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FDA's top drug regulator resigns after federal officials probe 'serious concerns'

FDA's top drug regulator resigns after federal officials probe 'serious concerns'
FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION, OVER 3000 FROM THE FOOD AND DRUG ADMINISTRATION. MORE THAN A THOUSAND FROM THE NATIONAL INSTITUTES OF HEALTH, 300 FROM THE CENTERS FOR MEDICARE AND MEDICAID SERVICES, AND THOUSANDS OF OTHERS FROM WITHIN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. THE TRUMP ADMINISTRATION IS SLASHING THE AGENCIES RESPONSIBLE FOR HEALTH AND FOOD SAFETY IN AMERICA. DOCTOR ASHISH JHA IS THE DEAN OF THE BROWN UNIVERSITY SCHOOL OF PUBLIC HEALTH. THANK YOU FOR JOINING ME. THANKS FOR HAVING ME. LET’S HOP RIGHT INTO THIS. THERE ARE LOTS OF THINGS THESE AGENCIES ARE KIND OF MANAGING BEHIND THE SCENES. ABSOLUTELY. AND WE DON’T THINK ABOUT THEM BECAUSE THEY GENERALLY WORK PRETTY WELL. SO FOR INSTANCE, YOU MIGHT HAVE GRANDMA IN A NURSING HOME. THAT NURSING HOME NEEDS TO BE INSPECTED. THE FEDERAL GOVERNMENT HAS INSPECTORS THAT ACTUALLY GO INTO NURSING HOMES TO MAKE SURE THAT THEY’RE MEETING FEDERAL STANDARDS. WE HAVE MANUFACTURING PLANTS THAT MAKE ALL OF OUR DRUGS. WE SEND IN INSPECTORS INTO THOSE PLANTS TO MAKE SURE THAT THERE’S NOT ADULTERATED MEDICINES COMING OUT OF THOSE PLANTS. SO THERE’S A LOT OF WORK HAPPENING BEHIND THE SCENES THAT MAKES IT EASY FOR US TO GO ABOUT OUR DAILY ACTIVITY, NOT WORRYING ABOUT WHETHER THE MEDICINES WE’RE TAKING OR THE FOOD WE’RE EATING IS SAFE OR NOT. WHO EXACTLY ARE THE PEOPLE WHO ARE BEING LAID OFF? UNFORTUNATELY, EVERYTHING WE HAVE SEEN SO FAR SHOWS ME TWO THINGS. WE’RE LAYING OFF SOME OF THE BEST PEOPLE IN THESE AGENCIES, THE EXPERTS WHO’VE BEEN THERE FOR A LONG TIME, WHO REALLY UNDERSTAND THEIR WORK. AND THE SECOND IS PEOPLE WHO DO THOSE CRITICAL SERVICES, LIKE INSPECTING NURSING HOMES, LIKE INSPECTING MANUFACTURING PLANTS FOR MEDICINES. SO THESE CUTS ARE INDISCRIMINATE. AND I REALLY WORRY THEY’RE GOING TO HAVE A VERY NEGATIVE IMPACT ON THE HEALTH AND SAFETY OF AMERICANS. DOES HHS HAVE A WIDE NETWORK OF THINGS THAT WILL IMPACT, SAY, THE STATES, EVEN THOUGH WE’RE TALKING ABOUT FEDERAL LAYOFFS? YEAH. SO FIRST OF ALL, THE PUBLIC HEALTH BUDGETS OF YOUR STATE OF OF TOWNS, A LOT OF THAT IS MONEY COMING FROM THE CDC THAT IS GOING TO DRY UP. AND THAT MEANS WE WILL SEE LAYOFFS IN THE PUBLIC HEALTH INFRASTRUCTURE OF CITIES AND STATES. THE SECOND IS WHEN YOU THINK ABOUT OUTBREAKS, WHEN YOU THINK ABOUT THINGS THAT THE CDC HELPS MANAGE, THEY’RE BRINGING IN PRIVATE COMPANIES. SO IF YOU’RE GOING TO BRING TESTS, THE CDC SOMETIMES HAS ITS OWN TESTS, BUT OFTEN THEY WILL BUY THOSE TESTS FROM PRIVATE COMPANIES. IF THOSE PROGRAMS ARE ALL BEING CUT. NOT ONLY ARE THE CDC EMPLOYEES AFFECTED, NOT ONLY ARE THE STATE EMPLOYEES AFFECTED, BUT THE COMPANIES THAT SUPPLY THE TESTS OR SUPPLY THE TREATMENTS THEY’RE LOSING BUSINESS. THE SECRETARY OF HEALTH AND HUMAN SERVICES, ROBERT KENNEDY JR, HAS SAID YOU HAVE TO DO MORE WITH LESS. THAT’S THE QUOTE. DO YOU THINK THAT’S POSSIBLE? WELL, IT DEPENDS A LOT ON WHO’S BEING LAID OFF. WHEN YOU PUT PRESSURE ON PEOPLE TO LEAVE, THE BEST PEOPLE, THE PEOPLE WHO HAVE OPTIONS ELSEWHERE IN THE PRIVATE SECTOR OR IN IN UNIVERSITIES, THEY’RE THE FIRST ONES TO LEAVE. SO I WORRY ABOUT THE QUALITY OF THE WORKFORCE THAT WE WILL END UP WITH. AND, YOU KNOW, WE’VE ACTUALLY MADE A LOT OF PROGRESS ON A LOT OF HEALTH ISSUES. WE HAVE TURNED THE OPIOID EPIDEMIC AROUND. IT’S STARTING TO COME DOWN. WE ARE STARTING TO SEE GAINS IN CANCER AND HEART DISEASE MORTALITY. I WORRY THAT THOSE THINGS WILL STALL AND WE WILL NOT CONTINUE MAKING THE PROGRESS WE NEED TO MAKE. TO WHAT DEGREE DO YOU THINK THE U.S. COULD LOSE ITS POSITION AS A LEADER, SORT OF, IN BIOMEDICAL SCIENCE, WITH WHAT IS HAPPENING KIND OF ON THE WORLD STAGE? BIOMEDICAL SCIENCE HAS BEEN THIS HUGE BOON FOR AMERICA IN TERMS OF GENERATING JOBS, GENERATING TREATMENTS THAT HAVE HAD BIG IMPACTS ON PEOPLE’S HEALTH, NOT JUST FOR AMERICA, BUT THEN WHEN THOSE TREATMENTS GET OUT INTO THE WORLD, THEY OBVIOUSLY MAKE EVERYBODY ELSE’S HEALTH BETTER AS WELL. BUT IT ALSO GIVES US THIS HUGE INTELLECTUAL ADVANTAGE IN TERMS OF SOFT POWER. PEOPLE LOOK TO AMERICA. PEOPLE WANT TO COME TO AMERICA TO DO THAT NEXT GENERATION OF CUTTING EDGE RESEARCH THAT GENERATES A LOT OF WEALTH FOR OUR COUNTRY. AS WE’RE MAKING THESE CUTS. CHINA RIGHT NOW IS MAKING MASSIVE INVESTMENTS IN ITS BIOMEDICAL INFRASTRUCTURE BECAUSE IT BELIEVES THAT AS AMERICA WITHDRAWS, IT CAN STEP IN, TAKE THAT INTERNATIONAL LEADERSHIP ROLE. OUR BENEFITS ARE SUBSTANTIAL FROM THAT LEADERSHIP. BUT I WORRY WE’RE TURNING OVER THAT LEADERSHIP TO CHINA. DOCTOR ASHIS
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Updated: 8:16 AM EST Nov 3, 2025
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FDA's top drug regulator resigns after federal officials probe 'serious concerns'
AP logo
Updated: 8:16 AM EST Nov 3, 2025
Editorial Standards
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California's pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical's products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It's very unusual for an FDA regulator to single out individual companies and products in public comments online.According to the company's lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

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“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.

The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.

Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California's pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.

The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.

In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical's products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It's very unusual for an FDA regulator to single out individual companies and products in public comments online.

According to the company's lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.

Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.

Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.

The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

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