To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

# HR 1843: Generic Drug Transparency Bill **What It Does** This bill would require the FDA to be more transparent when reviewing applications for generic drugs. Specifically, it would require the FDA to tell generic drug makers—either when asked or during the review process—whether their proposed drug is chemically identical to the brand-name version it's meant to replace. If the drugs aren't the same, the FDA would have to explain why.

The bill also requires the FDA to publish or update guidance explaining how it determines whether generic and brand-name drugs are equivalent. **Who It Affects** Generic drug manufacturers, brand-name drug companies, and ultimately consumers who use generic medications would be affected. The changes could make it easier for generic drug makers to understand FDA requirements during the approval process, potentially affecting how quickly and easily generic drugs reach the market. **Current Status** The bill was introduced in the 119th Congress by Rep. Neal Dunn (R-FL) and is currently in committee, meaning it has not yet been voted on by the full House of Representatives.