Three Principles That Govern FDA Advertising and Promotion Regulation
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
THREE PRINCIPLES THAT GOVERN FDA ADVERTISING AND PROMOTION REGULATION WAYNEL. PINES President, Health Care Practice, Director, Crisis Communications, APCO Associates, Inc.. Washington, District of Columbia
The Food and Drug Administration (FDA) has few formal regulations applicable to pharmaceutical promotion, and lately has taken few publicly-available enforcement actions. This makes it challenging for companies to comply with FDA policies. Over the years, however; the agency has followed a few basic principles that apply to advertising and promotion. These include FDA’s view that it has jurisdiction over all marketing activities; that “off-label’’promotions are prohibited: and that claims must be fairly balanced and represent full disclosure. FDA should do a better j o b of explaining its policies and actions, but in the meantime, regulated companies can understand how to comply by understanding these basic principles. Key Words: Advertising; Promotion; Marketing; DDM AC; “Off-label”
ONE OF THE UNUSUAL characteristics of how the Food and Drug Administration regulates the advertising and promotion of drugs and biologics is that the number of specific regulations are limited in scope. In other areas of FDA regulation, such as, for example, the manufacturing area, the rules are written in great detail in the Code of Federal Regulations. All have undergone a formal administrative process during which there was an opportunity for companies or individuals to comment on the proposed rules and solicit changes or clarification from FDA. This formal process is the standard way that all government agencies issue rules and standards.
Presented at the DIA 32nd Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9-13, 1996, San Diego, California. Reprint address: Wayne L. Pines, APCO Associates, Inc., 1615 L. St. NW, Suite 900, Washington, DC 20036.
The regulations that govern traditional paid advertising have never gone through this formal rule making process. These regulations date from the 1960s, and were issued after the Congress gave FDA the authority to regulate the advertising of prescription drugs (1). But the issues that advertisers and marketers are most concerned about today, in the present highly-competitive and informationintense environment, have never undergone a formal process. These issues involve press releases, video news releases, Internet activities, oral communications, and direct-to-consumer promotion. FDA’s views on these issues have been communicated over the years, for the most part in the last decade, in letters to industry, i n podium pronouncements by key policy makers, in informed guidances, and in agency enforcement actions. Indeed, to keep up with FDA’s advertising/promotion policies requires advertisers and marketers to monitor FDA almost on a consistent basis. Lately, even careful monitoring has not been enough. In the
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