Makary, Hoeg Out at FDA; New ACIP Rules Established

The FDA has experienced a shakeup, with Director Marty Makary resigning after reports that he would be ousted, and Tracy Beth Hoeg being fired from her role as head of the Center for Drug Evaluation and Research (CDER). MAHA advocates are concerned that their influence is being lost in the Department of Health and Human Services (HHS), which is still led by Secretary Robert F. Kennedy Jr. The American Academy of Pediatrics is locked in a court battle with Kennedy that has temporarily reversed the ACIP panel’s decisions made in meetings last year and the CDC vaccine schedule changes made in January. A new Federal Register notice has been published to establish a new ACIP vaccine panel.

Director Makary moved the agency away from universal approval of COVID-19 vaccine boosters. He also supported former Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad in his push to require placebo trials for new COVID-19 vaccines. Director Makary also supported the removal of artificial food dyes, reviews of food additives, and supported Secretary Kennedy’s goal of moving consumption habits away from ultra-processed foods in America.

One point of criticism against Director Makary within the Trump administration and amongst President Trump’s supporters is that Makary hasn’t conducted a fast review process of the chemical abortion pill Mifepristone. Two-thirds of abortions in the United States are from chemical pills that can be sent via mail to states with abortion bans. The Supreme Court ruled last week that mail access to Mifepristone will continue during Louisiana’s court case against the FDA.

Kyle Diamantas has been named as the acting FDA director following Makary’s resignation. Diamantas said reviewing the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone is a top priority. “Acting Commissioner Kyle Diamantas is personally committed to delivering on President Trump’s pro-life and pro-family agenda at the FDA,” said HHS Spokesperson Andrew Nixon. “Both he and other administration officials will continue regularly interacting with stakeholders in this community to inform FDA decision-making,” he said.

Diamantas was on the phone with pro-life organizations and promised to be the most pro-life FDA director ever. Diamantas represented Planned Parenthood in a property dispute case, but said he asked to be taken off the case due to his moral opposition to abortion.

No official statement was made by Secretary Kennedy, President Trump, or media releases regarding the reasons for Makary’s departure. There were articles suggesting Makary would be fired in the week leading up to his resignation, and he has not made any statements regarding the reasons for his exit.

The exit of Makary and Hoeg is less than a month after Prasad officially left his position as CBER director. The administration faced criticism from drug manufacturers for delayed reviews and unpredictable shifts in guidance under Makary’s leadership.

The Trump administration has maintained a strong relationship with pharmaceutical manufacturers, including through the creation of TrumpRx and “most favored nation pricing.” A recent report from Open Secrets notes that the 17 manufacturers involved in TrumpRx increased their 2025 lobbying expenditures by 26%, which outpaced the rest of the industry. The majority of the lobbyists working on behalf of these companies are “revolving door” lobbyists who once held government positions.

Hoeg told Maryanne Demasi that she was asked to resign and would be fired if she refused. According to Hoeg, the officials who asked for her resignation said the call came from “someone way above their pay grade.” Hoeg gave a presentation in December at the ACIP meeting comparing the U.S. childhood vaccine schedule with that of Denmark. In January, the CDC updated the vaccine schedule to align more closely with Denmark’s, but those revisions are now on hold pending the AAP’s court case against Secretary Kennedy.

“Marty and I, and Vinay [Prasad] as well, I think we all leave holding our heads high because we refused to bow to political pressure and to pressure from lobbyists to do things in order to keep our jobs or protect our reputations,” Hoeg said during an interview with Demasi.

Hoeg stands behind her work at the agency. She said she followed the science throughout all the decisions and did not cave to pressure. Hoeg added that the perceived chaos occurring in the FDA was manufactured by the media.

HHS is working to reestablish the ACIP committee and updated the charter to allow for a diverse range of experts to serve on the panel, including those “who are knowledgeable in the fields of medicine, vaccines, immunization practices, immunology, toxicology, pediatric neurodevelopment, epidemiology, data science, statistical analysis, health economics, recovery from serious vaccine injuries, or public health.” The new charter requires the committee to identify “gaps in vaccine safety research” and evaluate cumulative vaccine exposures, vaccine, ingredients, international schedules and novel platforms. Many of the updates to the charter reflect suggestions sent to Secretary Kennedy by Attorney Aaron Siri on behalf of the Informed Consent Action Network (ICAN).

The updated ACIP charter and federal register notice constitute a procedural reset that addresses the AAP’s allegations that previous ACIP members lacked the required expertise. Secretary Kennedy can now start vetting people with appropriate expertise to serve on the new ACIP panel. No official announcement or timeline has been established.