FDA and industry know what they want out of MDUFMA II, as negotiations are just about complete. The stumbling block, however, is Congress. Congressional Democrats are unhappy with the pharmaceutical industry, and the device industry could get caught up in their wrath, TheHill.com reported in a feature last week. Congressional Democrats want to tie reauthorization of the pharmaceutical user-fee program to new drug safety requirements. MDUFMA is likely to be bundled with the pharma bill, which could lead to delays in its reauthorization as the pharma battle plays out, and/or more stringent safety requirements mandated for devices, too. A hearing on pediatric drug and device safety will take place Thursday. Any legislation, including new safety requirements, concerning the device industry should be made based on what makes sense for the device industry and the patients it serves.Â Merely graftingÂ drug legislation onto devices could be burdensome or, in the worst case, harmful.
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