H.R. 1843 — To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

This section amends Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), upon request by a sponsor of an abbreviated new drug application (ANDA) for a generic drug or on HHS's initiative, to disclose whether the generic drug is qualitatively and quantitatively the same as the listed drug with respect to inactive ingredients required by regulation to match or for which there is scientific justification for in vitro bioequivalence testing. (1) If not the same, HHS must identify the differing ingredient(s) and any quantitative deviations; (2) if the same, HHS may not change the determination after ANDA submission absent a listed drug formulation change for safety or effectiveness reasons or a documented error, with notice provided in the latter case; and (3) such disclosures are authorized by law, including for purposes of 18 U.S.C. 1905 (prohibiting unauthorized disclosure of trade secrets, confidential business information, and related data by federal officers and employees). This section further directs HHS to issue draft guidance within one year of enactment on sameness determinations (including for pH adjusters), with at least 60 days for public comment and final guidance within one year thereafter; the disclosure requirements apply upon enactment irrespective of guidance finalization.