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Nearly 10 leading global pharmaceutical companies have signed up to use PDRxpress to manage their product labeling submissions, which includes the printed package insert (PI). PDRxpress is a web-based information management system for labeling that was launched last June by Thomson PDR, publisher of the Physicians' Desk Reference.

The system is designed to electronically deliver the most current drug labeling to every dispensing site in the U.S. and its territories. The idea is to complement and possibly replace the PI with an electronic depository on the Internet.

PDRxpress supports the drug industry's paperless labeling initiative, spearheaded by a task force with the Pharmaceutical Research and Manufacturers of America (PhRMA). The initiative could save drug companies millions each year by eliminating printed package inserts. A large-scale beta test of a paperless labeling system is planned for later this year. It follows the successful pilot test in 2002 and may encourage drug companies to press on.

Right now, printed package inserts are required by law. Could this change? On Mar. 14, 2003, the Food and Drug Administration proposed amendments to its regulations. If those are finalized, drug companies would be able to submit product labeling in Portable Document Format (PDF) to FDA with new drug applications, biological license applications, abbreviated new drug applications, supplements and annual reports.

Some see this as a step toward eliminating printed PIs altogether.

The case against

PhRMA's paperless labeling initiative is not without its opponents. The Pharmaceutical Printed Literature Association (PPLA) argues that it puts profits above patient safety. "We feel that paper has a permanence and is critical to consumer safety," says Alice Ducq, PPLA associate. She also points out that the drug information must be available consistently, and that not all pharmacies and patients are connected to the Internet.

FDA has solicited comments and will hold a public meeting on July 31, 2003, to "discuss the current status of the private sector's efforts to provide useful written prescription drug information to consumers." For meeting info, call 202-314-6421 or visit www.ntsb.gov/ events/newlocation.htm.

This is the Agency's response to a lawsuit filed against the Department of Health and Human Services (DHHS) by Public Citizen in February. In that suit, Public Citizen asks to force FDA to seek public comment on actions that could achieve the objective of the 1996 Public Law 104-180. That law's goal was that, by 2006, 95% of patients who receive new prescriptions would receive useful written information about the drug. An FDA-commissioned study conducted in 2001 showed that the average "usefulness" of the information was only about 50%, well short of the target.

It's doubtful that FDA will make any sweeping changes soon. Nevertheless, the drug industry plods on toward electronic rather than printed product labeling.

Thomson PDR

800-526-4870; www.thomson.com

Pharmaceutical Printed Literature

Association (PPLA)

703-538-5799; www.pplaonline.org

Pharmaceutical Research and

Manufacturers of America (PhRMA)

202-835-3400; www.phrma.org

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