Leadership Changes Affect FDA Priorities: Mintz Post
Two Mintz attorneys say recent leadership changes at FDA, coupled with many executive-level vacancies, have affected the priorities started by former commissioner Marty Makary. Writing in the one-year anniversary edition of their firm’s FDA in Flux newsletter, the attorneys say the leadership changes coincided with an immediate shift in the agency’s tone toward more carefully measured statements about current and developing programs.
They further say that more recent actions by the new leaders “show some pullback from Dr. Makary’s pedal-to-the-medal approach to implementing new initiatives and pilot programs, which created a constantly shifting regulatory landscape for the drug and biologic industries.”
Looking at some of Makary’s initiatives, the attorneys write that the Commissioner’s National Priority Voucher pilot program may have been renamed the National Priority Voucher pilot. They say that while at least 22 vouchers have been issued, stakeholders continue to request additional clarity and transparency on product eligibility and all procedural aspects of the program. Also, some members of Congress continue to strongly criticize the program as being rife with conflicts of interest and political interference, with what the attorneys say was apparently little engagement from Makary’s office in response to congressional inquiries.
On Makary’s Clinical Trial and Institutional Review Board process reforms, the attorneys say FDA recently extended to 6/29 the comment period on the initiative. Their review of the comments submitted to date shows that stakeholders generally broadly support the initiative, including Makary’s push for Real-Time Clinical Trials, but only with robust guardrails to protect procedural rigor, especially regarding safety, and minimize harmful biases.
While Makary’s push for so-called new approach methodologies (NAMs) for clinical tests that will reduce reliance on animals continues, the post notes that the transition to NAMs exclusively presents certain challenges that stakeholders have repeatedly pointed out, such as requests for more clarity on how to validate and qualify novel NAMs for specific uses.
“Although it may take some time for animal studies to be phased out,” the post concludes, “the congressional mandate driving both FDA and industry to further integrate NAMs into drug and biological product development and the scientific complexity associated with such a fundamental paradigm shift ensure that these issues will remain a high priority for the agency in a post-Makary environment.”