Stephen L. Forster’s practice spans a broad range of compliance counseling and transactional matters, with a focus on drug price reporting obligations, managed market contracting, and the federal Anti-Kickback Statute and False Claims Act. Steve advises life sciences companies on Medicare Parts B and D, Medicaid, pharmaceutical pricing, federal and state government price reporting laws, 340B program requirements, the Inflation Reduction Act, and contracting matters. Drawing from in-house experience at pharmaceutical companies and with the government, Steve provides strategic guidance through the myriad legal and regulatory issues involving drug pricing and generics, rebating, state price transparency reporting obligations, product distribution, and related contract negotiations and disputes.
As the former lead counsel of pricing and commercial access strategy at a pharmaceutical company, Steve advised and negotiated channel, trade, and distribution pricing contracts. He supported strategic pricing and contracting engagements, launches, compliance, and long-term business strategies. Steve is also adept in handling pharmacy benefit management (PBM) and group purchasing organization (GPO) agreements, as well as 340B Drug Pricing Program requirements.
Steve has worked with several different pharma product types, enabling him to build a robust understanding of both commercial and government distribution programs, risk evaluation and mitigation strategies (REMS) compliance, and specialty limited distribution products. Steve also handles non-IP-related litigation and government inquiries, including those involving the federal Food, Drug, and Cosmetic Act.
Steve also previously worked as an attorney in the US Drug Enforcement Administration’s Office of the Chief Counsel advising on drug diversion enforcement and licensure and DEA registration suspension and revocations, and served as an assistant attorney general in the Virginia Office of the Attorney General.
Recipient, 2021 Collaboration Award, 2022 Magnet Investment Award Recipient (Executive Nomination), Otsuka America Pharmaceutical, Inc.