2 days ago
Trump's chief intervened to save RFK Jr.'s top vaccine aide
According to the officials, Makary and Kennedy persuaded the White House to review statements by Prasad that Loomer said showed disloyalty, arguing they were taken out of context.
'I think it really is something good about the president that he's willing to change his mind when persuaded,' one of the senior administration officials said.
But the victory could prove pyrrhic if Prasad's ability to set policy is diminished. Before his firing, Makary had named him not only the head of the FDA's Center for Biologics Evaluation and Research, which oversees regulation of vaccines and gene therapies like Elevidys, but also the agency's chief medical and scientific officer.
Makary, like Prasad, was a leading critic of the Biden administration's response to the Covid pandemic. Prasad, a University of Chicago-trained hematologist and oncologist, was previously a professor of epidemiology and biostatistics at the University of California, San Francisco.
Sen. Ron Johnson (R-Wis.), the author of a 2018 law Trump signed that permits patients greater access to experimental therapies, told POLITICO he texted Trump days ahead of Prasad's ouster to raise concerns of the Duchenne muscular dystrophy patient community about the FDA's efforts to restrict Elevidys.
The company initially refused to comply with the agency's July 18 request that it halt shipment. It agreed on July 21 to stop shipping the medicine by the end of business the next day to maintain a 'productive and positive working relationship with FDA.' The agency then allowed the company to resume distribution to ambulatory patients on July 28, a day before Prasad's ouster.
Those patients are a subset of people with the condition, which weakens muscles and leads to the loss of the ability to walk, typically by age 12 . Most die before they reach 30 .
Johnson's Right to Try Act, which Trump repeatedly touted on the campaign trail as a signature achievement of his first term, aims to allow patients with life-threatening diseases to try experimental medicines without FDA involvement. The agency has a separate longstanding program known as compassionate use that allows such patients to access experimental treatments when other options do not exist.
'I have never met or spoken to Dr. Prasad,' Johnson said when asked about Prasad's return. 'I hope all the new appointees within HHS and its subsidiary agencies restore integrity to scientific research, fully respect both the letter and spirit of the Right to Try Act, and carefully listen to and empathize with the patients who are impacted by their decisions.'
Former FDA officials said they expect the power struggle between Republicans who support pharma and Kennedy to continue.
Loomer, meanwhile, says she now wants Trump to dismiss Stefanie Spear, Kennedy's principal deputy chief of staff and senior counselor, and Casey Means, Trump's nominee to be surgeon general. Casey Means is a close Kennedy ally and sister of Kennedy adviser Calley Means.
'I think she wants to split the MAHA and MAGA coalition,' one of the senior officials said of Loomer. 'She wants to split them in two.'
Tim Röhn is a member of the Axel Springer Global Network.
