To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
This bill amends the Federal Food, Drug, and Cosmetic Act to increase transparency around how generic drugs (ABBREVIATED new drug applications, or ANDAs) are determined to be the same as a listed reference drug. Specifically, it adds a new provision (505(j)(3)(H)) that requires the FDA to tell an applicant (upon request or during review) whether a generic drug that uses the same inactive ingredients in the same amounts as the listed drug is qualitatively and quantitatively the same. If the FDA finds they are not the same, it must identify which ingredients cause the difference and the exact amount of any deviation. If they are the same, the FDA generally cannot change that determination unless the listed drug’s formulation has changed for safety/efficacy reasons or an error is identified. The bill also requires the Department of Health and Human Services to issue guidance within a year on how to determine sameness, including considerations related to pH adjusters. The disclosures are explicitly authorized by law.
Key Points
- 1Adds a new requirement (505(j)(3)(H)) that, upon request or during review, the FDA must assess and disclose whether a generic drug with the same inactive ingredients in the same concentrations as the listed drug is qualitatively and quantitatively the same as the listed drug, or identify why it is not.
- 2If the FDA determines the generic is not the same, it must disclose the specific ingredient(s) causing the difference and the amount of any quantitative deviation.
- 3If the FDA determines the generic is the same, it generally cannot change that determination after the abbreviated application is submitted, unless the listed drug’s formulation has changed for safety/efficacy reasons or there is a written determination that an error requires changing the status; in such cases, the applicant must be notified and provided with the written determination.
- 4Disclosures under this provision are authorized by law (including for purposes of the general disclosure statute, 18 U.S.C. § 1905).
- 5The bill requires the Secretary to issue draft guidance within one year and final guidance within one year after the close of the public comment period, detailing how to determine sameness, including assessment of pH adjusters, with a formal public comment process.