On June 3, 1986, an attorney wrote to the Food and Drug Administration ("FDA") on behalf of the publisher of a monthly publication distributed to physicians that contains entries describing prescribing information for certain drug products. The attorney requested an advisory opinion on whether FDA would deem the product entries labeling under section 201(m) or advertising under section 502(n) of the Federal Food, Drug, and Cosmetic Act ("the Act") for those products that were the subject of a paid advertisement in the same publication. In response to this request, FDA issued an advisory opinion in accordance with 21 C.F.R. 10.85 which stated that the agency would not seek to regulate drug product entries in question as advertising or labeling under the Act. This guide describes the agency's enforcement policy reflected in that advisory opinion.
FDA generally will not seek to regulate drug product entries as labeling or advertising under the sections of the Act cited above, when in publications intended for distribution to physicians and other health professionals, unless the publications are intended for use in promoting drug products.
In judging whether a publication that contains drug product entries or reports may be subject to regulatory action as promotional, agency compliance personnel should consider the following factors:
- Whether the publication is published by an entity that is owned by, controlled by, or otherwise affiliated with a drug company.
- Whether the publication is primarily a compilation of factual, informative, and educational data on a variety of drug products.
- Whether the publication has been prepared solely for educational and informational use, rather than promotional purposes.
- Whether the publication determines which products will be included, and has final, complete editorial control over all product entries and other reports.
- Whether the publication promotes the use of particular drugs or the drugs of particular firms other than by providing space for advertising.
- Whether the publication accepts advertising and other promotional material from a variety of drug firms.
- Whether the product entries cover a wide variety of drugs from a wide variety of drug firms.
- Promotional messages that appear in the publication as advertisements are the manufacturer's responsibility and are subject to the requirements of 21 C.F.R. 202.1. The publisher's product entry or report cannot serve as a "brief summary" for an advertisement since it is not produced by the promoter. In addition, if a manufacturer uses a product entry or report for promotional purposes, the manufacturer's use of that entry or report must comply with the Act's labeling or advertising requirements.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.