Can Industry Accept a Dysfunctional FDA?: Axios
Reflecting on the recent FDA turmoil over the resignation of CDER director George Tidmarsh, Axios questions how long industry can “tolerate an underperforming and dysfunctional FDA … before looking to other markets.” Tidmarsh resigned as controversy broke over comments he made on social media that were part of a lawsuit alleging that he used his government position to exact revenge against a former business associate (see earlier stories here and here).
The Axios report says it has heard from current agency staffers anonymously, who are expressing concern about the turmoil and feeling increasingly motivated to leave the agency.
It quotes former associate commissioner Peter Pitts, who now heads the Center for Medicine in the Public Interest, that “good people leave, and the other problem is, because of all this perceived chaos, it becomes even harder for FDA to recruit new employees. And it’s never been easy.”
Pitts warned that when drug companies on their own or smaller companies with their venture capital partners find that they can’t predict what FDA will do from day to day, “they simply take their investment dollars and place them elsewhere.”
This latest dust-up caps a year in which the agency has been roiled by significant reductions in force, leading to slowed product reviews and approvals, and the departure of controversial CBER director Vinay Prasad, at the urging of right-wing Trump-whisperer Laura Loomer, only to be returned to office by FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr.
Tidmarsh, who told at least one media outlet that he plans to fight his ouster, has said that he thinks the main reason he was targeted was that he spoke out against new agency efforts to speed some drug approvals and give more power to Prasad.
An HHS spokesperson told Axios that FDA “continues to carry out its mission to protect public health with the same rigor and independence the American people expect. The agency’s work to review and approve safe and effective medical products remains fully operational and guided by science, not politics.”
Meanwhile, FDA Matters president Steven Grossman says the Tidmarsh story has “inconsistent narratives and unsubstantiated ‘facts.’” He points out that it is also unclear whether Tidmarsh is on administrative leave or has resigned.
Grossman says Tidmarsh’s use of social media for a personal opinion on a regulated product “was a no-no. It undercuts FDA’s positioning as an agency that makes fair decisions and does so impartially and objectively. Furthermore, it seems off for a federal official to express personal views, rather than those of the agency, on issues and product reviews within their own purview.”
He says that so far, Tidmarsh’s response has been to deflect. “He has stated that the current investigation is a consequence of his opposition to the commissioner’s voucher program and his disagreement with Prasad’s leadership,” Grossman writes. “Regardless of how you feel about those two other controversies, neither is relevant to the evaluation of whether Dr. Tidmarsh abused his office. Let’s not obfuscate those separate issues.”