GPhA Pushes REMS Pay-for, Schedule III Hydrocodone In User Fee Bill

Generic association had officially been agnostic in the choice between House’s pay-for, which would speed biosimilar petition review, and the Senate provision, which ensures access to REMS products for ANDA development. But a letter to Congress now formally outlines GPhA’s hopes for the user fee conference.

The Generic Pharmaceutical Association is formally taking sides on how to pay for the FDA user fee legislation now being ironed out by the House and Senate negotiators. In a June 4 letter to the sponsors in both chambers, the group endorses the Senate provision, which ensures access to restricted-distribution drugs for sponsors aiming to develop generics.

The House pay-for is arguably a good deal for generic firms too, perhaps even a better one. The House legislation...