Bass, Berry & Sims attorney Jennifer Michael discussed the legality of Biogen’s use of patient assistance programs to distribute the company’s Alzheimer’s drug Aduhelm. The Federal Drug Administration (FDA) granted Biogen accelerated approval of Aduhelm in June 2021 and has since received calls for investigations into how the approval process was handled.
Despite the controversial approval and potential investigations, Biogen established the patient assistance program to help certain patients access its Alzheimer’s drug. If not properly structured, patient assistance programs can be considered kickbacks and run the risk of violating federal laws.
Based on a description of the patient assistance program for Aduhelm, Jennifer said the government could potentially view the free drug program as a “seeding” arrangement, and that “the government might be concerned that [such] seeding programs could result in the potential for overutilization or inappropriate utilization.”
The full article, “Biogen Declines To Say If It Seeks IG Advice On Aduhelm Giveaway,” was published by Inside Health Policy on the Inside Drug Policy blog on September 2 and is available online (subscription required).