December 17, 1997
FDA PUBLISHES GUIDANCE ON INDUSTRY-SUPPORTED ACTIVITIES
In the December 3, 1997, Federal Register, FDA announced the publication of "Final Guidance on Industry-Supported Scientific and Educational Activities." This guidance document was prepared by FDA¹s Intra-Agency Working Group on Advertising and Promotion.
FDA is providing this guidance to describe the Agency¹s enforcement policy with regard to scientific and educational activities supported by industry. The guidance seeks to clarify the distinction the Agency draws between scientific and educational activities that FDA considers nonpromotional and those that the Agency considers promotional, and to provide guidance on how industry may support such activities without being subject to the labeling and advertising provisions of the Federal Food, Drug, and Cosmetic Act (the Act). This jurisdictional line is important because the constraints on advertising and labeling, when applied to scientific and educational activities, can restrict the freedom of participants to discuss their data or express their views. In particular, discussions of unapproved uses, which can be an important component of scientific and educational activities, are not permissible in programs that are or can be subject to substantive influence by companies that market products related to the discussion. The Agency recognizes that industry-supported activities can be both nonpromotional and educational.
FDA does not intend to regulate, under the labeling and advertising provisions of the Act, industry-supported scientific and educational activities that are independent of the influence of the supporting company. Companies and providers who wish to ensure that their activities will not be subject to regulation should design and carry out their activities free from the supporting company¹s influence and bias, based on factors FDA considers in evaluating activities and determining independence. These factors are listed in the guidance document.
Copies of "Final Guidance on Industry-Supported Scientific and Educational Activities" (CVM number 65) may be obtained from the on-line library at CVM¹s Internet Home Page or by calling CVM¹s Communications Staff at 301-594-1755.
Comments on this document may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. Questions regarding this guidance in regard to prescription animal drugs may be directed to Dr. Edward L. Spenser, FDA/Center for Veterinary Medicine, HFV-216, 7500 Standish Place, Rockville, MD 20855, 301-594-1722.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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