The PDUFA "primary season" is almost over
Today, BioCentury reports, the Senate HELP Committee will deliberate on a PDUFA reauthorization bill that would relax conflict-of-interest restrictions on advisory committee members, and enact new provisions intended to improve risk-benefit decision-making, facilitate global harmonization of clinical trials and promote regulatory science.
The PDUFA reauthorization manager's amendment would eliminate limits on the numbers of conflict-of-interest waivers FDA can issue for advisory committee members. It would require FDA to "implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decision-making, and the communication of the benefits and risks of new drugs." It also would instruct FDA to work with international regulators and industry to "encourage uniform, scientifically-driven clinical trial standards" that would facilitate simultaneous global development of new medical products. Another new provision would require FDA to identify regulatory and scientific gaps that impede product reviews and approvals and draft plans with specific milestones for addressing the gaps.
The House Energy and Commerce Subcommittee on Health will mark up its version of the FDA user fee reauthorization legislation on Thursday.
Is the final vote a sure thing? Probably.
But is any election ever a sure thing?