Unlicensed healthcare products: No advertising or promotion allowed
Internationally, regulations exist to prohibit the advertising or promotion of unlicensed healthcare products. In Canada, Section 9(1) of the Food and Drugs Act states that, “no person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its composition, merit or safety.” Since the terms and any proposed indication of unlicensed healthcare products have not been established, advertising such products is not permitted.1
Similar provisions are laid out in the US Code of Federal Regulations (CFR), Title 21, section 312.7(a) and 812.7(a)―the promotion of any investigational drug or medical device (including a new use under investigation for an existing device) is expressly prohibited. 2,3
Why the promotion or advertising of unlicensed healthcare products is prohibited
The primary concern about the promotion or advertising of unlicensed healthcare products or off-label uses is that a healthcare provider may form an opinion about a product’s use on the basis of the claims made by its company before it receives regulatory approval, and that opinion may be incorrect relative to the pending regulatory approval. Such an erroneous opinion on the part of the healthcare provider could lead to incorrect use of the licensed product, thus using the product off-label.4
When disseminating information on unlicensed healthcare products may be deemed acceptable
Although companies that develop healthcare products are not allowed to promote unlicensed products or off-label uses, disseminating information about an investigational product may be acceptable under certain circumstances, as outlined below.
Scientific information: Medical conferences and continuing medical education
The US 21 CFR section 213.7(a) recognizes that the prohibition of promoting investigational healthcare products is not intended to restrict the full exchange of scientific information concerning such a product, including presenting scientific findings in scientific or lay media. Additionally, it is recognized by the EU Advertising Directives that without industry sponsorship of scientific meetings and attendance by doctors at such meetings, the medical community would be less well informed.
Companies that develop healthcare products commonly sponsor medical conferences, continuing medical education (CME) or events for the exchange of scientific information (for example, a poster presentation of a disease state at a medical conference). All sponsorships should be developed in line with the following:
- Distinguish the critical difference between the provision of information, and promotional material (advertising). Evaluate whether the material is informational or promotional. Do not distribute information if it is promotional in nature.
- Avoid “unduly influencing” speakers to disseminate off-label information.
- Clearly label the marketing status of the product so that you do not mislead your audience. (For example, you may encounter a situation where a product is approved in some jurisdictions but not in the country of a conference, or that in that particular country is has a different approved indication of use).
To ensure compliance, companies may establish internal programs, procedures and policies that follow industry guidelines regarding CME events and the exchange of scientific information. For instance, the Accreditation Council for Continuing Medical Education (ACCME) has strict accreditation requirements to which CME providers must adhere when holding an event and providing related educational materials. 4,5
When a new drug or medical device, or a new use of a licensed product, is under investigation, any claims of safety and effectiveness about such healthcare products are prohibited unless the company is seeking to recruit clinical investigators or enroll patients in a study. 4 Permissible activities may include:
- “Institutional ads” in which a company states that it is conducting research in a certain therapeutic area to develop a new product, but does not mention the proprietary or established name of the product
- “Coming soon” advertisements, which state the name of the product, but make no representation about the new product’s safety, efficacy or intended use
Unsolicited requests for information
Often, physicians request scientific information from a company regarding certain healthcare products, and the company’s response can contain off-label information. For example, a physician may inquire whether a drug prescribed at Xmg/kg for a certain indication can be given at a different dose for another indication for which the drug is not approved. Responses that are non-promotional with balanced scientific information are not considered advertising as long as the company documents the nature of the requests and does not show a pattern of repeatedly disseminating any off-label information. 4
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012
- Department of Justice Canada. (2012, August 16). Food and Drugs Act, Section 9. Retrieved September 3, 2012, from http://laws-lois.justice.gc.ca/eng/acts/F-27/page-4.html#docCont.
- United States Code. (2012, April 1). Title 21, Part 312, Investigational New Drug Application. Retrieved October 9, 2012, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.7.
- United States Code. (2012, April 1). Title 21, Part 812, Investigational Device Exemptions. Retrieved October 9, 2012, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.7.
- Drake, K.L. (2009). Chapter 9. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices. In Pisano, D.J., Mantus, D.S. (Eds.), FDA regulatory affairs. A guide for prescription drugs, medical devices, and biologics (2nd ed.). NY: Informa Healthcare.
- de Wet, C. (2009). Chapter 12. Information and promotion. In Griffin, J.P. (Ed.) The textbook of pharmaceutical medicine (6th ed.). West Sussex: John Wiley & Sons Ltd.