The FDA's proposed rule changes for generic pharmaceutical labels and the GPhA response

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Following the Court's decision in Pliva Inc. v. Mensing that generic drug makers were shielded from liability for inadequate warnings because of their inability to easily strengthen those warnings, the FDA began a rulemaking procedure to change the rule governing generic drug labeling. On November 13, 2013 the FDA published its proposed rule to provide an opportunity for comments by industry and other interested parties.¹ The proposed rule is intended to remove the restrictions on generic drug labeling that lead the Pliva majority to rule that it was impossible for a generic drug company to comply with a state court's determination that generic drug was unreasonably dangerous because the label failed to adequately warn doctors and patients of the drug's risks:

The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug

The FDA explained that because generic companies that received approval to market a drug under an ANDA, just as the sponsors of new drug applications receiving approval under an NDA, "have an ongoing obligation to ensure their labeling is accurate and up-to-date" and that therefore:

tension has grown between the requirement that a generic drug have the same labeling as its RLD, which facilitates substitution of a generic drug for the prescribed product, and the need for an ANDA holder to be able to independently update its labeling as part of its independent responsibility to ensure that the labeling is accurate and up-to-date.

At the time this is written, the FDA had not closed the comment period, so the rule is not yet in its final form. However, the FDA is clearly taking the position that the potential for tort liability is an important incentive for pharmaceutical companies' efforts to monitor the safety of their drugs, and that the decision in Pliva, by shielding generic manufacturers from liability, undermined their incentive during an important period in a drug's use. In its statement in support of the proposed rule, the FDA cited its own study of the safety-related labeling changes made in 2010, which found that the "most critical safety-related label changes, boxed warnings and contraindications, occurred a median 10 and 13 years after drug approval."²