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Drug pricing decisions have come under intense scrutiny. Over the past several weeks, an FTC investigation, federal and state legislative initiatives, and agency compliance investigations have commenced. Substantiating pricing decisions by value-based health evidence and demonstrating strong pricing compliance records are important to navigating such investigations and initiatives.

We represent and counsel companies of every size and stage across multiple industries.

Representing pharmaceutical companies regarding government price reporting requirements under the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90), the Deficit Reduction Act of 2005, the Medicare Modernization Act, the 340B program, the Veterans Health Care Act and emerging strategic pricing and price reporting considerations.

Representing pharmaceutical companies in performing government pricing calculations, settlement negotiations with the Office of Inspector General (OIG), and Department of Justice (DOJ) on price reporting and false claim allegations, compliance reviews and system implementations.

Negotiated settlement of price reductions clause, defective pricing, overpayment and Trade Agreement clause claims against multiple U.S. pharmaceutical companies and negotiated some of the largest pharmacy benefit contracts in US history.

Counseled companies engaging in strategic planning and decision making about government funding through grants, cooperative agreements and grants, Other Transaction Authority (OTA) acquisitions, contracts, intellectual property issues arising from contracts, subcontracts and related compliance considerations and Cooperative Research and Development Agreements (CRADAs).

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