A bipartisan drug pricing bill currently awaiting a vote on the Senate floor could have unintended consequences for generics, according to the Association for Accessible Medicines.
S. 1895, introduced by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash), is primarily aimed at preventing surprise medical billing, but it includes a section that would allow the FDA to more easily approve ANDAs under certain conditions.
Already passed by the House as the BLOCKING Act, the section aims to increase generic competition by allowing the FDA to approve subsequent applications if the first ANDA does not receive final approval within 30 months of submission.
An AAM-commissioned analysis concluded that the bill would put the existing 180-day exclusivity period for the first generic applicant at risk and could cause generic manufacturers not to challenge patents on branded drugs.