Compliance Overview

Over 60 years of experience in labeling communication has positioned PDR^® as the critical mechanism to distribute prescribing information. As one of the most commonly consulted sources of information about drugs¹, PDR has helped pharmaceutical companies meet their legal labeling requirements effectively and efficiently.

Pharmaceutical companies have a "duty to warn" prescribers about the safety of their products. The FDA requires the pharmaceutical companies to distribute approved prescribing information for a drug or biologic in connection with their marketing, promotional, and distributional activities.

PDR is a critical mechanism for companies to disseminate prescribing information and satisfy their "duty to warn".

• PDR is referenced in over 152 court decisions at both the state and federal level between 2006 and 2007.
• Pharmaceutical companies regularly point to their participation in PDR as proof of their efforts to fulfill their “duty to warn” mandate.
• A number of courts have held that dissemination of the FDA-approved prescribing information through the PDR satisfies the company’s duty to warn physicians in accordance with the learned intermediary defense.

The new PDR^® Drug Information Service and REMS Risk Communication Programs assist pharmaceutical companies with their compliance initiatives and help satisfy the "duty to warn" mandate. To learn more, please click on the tabs above.

¹ Jerry Avorn, M.D., and William Shrank, M.D., M.S.H.S. The New England Journal of Medicine, June 8, 2006