Goodwin Center for Market Access and Pricing

A go-to resource for managing regulation and enforcement across the drug supply chain and ensuring patient access to medicine

The Goodwin Center for Market Access and Pricing (GMAP) provides life science and healthcare companies with strategic legal, regulatory, transactional, and enforcement advice on all aspects of their market access and drug pricing strategies. We draw from a deep bench of expertise including lawyers who are former corporate general counsel and have served in senior roles at the Department of Health and Human Services Office of Inspector General (HHS-OIG), the Department of Justice (DOJ), leading industry associations, and the Offices of the United States Attorneys.

Our team regularly advises on obligations under the Medicaid Drug Rebate Program (MDRP), the 340B Drug Pricing Program (340B), Medicare Parts B and D, state drug pricing laws, and other regulations and statutes applicable to all entities in the ever-evolving drug supply chain. Our lawyers regularly monitor the legislative and regulatory developments affecting market access and drug pricing as well as the priorities of federal and state enforcement agencies focused on the drug supply chain.

As part of our commitment to monitoring developments in the drug supply chain, we regularly host events and contribute to industry thought leadership. We also work with lawyers across Goodwin’s market-leading life sciences platform. Below, we list GMAP’s upcoming and past events, representative experience, select thought leadership, and team members.

Related Goodwin resources include our Late Stage Drug Development and Inflation Reduction Act pages as well as our Life Sciences Quarterly Tracker and Life Sciences Perspectives blog.

UPCOMING GMAP EVENTS

Spring 2026 – First Annual GMAP Summit

Representative Experience

Advised drug manufacturers on compliance with federal drug price reporting requirements under the MDRP, 340B, Medicare, and the Veterans Health Care Act and Veterans Affairs (VA) Master Agreement
Advised manufacturers on interpreting regulations and conducting audits associated with Average Manufacturer Price (AMP), Best Price, Average Sales Price, 340B, non-Federal AMP calculation, Federal Supply Schedule, and other drug price reporting regulations as well as drafting reasonable assumptions and restatements and preparing affirmative disclosures and responses to the government
Advised manufacturer drug pricing committees and market access teams on all types of drug launches and ongoing commercialization regulatory support, including:
- Structuring patient assistance programs (e.g., reimbursement support, copay assistance, bridge, quick start, and free drug)
- Conducting bona fide service fee and fair market value analyses connected to federal drug price reporting and Anti-Kickback Statute requirements
- Analyzing proposed drug pricing, discounting, and compensation strategies for regulatory and statutory compliance
Advised drug manufacturers on compliance with physician payment laws (e.g., the Physician Payments Sunshine Act)
Advised drug manufacturers on state drug price transparency reporting, state prescription drug affordability review boards, and other state-level requirements for prescription drug manufacturers, distributors, and pharmacy benefit managers (PBMs)

Negotiated all manner of agreements with PBMs, group purchasing organizations (GPOs), integrated delivery networks (IDNs), distributors, pharmacies, hospital systems, managed care organizations, etc., and any associated data-sharing obligations
Advised a large drug manufacturer on its successful implementation of many value-based purchasing agreements with state Medicaid agencies and commercial payors and navigated Medicaid Best Price, temporal bundling, and other price reporting regulations

Represented drug manufacturers in investigations and civil monetary penalty settlements with HHS-OIG concerning alleged late and inaccurate reporting of drug price information to the federal government
Represented drug manufacturers in DOJ investigations and False Claims Act litigation concerning sales and marketing practices, price reporting requirements, and reimbursement-related issues
Represented private equity investor in DOJ investigation of drug manufacturer’s sales, marketing practices, and rebate program

Advised on private equity, M&A, and capital markets transactions in connection with conducting due diligence of a target’s market access profile and compliance with drug price reporting requirements
Advised on market access and drug price reporting regulatory considerations for key representations and warranties in transactional documents (e.g., merger agreements, underwriting agreements)

Prepared public notice and comment submissions to the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and other related agencies regarding proposed rulemaking and agency requests for information
Advised clients on new legislation and regulations affecting drug pricing and drug price reporting compliance
Partnered with nonprofit organizations such as OUTbio Greater New York to support investment in the biotechnology and healthcare industries