Bill > HR1051

This bill amends the Federal Food, Drug, and Cosmetic Act to modify the 180-day exclusivity period for generic drug applications (abbreviated new drug applications or ANDAs). Currently, the first generic drug applicant receives a 180-day exclusivity period before other generic versions can be approved. The bill creates a new pathway for subsequent applicants to gain approval if the first applicant fails to begin commercial marketing within 75 days of approval. Specifically, a subsequent applicant can receive approval if: (1) at least 33 months have passed since the first application was submitted, (2) the first applicant's approval is not precluded, (3) no first applicant's application is effectively approved when the conditions are met, and (4) the subsequent applicant certifies they can begin marketing within 75 days. If the subsequent applicant fails to commence commercial marketing within the 75-day period, their approval is deemed tentative, and they can only regain approval by proving an unforeseeable event prevented marketing and that they have resolved any issues. This change aims to ensure faster access to generic drugs by creating a mechanism to bypass delays caused by the first generic applicant's failure to bring a drug to market.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/1051/all-info