Member Article

This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act).  Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars.  Last November, the Food and Drug Administration (FDA) issued a proposed rule that would fundamentally alter the generic drug industry.  If finalized, the proposed rule would require generic drug manufacturers to submit a "changes being effected" (CBE-0) supplement and revise the labeling of their generic drugs to reflect newly acquired safety information and then distribute the revised labeling in advance of the FDA's review of the labeling change - irrespective of whether the revised labeling differs from that of the brand-name reference listed drug (RLD).  The FDA has asserted that the public health would be benefited if generic manufacturers, like their brand-name counterparts, had "the ability to independently update drug product labeling to reflect newly acquired information regarding important drug safety issues through CBE-0 labeling supplements."  In addition, the FDA claims that the proposed rule would "create parity" between brand-name manufacturers and generic manufacturers "with respect to submission of CBE-0 supplements for safety-related labeling changes." 1

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FDA’s Proposed Generic Drug Labeling Rule, The Food and Drug Law Institute

 

Footnotes: 1.  FDA, Proposed Rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985, 67,989, 67, 995 (Nov. 13, 2013) [hereinafter "Proposed Rule"].