Healthy Skepticism Library item: 2899

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

Rheinstein PH, Mazis MB.
Regulation of O-T-C drug advertising: the FDA "prescription".
J Am Pharm Assoc 1976 Sep; 16:(9):505-6,

Abstract:

In recent years there has been increasing regulatory interest in OTC drug promotion, partly due to the FDA’s review of OTC drug labeling claims. The Federal Trade Commission retains primary regulatory responsibility. Since 1962, FDA has overseen prescription drug promotion. Recognising the close relationship between the two issues, FTC recently proposed rules requiring OTC marketers to adhere more closely to FDA-approved labeling indications and warnings. This paper provides FDA’s perspective on OTC drug regulation. Economists have noted at least two benefits of truthful and informative advertising: it disseminates information and it facilitates competition. However, government regulation of false and misleading advertising is important. Particular concern exists about promotion of OTC drugs because they are bought without prescription. Further concern exists because certain segments of the population may be particularly vulnerable to advertising. Critics have argued that OTC ads contribute to accidental ingestion of drugs by children, but there is no solid evidence. Another accusation is that OTC ads contribute to permissive use of drugs, but the evidence is unclear. OTC ads may encourage overuse of sedatives etc. It is argued also that there are insufficient warnings. The history and relevance of the Food, Drug, and Cosmetic Act is briefly discussed.

Keywords:
*analysis/United States/Advertising* Drugs, Non-Prescription* Legislation, Drug United States United States Food and Drug Administration*