This bill aims to increase transparency in the generic drug application process by requiring the FDA to disclose information about the sameness of generic drugs compared to their brand-name counterparts.
Margaret "Maggie" Hassan
Senator
NH
The "Increasing Transparency in Generic Drug Applications Act" amends the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications by requiring the Secretary of Health and Human Services to disclose information about the sameness of a proposed generic drug to the listed drug, and to issue guidance on how sameness is determined. This ensures generic drug manufacturers understand the requirements for approval, and prevents the Secretary from changing a determination of sameness unless specific conditions are met. It also protects trade secrets and confidential information while promoting transparency.
FDA Must Now Tell Generic Drug Makers How Their Formulas Stack Up, New Bill Mandates
This bill, the "Increasing Transparency in Generic Drug Applications Act," changes the game for companies looking to bring lower-cost generic drugs to market. It requires the Food and Drug Administration (FDA) to provide specific feedback to generic drug applicants about how their proposed drug's formulation compares to the original brand-name version.
Getting the Recipe Right (Mostly)
Here’s the core change: If a company submits, or even just intends to submit, an application for a generic drug, they can formally ask the FDA if their product is "qualitatively and quantitatively the same" as the brand-name drug it copies. That basically means asking, "Does our version have the exact same active and inactive ingredients in the exact same amounts?" Under this bill, the FDA must answer that question.
If the FDA determines the generic isn't identical, they can't just say "no." Section 2 mandates they identify which specific ingredient(s) are different and by how much. Think of it like getting feedback on a recipe – instead of just 'tastes wrong,' you're told 'too much salt, not enough spice.' This aims to reduce the guesswork for generic manufacturers, potentially speeding up the development process. However, the bill clarifies this disclosure doesn't spill all the beans; it won't reveal nonpublic details about the brand-name drug's formula that count as trade secrets.
Locking It In
Once the FDA gives a thumbs-up, determining a generic is qualitatively and quantitatively the same, that decision is generally locked in. According to the text, the FDA can't change its mind after the company submits its official application unless one of two things happens: the original brand-name drug's formulation changes due to safety or effectiveness concerns, or the FDA identifies an error in its initial assessment. If an error is found, the FDA must notify the company and explain the change in writing.
Writing the Rulebook
The bill also directs the Secretary of Health and Human Services to develop clear guidance on how the FDA will make these 'sameness' determinations. This includes specifics on assessing ingredients like pH adjusters, which can be tricky. Draft guidance is required within one year of the bill's enactment, followed by a public comment period, with final guidance due a year after comments close. Importantly, the requirement for the FDA to provide this feedback starts immediately upon the bill's enactment, even before the final guidance is published.