The Department of Health and Human Services asked the Department of Justice to investigate Hims & Hers for potentially violating federal law over its plan to make a compounded version of a low-cost weight loss pill widely available on its telehealth platform, according to a social media post by HHS general counsel Mike Stuart.
The move came shortly after the Food and Drug Administration said it will take “decisive steps” to thwart companies from mass marketing unapproved, compounded versions of GLP-1 drugs — a category that includes obesity and diabetes medicines — in response to the announcement from Hims & Hers.
In a brief statement, the agency said it will “restrict the use” of active pharmaceutical ingredients that could be used in compounded versions of these drugs in order to “safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.”Continue to STAT+ to read the full story…