Healthy Skepticism Library item: 3166

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Millstein LG.
The regulation of prescription drug advertising.
Am Pharm 1983 Sep; NS23:(9):54-7

Abstract:

The 1906 Federal Food and Drugs Act was replaced in 1938 by the stronger Food and Drug, and Cosmetic Act (FDCA), which has been further strengthened by amendments to address new problems. Advertising regulations were introduced in 1962 and revised in 1967. During the 1950s and 1960s, there were only gradual changes in prescription drug promotion. The 1970s saw many new drug entities enter the marketplace, and new and broader promotional efforts. Prescribers and dispensers are inundated by ads, direct mail promotions, samples, gadgets, and drug representatives. Advertising within the context of the FDCA involves all forms of communication calling attention to drugs. Even drug labels and package inserts can have advertising impact. Reminder ads, w hichcall attention to drug names but do not mention indications, are not permitted for drugs whose labelling contains a boxed warning of a serious hazard. FDA has several areas of concern. The volume of advertising has increased markedly in the 1980s, and new media are being utilised. FDA cannot require preclearance of ads for new drugs, which would be considered an abridgement of the First Amendment guarantee of free speech. However, each time a new ad is initiated, a copy must be submitted to the FDA. Pharmacists pose a new challenge for drug promotion, with increased ads in pharmacy journals. FDA takes action against misleading ads on the basis that labeling and advertising should provide adequate information to prescribers and dispensers for safe and effective use of drugs. FDA objects to promotional activities for unapproved dugs at medical or pharmacy conventions. Another developing trend that concerns FDA is DTCA, a complex issue on which it has not yet formulated a policy. As more information is provided to consumers, pharmacists and physicians must be well prepared to respond to questions.

Keywords:
*analysis/United States/ Advertising/legislation & jurisprudence* Prescriptions, Drug* United States United States Food and Drug Administration