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‘Dear Doctor’ notification network evolves into a leading provider of REMS program information
The news is that PDR Network (Montvale, NJ) has hired Christine Côté, MD, whose 24-year career includes J&J and Zeneca Pharmaceuticals, as chief medical officer, and John Loucks, formerly chief customer officer of Relsys (a regulatory compliance company acquired last year by Oracle), as VP sales. And PDR Network itself claims, with some validity, to be the largest distributor of FDA-approved drug information in the country, while it “REMS up” its organization to become the preferred vendor for delivering medication guides and related REMS information to doctors.
REMS, of course, is the growing FDA program for attaching Risk Evaluation and Mitigation Strategies to newly launched (as well as existing) pharma products. A feature of most basic REMS programs is developing medication guides to be used by patients or physicians (in addition to package inserts) when there are concerns over appropriate use, dosage or side effects. Most new product launches now include a REMS component, and the program threatens to radically change the distribution of opioid-based pain medications.
But the story behind PDR Network represents an interesting evolution of how medication guidance is being delivered today. It starts with the Health Care Notification Network (HCNN), an effort by a nonprofit, the iHealth Alliance, to automate the delivery of “Dear Doctor” and similar notifications when FDA rules on changes in how medications are to be prescribed, or when product recalls are launched. HCNN grew by affiliating itself with a large and growing number of medical societies; these societies gave HCNN e-mail access to their members. Last fall, HCNN picked up the “iconic” Physician’s Desk Reference (PDR) business from publisher Thomson Reuters, and rebranded itself as the PDR Network.
Along the way, the capability of PDR Network to reach a sizable fraction of prescribers (the network includes physicians and physician assistants) has made it an efficient channel for delivering REMS notices. Ed Fotsch, president, says that the company was involved with one out of three REMS programs in 2009, and delivered five million e-mails and faxes (of all types of notifications) since it went live in late 2008, mostly funded by pharma companies. Fotsch adds that PDR Network brings some powerful benefits to prescribers using its service: in some cases, they can receive continuing medical education (CME) credit for accessing the information; and some medical-liability carriers (who were active participants in HCNN) provide discounts on liability insurance. Eventually, says Fotsch, there will be an opportunity to mine liability data from the carriers in order to refine patient-safety procedures—a benefit to prescribers, the carriers, the pharma industry and, ultimately, patients themselves.