FDA Drug Chief Placed on Leave Following Controversial Program Critique
Dr. George Tidmarsh, the head of the Food and Drug Administration’s (FDA) drug division, has been placed on administrative leave following his concerns regarding a new program intended for the rapid approval of certain drugs. This decision came on October 20, 2023, and is part of an investigation led by the inspector general of the Department of Health and Human Services (HHS).
In an interview on October 22, 2023, Dr. Tidmarsh expressed his belief that the program introduced political influences into the drug approval process, undermining the scientific basis traditionally used for such evaluations. He described the environment at the FDA as “toxic” and suggested that his leave was a retaliatory measure for voicing his concerns. Dr. Tidmarsh indicated that he has offered his resignation as he no longer wishes to work under these conditions.
The controversy began when the FDA announced plans in mid-October to expedite the approval of several drugs, aimed at addressing unmet medical needs and supporting reduced pricing. Among the candidates for expedited approval were a drug designed to assist individuals in overcoming vaping addiction and another intended to aid children born with hearing impairments. Dr. Tidmarsh warned that the program could disrupt the established legal foundations for drug approvals that have been in place for decades.
He stated, “The effort was going to basically change the entire paradigm of the legal underpinnings of drug approvals that have for decades supported the actions on the safety and effectiveness of drugs.” He raised issues regarding the insufficient legal support for the expedited approval process, leading him to disagree with the initiative.
The situation escalated during a meeting last week when FDA officials were expected to make their first official approval decision under this new program. Normally, this process spans several months and involves thorough review and formal dissent opportunities among agency scientists. In this case, the decision was anticipated to be made within a single day.
Dr. Tidmarsh shared his concerns about the legality of the rapid approval process, stating, “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.” Following the meeting, he was informed that his leave was linked to an investigation regarding a LinkedIn post he had made and subsequently deleted, which outlined his worries about the FDA’s drug approval standards.
In his post, Dr. Tidmarsh discussed the concept of surrogate endpoints, which the FDA sometimes employs in drug approval decisions. For instance, one endpoint could evaluate whether a cancer treatment reduces tumor size. However, more definitive evidence would include extending patient survival rates or significantly improving quality of life.
The turmoil at the FDA reflects ongoing challenges within the agency, particularly under the leadership of Health Secretary Robert F. Kennedy Jr., who has experienced numerous staff changes and resignations in recent months. Notable among these was the dismissal of Susan Monarez, who was removed from her role as director of the Centers for Disease Control and Prevention (CDC) after just one month, reportedly due to her refusal to endorse recommendations from Kennedy’s vaccine advisory panel, which consists largely of vaccine skeptics.
The ongoing investigation into Dr. Tidmarsh’s situation has yet to yield a public response from HHS officials, leaving many questions about the future direction of the FDA and its drug approval processes. As this story develops, the implications for drug regulation and public health are likely to be significant.
