“A bill to provide for increased transparency in generic drug applications.”
No CRS summary available for this bill.
This section requires the Secretary of Health and Human Services (HHS), upon request by a person submitting or intending to submit an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act for a generic drug required (or scientifically justified) to contain specified inactive ingredients matching the listed drug, to disclose whether those ingredients are qualitatively and quantitatively the same as in the listed drug. (1) If not the same, HHS must identify differing ingredients and any quantitative deviations; (2) if the same, HHS may not change the determination after ANDA submission absent listed drug changes for safety or effectiveness or a documented error; and (3) such disclosures are authorized by law, including under 18 U.S.C. 1905 (prohibiting unauthorized disclosure of trade secrets and confidential information by federal officers). This section further directs HHS to issue draft guidance within one year of enactment on sameness determinations (including for pH adjusters), with at least 60 days for public comment and final guidance within one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 regardless of guidance status.