Christopher SchottPartner at Latham & Watkins LLP
Christopher Schott primarily advises on price reporting and other compliance obligations related to the Medicaid, Medicare, and 340B drug pricing programs. He combines extensive regulatory insight with deep industry knowledge to support pharmaceutical clients at all stages of the product life cycle. Market entrants and investors also seek Mr. Schott’s advice when evaluating potential opportunities and strategies.
Methodologies and reasonable assumptions that support the periodic certification and submission of price reporting metrics are at the heart of compliance with the federal programs, and Mr. Schott frequently advises clients in connection with reporting Average Manufacturer Price and Best Price under the Medicaid Drug Rebate Program, Average Sales Price under Medicare Part B, and the 340B ceiling price. The definitions of the price types and how the federal programs use the data are relevant to many different facets of the pharmaceutical business, which is why Mr. Schott bases his counsel on a full consideration of the client’s product portfolio, distribution model, and strategic goals.
The drug pricing policy landscape is ever evolving, and Mr. Schott assists clients through policy advocacy, such as by evaluating legislative and policy proposals, drafting white papers, and meeting with stakeholders. Mr. Schott also helps pharmaceutical manufacturers proactively engage with federal regulators through in-person advocacy and comment drafting. Additionally, he frequently advises drug manufacturers seeking guidance from regulators regarding specific issues or commercial proposals.
Mr. Schott draws on his regulatory knowledge and understanding of the pharmaceutical industry to support a range of corporate transactions, including acquisitions and divestitures, as well as licensing and co-promotion arrangements. He regularly helps clients evaluate the impact of price reporting requirements on proposed mergers and acquisitions, as well as to navigate due diligence matters and the post-closing transition of regulatory responsibilities.
Fireside Chat: External Counsel Roundtable - The Washington Outlook - Where do we stand and what is likely to happen with current and proposed legislation, 9:45amView Session