On November 17, 2020, the U.S. House of Representatives passed the Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act of 2020 (H.R. 5668). With bipartisan support, the bill was poised to be passed by the Senate. Per government websites which track legislation, the bill is listed as having passed the House only or specifically to have died in in the Senate at the end of the 2020 legislative session. See govtrack.us, H.R. 5668 (116th): MODERN Labeling Act of 2020; congress.gov, H.R. 5668—MODERN Labeling Act of 2020. However, while the stand-alone bill did indeed stall, the text of the bill was adopted wholesale into the Consolidated Appropriations Act, 2021. As such, those representing pharmaceutical drug manufacturers should understand what the act is and what it may mean for your clients.
The MODERN Labeling Act, codified with the addition of Section 503D to Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), permits the U.S. Food and Drug Administration (FDA) to require generic drug manufacturers to update the labeling for certain generic drugs to reflect new scientific evidence, updated requirements for format or content, new clinical uses, or other changes to benefit public health. The act aims to address an issue that occurs where a generic drug label, which, pursuant to the Hatch-Waxman Act (Drug Price competition and Patent Term Restoration Act of 1984 (Public Law 98-417)), must be identical to that of the branded drug product (also referred to as the reference listed drug (RLD)), essentially becomes frozen in time because the RLD leaves the market for reasons other than safety or efficacy. Under this scenario, historically, as new scientific information relevant to the drug’s indications, safety or efficacy became available, the generic manufacturer could not unilaterally update its label to incorporate that information, resulting in generic drug labels that may be, in some instances, lacking relevant and updated information.
The act attempts to resolve that issue by allowing the FDA to identify generic drug products that remain on the market after the RLD has been removed, and whose labeling needs to be updated to reflect new information, either through “cooperative agreements or contracts with public or private entities” or after seeking public input concerning certain drugs. See H.R. 5668 Sec. 503D(b). Specifically, the act states that the FDA could require a generic drug manufacturer to update its drug label where: (1) “there is new scientific evidence available pertaining to the existing conditions of use,” (2) “the approved labeling does not reflect current legal and regulatory requirements for content or format,” (3) “there is a relevant accepted use in clinical practice that is not reflected in the approved labeling,” or (4) “updating the labeling would benefit the public health.” Id. Sec. 503D(a)(1)(C). Notably, the act does not impose any obligations on generic drug manufacturers to take affirmative action prior to the FDA identifying a product and determining there is a basis to require updated labeling.