Legislation
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
Agency offered to drop annual IND fees for sponsors not conducting Phase I trials in US, but industry still raised several concerns about fee incentives for onshoring clinical development.
In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
FY 2026 OMUFA facility fees are $19,188 for OTC monograph drug manufacturers and $12,792 for contract manufacturing organizations also making the products. FY 2025 fees were $37,556 and $25,037.
Delaying or altogether eliminating limits on all THCs in lawful hemp Congress approved in 2025 could come down to either House Appropriations AG/FDA subcommittee, chaired by a proponent for lower limits, or Energy and Commerce Health subcommittee, chaired by a supporter for eliminating lower limits.
The agency offered to commission a third-party study of efficiency, workload and other factors to determine whether the base PDUFA revenue should be lowered mid-program cycle.
Including OTC studies in special protocol assessments will be addressed in FDA guidance required in 15 months on improving predictability of process and standards for approval of OTC drug applications, while stepwise labeling information will be post online to improve visibility and searchability fo
During a candid and revealing discussion, lobbying experts shared trade secrets with the AAM’s Access! 2026 conference on how to get the generics and biosimilars industry’s message heard by lawmakers, as well as looking ahead to the importance of upcoming US midterms.
Legal procedures brought by Poland and Ireland could still force a rethink of controversial measures in the updated Urban Wastewater Treatment Directive, despite a recent legal setback for the pharmaceutical industry.
When House Agriculture Committee on March 3 considers five-farm bill year reauthorization, it will vote whether to add an amendment to extend by a year the Nov. 12 deadline for compliance with lower limits on all THC levels allowed in lawful hemp.
Bills from lawmakers in California (AB 2030) and Connecticut (SB 227) follow similar legislation being considered during current legislative sessions in Alaska, Hawaii, Massachusetts, Michigan and Washington.
User fee program changes traditionally are technical and FDA-specific, but the Trump Administration appears to also want policies advocating its “America First” agenda included.