Pfizer lost a legal battle focused on the company’s financial assistance program against the Department of Health and Human Services Office of Inspector General (OIG) in the U.S. District Court for the Southern District of New York. The agency denied the pharmaceutical company’s request to vacate an OIG advisory opinion that effectively precludes the manufacturer from providing financial assistance directly to certain patients prescribed the manufacturer’s drug. The court also denied the manufacturer’s request for a declaratory judgment that the manufacturer’s contributions to an existing charity — which would use the funds to assist certain patients with their copayments for the manufacturer’s drug — do not violate the Anti-Kickback Statute. and how the opinion’s wording may leave the door open to drugmakers to challenge unfavorable advisory opinions in the future.
During this webinar, we will cover the following topics:
- Overview of OIG’s historical guidance on patient financial assistance.
- DOJ’s enforcement actions against PAPs and manufacturer donors.
- OIG Advisory Opinions on direct patient assistance.
- Pfizer’s suit against HHS-OIG.
- Best practices when structuring patient assistance programs.
Who Should Attend?
- In-house legal counsel.
- Compliance officers.
- Privacy officers.
Accreditation
Tennessee CLE
This program has been approved for 1.5 hours general Tennessee CLE credit. Please provide your BPR number upon registration in order for Bass, Berry & Sims to report your participation to the Tennessee CLE Commission following the conference.
Other State CLE
Bass, Berry & Sims does not seek direct accreditation from states outside of Tennessee, but some states allow attorneys to earn credit through reciprocity or self-submission. Certificates of completion and other common supporting documents will be provided for use in jurisdictions outside of Tennessee.
Questions
Submit your questions for presenters upon registration or email questions to Tara Swint.