FDA · 25 posts
Lede Brief 10h ago

Former FDA Deputy Says Makary Misread Administrative Power

FDA Commissioner Marty Makary resigned, leaving the agency without confirmed leadership in its top post and in its drug and biologics divisions, according to STAT News. Said former FDA principal deputy commissioner Joshua Sharfstein: "The administration's norm-shattering masks a more fundamental misunderstanding of how administrative power can bring about lasting change," adding that Makary and deputy Vinay Prasad repeatedly overruled staff scientists and announced policy by press release rather than through official vetted documents.

Source: STAT News FDARFKJrExecutive
Brief 19h ago

FDA Drug Center Acting Director Høeg Leaves Post

Dr. Tracy Beth Høeg, acting director of the FDA's Center for Drug Evaluation and Research since December, is leaving her post, according to CBS News. Said one agency source when Høeg was appointed: "Putting Tracy Beth in charge is like dropping an atom bomb." Her departure comes three days after FDA Commissioner Dr. Marty Makary resigned amid internal disputes, including over the administration's decision to approve flavored e-cigarettes over Makary's reported objections.

Source: CBS News Politics FDAExecutivePublicHealth
Brief 21h ago

FDA Fires Top Drug Regulator Dr. Tracy Beth Hoeg

The Food and Drug Administration fired Dr. Tracy Beth Hoeg, a senior drug regulator, amid broader turmoil at the agency, according to the New York Times. Said Hoeg: she did not know who had fired her or why.

Source: NYT Politics FDARFKJr.ExecutiveBranch
Brief 24h ago

FDA Drug Center Acting Director Tracy Beth Høeg Resigns

Tracy Beth Høeg, acting director of the FDA's Center for Drug Evaluation and Research, is leaving the agency, according to three sources familiar with the matter, as reported by STAT News. Her departure comes days after Commissioner Marty Makary submitted his resignation; Michael Davis, currently the center's deputy director, will serve as acting director in her place, according to STAT News.

Source: STAT News FDAHHSExecutive
Brief 2d ago

Makary Leaves FDA With Acting Commissioner Kyle Diamantas Named

Marty Makary is departing as FDA commissioner, with Kyle Diamantas named as acting replacement, according to STAT News. Bill Cassidy, chair of the Senate health committee, faces a primary challenge this weekend from two rivals including a Trump-backed candidate, a race STAT describes as having "far reaching implications for Trump's health care agenda."

Source: STAT News FDAHHSExecutive
Brief 2d ago

Kyle Diamantas Takes Over as Acting FDA Commissioner

Kyle Diamantas, who previously served as the FDA's top food regulator, has been installed as acting commissioner following Marty Makary's resignation, according to STAT News. Industry sources told STAT that biotech companies and sector investors expect Diamantas to be a stabilizing presence rather than a disruptive one at the agency.

Source: STAT News FDAHHSPublicHealth
Brief 3d ago

FDA Commissioner Makary Resigns Four Days After Reported Firing

FDA Commissioner Marty Makary resigned Tuesday, four days after the Wall Street Journal reported that President Trump had signed off on his removal, according to The Dispatch. When asked Friday about plans to fire Makary, Trump said: "I've been reading about it, but I know nothing about it."

Source: The Dispatch FDAExecutiveRuleofLaw
Brief 3d ago

Pharma CEOs Call for Stability After Makary Resignation

Pharmaceutical industry executives urged the next FDA commissioner to restore regulatory predictability following Commissioner Marty Makary's resignation, according to Axios. Said PhRMA CEO Steve Ubl: "What we really need from the next leader of the FDA is to calm the waters and reestablish that certainty and predictability." Bristol Myers Squibb CEO Chris Boerner echoed the call, citing the years of investment required to bring a drug to market.

Source: Axios Politics FDAPublicHealthExecutive
Brief 3d ago

Trump Administration Searches for New FDA Commissioner After Makary Resignation

The Trump administration is searching for a new FDA commissioner with priorities including rebuilding staff trust, food policy, and drug-approval reform, with officials hoping to complete the process over "the next several weeks," according to STAT News. No short list of candidates currently exists, an anonymous official said, and acting commissioner Kyle Diamantas — formerly head of the FDA's food center — could still hold the role when midterms arrive in November.

Source: STAT News FDAHHSExecutive
Brief 3d ago

FDA Commissioner Resigns After White House Sides With Tobacco Industry on Vapes

The Trump administration overrode its own FDA commissioner on a vaping regulatory dispute, siding with tobacco companies that had donated to Trump-aligned political groups, according to The New York Times. The FDA commissioner resigned in protest.

Source: NYT Politics ExecutiveFDARuleofLaw