Drugs

Hims & Hers Names Ex-FDAer Autor as Chief Policy Officer

Hims & Hers Health has appointed former FDA Global Regulatory Operations and Policy deputy commissioner Deb Autor as its first chief policy officer, tasking her with leading the company’s global public policy, regulatory, and government affairs efforts. Autor has been a member of Hims & Hers’ Board of Directors since 2024, and in her new role she will collaborate with stakeholders across healthcare, including telehealth platforms, providers, advocacy groups, medical associations, pharmaceutical and medtech companies, policymakers, and regulators, according to the company. She will focus on shaping policies that support the integration of technology with personalized care, helping to define the “healthcare of the future,” it says.

Autor brings more than three decades of experience spanning government, industry, and nonprofit sectors. At FDA, she oversaw worldwide inspections, enforcement, and international engagement. She also held leadership roles at AstraZeneca and nonprofit organizations, and earlier in her career acted as a trial attorney for the U.S. Department of Justice.

“Extraordinary innovation in areas such as AI, robotics, and at-home diagnostics provides an opportunity to reshape how we deliver access to healthcare,” Autor is quoted in a company release as saying. “Hims & Hers is setting a new standard for responsible progress in healthcare, and I’m excited to help shape the policies that will make that future a reality.”

Hims & Hers recently found itself in FDA hot water after the agency sent it a Warning Letter regarding its knockoff version of Novo Nordisk's semaglutide. The 9/9 letter noted that Hims & Hers marketed compounded semaglutide on its Web site and claimed its product uses the “same active ingredient as Ozempic and Wegovy,” which Novo sells as treatments for Type 2 diabetes and obesity. The compounded drug uses “clinically proven ingredients,” the agency said. “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome