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Continue LogoutHHS Secretary Robert F. Kennedy Jr. on Monday announced several initiatives aimed at reining in the prescription of selective serotonin reuptake inhibitors (SSRIs), the most widely prescribed class of antidepressants, in today's roundup of the news in healthcare politics.
HHS Secretary Robert F. Kennedy Jr. on Monday announced several initiatives aimed at reining in the prescription of SSRIs, the most widely prescribed class of antidepressants, which he argued are exceptionally hard to quit.
SSRIs were introduced 40 years ago and surged in popularity partly because they had fewer side effects than previous antidepressants and could be prescribed by general practitioners. In 2026, 16.6% of all U.S. adults reported currently taking an SSRI. But while doctors have typically told patients that going off SSRIs is straightforward, many patients have reported withdrawal symptoms.
The new initiatives introduced by HHS include new trainings, reimbursement mechanisms, and clinical guidelines aimed at pushing healthcare providers to help patients stop taking SSRIs and consider nonpharmaceutical interventions like therapy, nutrition, and exercise.
"Psychiatric medications have a role in care, but we will no longer treat them as the default, we will treat them as one option, to be used when appropriate, with full transparency and with a clear path off when they are no longer needed," Kennedy said.
"Let me be clear: If you are taking psychiatric medication, we are not telling you to stop," he added. "We are making sure you — and your clinician — have the information and support to make the right decision for you."
Marketa Wills, CEO and medical director of the American Psychiatric Association (APA), said that while she "may take issue with this blanket 'overprescribing' hypothesis that underpins the secretary's statements," she welcomed Kennedy's focus on mental health and hopes to be involved in developing clinical guidelines around deprescribing.
"We, as the APA, want to be at the table for all these discussions and policy improvements," she said. "The bottom line is, we believe clinical care is safe and should be individualized for all patients, and we believe the secretary is taking steps that are beneficial for the field."
(Barry, New York Times, 5/4)
The Substance Abuse and Mental Health Services Administration (SAMHSA) last month sent a letter to state health departments and grant recipients across the U.S. saying the federal government will no longer pay for test strips that can signal whether a street drug contains fentanyl or other contaminants, saying the strips are "intended for use by people using drugs."
The test strips are a common overdose prevention tool often widely distributed at college campuses, music festivals, and community clinics. The policy reversal by SAMHSA concerned administrators of programs that have handed out the test strips for years to stave off overdoses.
"Having more information about drugs rather than less can really impact people's behavior," including stopping them from taking something that could kill them, said Yngvild Olsen, former director for the Center for Substance Abuse Treatment at SAMHSA.
Emily G. Hilliard, a spokesperson for HHS, which oversees SAMHSA, said that the letter "furthers the agency's clear shift away from harm reduction and practices that facilitate illicit drug use and are incompatible with federal laws."
(Hoffman, New York Times, 4/27)
FDA last week named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, gene therapies, and the blood supply, replacing Vinay Prasad.
Szarama joined FDA at the end of last year as Prasad's deputy. She previously trained as a biophysicist at Johns Hopkins and the Karolinska Institutet and worked as a research analyst at CMS, a director of clinical trials at Arnold Ventures, and a program manager at the Advanced Research Projects Agency for Health.
It's unclear whether Szarama will ultimately serve as the head of CBER permanently. Sources told STAT that Houman Hemmati, an ophthalmologist, biopharma executive, and Fox News contributor, was a candidate for the role.
(Lawrence, STAT+ [subscription required], 4/30)
FDA last week announced an effort to make clinical trials more efficient by utilizing AI and other data science tools to monitor the trials in real time and cut down on the review time for new drugs.
The agency announced the launch of two "proof of concept" real-time trials for an AstraZeneca drug used to treat lymphoma and an Amgen drug to treat small cell lung carcinoma. FDA also asked for public input on a potential pilot program to work with companies using AI to enhance safety monitoring and medication dose selections, identify safety signals, and improve patient recruitment for clinical trials.
"Today is a milestone day for us to challenge the assumption that it takes 10 to 12 years for a new drug to come to market," said FDA Commissioner Marty Makary.
Jeremy Walsh, the chief AI officer at FDA, said "there is opportunity to shave off" as much as "20, 30, 40% of an overall clinical trial time."
Agency officials said they've validated signals for AstraZeneca's trial through a real-time data platform designed by Paradigm Health, confirming the feasibility of real-time signal sharing.
Kent Thoelke, CEO of Paradigm, said that what FDA has done is "instead of asking for data, they're asking for us to identify when signals happen to a patient in the electronic health record. Then we send that signal to the pharma sponsor and the agency."
"When a patient in a clinical trial develops a fever or is hospitalized, or a tumor shrinks and a radiologist reads the new tumor size, the FDA regulators can see in the cloud in real time exactly what's happening," Makary said.
(Lawrence, STAT+ [subscription required], 4/28; Sullivan, Axios, 4/29)
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