Increasing Transparency in Generic Drug Applications Act

The Increasing Transparency in Generic Drug Applications Act would add a new transparency requirement to the FDA’s review of generic drug applications (the abbreviated new drug application, or ANDA process). When a sponsor asks for or an agency initiates review of a generic drug that uses the same inactive ingredients in the same concentrations as the listed (reference) drug, the Secretary of Health and Human Services would must tell the applicant whether the generic is qualitatively and quantitatively the same as the listed drug. If the drug is not the same, the FDA must disclose which ingredients cause the difference and, for any ingredient with a quantified deviation, the amount of that deviation. If the drug is the same, the FDA could change that determination only under narrowly defined circumstances (e.g., a change in the listed drug’s formulation due to safety/efficacy concerns or a written determination that an error requires changing the determination), and, if such a change is issued, the agency must notify the requester. The bill also requires the FDA to issue formal guidance within a year on how it will assess sameness, including considerations for pH adjusters, with a public comment window. The disclosures are authorized by law and designed to balance transparency with protection of nonpublic information and trade secrets. The new requirements take effect upon enactment.