US F.D.A. Drug Chief Resigns Amid
Ethics Probe and Lawsuit by Pharmaceutical Firm Aurinia Pharma
The official, Dr. George Tidmarsh, has become
embroiled in an ethical dispute and is now the target of a lawsuit over his actions
involving certain drugs tied to a business associate.
Dr. George
Tidmarsh, head of the U.S. Food and Drug Administration’s drug division,
resigned on November 2, 2025, after being placed on administrative leave
amid an ethics investigation and a lawsuit alleging misconduct
involving a former business associate.
The
lawsuit, filed by Aurinia Pharmaceuticals, accuses Dr. Tidmarsh of retaliation
and extortion against investor Kevin C. Tang, who had previously
ousted him from several companies. It cites a LinkedIn post by Dr.
Tidmarsh criticizing Aurinia’s lupus drug voclosporin as “toxic” and of “little benefit,” which triggered
a 20% stock drop and allegedly cost the firm $350 million in
market value. Dr. Tidmarsh denies wrongdoing, insisting his comments were
scientifically valid and unrelated to personal disputes.
The Department
of Health and Human Services Inspector General is investigating overlapping
complaints about Dr. Tidmarsh’s conduct. He claims the review is retaliation
for his public criticism of a new fast-track drug approval program,
which he said politicized the process and undermined scientific rigor.
The
controversy comes amid broader turmoil within the Kennedy administration’s
health leadership, which has seen a string of resignations and
dismissals, including that of CDC Director Susan Monarez and
disputes involving F.D.A. scientific officer Dr. Vinay Prasad.
Dr.
Tidmarsh maintains he “gave up everything to go into government” and that his
actions at the F.D.A. targeted only unapproved drugs, not personal rivals. The
agency has not been named in the lawsuit.
Dr.
George Tidmarsh, the head of the Food and Drug Administration’s drug division, resigned
on Sunday (02.11.2025) amid an investigation into criticism he aired publicly about
a drug tied to a former business associate.
Dr.
Tidmarsh said he believed the review was opened in retaliation to concerns he raised
last week about the legal basis of a new program for the rapid approval of some
new drugs.
Dr.
Tidmarsh, a drug industry veteran who joined the agency in July, said in an interview
Sunday that he believed the new program injected politics into the drug review program,
superseding decisions based on science.
Late
on Sunday, a pharmaceutical company lodged explosive claims against Dr. Tidmarsh
in a lawsuit claiming that the regulator had acted vengefully against its board
chairman and investor, Kevin C. Tang, who had previously asked Dr. Tidmarsh to leave
several companies. The lawsuit claimed that Dr. Tidmarsh attempted to extort him.
Dr. Tidmarsh denied the allegations, saying he had no interest in revenge against
Mr. Tang, a San Diego investor.
At
the F.D.A., Dr. Tidmarsh was placed on leave Friday pending the outcome of an investigation
by the inspector general for the Department of Health and Human Services that is
looking into some of the same claims.
On
Sunday, he offered his resignation, and Emily Hilliard, an F.D.A. spokeswoman, said
it had been accepted. Ms. Hilliard said on Sunday that the administrative leave
had been imposed earlier “after the office of the general counsel and the office
of the inspector general were notified of serious concerns about his personal conduct.”
But
Dr. Tidmarsh continued to maintain on Sunday evening that he was still on administrative
leave.
Dr.
Tidmarsh said he was told Friday that the leave was related to a complaint lodged
by Mr. Tang, a major investor in Aurinia Pharmaceuticals, a Canada-based company
that makes the drug voclosporin, a treatment for a type of lupus affecting the kidneys.
The complaint involved a post that Dr. Tidmarsh wrote on LinkedIn in September that
criticized the drug as having little benefit and “significant toxicity.” Aurinia
defended the drug’s benefits over its risks in response to the post.
The
company’s stock dropped about 20 percent, but has gone up since then.
Aurinia’s
lawsuit alleges that Dr. Tidmarsh sent messages threatening revenge against Mr.
Tang, after he had asked Dr. Tidmarsh to resign from three companies.
The
lawsuit, filed in federal court in Maryland, was first reported by STAT News. The
F.D.A. was not named in the lawsuit.
Dr.
Tidmarsh said in an interview that he had not thought of Mr. Tang since starting
at the F.D.A. “He was irrelevant to me,” Dr. Tidmarsh said.
One
of the companies, American Laboratories, made ingredients for a thyroid product
that Dr. Tidmarsh “pushed F.D.A. to effectively remove” from the market within weeks
of starting work at the agency, according to the lawsuit. It also claimed that Dr.
Tidmarsh, through his lawyer, attempted to solicit a bribe by asking Mr. Tang to
continue payments from American Laboratories to a company associated with him until
2044.
Dr.
Tidmarsh said that he did not “send anything to” Mr. Tang and that he “gave up everything”
to go into government. He said he pursued the thyroid medications because they were
marketed without F.D.A. approval, something that the agency had scrutinized for
years.
The
lawsuit claims that the LinkedIn post cost Aurinia about $350 million in value.
The
tumult at the F.D.A. is just the latest in a series of ousters, firings and high-profile
disagreements under the nation’s health secretary, Robert F. Kennedy Jr. Several
of his top staff members were pushed out or resigned in recent months.
The
most high-profile so far was the firing of Susan Monarez after she had served only
a month as director of the Centers for Disease Control
and Prevention. She told senators that she was fired after she had refused to sign
off on recommendations from Mr. Kennedy’s vaccine advisory panel, which he has filled
mainly with vaccine skeptics.
In
the interview, Dr. Tidmarsh also described a “toxic environment” that he attributed
to Dr. Vinay Prasad, the F.D.A.’s chief medical and scientific officer, who also
oversees vaccines and gene therapies. Dr. Prasad had frustrated scientists within
the agency for overriding some staff decisions on drugs and also on Covid vaccines.
He was ousted from the agency in July but brought back.
Dr.
Tidmarsh said his concerns stemmed from the F.D.A.’s announcement in mid-October
that it would approve a slate of drugs in record time. The program was meant to
convey quick authorizations to drugs that reflected the administration’s priorities,
which included addressing unmet medical needs or supporting lower pricing. Candidates
for the program included a drug meant to help people break their addiction to vaping
and another meant to help children who were born deaf.
“The
effort was going to basically change the entire paradigm of the legal underpinnings
of drug approvals that have for decades supported the actions on the safety and
effectiveness of drugs,” Dr. Tidmarsh said. “There was insufficient legal support
for what they wanted to do, and so I didn’t agree.”
Dr.
Tidmarsh said the issue came to a head last week when officials met to make the
agency’s first official decision under the new program. The process would typically
take months, with extensive review and formal opportunities for debate among agency
scientists. But at the meeting, officials were expected to decide in a day.
“I
didn’t know the legal underpinnings so all I did is say, ‘I don’t think this is
a decision,’” he said. “‘I see this as practice run,’ because no one had given anything
about the process, the legality of it.”