High-Level Changes and Layoffs at FDA Spark Controversy

Key Points:

FDA Layoffs and Leadership Changes:

The FDA conducted widespread layoffs, removing Brian King, head of the Center for Tobacco Products, and dismissing dozens of experts.

Nearly all senior FDA officials have changed in recent months, mainly through resignations and retirements.

Tobacco Regulation Controversy:

Brian King faced criticism for banning fruit- and candy-flavored e-cigarettes, though youth vaping rates have dropped to a 10-year low.

The FDA has rejected millions of flavored e-cigarette applications, leading to multiple lawsuits, one of which has reached the Supreme Court.

Challenges for the New Commissioner:

New FDA Commissioner Marty Makary inherits a workforce lacking top experts and must navigate the consequences of the layoffs while shaping tobacco policy.

E-Cigarette Industry Reactions:

The Vapor Technology Association welcomed Brian King’s removal, calling it a first step toward correcting FDA’s regulatory missteps.

Tobacco and e-cigarette companies have criticized the FDA for its slow approval process, particularly for low-risk products.

Other High-Level Departures:

Several senior officials have recently left or retired, including Deputy Commissioner for Human Foods Jim Jones and Director of the Center for Drug Evaluation and Research Dr. Patrizia Cavazzoni.

According to an April 2 report by the Associated Press, the US Food and Drug Administration (FDA) recently conducted a comprehensive downsizing operation, resulting in the dismissal of tobacco regulation chief Brian King on Tuesday, April 1st. This action has affected top experts in various fields such as food, drugs, vaccines, and nicotine-containing products.

Brian King, the head of the FDA Center for Tobacco Products (CTP), wrote in an email to his team,

"It is with a heavy heart and profound disappointment that I share I have been placed on administrative leave."

Dozens of other employees in FDA’s tobacco center also received notices Tuesday morning that they were being dismissed, including two entire offices responsible for drafting new tobacco regulations and setting policy.

The FDA’s former tobacco chief Mitch Zeller said in an interview,

"If you make it virtually impossible to create and draft policy, then you are eviscerating the role of the center. From a public health perspective it makes absolutely no sense."

Elsewhere at the FDA, the entire press office was also given notice. Senior officials who help oversee new drug reviews and vaccines were also let go, according to FDA staffers who spoke on condition of anonymity because they did not have permission to speak publicly.

In 2022, King, who joined the FDA, faced strong criticism from e-cigarette lobbyists for forcing thousands of companies to remove fruit and candy flavored e-cigarettes from the market. During his tenure, the proportion of American teenagers using e-cigarettes has dropped to a new low in 10 years.

His removal comes just days after FDA vaccine chief Dr. Peter Marks was forced out, citing Health Secretary Robert F. Kennedy Jr.'s support for vaccine “misinformation and lies” in his resignation letter.

This latest change indicates that in recent months, there have been almost complete turnovers in the top leadership of the FDA, responsible for regulating drugs, food, vaccines, medical devices, and tobacco products, mainly through resignations and retirements.

Former FDA Commissioner Robert Califf wrote online, “history will see this as a huge mistake.”

"The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed," said Califf, who stepped down at the end of the Biden administration.

Kennedy is preparing to dismiss 3,500 FDA employees and advance plans to review highly processed foods, children's vaccines, antidepressants, and other longstanding products, all while facing leadership vacancies at the FDA.

This wave of resignations signifies that the newly appointed FDA Commissioner, Marty Makary, confirmed last week, will be taking over an agency lacking many top experts and a staff team that has been in turmoil following weeks of layoffs and chaotic rehiring processes. Only a few FDA employees are political appointees, with the majority of the agency's scientific reviews and decisions being overseen by career officials.

During the confirmation hearing, Makary told Senate members that he hopes to "evaluate the recent layoffs during the probation period".

Both Makary and Kennedy did not elaborate much on how tobacco policy would be integrated into their "Make America Healthy Again" plan. Despite smoking rates being at historic lows, tobacco-related diseases still remain a leading preventable cause of death in the United States, resulting in over 490,000 deaths each year.

In recent years, CTP has been under pressure from various critics. Politicians, parents, and anti-tobacco groups are urging the FDA to further crack down on unauthorized e-cigarette products, which may appeal to young people, many of which come from China. Tobacco and e-cigarette companies argue that the FDA is approving new products targeted towards adult smokers (including e-cigarettes) too slowly, with the risks of these products often being much lower than traditional cigarettes.

Under King's leadership, the FDA has refused to approve applications for millions of flavored e-cigarettes, citing a lack of data to prove that these products help adult smokers. These rejections have led e-cigarette manufacturers to file multiple lawsuits against the FDA, one of which is scheduled to be heard by the Supreme Court in December 2024.

The Vapor Technology Association, which holds a highly critical stance towards Jin's leadership, stated that king's dismissal "is the first step in correcting the broken mindset that has crippled the FDA and the Center for Tobacco Products over the past four years."

Other recent departures of FDA leaders include:

— Deputy commissioner for foods, Jim Jones, who resigned in February after dozens of his staffers were fired.

— The director of FDA’s drug center, Dr. Patrizia Cavazzoni, who stepped down days before President Donald Trump took office.

— The agency’s second-ranking official, Dr. Namandje Bumpus, who resigned late last year.

— FDA’s longtime medical devices director, Dr. Jeffrey Shuren, who retired last summer.

Many deputies and senior scientists have also retired or stepped down in recent weeks.