The U.S. Congress represents a crucial component of the regulatory, litigation and public relations environment for FDA-regulated companies, U.S. House and Senate oversight committees — as well as individual members of the U.S. Congress on both sides of the aisle — have launched numerous investigations of pharmaceutical and medical device manufacturers' practices, including research, marketing, and outsourcing.
Our FDA group has decades of experience working on Capitol Hill, drafting legislation, developing public policy positions and lobbying on behalf of clients. This experience extends to working on investigations before the Congressional committees that most frequently investigate life sciences companies, including the U.S. Senate Finance Committee, the U.S. House Committee on Oversight and Government Reform, and the Subcommittee on Oversight and Investigations of the U.S. House Energy & Commerce Committee. In addition, we routinely respond to subpoenas or informal document requests, represent clients in interviews with Congressional investigative staff, prepare for Congressional hearings and coordinate these activities to minimize a company's risk of adverse publicity, enforcement action or litigation exposure.
Here are some examples of our Congressional investigations and public policy representations:
- We advised several pharmaceutical manufacturers on educational grants policies, and we assisted the companies in responding to Congressional investigations into such policies.
- We represented a pharmaceutical company in a Congressional investigation into the production and importation of a contaminated drug ingredient into the United States from China. Our involvement in this matter included working with committee staff on responses to document requests, negotiating the scope of the public release of portions of the produced documents, answering committee questions, preparing the company’s CEO and another top executive for testimony before the committee, and working with a public relations agency to handle media relations around the investigation and Congressional testimony.
- We represented a leading multinational pharmaceutical company in connection with an investigation by U.S. House and Senate committees and subcommittees into alleged off-label promotion and other allegedly improper promotion of their products.
- Our firm serves as co-counsel to the Medical Information Working Group, a coalition of more than a dozen pharmaceutical and device manufacturers that is seeking clarity in government policies pertaining to promotional practices.
- We represented biotechnology and pharmaceutical companies in connection with federal legislation that created an approval pathway for biosimilars.
- We negotiated with Congressional staff over the scope of document productions and the protection of company trade secrets and confidential business information.
- Represented an FDA-regulated company under congressional investigation related to assorted promotional issues.