FDA Regulations of Drugs – The FDA can regulate only prescription drug promotional activities that fall within the legal definitions of labeling or advertising. However, the FDA has defined its authority to cover any material issued by or sponsored by a PC. Labeling is “any written, printed or graphic matter upon or accompanying the drug”.
For example, brochures, calendars, videos, letters, detailing pieces, and even books are used to promote a product. The FDA views advertising as “anything other than labeling that promotes a drug product and that is sponsored by a manufacturer” (Kessler & Pines, 1990). Such promotions include PC-sponsored symposia, exhibits, and even statements made by PCRs.
FDA Regulations of Drugs
Essentially, promotion according to the FDA is any activity not considered labeling that promotes a drug product. Although the FDA can regulate drug promotional activities considered labeling or advertising, it cannot regulate purely educational activities. Commercial speech is considered promotional, whereas non-commercial speech is considered educational.
Educational activities and materials are protected under the First Amendment. The FDA does not have clear-cut policy guidelines to differentiate between education and promotion. Educational activities are evaluated on a case-by-case basis.
The agency does, however, provide situations where activities thought to be educational may be considered promotional. The criteria used to distinguish educational from promotional activities are:-
1. the independence of the program from the PC.|
2. Who controls the program selects speakers and audience, and what is discussed in the content of the program.
3. The location of the symposium and where the presentation takes place.
4. Inducements such as meals, travel, and entertainment.5. Whether the program is a single scientific symposium or multiple symposia on the same subject.
The appropriateness of some of the gifts that are given to physicians by companies in the pharmaceutical industry is increasingly questioned. Many gifts serve an important and socially beneficial function.
Grand promotional schemes, including “educational” symposia, have cost the drug company (and ultimately the consumer) up to $500,000 for each occurrence. Moreover, the US Congress has indicated their disapproval of the 14 fold increase in industry funding of medical symposia, of $6 million in 1975 to $86 million in 1988 (inflation-adjusted)