Sec. 400.700 Drug Product Entries in Periodic Publications (CPG 7132b.17)
BACKGROUND:
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.
POLICY:
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:
1. Whether the publication is published by an entity that is owned by, controlled by,
or otherwise affiliated with a drug company.
2. Whether the publication is primarily a compilation of factual, informative, and
educational data on a variety of drug products.
3. Whether the publication has been prepared solely for educational and informational
use, rather than promotional purposes.
4. Whether the publication determines which products will be included, and has final,
complete editorial control over all product entries and other reports.
5. Whether the publication promotes the use of particular drugs or the drugs of
particular firms other than by providing space for advertising.
6. Whether the publication accepts advertising and other promotional material from a
variety of drug firms.
7. 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.
Issued: 8/15/89