Stephen L. Forster (Steve)

Steve Forster focuses on coverage and reimbursement, pricing and price reporting for pharmaceuticals, market access and commercialization strategies for pharmaceuticals and medical devices, product launch planning and execution, and commercial and managed care contracting. Steve advises pharmaceutical and medical device manufacturers, biotechnology, diagnostic and digital health companies, health systems, and private equity investors.

Drawing on experience in private practice, government service, and senior in-house legal roles within global pharmaceutical companies, Steve provides practical business-oriented advice to support clients at all stages throughout a product life cycle. He advises clients on compliance with federal and state price reporting programs, Medicare and Medicaid reimbursement, 340B Drug Pricing Program, state price transparency legislation, coding, coverage and reimbursement pathways for emerging technologies, and patient assistance programs. His work includes counseling on biosimilars, companion diagnostics, laboratory-developed tests, long-acting injectable therapies, controlled substances, REMS (risk evaluation and mitigation strategy)-restricted products, digital health solutions, direct-to-consumer and telehealth platforms, and specialty distribution models that require alignment of commercial objectives with evolving regulatory requirements.

Steve also advises clients on compliance and risk management matters arising under the Anti-Kickback Statute; False Claims Act; Food, Drug, and Cosmetic Act; and related federal and state health care laws, including government inquiries and investigations.

Steve supports strategic transactions across the life sciences sector. He advises private equity investors and portfolio companies on health care regulatory diligence in mergers and acquisitions and licensing transactions. Following closing, he assists clients with integration including drafting and updating internal compliance policies and procedures.

Steve previously served as an attorney at the U.S. Drug Enforcement Administration (DEA) and with the Virginia Office of the Attorney General.