Makary Pledges FDA Staff Assessment Due to Firings
FDA commissioner-nominee Marty Makary has pledged to do his own “independent assessment on personnel” before recommending if any additional staff cuts are warranted at the agency. During his 3/6 Senate confirmation hearing before the Health Education Labor & Pensions (HELP) Committee, Makary made the promise to appease criticism from several Democrat members about the Trump Administration’s “willy nilly” firing of 1,000 agency employees last month (see story). By agreeing to conduct his own independent personnel assessment, Makary was indirectly acknowledging a 3/4-revised memo from the Office of Personnel Management that noted agencies have “ultimate decision-making authority over, and responsibility for, such personnel actions.”
During opening remarks, Makary thanked the Trump Administration for providing a “generational opportunity to usher in radical transparency, to facilitate more cures, meaningful treatments and diagnostics at the FDA to help people take care of their own health.” Questioning by HELP Committee chair Bill Cassidy (R-LA) raised concerns about a lack of transparency in HHS’ decision to abruptly cancel without explanation a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that would otherwise select the strains and the composition of next season’s influenza vaccines.
Makary said the vaccine advisory committee is a rubber stamp of the recommendations made by the Global Immunization Division consortium and it is not critically needed to determine the next vaccine’s composition. Cassidy said that canceling the meeting hurts transparency because the meeting would have reviewed the effectiveness of the previous vaccine and “what went right, and what went wrong, and how to make it better.” He asked Makary how he will ensure that advisory committees remain objective, transparent, and still benefit from the necessary expertise of external experts?
“So you have my commitment to review what the committees are doing, and how they’re being used,” Makary told Cassidy. He noted that when an issue arises and it is critically important to have expert opinions, convening an advisory committee “not only provides some of that wisdom, but it also increases the perception of confidence from the general public.” When pressed by Patty Murray (D-WA) about the vaccine meeting being canceled and whether he will reconvene the meeting if confirmed, Makary evaded the question and said he was not responsible for the decision to cancel it.
Regarding the abortifacient mifepristone, Murray asked Makary to commit to upholding the science and evidence-based drug approvals for all FDA-approved products, including medication abortion? “You have my commitment to follow the independent scientific review process at the FDA, which is a tried and true process and has been around and so that is my commitment to you, Senator,” Makary said as he dodged the question. “Well I want to be clear, there have been over 100 high-quality studies over more than two decades backing up the science and safety of mifepristone,” Murray concluded.
Asked by Rand Paul (R-KY) whether advisory committee members should be more rigorously vetted for any potential conflict of interest, Makary said there should be a re-review of the ethics policy, “because people see things that appear to be a cozy relationship between industry and the regulators that are supposed to be regulating the products. Now I want American companies to thrive. I want life sciences companies to thrive, but we need to call balls and strikes and to keep that independent scientific review process free of any conflicts. So I do think it deserves a look.”