antiabortion

WASHINGTON — 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 Trump.

He steps down after just over a year leading the powerful health regulatory agency, according to a White House official who was not authorized to speak before an announcement expected Tuesday and requested anonymity.

Kyle Diamantas, the agency’s chief for foods, will take over as acting commissioner, the official said. Diamantas is an attorney with personal ties to Donald Trump Jr.

A surgeon and health researcher, Makary came to prominence among Republicans as an outspoken critic of COVID-19 health measures during the pandemic when he frequently appeared on Fox News.

But he struggled to manage the FDA’s bureaucracy and failed to win the confidence of its staff after mass layoffs, leadership changes and a series of controversies in which the agency’s scientific principles appeared to be overridden by political interests, including those of Health Secretary Robert F. Kennedy Jr.

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.

Makary 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.

Virtually all of the FDA’s senior career officials resigned, retired or were forced out in the first year of the second-term Trump administration, leading to a steady stream of leaks and negative stories in the media cataloging low morale, dysfunction and frustration among staff.

Makary’s handpicked deputy, Dr. Vinay Prasad, was pushed out of the agency twice in less than a year for running afoul of specialty drugmakers and groups for patients with rare diseases. Makary appeared poised to weather the controversy, despite an ongoing pressure campaign calling on Trump to fire him.

Recent months brought fresh criticisms from other interest groups that the White House considers key to Republican chances in November elections.

Anti-abortion groups have criticized Makary for allegedly slow-walking an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target for conservative activists.

Vaping executives told Trump that Makary was blocking approval of their products, including new flavored e-cigarettes seen as crucial to the industry’s survival.

Last week, the agency abruptly changed course on vaping: authorizing the first fruit-flavored products and issuing guidelines that loosened marketing for major manufacturers. But it wasn’t enough to keep Makary in the job.

A permanent replacement for FDA commissioner will need to be nominated by Trump and confirmed by a majority vote in the Senate.

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.

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.”

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 upheavals that created headaches for drugmakers, investors and patients.

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 previously had 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.

Vaccine moves denounced

Prasad repeatedly overruled vaccine staffers to restrict eligibility for new COVID shots. In February, Prasad initially refused to even consider Moderna’s mRNA shot for flu. The FDA was forced to reverse itself after Moderna pledged to formally challenge the decision and called for intervention by the White House.

Some of Makary and Prasad’s most controversial vaccine proposals never came to fruition, despite stoking confusion and anxiety within the FDA and beyond.

In an internal memo in November, Prasad claimed — without publishing evidence — that the FDA had linked COVID shots to the deaths of 10 children. Prasad used that to justify a planned wholesale overhaul of the agency’s approach to approving and updating vaccines.

A dozen former FDA commissioners issued a scathing denunciation of the plan, warning that it would “undermine the public interest” and decimate vaccine development. The FDA has not released its analysis of the deaths or its plan for the vaccine overhaul.

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.

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.

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.

With 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.

Democrats in Congress have questioned the legality of some of those efforts, including a program that offers drugmakers expedited reviews for innovative medicines.

Perrone and Kim write for the Associated Press.

WASHINGTON — The Trump administration fired four Justice Department prosecutors involved in cases against anti-abortion activists, accusing the Biden administration on Tuesday of abusing a law designed to protect abortion clinics from obstruction and threats.

The firings are the latest wave of terminations of employees involved in cases criticized by conservatives or because they were perceived as insufficiently loyal to President Trump’s agenda. The terminations came before the release of a report accusing the Biden administration of biased prosecutions under the Freedom of Access to Clinic Entrances Act or FACE Act.

“This Department will not tolerate a two-tiered system of justice,” Todd Blanche, the acting attorney general, said in a statement. “No Department should conduct selective prosecution based on beliefs. The weaponization that happened under the Biden Administration will not happen again, as we restore integrity to our prosecutorial system.”

The report is the first released from the Justice Department’s “Weaponization Working Group,” created by former Atty. Gen. Pam Bondi to scrutinize the federal prosecutions of Trump and other cases criticized by conservatives.

Biden’s attorney general, Merrick Garland, and Jack Smith, the special counsel who prosecuted Trump, have said they followed only the facts, the evidence and the law in their decisions. Critics of the Trump administration say Bondi — who was fired by Trump this month — and Blanche are the ones who politicized the agency, with the norm-breaking actions that have stirred concern that the institution is being used as a tool to advance Trump’s personal and political agenda.

The Biden administration brought cases against dozens of defendants under the FACE Act, which makes it illegal to physically obstruct or use the threat of force to intimidate or interfere with a person seeking reproductive health services, and prohibits damaging property at abortion clinics and other centers. It was signed into law in 1994, when clinic protests and blockades were on the rise along with violence against abortion providers such as Dr. David Gunn, who was murdered.

The Trump administration alleges in the report that prosecutors under Biden often “ignored and downplayed” attacks against pregnancy resource centers or houses of worship, which are also protected under the law. It also claims that the Biden administration pushed for harsher sentences against anti-abortion activists than it did in cases against abortion-rights defendants. Trump last year pardoned anti-abortion activists convicted of blockading abortion clinic entrances, calling them “peaceful pro-life protesters.”

Kristen Clarke, who led the Justice Department’s Civil Rights Division under Biden, defended the prosecutions, saying the attorneys “enforced the law even-handedly and put public safety at the center of this work.”

“The Civil Rights Division brought law enforcement leaders, crisis pregnancy center representatives, faith leaders, and reproductive health care staff together to address the real violence, threats of violence, and obstruction that too many people face in our country when it comes to reproductive health care,” Clarke said in an emailed statement on Tuesday.

The firings are part of a broader personnel purge that has shaken career Justice Department lawyers generally insulated from changes in administrations thanks to long-recognized civil service protections.

Justice Connection, a network of former department employees, said the agency leadership’s “cruelty and hypocrisy are on full display in this report.”

“They insist on zealous advocacy by career staff in advancing the President’s priorities, while shaming and firing those who did just that in the prior administration,” Stacey Young, a former department lawyer who founded Justice Connection, said in a statement. “They’ve put career employees on notice: if they do their jobs, they face potential termination if future political leadership disagrees with the policy goals of prior leadership.”

Richer writes for the Associated Press.