When Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the "Hatch-Waxman Act," it sought, in part, to expedite the approval of generic drugs by the U.S. Food and Drug Administration (FDA). In order for a generic drug manufacturer to obtain such expedited approval under Hatch-Waxman, the manufacturer must show that: (1) the proposed generic drug is the chemical equivalent of an approved branded-drug; (2) the proposed generic is "bioequivalent" to an approved branded-drug; and (3) the proposed labeling for the generic drug is the same as the labeling for an approved branded-drug. See 21 U.S.C. §355(j)(2)(A)(ii)-(v) (2013). While Hatch-Waxman has successfully brought thousands of generic drugs to the market at a much swifter rate than its branded equivalents, it has not done so without some legal pitfalls.
Two years ago, we wrote about one such legal quagmire—whether a state's failure-to-warn claims for generic drugs are preempted under the Supremacy Clause by federal statutes and regulations. John F. Parker and Paul S. Danner, "Supreme Court Holds Federal Law Preempts State Failure to Warn Claims," 246 NYLJ 42 (2011). In that article, we discussed the U.S. Supreme Court's ruling in Pliva Inc. v. Mensing, 131 S.Ct. 2567 (2011), that state-law failure-to-warn claims are preempted under the Supremacy Clause. The Supreme Court reasoned that because federal law prohibits a generic drug manufacturer from independently changing its drug labels, state tort laws seeking to legislate such labels by imposing liability when those labels do not provide adequate warnings were preempted.
