Increasing Transparency in Generic Drug Applications Act

This bill aims to make the generic drug approval process clearer. When a company asks, the FDA must say whether a proposed generic uses the same kinds and amounts of inactive ingredients as the brand-name drug. If it doesn’t match, the FDA must tell the company which ingredients are different and by how much. These limited disclosures are allowed by law and don’t open the door to sharing broader trade secrets.

If the FDA says a generic’s inactive ingredients do match, it can’t reverse that decision after the application is filed—unless the brand’s formula changed and was pulled for safety or effectiveness, or the FDA finds an error. If there’s an error, the FDA must send a written notice explaining the change. The FDA must also issue guidance within one year on how it will decide if a generic’s ingredients match, take public comments for at least 60 days, and then finalize the guidance within a year after comments close. The new rules apply as soon as the law takes effect, even before the guidance is finished.

Key points

• Who is affected: Generic drug makers and the FDA; patients may benefit from clearer, more predictable reviews.
• What changes: FDA must confirm if inactive ingredients match, disclose specific differences, keep decisions stable unless safety changes or errors, and publish guidance on how it makes these calls .
• When: Takes effect at enactment; draft guidance due within one year; at least 60 days for comments; final guidance due within one year after comments close.