The woman now running the FDA’s powerful drug center presented a colleague’s research as her own, agency staffers say, then moved to hire that colleague and press for faster review of his petition seeking a new warning label on antidepressants used by millions of pregnant women.
The arrangement has triggered conflict-of-interest alarms at the Food and Drug Administration, where Dr. Tracy Beth Hoeg is pushing to add a boxed warning to SSRIs, the most widely prescribed antidepressants in America, over the objections of reproductive psychiatrists who say the science simply isn’t there, the Associated Press reported.
Dr. Adam Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, is pressing the FDA to add a boxed warning to SSRIs, the drugs most commonly prescribed for depression. Dr. Urato’s petition says the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children.
That proposed labeling change has become a top priority for Dr. Hoeg, who regularly consults with Dr. Urato and is working to bring him on as a full-time FDA employee, according to the AP.
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Within the agency, Dr. Hoeg’s close relationship with Dr. Urato is viewed by some FDA staffers as a potential conflict of interest that they said would typically prompt a recusal review, according to the AP. But Dr. Hoeg is actively working to speed up the agency’s review of his proposal, the wire service reported.
Outside experts said the petition relies on what they described as flimsy data, including animal studies and small trials in people, according to the AP. They fear a new FDA warning could cause pregnant women to stop medication unnecessarily, leading to serious health risks from untreated depression.
“A black box warning is a big red flag with both practitioners and patients,” said Dr. Jennifer Payne, a University of Virginia reproductive psychiatrist. “What’s missing in this petition is an understanding of the risks of maternal mental illness during pregnancy, not just to the woman, but to the pregnancy and ultimately the infant.”
The FDA is legally required to respond in writing to each citizen petition and explain its reasons for granting or denying the request.
SSRIs include most of the bestselling depression medications, including Prozac, Paxil, Zoloft and their generic equivalents.
More than 15% of U.S. women take medication for depression, according to federal figures. Professional guidelines state that antidepressants are generally safe during pregnancy and should be discontinued only after careful consultation with a doctor.
Last fall, Dr. Hoeg gave a talk on the SSRI petition to top FDA drug officials, presenting the work as her own, according to the AP. Staffers who reviewed her slides said they were created by Dr. Urato, according to people who spoke to the wire service on condition of anonymity to discuss confidential FDA matters. The incident was first reported by STAT News.
Dr. Urato said in an email Wednesday that Dr. Hoeg is “an excellent scientist,” and that they have known each other for several years.
“I am friendly with her, as I am with many colleagues, but we do not have a longstanding personal friendship that would in any way prevent her from reviewing the citizen petition,” Dr. Urato said.
A spokesman for the Department of Health and Human Services, which oversees the FDA, said that the agency would respond directly to Dr. Urato about his petition.
In January, Dr. Urato was named to the Centers for Disease Control and Prevention’s panel on vaccine recommendations, which has been overhauled by Health Secretary Robert F. Kennedy Jr. to include several members who have criticized vaccine policy.
The latest COVID-19 contrarian elevated into FDA’s leadership
The antidepressant review is the latest in a series of controversial topics taken up by Dr. Hoeg, a sports medicine physician whom the AP reported has no previous government or management experience.
During the COVID-19 pandemic, Dr. Hoeg attracted attention as a critic of masking, vaccine mandates and other public health measures. She co-wrote papers with medical contrarians who would go on to join the Trump administration, including FDA Commissioner Marty Makary and FDA’s biologics chief, Dr. Vinay Prasad, the AP reported. All three have become top surrogates for Mr. Kennedy.
Before the pandemic, Dr. Hoeg had published only a handful of medical papers, including one on health issues affecting ultramarathon runners, according to the AP.
A Danish-American citizen and marathon runner, Dr. Hoeg played a key role in the Republican administration’s recent decision to drop a number of vaccine recommendations for children — a change she has long proposed, to bring the United States more in line with Denmark.
Like many critics of vaccines, including Mr. Kennedy, Dr. Hoeg has also been skeptical of antidepressants, questioning their safety and benefits. Last July, she hosted a panel of outside experts at the FDA on SSRIs that included Dr. Urato and nine other critics of the drugs.
“Never before in human history have we chemically altered developing babies like this, especially the developing fetal brain, and this is happening without any real public warning,” Dr. Urato said at the meeting.
On a podcast shortly afterward, Dr. Hoeg echoed many of Dr. Urato’s points.
“I think women should be informed about the potential risks so that they have time to come off SSRIs if they want to when they’re trying to get pregnant,” Dr. Hoeg told the hosts of the Mom Wars podcast.
FDA officials typically avoid making public comments about matters under review because it could suggest the agency is basing its decision on individual opinions, rather than science.
But Dr. Hoeg has taken a hands-on approach to the SSRI petition, telling FDA staffers that their proposed review timeline of nine months needed to be shortened, according to people familiar with the situation who spoke to the AP.
Reviewing a citizen petition involves detailed analysis of scientific references, legal issues and a number of other steps to ensure that the agency’s final decision can be defended in court.
“Apart from it serving FDA’s public health mission, there’s always going to be some concern about legal risk if the agency doesn’t take sufficient time to consider all the relevant data and arguments,” said Patti Zettler, a former FDA attorney now at Ohio State University’s law school.
Dr. Hoeg was tapped to lead the FDA’s drug center in December, inheriting the job during a period of unprecedented upheaval, including layoffs, buyouts and leadership changes, the AP reported. She is the sixth person to lead the 5,000-person center in the past year, according to the wire service.
Staffers did not hear from Dr. Hoeg directly until a town hall last month, where she voiced her concerns about the safety of SSRIs and injectable RSV shots for children, a class of drugs that the FDA is reviewing at her request, the AP reported. RSV is a respiratory virus that sends thousands of children in the United States to the hospital each year.
Antidepressant questions clouded by other health factors
The safety of antidepressants has been scrutinized for decades, leading to several updates to their FDA label, including the addition of a black box warning about the risk of suicidal behavior in children.
For pregnant women, the current label lists a number of documented safety issues, including risks of excess bleeding after giving birth.
Doctors who treat women with depression say they discuss those risks with their patients, balancing the possible safety issues against the potential harms of relapsing into depression: self-harm, substance abuse and other behaviors that negatively impact women and fetuses.
Researchers who have reviewed Dr. Urato’s SSRI petition said many of the studies claiming to show connections to disorders such as autism don’t take into account other important health factors, according to the AP. For example, women with depression have higher rates of smoking, diabetes and family histories of mental illness that can all increase the likelihood of developmental disorders.
“So how do we say that these outcomes are a result of the SSRI when all of these other factors are at play?” said Dr. Amritha Bhat, a University of Washington perinatal psychiatrist.
Dr. Bhat and other researchers say they support more research into the effects of SSRIs, and they acknowledge possible downsides to their use.
“But in the meantime we need to provide options to people that are struggling with these symptoms during pregnancy,” she said. “We cannot just ask them to white knuckle their way through it.”
What is a boxed warning?
A boxed warning — also known as a black-box warning — is the FDA’s most serious caution short of pulling a drug from the market entirely. Printed inside a black border on a drug’s label, it is designed to alert physicians and patients to severe or life-threatening risks, and in practice it carries significant weight in prescribing decisions.
The consequences of such warnings can be far-reaching. When the FDA added a boxed warning to antidepressants in 2004 linking them to suicidal thoughts in children and adolescents, prescriptions for the drugs in that age group fell sharply in the years that followed. Researchers later reported increases in suicide attempts among young people during the period when prescribing declined; experts have debated how much of that trend can be attributed to the warning itself and how much to related media coverage and public concern.
Studies show that roughly half of women already discontinue their antidepressants before or during pregnancy, often driven by a generalized fear of medication use during gestation — meaning a new federal warning could accelerate a trend that doctors say is already putting patients at risk.
The Associated Press’ Matthew Perrone contributed to this report.
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