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HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch

By Craig B. Bleifer & Jessica L. Vaughn, Ph.D. on February 5, 2026
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In advance of the anticipated rollout of the “TrumpRx” website, a platform promising lower-priced drugs sold directly to consumers, the Office of Inspector General of the Department of Health and Human Services released a special advisory bulletin on Jan. 27, 2026, outlining the Federal Anti-Kickback Statute implications for direct-to-consumer drug sales. The OIG concludes that the risk of AKS violations is minimal if certain guidelines are followed, adding that its bulletin “clears the path” for DTC programs including the TrumpRx program. However, a letter from Sens. Richard Durbin, Elizabeth Warren, and Peter Welch to the OIG suggests that not all stakeholders share this confidence in TrumpRx, citing to concerns arising from a recent investigation into other DTC platforms. Pharmaceutical companies and other stakeholders can submit public comments until March 30, 2026. Read on to learn more about the guidance and what the pharmaceutical industry should know.

Photo of Craig B. Bleifer Craig B. Bleifer

Craig is a seasoned healthcare executive, previously serving as general counsel for two major pharmaceutical companies, Novo Nordisk and Daiichi Sankyo. With over 30 years as a corporate and life sciences lawyer, he provides counsel on legal, compliance, policy, and regulatory issues related…

Craig is a seasoned healthcare executive, previously serving as general counsel for two major pharmaceutical companies, Novo Nordisk and Daiichi Sankyo. With over 30 years as a corporate and life sciences lawyer, he provides counsel on legal, compliance, policy, and regulatory issues related to healthcare products and businesses. He provides strategic advice based on his practical real-world experiences, spanning discovery to commercialization.

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Photo of Jessica L. Vaughn, Ph.D. Jessica L. Vaughn, Ph.D.

Jessica provides clients with legal and regulatory support to life sciences companies, focusing on pharmaceuticals, medical devices, cosmetics, food products and dietary supplements. With an advanced scientific degree in toxicology and experience as an in-house counsel at a global biotechnology company, Jessica provides…

Jessica provides clients with legal and regulatory support to life sciences companies, focusing on pharmaceuticals, medical devices, cosmetics, food products and dietary supplements. With an advanced scientific degree in toxicology and experience as an in-house counsel at a global biotechnology company, Jessica provides unique insight into pharmaceutical and medical device matters.

Read more about Jessica L. Vaughn, Ph.D.Email
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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    The FCA Insider
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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