MANUFACTURERS

PDR Network services are the most comprehensive, effective and cost-efficient means to distribute FDA-approved drug information, updates, patient safety communications, IND notifications, recalls and REMS programs to U.S. prescribers.

How do manufacturers use PDR Network?

Nearly all pharmaceutical companies use PDR Network services to either distribute drug information via the PDR (print or online editions) or to send urgent product safety Alerts electronically via the HCNN. This is in full accordance with the FDA’s 2006 guidance to manufacturers, which states that electronic Alert systems like those offered by PDR Network’s HCNN service are preferable for delivering these Alerts. Increasingly, manufacturers use PDR Network to distribute REMS information to prescribers.

How does this service help manufacturers protect patient safety?

PDR Network improves patient safety and protects the interests of consumers and healthcare providers through delivery of an annual, comprehensive compendium of pharmaceutical product information, updated regularly, together with time-sensitive communication on important product safety developments throughout the year. This unique combination of services fulfills duty-to-warn and FDA requirements and offers healthcare providers a single resource for all important product information and updates.

Which manufacturers are already using PDR Network?

While all major pharmaceutical manufacturers currently use some or all of the services of PDR Network, an increasing number of small-to-medium sized organizations – including emerging biotechs and generics – are increasingly turning to PDR Network for safety and compliance communication needs.

How does PDR Network relate to the FDA’s new Risk Evaluation and Mitigation Strategies (REMS) requirements of pharmaceutical firms?

REMS and other risk communication represent substantial and growing challenges for pharmaceutical manufacturers. Among these challenges is the need to successfully engage and communicate with prescribers and dispensers, and a communication strategy is a central requirement in every REMS program. Prescribers are increasingly busy with patient care and are bombarded with new regulatory, administrative and clinical requirements. At the same time, promotional outreach is on the rise. As a result, effective communication and outreach for REMS and other risk programs are considerably difficult and expensive. PDR Network provides leading industry expertise in the development and execution of REMs programs – including CME and patient education – and offers a powerful distribution channel for rapidly and inexpensively distributing REMS programs to physicians and other prescribers.

Manufacturer Advisory Committee

Dr. Alan Lembitz - Chair (COPIC)
Dr. G. K. (Dina) Anand (Johnson & Johnson Pharmaceutical Research & Development)
Mr. Craig Audet (sanofi-aventis)
Mr. G. Edward Collins (GlaxoSmithKline)
Dr. Alan Goldhammer (PhRMA)
Dr. Robert Hoff (Abbott Laboratories, Inc.)
Ms. Andrea Masciale (Johnson & Johnson Pharmaceuticals Group)
Mr. James Nickas (Genentech)
Dr. Ed Tucker (Bayer HealthCare Pharmaceuticals)
Dr. Edward Fotsch (PDR Network)
Dr. Christine Côté (PDR Network)