The head of the Food and Drug Administration”s (FDA) drug division, Dr. George F. Tidmarsh, was placed on administrative leave on Friday. This decision followed his concerns regarding the legal foundation of a new initiative aimed at expediting the approval of certain medications.
Dr. Tidmarsh, who has extensive experience in the pharmaceutical industry and joined the FDA in July, expressed in a Sunday interview that he believed the new program was infusing political elements into the drug review process, overshadowing decisions grounded in scientific evidence. His leave is pending an investigation by the inspector general of the Department of Health and Human Services.
In the same interview, Dr. Tidmarsh suggested that the inquiry was retaliatory in nature and mentioned that he had considered resigning. He attributed the toxic atmosphere to Dr. Vinay Prasad, the agency”s chief medical and scientific officer, who oversees vaccines and gene therapies. Dr. Prasad had previously been removed from the agency in July but was reinstated shortly afterward.
A spokesperson for the health department did not immediately respond to inquiries regarding the situation. This incident at the FDA adds to a pattern of high-profile dismissals and conflicts under Robert F. Kennedy Jr., the nation”s health secretary, who has seen several top aides either forced out or resign in recent months. Notably, Susan Monarez was terminated after only one month as director of the Centers for Disease Control and Prevention after she reportedly refused to endorse recommendations from Kennedy”s vaccine advisory panel, which has been criticized for its composition of vaccine skeptics.
Dr. Tidmarsh”s concerns arose following the FDA”s mid-October announcement of a plan to approve a series of drugs at unprecedented speed. This initiative aimed to prioritize medications addressing significant medical needs and facilitating lower costs. Among the candidates for this program were treatments intended to assist individuals in overcoming vaping addiction and therapies for children born with hearing impairments.
Dr. Tidmarsh cautioned that this approach could fundamentally alter the legal principles that have historically underpinned drug approvals, which have focused on safety and efficacy for decades. He stated, “There was insufficient legal support for what they wanted to do, and so I didn”t agree.” The situation escalated last week when FDA officials convened to make their first official approval decision under this new framework, a process that typically requires months of thorough examination and formal dissent opportunities among agency scientists, but was anticipated to conclude in a single day.
Expressing his discomfort with the rapid decision-making, Dr. Tidmarsh remarked, “I didn”t know the legal underpinnings, so all I did is say “I don”t think this is a decision.” I see this as a practice run because no one had provided clarity about the process or its legality.”
Following the meeting, he was informed that his leave was due to an investigation concerning a LinkedIn post he made and subsequently deleted, in which he articulated his apprehensions regarding the FDA”s use of surrogate endpoints in drug approval processes. An example of such an endpoint might be assessing whether a cancer treatment reduces tumor size, while more definitive evidence would involve prolonging patient survival or significantly enhancing life quality.
