Drug Shortages: Generic Industry’s Self Regulation Proposal Questioned At House Hearing
This article was originally published in The Pink Sheet Daily
Mylan’s Heather Bresch still has questions and House members ask whether it could coexist with mandatory FDA reporting legislation.
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GPhA enlists IMS Health for analysis of production data to help FDA devise roadmap to ameliorate shortages when a company plans to halt or interrupt a drug’s manufacture.
Democratic Senator has terse exchange with FDA at hearing and says Congress must do more than what is already in pending legislation. Blumenthal said he is willing to consider the Generic Pharmaceutical Association proposal calling for an independent third party to compile supplier data and predict coming shortages.
Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.