Trump FDA Commissioner Marty Makary out
President Donald Trump said Tuesday that Dr. Marty Makary has been ousted as FDA commissioner, ending his controversial tenure at the health agency.
“Makary is a great guy and he will be on leave and his deputy, his deputy, will take over temporarily,” Trump told reporters on Tuesday.
“He’ll move on and have a good life,” he added.
Various news sources Makary reportedly resigned On Tuesday, there were days of reporting that the White House was planning to fire him.
According to reports, Kyle Diamantas, who previously worked as a senior food official at the FDA, will take over as acting commissioner. Trump did not name Diamantas on Tuesday.
Makary, a surgical oncologist known for criticizing the government’s response to the Covid epidemic, has reportedly fallen out of favor with both FDA staff and the White House in recent months. He headed the agency responsible for regulating food, drugs and medical devices for more than a year.
His tenure has been marked by internal dysfunction and leadership turmoil at the FDA, as well as escalating backlash from drugmakers, doctors and patient groups over regulatory decisions, including high-profile rejections of some rare disease treatments. Also the White House reportedly becoming increasingly impatient It was seen as slow progress on Trump’s key policy initiatives, such as legalizing flavored e-cigarettes.
Makary touted his accomplishments as commissioner, including the priority voucher program that accelerated review times for certain drugs.
But staff morale at the agency plummeted following the layoffs and departures of career agency scientists; Among them is Dr., who has been organizing cancer for a long time. Richard Pazdur was also present. Showed Makary’s leadership as a reason for leaving. Meanwhile, distrust in leadership was reported to be increasing among remaining staff.
Among Makary’s most polarizing appointments was Vinay Prasad, who served as a key agency official overseeing vaccines and biotechnology treatments before leaving the post at the end of April. Prasad, an outspoken academic and podcaster, left the agency following mounting criticism of the FDA among the biotechnology and pharmaceutical industries and former health officials.
For example, the FDA initially refused to review Moderna’s flu vaccine; The biotechnology company said this decision was inconsistent with previous agency guidance and was specifically driven by Prasad. The FDA later reversed course on the vaccine.
Prasad also faced backlash earlier this year for rejecting uniQure’s Huntington’s disease gene therapy; He claimed that the FDA required him to perform mock brain surgery to evaluate whether the treatment was working. In an interview with CNBC in March, Makary appeared to criticize this treatment anonymously.
In April, the FDA rejected Replimune’s melanoma drug candidate for a second time, following its first rejection in July. The agency cited insufficient evidence of effectiveness and objected to the single-arm trial design.
In an interview with CNBC in May, Makary said three independent teams came to the same conclusion about the drug and that the FDA was not making “corrupt sweetheart deals.”
“I don’t work for Replimune, I work for the American people and I stand with the scientists at the FDA,” Makary said in an interview with CNBC’s David Faber.
In March, Sen. Ron Johnson, R-Wisc., announced that an investigation has been launched FDA’s rejection of rare disease treatments.
