FDA Policy/General

Laura Loomer Targets Makary Over Prasad Exit

Right-wing activist and commentator Laura Loomer is now publicly criticizing FDA commissioner Marty Makary over recent comments surrounding the departure of CBER director Vinay Prasad, accusing Makary of undermining the authority of president Donald Trump and his top advisors. Her criticism of Makary in an 8/5 X post follows comments a day earlier on C-SPAN where he dismissed the narrative that Prasad was pushed out of the agency. Prasad simply “saw some media headlines and didn't want to be a distraction,” Makary said. “We have encouraged him to reconsider, and we’re still doing that.”

Based on conversations with four anonymous knowledgeable sources, Politico last week reported that Trump overruled Makary and HHS secretary Robert F. Kennedy, Jr., to insist that Prasad be removed from FDA. Prasad had come under attack from Loomer, former Sen. Rick Santorum (R-PA), and the Wall Street Journal editorial board (see story).

In her fiery social media post, Loomer questioned why someone she characterized as a “Trump hater and devout progressive leftist” like Prasad would be “welcomed back” into the Trump administration, as Makary reportedly suggested. “Why do these people on the Left who have made their way into the admin think their decisions get to override President Trump’s and Susie Wiles’?” Loomer wrote, referencing Trump’s chief of staff. “It’s called the TRUMP ADMINISTRATION. Not the PRASAD administration.”

She also questioned whether the White House agrees with Makary’s “insinuation” that Prasad could rejoin the administration if he chose to do so. “I genuinely want to know if @DrMakaryFDA thinks the White House appreciates his comments,” Loomer wrote, before warning that “there is a vetting crisis because there is a lack of regard for chain of command.” Without naming others, Loomer claimed that multiple Trump officials have “gone rogue” in an effort to elevate their own profiles, undermining both the president and his chief of staff. “You can’t have a bunch of rogue actors speaking for the admin,” she warned. “It always ends in a disaster when people who aren’t Trump try to speak for Trump.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome