FDA Commissioner Mark Makary Resigns Amidst Controversy Over Drug Reviews and Political Pressures
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Makary’s exit might not be solely due to his mishandling of the mifepristone issue. Trump was reportedly frustrated with the FDA head’s resistance to approving flavored vapes and pharmaceutical companies disliked Makary’s regulatory style. But his departure will prove to be a pivotal point for pro-lifers who want to see the administration take action on abortion pills.
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Democracy NowShortly before his resignation, Makary had drawn the ire of President Trump for attempting to block the approval of fruit-flavored vapes, and anti-abortion groups for not placing harsher restrictions on the abortion pill mifepristone. But even before Makary took the helm, mass layoffs and the loss of scientific expertise had already thrown the FDA, which has oversight powers extending to more than a fifth of the U.S. economy, in turmoil.
PBS NewsHourAP report: Marty Makary resigning as Trump's FDA chief At the FDA, Makary failed to win the staff's confidence after mass layoffs, leadership changes and a series of controversies in which the agency's scientific principles appeared to be overridden by political interests.
NPR NewsMakary's resignation would end a tumultuous 13-month tenure at the agency. At times he angered the Make America Healthy Again movement galvanized by Health Secretary Robert F. Kennedy Jr., who is Makary's boss, for not advancing its agenda quickly enough. He also upset people looking for a more traditional approach to regulation by the FDA as they knew it before Trump was elected for a second term.
Washington ExaminerPresident Donald Trump’s first commissioner, Dr. Marty Makary, abruptly resigned from office on Tuesday afternoon following a series of controversies at the FDA, one of the largest regulatory agencies within the sprawling Department of Health and Human Services. Diamantas, previously director of the Human Foods Program at the FDA, was selected to be the acting director when Makary’s resignation was announced.
Fox NewsThough Makary's resignation is not attributable to a specific issue, according to the White House official, his tenure atop the FDA has put him at the center of fights over abortion drug mifepristone – otherwise known as the "abortion pill" – vaccine policy and drug approvals, frustrating pro-life activists and MAHA-aligned critics who argued the agency has moved too slowly to carry out Trump’s health agenda.
VoxWhat happened? Makary, who led the federal agency in charge of regulating drugs, medical devices, food safety, cosmetics, and more, resigned under pressure on Tuesday, after reports surfaced last week that President Donald Trump had approved a plan to fire him.
USA TodayWASHINGTON — Food and Drug Administration Commissioner Marty Makary resigned on May 12, President Donald Trump said, marking the latest high-profile leadership shakeup in the nation's health department.
The HillNext FDA chief to face similar headwinds after Makary’s ouster Marty Makary’s resignation from the Food and Drug Administration (FDA) may help release some pressure by removing one of the Trump administration’s more embattled health leaders. But the next head of the agency will have to navigate many of the same headwinds — political interference, funding cuts and balancing the demands of the “Make America Healthy Again”…
HuffPostMakary faced a unique challenge in balancing calls by Trump and other Republicans to cut red tape at the FDA, while also tending to Kennedy’s interest in scrutinizing the safety of vaccines, drugs and food additives. The decision to get rid of Makary was made by Kennedy, and then the White House signed off on it, according to an administration official who was granted anonymity because they were not authorized to describe internal dynamics.
Washington TimesThe resignation ends a contentious tenure at the FDA, which is responsible for overseeing the safety of food, drugs and veterinary products. Under Dr. Makary’s leadership, the agency drew criticism from Republicans for not reversing a Biden-era rule that let abortion drugs be mailed and dispensed via telehealth. He was also blasted by healthcare advocates after the FDA announced last week that it authorized fruit-flavored vapes for adults.
BreitbartU.S. Food and Drug Administration (FDA) Commissioner Marty Makary resigned from his position on Tuesday, amid reports that President Donald Trump was considering firing him.
NBC NewsDr. Marty Makary is out as commissioner of the Food and Drug Administration, the fourth high-profile departure of a member of the Trump administration this year, according to two people familiar with the decision.
Associated PressWASHINGTON (AP) — The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after a rocky tenure that drew months of complaints from health industry executives, anti-abortion activists, vaping lobbyists and other allies of President Donald Trump.
The Guardian USDiamantas’s ascension to the top role at the agency comes after his predecessor Marty Makary resigned on Tuesday. Makary’s 13-month tenure at the regulatory agency was marked by tumult and frustration from both sides of the aisle. He clashed with lawmakers on Capitol Hill about drug regulation decisions and a review of mifepristone, an abortion medication, which conservative members of Congress accused him of slow-walking.
The Daily WireThe resignation of FDA Commissioner Dr. Marty Makary creates an opportunity for the agency to return to its mission of protecting the public by ensuring drugs are safe. Whether Kyle Diamantas is running the agency long-term or the administration expediently appoints someone new, now is the time to address the most significant public health crisis of our time: the widespread distribution of mail-order abortion drugs.
New York PostFood and Drugs Commissioner Marty Makary resigned his position Tuesday after irking President Trump with his slow-walking of flavored e-cigarette approvals, according to multiple reports.
ABC NewsMakary, a surgeon by training, took office in March 2025. Food and Drug Administration Commissioner Marty Makary intends to resign on Tuesday, two sources familiar with the matter told ABC News.
New York TimesF.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure The agency’s top food official will step in as acting commissioner, after Dr. Makary’s tumultuous run as the nation’s top food, drug, tobacco and medical device regulator.
RealClearPoliticsInside Marty Makary's Downfall at the FDA
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A permanent replacement for FDA commissioner will need to be nominated by Trump and confirmed by a majority vote in the Senate.
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HuffPostA permanent replacement for the FDA job will need to be nominated by Trump and confirmed by the Senate.
Washington ExaminerCassidy’s committee is responsible for confirming the president’s FDA commissioner nominee.
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Several key positions in the Trump administration still remain vacant. Neither Nicole Saphier, Trump’s third pick for US surgeon general, nor Erica Schwartz, who would be the fifth director of the US Centers for Disease Control and Prevention (CDC) in the past year, have yet undergone the confirmation process before the Senate. Jay Bhattacharya, the director of the National Institutes of Health, is temporarily leading the CDC.
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VoxCenters for Disease Control and Prevention Director Susan Monarez was forced out in August after clashing with Kennedy over vaccines, and HHS Deputy Secretary Jim O’Neill, who took over as acting CDC director after Monarez left, departed in February. Trump has yet to have a surgeon general nominee confirmed, and earlier this month made his third nomination for the role.
USA TodaySusan Monarez, former director of the Centers for Disease Control and Prevention, left the department in August 2025 after policy disagreement with Kennedy. Trump in April nominated Erica Schwartz to replace Monarez while National Institutes of Health Director Jay Bhattacharya serves as acting CDC director.
Associated PressSince then, multiple HHS officials have been acting director. National Institutes of Health Director Jay Bhattacharya has been overseeing the CDC since February. Last month, Trump nominated Dr. Erica Schwartz, a former deputy surgeon general, to be the next CDC director, a choice the Senate must confirm.
Washington ExaminerCritics contend that Cassidy had a strong hand in blocking the nomination of Trump’s surgeon general nominee, Dr. Casey Means, who did not have enough Republican votes in the HELP committee to advance. Means’s nomination was eventually withdrawn. She was replaced by former Fox News contributor Nicole Saphier, who also awaits a confirmation hearing before Cassidy’s committee.
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Health and Human Services Secretary Robert F. Kennedy Jr.’s chief spokesperson resigned from the role on Wednesday, citing irreconcilable differences with an effort to advance e-cigarette flavors that could cause children to become addicted.
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USA TodayHis exit adds to a multitude of public health vacancies under the leadership of Health and Human Services secretary Robert F. Kennedy Jr., whose views on vaccines have rankled many in the health community.
New York TimesTop Kennedy Spokesman Resigns in Protest Over New Vaping Policy In a letter to President Trump, the spokesman, Rich Danker, said moves to allow the sale of flavored e-cigarettes would enhance their appeal to children.
VoxHis ouster is just the latest upheaval for the country’s public health infrastructure, which has been in turmoil under Health and Human Services Secretary Robert F. Kennedy Jr.
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The FDA has so far not released its review of the abortion pills, and Bloomberg News reported that Makary asked officials to delay the release until after the midterm elections.
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The FederalistEven in the face of polling showing a majority of likely voters want the FDA to protect women from the dangers of abortion pills, the FDA declined to act or offer a measurable update on its abortion drug evaluation.
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“He seems fine,” Trump responded when asked about Makary on Friday. When pressed if he would fire Makary, Trump said: “I’ve been reading about it, but I know nothing about it.”
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Fox News"I've been reading about it, but I know nothing about it," Trump said the same day after he was asked by reporters if Makary would be fired.
BreitbartWhile taking questions from reporters on Tuesday before departing for China, Trump was asked if he had fired Makary or if he had asked him, “to resign.” Trump responded that he did not “want to say,” and described Makary as a “friend” of his and “a wonderful man.”
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In another post on Truth Social, Trump shared a text message from Makary, in which he asked Trump to “accept” his resignation. Makary highlighted how he had “announced 50 major FDA reforms.”
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HuffPostIn that post, the president included what appeared to be a text message from Makary submitting his resignation. In it, he noted that “I announced 50 major FDA reforms. Joe Biden’s FDA had none,” and thanked Trump for the chance to serve.
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The FDA commissioner, as the leader of an agency that regulates billions of dollars in consumer goods and medicines, is often required to juggle competing priorities that straddle science and politics.
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Associated PressThe FDA commissioner, as the leader of an agency that regulates billions of dollars in consumer goods and medicines, is often required to juggle competing priorities that straddle science and politics.
NPR NewsBut at times his own priorities as commissioner seemed to clash with one another. For example, he pushed for single pivotal clinical trials instead of the usual two to speed up the drug approval process, but under his leadership the agency also requested additional studies from companies seeking approval.
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01:40 Tom Llamas in China ahead of Trump’s historic trip 01:22 Supreme Court temporarily extends full access to abortion pill by mail
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Faster Drug Reviews Are Overshadowed As a former regular on Fox News, Makary was aggressive about promoting his accomplishments on cable television and podcasts and in online opinion pieces.
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Associated PressFaster drug reviews are overshadowed As a former regular on Fox News, Makary was aggressive about promoting his accomplishments on cable television and podcasts and in online opinion pieces.
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More than a half-dozen initiatives from Makary aimed to speed up or streamline FDA drug reviews, including dropping certain study requirements, incorporating artificial intelligence into drug evaluations and offering expedited reviews to medicines that support “national interests.”
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HuffPostA string of initiatives from Makary aimed to speed up or streamline FDA drug reviews, including dropping certain study requirements, incorporating artificial intelligence into drug evaluations and offering expedited reviews to medicines that support “national interests.”
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But pharmaceutical executives rely on the predictability and consistency of FDA decisions, even more than speedy reviews. Makary’s efforts on drug reviews were overshadowed by internal conflicts and disputes that created headaches for drugmakers, investors and patients.
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Associated PressBut pharmaceutical executives rely on the predictability and consistency of FDA decisions, even more than speedy reviews. Makary’s efforts on drug reviews were overshadowed by internal conflicts and upheavals that created headaches for drugmakers, investors and patients.
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A number of specialty drugmakers studying therapies for rare or hard-to-treat diseases said they received rejection letters or requests to run additional studies for drugs that had previously been given the go-ahead by FDA staff. Those drugs were primarily overseen by Prasad, who stepped down for a second time from his role as FDA’s vaccine and biotech chief in April.
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HuffPostMore than a half-dozen drugmakers studying therapies for rare or hard-to-treat diseases said they received rejection letters or requests to run additional studies for drugs that had previously been given the go-ahead by FDA staff. Those drugs were primarily overseen by Prasad, who stepped down for a second time from his role as the FDA’s vaccine and biotech chief in April.
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Some of Makary and Prasad’s most controversial vaccine proposals never came to fruition, despite stoking confusion and anxiety within the FDA and beyond.
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Associated PressSome of Makary and Prasad’s most controversial vaccine proposals never came to fruition, despite stoking confusion and anxiety within the FDA and beyond.
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FDA’s Drug Center Had A Revolving Door In the FDA’s drug center, which is the agency’s largest division, Makary oversaw a revolving door of leadership changes. Six people served as director over the course of one year.
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Associated PressFDA’s drug center had a revolving door In the FDA’s drug center, which is the agency’s largest division, Makary oversaw a revolving door of leadership changes. Six people served as director over the course of one year.
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Makary’s initial pick for the job, Dr. George Tidmarsh, was forced to resign after allegations that he used his FDA position to pursue a personal vendetta against a former business partner.
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Associated PressMakary’s initial pick for the job, Dr. George Tidmarsh, was forced to resign after allegations that he used his FDA position to pursue a personal vendetta against a former business partner.
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His replacement, longtime FDA cancer specialist Dr. Rick Pazdur, announced he would retire after just three weeks on the job, after clashing with Makary on multiple issues involving drug reviews.
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HuffPostHis replacement, longtime FDA cancer specialist Dr. Rick Pazdur, announced he would retire after just three weeks on the job, after clashing with Makary on multiple issues surrounding drug reviews.
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With Makary’s departure, the fate of many of his fledgling initiatives is uncertain.
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Associated PressWith Makary’s departure, the fate of many fledgling initiatives is uncertain. Most of the programs Makary introduced have not gone through federal rulemaking required to enshrine them in U.S. regulations and could easily be overturned by his successors.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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Associated PressThe Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
14 details only one outlet reported
Independent claims that didn't surface elsewhere in our corpus. Treat as supplementary — not corroborated across outlets.
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01 The Daily Wire This Biden policy is the reason abortions have risen, not fallen, in the post-Dobbs era, with more than one million unborn children dying annually. Even in states with strong pro-life protections, tens of thousands of abortions persist each year, driven in large part by this unchecked spread of mail-order abortion drugs. We know 90,000 abortions are occurring annually just in the states that protect life all throughout pregnancy.
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02 Washington Examiner EXCLUSIVE — Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy (R-LA) said the new acting Food and Drug Administration commissioner, Kyle Diamantas, does not have the prerequisite expertise to oversee the agency’s complex medical device and pharmaceutical oversight.
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03 The Hill “Routine approval of these products would undermine the agency’s Flavored Electronic Nicotine Delivery Systems Premarket Applications Considerations Related to Youth Risk guidance for industry issued March with the support of the White House,” he added.
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04 Associated Press WASHINGTON (AP) — When the week began, several senior positions at the U.S. Department of Health and Human Services were already sitting empty.
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05 New York Times With a Friend in Trump, the Tobacco Industry Secures a Lucrative Win In a dispute over vapes, the president sided with tobacco companies that filled his groups’ coffers over his own F.D.A. commissioner, who resigned in protest.
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06 The Guardian US Within the agency, Diamantas is generally viewed as a non-controversial pick to temporarily lead, according to reporting from the Washington Post. Two former officials told the outlet that Diamantas was able to avoid controversy by keeping senior leadership in place at the Human Foods Program (HFP), compared to other centers which saw high turnover.
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07 The Federalist The reason for Makary’s departure was not immediately clear, but the pro-life movement quickly hailed his exit as a win and an opportunity to replace him with a motivated ally.
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08 Breitbart “Did you ask Marty Makary to resign, sir, or did you fire your FDA commissioner?” a reporter asked.
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09 USA Today Trump news, updates May 8: Iran 'trifle', Reflecting Pool motorcadeTrump-backed challengers topple Indiana GOP incumbentsDemocrats face major redistricting setbacks in Tennessee, VirginiaSee Trump motorcade drive across empty reflecting pool
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10 NPR News President Trump spoke at the White House about the expected FDA leadership change in remarks as he was preparing to leave on his trip to meet China's President Xi Jinping.
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11 NBC News 02:18 - UP NEXT Trump says he doesn't think about Americans' financial situation during Iran negotiations
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12 HuffPost Recent weeks brought fresh criticisms from other interest groups that the White House considers key to Republican chances in November elections.
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13 Fox News The resignation comes one day before Makary was set to testify in front of the Senate Appropriations Committee Wednesday.
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14 ABC News His departure was in the works after he clashed publicly with lawmakers, major pharmaceutical companies and President Donald Trump himself. He was scheduled to testify on Capitol Hill on Wednesday.
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