ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA suggests “restricting and simplifying” user fees; Rep. Auchincloss urges caution; agency tags change plans; panel grants CPT codes; EU proposes an expert panel for orphan and pediatric devices; the UK updates its postmarket guides; Singapore eyes AI device exemptions; and Pakistan clinical documents.
US Picks
User fees, Auchincloss, PCCPs, and CPTs:
FDA eyes “restricting and simplifying” user fees. Despite contentions by HHS Secretary Robert F. Kennedy Jr. and allies that FDA user fees contribute to corruption, the Trump administration appears willing to engage in efforts to reauthorize the fee programs that fund large portions of the agency’s activities. During a May 16 presentation, Grace Graham, FDA’s deputy commissioner for policy, legislation, and international affairs, made it clear that RFK Jr.’s claims that user fees contribute to industry “capture” of reviewers is influencing the agency’s thinking. “The perception of a company handing over a multi-million-dollar application fee when they are submitting an application may cause some American people to question the outcome of those reviews,” Graham said at the Food and Drug Law Institute’s annual meeting in Washington DC. At the same time, her comments signaled that, while the administration wants to rethink some elements of user fees, it is not abandoning the programs. “It is worth exploring whether and how restricting and simplifying the user fee program may help rebuild trust in the FDA and its decisions, and take advantage of the upcoming reauthorization to do so,” she said.
