S-1302 : Still Just a Bill

The "Increasing Transparency in Generic Drug Applications Act" (S. 1302) aims to enhance transparency in the generic drug approval process. Here's a summary of the key provisions:

• Transparency in Inactive Ingredients: Requires the Secretary of Health and Human Services to inform generic drug applicants, upon request, whether their drug has the same inactive ingredients in the same concentrations as the original brand-name drug. This applies when regulations require the same inactive ingredients or when a scientific justification supports using in vitro testing to demonstrate bioequivalence.
• Disclosure of Differences: If the generic drug is not qualitatively or quantitatively the same as the original, the Secretary must disclose the differing ingredient(s) and the amount of any quantitative deviation.
• Consistency in Determinations: Prevents the Secretary from changing a determination that a generic drug is qualitatively and quantitatively the same as the original after an application is submitted, unless:
  • The original drug's formulation has changed and was withdrawn for safety or effectiveness reasons, or
  • An error has been identified in the prior determination.
• Guidance on Sameness: Mandates the Secretary to issue or update guidance within one year, describing how the agency determines whether a drug is qualitatively and quantitatively the same as the listed drug, including how pH adjusters are assessed.
• Applicability: The provisions of the Act take effect immediately upon enactment, regardless of when the guidance is finalized.