Opinion ID: 902503
Heading Depth: 3
Heading Rank: 1

Heading: Hatch-Waxman Amendments and FDA Regulations

Text: The labeling of prescription drugs is governed by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. “[A] manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate.” Mensing, 564 U.S. at ___, 131 S. Ct. at 2574. In 1984, Congress amended the FDCA to allow manufacturers of generic drugs to obtain “FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA.” Id. at ___, 131 S. Ct. at 2574 (citing 21 U.S.C. § 355(j)(2)(A)). The amendments, commonly referred to as the HatchWaxman Amendments, permitted generic “manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug.” Id. at ___, 131 S. Ct. at 2574. -8- To obtain approval for a generic drug, the manufacturer generally must show the generic drug is “bioequivalent” to the brand name drug and has the same active ingredients, route of administration, dosage, and strength. 21 U.S.C. § 355(j)(2)(A). The generic manufacturer must also “‘show that the [safety and efficacy] labeling proposed . . . is the same as the labeling approved for the [brand-name] drug.’” Mensing, 564 U.S. at ___, 131 S. Ct. at 2574 (quoting 21 U.S.C. § 355(j)(2)(A)(v)) (alterations in Mensing). This federal duty of “sameness” regarding the warning label is “ongoing.” Id. at ___, 131 S. Ct. at 2575. FDA regulations permit “changes to generic drug labels only when a generic drug manufacturer changes its label to match an updated brand-name label or to follow the FDA’s instructions.” Id. at ___, 131 S. Ct. at 2575-76 (deferring to the FDA’s interpretation of its change process and regulations). The federal labeling regulations also apply to letters providing “additional warnings to prescribing physicians and other healthcare professionals” (Dear Doctor letters), which must be “‘consistent with and not contrary to [the drug’s] approved . . . labeling.’” Id. at ___, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 201.100(d)(1)) (alterations in Mensing). Letters containing “substantial new warning information would not be consistent with the drug’s approved labeling” and, if sent by the generic manufacturer but not the brand name manufacturer, “would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly ‘misleading.’” Id. at ___, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 314.150(b)(3)).