Pharma

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.

April 28 (UPI) — A federal judge on Tuesday sentenced Purdue Pharma to pay more than $5 billion in criminal penalties, clearing the way for the OxyContin maker to complete its bankruptcy settlement agreement and resolve thousands of opioid-related lawsuits filed against it by states, local governments, tribes and other plaintiffs.

The sentence, handed down by a federal court in Newark, N.J., comes after Purdue pleaded guilty in October 2020 to charges over its role in the opioid crisis.

Prosecutors said the Sackler family-owned company worsened the crisis that has killed hundreds of thousands across the United States by aggressively marketing its addictive drugs while downplaying the risks of overdose and addiction.

Thousands of lawsuits have been filed against the company over its role in the crisis, and Purdue filed for Chapter 11 bankruptcy in 2019 as part of an agreement to resolve them.

With Tuesday’s sentence, Purdue can be dissolved and replaced by the public benefit company Knoa Pharma, which will receive the assets and expertise of the old company to produce addiction treatments and overdose-reversal medications.

“Purdue Pharma put profits over patient health and safety,” Acting Attorney General Todd Blanche said in a statement announcing the sentence handed down by a federal court in Newark, N.J.

“The company willfully rejected the law and ignored the diversion of their highly addictive prescription drugs.”

About 806,000 people died from an opioid overdose from 1999 to 2023, according to the U.S. Centers for Disease Control and Prevention.

Court documents accused Purdue of illegally marketing its opioids from 2007 to 2017, generating billions in profit.

The penalties announced Tuesday include a $3.544 billion criminal fine and an additional $2 billion in criminal forfeiture, though the Justice Department said it will credit up to $1.775 billion against the forfeiture amount based on the value conferred to state, local and tribal governments through its bankruptcy.

“No penalty can undo the widespread devastation Purdue has inflicted, but today’s sentence serves long-overdue accountability for its reckless and unlawful conduct,” Inspector General T. March Bell of the U.S. Department of Health and Human Services said in a statement.