Medical Marketing and Media (MM+M) quoted McGuireWoods healthcare and life sciences partner Craig Bleifer in a Feb. 27, 2026, article examining whether the growth of direct-to-consumer (DTC) pharmaceutical sales and distribution platforms could lead to increased anti-kickback risks.
The article explores the regulatory landscape following the Department of Health and Human Services’ Office of Inspector General (OIG) bulletin outlining guidance for pharmaceutical companies operating DTC platforms. Bleifer, who previously served as general counsel for Novo Nordisk and Daiichi Sankyo, offered insights on the OIG’s objectives and the regulatory framework surrounding these emerging business models.
“The OIG wants to ensure that when manufacturers are providing some sort of discount to anyone — whether it’s a physician or a patient or anybody — that it doesn’t somehow inappropriately incentivize somebody to use one drug over another, and also that it doesn’t inappropriately increase the costs of the federal health care program through those incentives,” explained Bleifer, who advises pharmaceutical, biotechnology and medical device companies on regulatory compliance, government investigations and corporate transactions.
Bleifer added, “It’s very helpful to anybody working in this space to have [the OIG’s] view, especially since this is a new business model. It’s good that the OIG is being so responsive to a new business model.”
Bleifer also addressed the inherent compliance challenges these platforms present. While sophisticated pharma companies launching DTC platforms are careful about compliance, “inherent to the nature of the relationship, there’s risk of inappropriate influence.”
Looking ahead, Bleifer said marketers should be mindful that advertising of DTC platforms, while not inherently illegal, must be approached carefully because both the OIG and FDA “will be watching.”
MM+M’s coverage follows McGuireWoods’ recently published client alert on the TrumpRx Launch and the OIG Bulletin: HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch – McGuireWoods.