Medical Device Link.

Originally Published PMPN November 2001

OUR VIEW

New association promotes the need for printed inserts and outserts.

As the baby boom generation moves into middle age and beyond, the already growing demand for pharmaceuticals will accelerate even further. The pharmaceutical industry's research pipeline will be delivering newer, better weapons to combat disease. The Internet will further alter pharmacy practice, already dramatically affected by direct mail. Direct-to-consumer (DTC) advertising, along with expanded access and links to innumerable health, disease, and drug sites—some accurate, some questionable, some false—will further whet an informed public's already insatiable appetite for information.

Against this backdrop, a group of companies has come together to ensure that printed literature developed by pharmaceutical manufacturers continues to help ensure that drugs are properly dispensed and consumed.

Known as the Pharmaceutical Printed Literature Association (PPLA), the group is focused on leveraging the proven effectiveness of printed literature to improve the interface and exchange of information between consumers, healthcare professionals, and pharmaceutical manufacturers as pharmacy practice changes. PPLA believes that printed literature developed by pharmaceutical manufacturers will meet the exploding demand for reliable information.

PPLA's goal is to help the pharmaceutical industry help consumers benefit from existing and new drugs—a return on investment of billions of research and development dollars—by taking those drugs as prescribed, with precautions clearly understood. The desired outcome is a win-win-win situation: consumers enjoy better health, the healthcare system operates at lower total costs, and drug manufacturers report higher sales.

As a result of the evolution of the Food, Drug, and Cosmetic Act of 1938, the carefully regulated content of printed literature provided by pharmaceutical manufacturers has been the primary means for communicating to physicians and pharmacists how and when patients should take drugs correctly, and how to avoid mistakes. But despite this history, there is still no guarantee that patients will get accurate information directly from the manufacturer each time they have a prescription filled. And today, consumers are playing an increasing role in identifying medications and specifically requesting that their doctors write prescriptions for one drug instead of another.

This trend has already caused liability concerns in at least one state, New Jersey, where the state's supreme court has abolished the "learned intermediary" defense for pharmaceutical manufacturers who engage in DTC ad- vertising. One of the functions of the PPLA, therefore, is to offer input to FDA, Congress, and other governmental agencies on how to provide reliable, detailed, and controlled information for healthcare professionals and consumers in the age of DTC and Internet information. Working together, PPLA members are confident that we will be able to achieve each of these goals.

For more information, please call PPLA's offices in Washington, DC, at 703/538-5799.

Copyright ©2001 Pharmaceutical & Medical Packaging News