The head of the Food and Drug Administration”s (FDA) drug division, Dr. George F. Tidmarsh, was placed on administrative leave on Friday after voicing concerns regarding the legal foundation of a new program designed for the expedited approval of certain medications. In an interview on Sunday, Dr. Tidmarsh, who has extensive experience in the pharmaceutical industry and joined the FDA in July, expressed that he believed the initiative was introducing political considerations into the drug approval process, overshadowing scientific decision-making.
This administrative leave will continue pending an investigation by the inspector general of the Department of Health and Human Services. Dr. Tidmarsh indicated that he perceived the inquiry as retaliatory and mentioned that he had submitted his resignation. He attributed the negative workplace atmosphere to Dr. Vinay Prasad, the agency”s chief medical and scientific officer, who is also responsible for overseeing vaccines and gene therapies. Dr. Prasad was previously removed from the agency in July but has since returned.
A spokesperson for the health department did not respond to inquiries following the announcement. This incident at the FDA represents the latest in a series of dismissals and contentious disputes that have occurred under the leadership of Health Secretary Robert F. Kennedy Jr.. In recent months, several prominent staff members have either been dismissed or have resigned, with the most notable case being Susan Monarez, who was terminated just one month into her role as director of the Centers for Disease Control and Prevention (CDC). Monarez claimed her dismissal followed her refusal to endorse recommendations from Kennedy”s vaccine advisory panel, which has been criticized for featuring predominantly vaccine skeptics.
Dr. Tidmarsh”s concerns arose after the FDA announced in mid-October its intent to approve a series of drugs in record time. This initiative aims to provide swift authorization for drugs that align with the administration”s priorities, such as addressing unmet medical needs and promoting affordable pricing. Potential candidates for this program include a treatment to assist individuals in overcoming vaping addiction and another aimed at aiding children born with hearing impairments.
Dr. Tidmarsh remarked, “This effort was going to fundamentally alter the entire paradigm of the legal foundations for drug approvals that have, for decades, underpinned the safety and efficacy assessments of medications.” He expressed that there was inadequate legal justification for the proposed changes, leading to his dissent.
The situation escalated last week during a meeting to determine the agency”s first official approval decision under this new framework. Typically, such processes are lengthy, requiring thorough reviews and opportunities for dissent from agency scientists. However, this decision was anticipated to be finalized within a single day. Dr. Tidmarsh recounted, “I was unaware of the legal underpinnings, so I simply stated, “I don”t think this is a decision.” I viewed it as a practice run because no one had clarified the process or its legality.”
Following this meeting, he was informed that he had been placed on leave due to an investigation into a LinkedIn post he had written and subsequently deleted, which discussed drug approval standards. In his post, Dr. Tidmarsh expressed his apprehensions regarding surrogate endpoints—criteria the FDA sometimes uses in drug approval evaluations. For instance, one surrogate endpoint might involve assessing whether a cancer treatment reduces tumor size, whereas more definitive evidence of a drug”s effectiveness would include extending survival rates or significantly enhancing quality of life.
