CBER Chief Prasad Fired, FDA ‘Gold Standard’ Out Too?
[Analysis by Jim Dickinson and David McFarland] As FDA reels and staff morale plummets under anti-science political interference from the Trump Administration, newly appointed CBER director Vinay Prasad has abruptly departed the agency after being attacked by Trump influencer Laura Loomer for expressing purportedly left-wing political views as a California academic scientist years ago. Commissioner Marty Makary stoutly defended Prasad from Loomer’s attack, saying Prasad “didn’t have a political bone in his body.” Additionally, CBER-regulated industry voices have criticized Prasad’s pro-regulation statements in office, although others, including Makary, thought they upheld FDA’s internationally recognized “Gold Standard.”
Adding to the criticism, former U.S. Senator Rick Santorum (R-PA) recently called Prasad “the man destroying President Trump’s legacy for helping patients,” and a Wall Street Journal opinion piece headlined, “Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag” likely contributed as well. Santorum reportedly has ties to Sarepta, which has been embroiled in an FDA regulatory matter over its Duchenne muscular dystrophy gene therapy Elevidys, the marketing of which the agency recently requested be suspended over patient deaths, only to reverse its request days later.
There was a time when politics never touched FDA Center directors. Long-serving civil servants, they were shielded from political interference by the FDA commissioner and the HHS secretary. That began to change during the tenure of CDER director Janet Woodcock (1994-2004, 2007-20) when she and other leaders were forced by the Republican Bush administration to put regulatory science second to the politics of birth control.
As FDA Webview reported exclusively in 2006, "selected excerpts" from depositions taken by the Center for Reproductive Rights (CRR) from senior FDA managers suggested that they felt the agency's highest-level scientific credibility was unraveling under Bush Administration political pressures. Both Woodcock, then deputy commissioner for operations, and her successor as CDER director, Steven Galson, were depicted in the excerpts as feeling that way just before the agency decided to reject the emergency contraceptive Plan B the first time (2004) for over-the-counter sale. Barr Laboratories' second application for the switch was finally approved 8/24 after the second of two age-restriction revisions was agreed upon.
In a deposition excerpt posted on the CRR Web site, former FDA assistant commissioner for women's health Susan Wood was asked about Woodcock's reaction when she resigned the previous year over the Plan B issue. Wood said Woodcock was "very understanding as to why I needed to resign in order to maintain my credibility ... She wasn't sure how long, you know, that she would be able to feel credible at the FDA herself ..."
Asked about how Galson relayed the non-approvable decision to her, Wood answered that he said he had "reached concerns" about use by younger teens and also felt that issuing the decision was "necessary if he was going to be able to be an effective leader of the Center for Drug Evaluation and Research."
Asked what she thought Galson meant when he said the denial was necessary to be an effective leader, Wood said she couldn't remember his exact words, "but my understanding of it was that he felt he would not be able to work with the leadership of the agency in an effective manner if this letter – this denial did not go through. My understanding from the meeting was that he felt that this was necessary if he was going to be an integral part of the leadership of the agency in terms of being able to work with his supervisors in the Center for Drugs."
In another excerpt, CRR posted responses from CDER director of new drugs John Jenkins when deposed about Galson's explanations to him for ruling against Plan B the first time. "... there were occasions where, in conversations with Dr. Galson, that he told me that he felt he didn't have a choice, and he characterized that in a sense that he wasn't sure he would be allowed to remain as Center director if he didn't agree with the action." It implies that Galson opted to continue his career rather than follow the science — and that it was then-commissioner Mark McClellan who put that choice on him.
In his own deposition to the CRR attorneys, Galson said something quite different, that the decision was his alone: "I did not rely on any factors of consideration which are not contained in the administrative record, and certainly did not rely on views, analyses, concerns and recommendations that may have been submitted to me informally (e.g., shared at a meeting or discussed in a telephone call) but which were not memorialized for inclusion in the administrative record." That record contained no reference to his career being a consideration.
Not only did this Jenkins excerpt suggest that Galson's allusion to deciding Plan B alone and on the basis of science-over-politics was false, but another posted excerpt from CDER Office of Drug Evaluation III director Florence Houn appeared to reinforce the same impression.
Similar political squirming is being seen in the current administration’s flowery explanations for Prasad’s sudden departure from CBER.
An HHS statement says of his aborted three months tenure: “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family. We thank him for his service and the important reforms he was able to achieve in his time at FDA.”
Meanwhile in Prasad’s absence, Makary has asked newly appointed CDER director George Tidmarsh to serve also as acting director of the biologics Center alongside deputies Scott Steele and Brittany Goldberg. Tidmarsh, who hails from Stanford as a pediatrics (neonatology) adjunct professor and has worked in a senior capacity in industry for over 30 years, has been on the job for a little over a week.
What next for the FDA “Gold Standard” in regulatory science?