drug administration

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 Food and Drug Administration will hold a meeting in the summer to consider easing restrictions on more than a half-dozen peptide injections, a group of unapproved therapies that have become popular among wellness influencers, fitness gurus and celebrities.

The meeting announcement Wednesday follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger. There’s little research behind those claims and most peptides have not been reviewed for safety by the FDA.

Kennedy has discussed using peptides for his own injuries. And some major supporters of his Make America Healthy Again movement are big proponents of them, including Gary Brecka, a self-described “longevity expert” who sells various peptide formulas through his website.

The FDA said in a federal notice Wednesday that it will ask a panel of outside advisors to review seven peptides at a meeting in July, specifically whether they should be added to a list of substances that can be safely produced by pharmacies. In the meantime, the agency said it would soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs. The peptides under discussion include some of the most popular among influencers, such as BPC-157, which is marketed to heal injuries and reduce inflammation.

“The Wild West is about to become wilder,” said Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, Lurie said allowing peptides on the market without clinical testing poses a “profound threat” to FDA’s decades-old system for vetting drugs.

“I don’t see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” he said.

Under President Biden, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies — businesses that mix medications that aren’t available from drugmakers.

At the time, the FDA’s panel of pharmacy advisors voted overwhelmingly that the peptides did not meet the criteria for substances that can be safely compounded. And FDA regulators agreed, saying later that the substances “present significant safety risks,” because most have not been extensively tested in humans.

Many of the FDA advisors and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has a number of vacancies, which Kennedy could fill before the July meeting.

Kennedy previewed Wednesday’s move in an interview with podcast host Joe Rogan. Both men have repeatedly spoken about peptides and claimed to have benefited from their use.

RFK Jr. claims personal benefit from peptides

“I’m a big fan of peptides,” Kennedy told Rogan. “I’ve used them myself and with really good effect on a couple of injuries.”

Given Kennedy’s statements, Lurie said it was doubtful the drugs would receive real scrutiny from FDA.

“Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”

Scott Brunner of the Alliance for Pharmacy Compounding said the coming meeting will be the start of a “protracted process.” Even if the panel votes to make the peptides available, and the FDA agrees, the agency will still have to draft and publish rules on the change, he noted.

Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger hormones needed for growth, metabolism and healing.

In recent years peptides have become widely known through the blockbuster success of GLP-1 medications, which the FDA has approved for treating obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based drugs for several medical conditions.

But many of the peptides promoted online have never been approved, making them technically illegal to market as drugs. Several peptides, such as BPC-157 and TB-500, are banned by international sports authorities as doping substances.

But that has not stopped them from gaining a foothold in the burgeoning marketplace for wellness hacks and alternative remedies.

“I think this is a disaster in the works,” said Dr. Eric Topol of Scripps Research Translational Institute, who has studied the issue. “These peptides have no data to support their safety and efficacy.”

Meanwhile, some dietary supplement makers have begun mixing peptides into capsules, protein powders and gummies. At a recent FDA meeting, the industry argued for expanding the federal definition of supplements to permit the use of newer ingredients such as peptides in their products.

Safety risks were cited previously

When the FDA added a number of injectable peptides to its list of restricted substances in 2023, it cited safety risks including cancer and liver, kidney and heart problems.

That triggered pushback from wellness entrepreneurs, compounding pharmacies and their allies in Washington.

Last year several members of Congress, including Republican Sen. Tommy Tuberville of Alabama, sent letters to Kennedy asking him to lift limits on peptide production.

Some in the compounding industry argue that FDA restrictions have given rise to an illicit market of imported chemicals from China and other countries, which are not subject to U.S. drug standards.

Kennedy has echoed those concerns.

“With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.”

Perrone writes for the Associated Press.