FDA Reform Bill Goes Back To The Future In House With Tighter Safety Rules
This article was originally published in The Tan Sheet
Executive Summary
The discussion drafts of the FDA reform legislation being circulated by the House Energy and Commerce Committee contain many provisions that were removed during debate in Senate
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The discussion drafts of the FDA reform legislation being circulated by the House Energy and Commerce Committee contain many provisions that were removed during debate in Senate. The draft drug safety bill that will be marked up by the Health Subcommittee on June 14, following a June 12 hearing, shares many of the elements of legislation introduced earlier this year by Reps. Henry Waxman, D-Calif., and Edward Markey, D-Mass. That bill, H.R. 1561, is built around the same backbone as the Senate bill from Edward Kennedy, D-Mass., and Michael Enzi, R-Wyo. Both give FDA the authority to require "Risk Evaluation and Mitigation Strategies" for products, but the House language is stronger, applying the plans to essentially all new drugs and mandating more frequent reviews of the drugs and larger fines for violations. The Senate version of the bill reduced the authority it granted FDA after Republicans argued the agency should focus its resources on developing an active surveillance system to address drug safety instead of concentrating on developing product-specific requirements. Although elements of the House legislation appear to put the chambers on a collision course, the formatting may give the Senate a stronger hand in negotiations. Health Subcommittee Chairman Frank Pallone, D-N.J., is circulating nine separate drafts covering different elements of FDA reauthorization and reform, including two on device issues. The House proposals divide the drafts into pieces on user fee renewal, pediatric exclusivity, pediatric research requirements, clinical trial registries, advisory committee conflict of interest and an institute to advance the Critical Path initiative, as well as the piece on drug safety. Given the current political environment, it seems impossible the user fee renewal will not include substantial new safety authorities for FDA, but the committee prints, for the moment, hold out hope to industry of a "clean" renewal. If the bills move through the House separately, that may give the Senate increased leverage once they reach conference. - M. Nielsen Hobbs ([email protected]), "The Pink Sheet" |