ARTICLE SUMMARY:
FDA wants to reshape user fee programs to limit concerns in RFK Jr.’s “Make America Healthy Again” orbit about reviewer conflicts of interest. Industry and legal stakeholders anticipate that user fee deals will be reached but likely result in pared-down packages after the current programs expire in 2027.
FDA under the Trump administration is preparing to engage in efforts to reauthorize the user fee programs that fund large portions of the agency’s activities. This, despite a push by the administration to reduce rather than grow staffing at the agency and contentions by HHS Secretary Robert F. Kennedy Jr. that the industry fees contribute to corruption. Stakeholders, nonetheless, expect the reauthorization process to be challenging, with an outcome not assured, but likely to result in pared-down fee agreements after the current programs expire in 2027.
Grace Graham, FDA’s deputy commissioner for policy, legislation, and international affairs, underscored the administration’s concerns with user fees as a source of financial conflict of interest during her appearance at the Food and Drug Law Institute’s annual meeting on May 16 in Washington, DC. “The perception of a company handing over a multimillion-dollar application fee when they are submitting an application may cause some American people to question the outcome of those reviews,” Graham said. “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.”
