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FDA Proposes Rules Enabling Prompt Updates of Generic Drug Product Labeling

FDA Proposes Rules Enabling Prompt Updates of Generic Drug Product Labeling

The U.S. Food and Drug Administration recently issued proposed rules that would allow generic drug manufacturers to independently and promptly revise drug safety information by updating product labeling.

Generic drugs are bioequivalent versions of brand name drugs. The former are usually sold at much lower prices once the patent protection for the brand name counterpart has expired. Currently, "[m]ore than 80 percent of prescriptions filled in the U.S. are for generics," according to Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. However, under the existing rules, only brand manufacturers can independently update product labeling with new safety information. More specifically, brand manufacturers do not have to wait for the FDA to review and approve changes in the drug label before they can communicate such new safety information to prescribers or patients. On the other hand, generic manufactures must wait for both the FDA and the brand manufacturer to determine and approve labeling revisions, which could lead to "a delay in getting new [safety] information to [physicians] and patients." This limitation on the generic manufacturers' ability to revise drug labeling has served as the primary basis for the U.S. Supreme Court's ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) that generic drug manufacturers cannot be held liable under state law for failure to change a drug label to give an adequate warning.

FDA's proposed rules would allow generic manufacturers to update drug labeling without prior FDA approval and without the involvement of the brand name manufacturer, thus enabling prompt dissemination of new safety information about the great majority of prescription drugs. Furthermore, brand name manufacturers would "consider the information provided by the generic... manufacturer as part of [their] review and evaluation of adverse drug experience..."

In addition, the FDA plans to dedicate a public website to information on "safety-related changes proposed by [both generic and brand] drug manufacturers."

Sources:

FDA News Release, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374171.htm

FDA Voice Blog,

http://blogs.fda.gov/fdavoice/index.php/2013/11/working-to-improve-the-communication-of-important-drug-safety-information-about-generic-drugs/

FDA's Proposed Rule,

https://www.federalregister.gov/articles/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products

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