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Generic, brand companies have concerns about FDA's proposed drug shortage rule

Bloomberg BNA, January 9, 2014

In comments to the Food and Drug Administration, generic and brand drug companies said although they support the idea of notifying the agency of potential drug shortages, they have concerns with the agency's proposed rule. On Oct. 31, the FDA proposed a rule that would require drug manufacturers to report any supply chain disruptions (11 PLIR 1339, 11/8/13). The proposed rule, Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products, was called for under the FDA Safety and Innovation Act of 2012 (FDASIA). It was published in the Federal Register Nov. 4 (78 Fed. Reg. 65,904, Nov. 4, 2013), and comments were due Jan. 3.