop Risk Evaluation and Management Strategies (REMS) as part of drug development. Such plans would explain a company's adverse events monitoring program and whether there was a need for post-approval studies, additional patient information or restrictions on product distribution and advertising. The legislators anticipate that only a few drugs would warrant limits on distribution and use, as has been the case in the past. Disputes between FDA and manufacturers over risk management strategies would be resolved by a set system to avoid lengthy delays and costly legal fights. But companies that fail to comply with a REMS element would face strong penalties.

The bill calls for a new system for screening candidates for FDA advisory committees to reduce conflicts of interest, and it provides government support for a new research institute to develop tools to facilitate assessment of drug safety and efficacy.