This session will address the key legal and regulatory issues companies face when launching a commercial biotechnology or pharmaceutical product. Specific issues include FDA pre- and post-approval regulations, Medicare anti-kickback and coverage issues, state licensing and distribution issues, and legal issues arising from co-promotion arrangements, specialty distribution agreements, and contract sales forces. Panelists will use a series of hypotheticals (taken from actual commercial launches) to put the issues in more concrete terms and help audience members develope insight that they can use with their companies.

• Identify key legal and regulatory issues associated with the launch of FDA-regulated biopharmaceutical products
• Discuss how to anticipate and solve problems arising from common legal and regulatory hurdles
• Provide insight on specifi c issues arising from the launch of specialty biotechnology and pharmaceutical products