Stephen L. Forster’s practice spans a range of compliance counseling and transactional matters, focusing on pharmaceutical drug pricing and government price reporting obligations, managed market and payer 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. With in-house experience at pharmaceutical companies and the government, Steve provides strategic guidance through legal and regulatory issues involving drug pricing and generics, rebating, state price transparency reporting obligations, commercialization, product distribution, and related contract negotiations and disputes.
As the former lead counsel of pricing and commercial access strategy at a global pharmaceutical company, Steve advised and negotiated channel, trade, distribution, and specialty pharmacy 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 (DEA’s) Office of the Chief Counsel and advises clients on drug diversion enforcement and licensure, DEA facility and practitioner registration suspension and revocations, and freight forwarding facility approvals. He also 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.