Regulation of Pharmaceutical Promotion in the Twenty-First Century
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Drug Information Journal,Vol. 34, pp. 861-873, Zoo0 F’rinted in the USA. All rights reserved.
REGULATION OF PHARMACEUTICAL PROMOTION IN THE TWENTY-FIRST CENTURY LOUISA. MORRIS,PHD SCP Communications, Melville, New York
WAYNE
L.
PINES
APCO Associates, Washington, District of Columbia
This article outlines how the authors believe the drug promotion regulatory system should be redesigned to provide physicians, other health professionals, and consumers with truthful and balanced information in the new century. Basic legal and regulatory concepts underlying the current regulatory framework and “cultural” changes that pose new challenges for regulators are highlighted. An innovative framework for pharmaceutical promotion regulation is proposed. This framework includes the FDA focusing on using technology to identify materials that are likely to be harmful to the public; using quality control processes in review; and making judgments based more on scientific information about how people receive and use information. The system must be based on the proven principles that have evolved over the years but also be flexible enough to deal with a new world in which information and technology are the hallmarks of a new medical system. Key Words: Pharmaceutical promotion; Regulation; Information; Technology
THE LEGAL AUTHORITY FOR regulating drug advertising dates from 1962, when Congress granted the Food and Drug Administration (FDA) authority for assuring the dissemination of truthful information about pharmaceutical products. Since then, there have been dramatic changes in the pharmaceutical marketplace: 0
Once confined largely to journal advertisements and detailing, promotional practices have mushroomed to engender an everwider variety of communication channels, many unthought of in 1962, Once confined to physicians, the audiences
Reprint address: Louis A. Moms, PhD, SCP Communications, c/o PRR, Inc., Suite 310, 84 South Service Road, Melville, NY 11747.
for pharmaceutical promotion have grown to include an increasing number of people, from formulary decision makers to patients. The health care delivery system itself is radically different from 1962, 0 Once focused on promoting a limited number of well-known drugs, the pharmaceutical industry now aggressively markets an augmented list of complex chemicals treating many diseases for the first time or with innovative chemical approaches. In short, the pharmaceutical marketplace, as we enter the new century, has never been more competitive, more diverse, or more promising. And the patient has never been so well educated and so much in need of information. Despite huge increases in patient-oriented information dissemination,
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levels of undertreatment (through both unrecognized disease and noncompliant behavior) remain in epidemic proportions. In the 1990s FDA recognized that the combination of help-seeking and reminder broadcast advertising left consumers in a quandary regarding the advertised product. This led to a new policy permitting the broadcast of consu
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