The 110th Congress: FDA and Industry at a Crossroads

The 110th Congress is considering important changes to the Federal Food, Drug, and Cosmetic Act. For pharmaceutical and biotech companies, factors such as the reauthorization of the Prescription Drug User Fee Act, investigations of FDA and industry, and enormous pressures on drug and biologic costs have combined to create an environment in which the enactment of FDA legislation is highly likely.

This program will address:

• The policy and politics of user fee reauthorization.
• Current proposals to change the regulation of drug safety and mandate systemic risk management.
• The prospects for passage of follow-on biologics legislation, and the likely contours of a follow-on statutory framework.
• The congressional focus on pharmaceutical marketing, including off-label promotion and direct-to-consumer advertising.
• The role of oversight and investigations in driving FDA actions and legislation.
• The status of proposals on importation, clinical trials transparency, and conflicts of interest.