White House Supporting Makary in Turmoil: Report
President Donald Trump and the White House have “total confidence” in FDA commissioner Marty Makary as he weathers yet another agency crisis with the abrupt departure of new CDER director George Tidmarsh, who was accused of official misconduct by a drug company. A Politico article quotes from an e-mail it received from a White House spokesperson saying that, “President Trump pledged to lower costs and Make America Healthy Again by cutting red tape and embracing innovation. FDA under Marty Makary’s leadership has consistently delivered on this pledge, and the White House maintains total confidence in FDA and the entire HHS team to continue delivering more victories for the American people.”
Likewise, the report says, an HHS spokesperson said, “The secretary (Robert F. Kennedy, Jr.) has full trust and confidence in Dr. Makary to lead FDA.”
Makary has managed to avoid becoming embroiled in many of the agency’s controversies, although he intervened when CBER director Vinay Prasad was fired on the recommendation of conservative Trump-whisperer Laura Loomer, and convinced the administration to allow Prasad to return to his post. He has also been faulted by some conservative members of Congress over the agency’s approval of a generic form of the medical abortion drug mifepristone.
Politico reports that an administration official who was granted anonymity to discuss Prasad’s tenure acknowledged there have been some issues with his management style and communication style. “I wouldn’t say he’s in hot water,” the official said, “but I wouldn’t say he’s not in hot water either.”
The official said Prasad is seen as aligning with what the president wants and described him as “an innovative mind who can deliver.” The official said frustrations over Prasad’s personal leadership style are not “representative of systemic issues at FDA or its leadership.”
Noting the low morale of rank-and-file agency employees in the recent months following major reductions in force and other disruptions, the article says two current employees who were granted anonymity said the CDER staff thought Tidmarsh was a professional with whom they could work.
“He worked hard to ensure that our staff are retained and to make sure our processes are continuing,” one staffer said. “We were working with him, he was a good partner.” Tidmarsh did not respond to a Politico request for an interview.
“There is more concern about the fate of the agency than at any time in its history,” a former official who was granted anonymity said. “FDA is in crisis.”