On May 6, the Food and Drug Administration (FDA) announced it was withdrawing the 2004 draft guidance on “help-seeking” and other disease awareness communications by drug and medical device manufacturers. The draft is among the 47 draft guidance documents for drug, medical device and blood products published before December 31, 2013, that FDA is withdrawing “to help improve the efficiency and transparency of the guidance development process.” The background legal and regulatory principles applicable to manufacturer communications remain unaffected by FDA’s action. As a result, disease awareness communications and other “unbranded” materials are subject to regulation if they “effectively promote” a drug or medical device. Pre-2004 guidance and correspondence from FDA reflect the Agency’s approach to policing the line between disease awareness materials and product promotion.
The 2004 Draft Guidance The 2004 draft guidance addressed several issues that had bedeviled advertisers interested in engaging in unbranded communications about disease states. The draft guidance announced principles for the content of disease awareness communications (e.g., they should “enhance education”). It also addressed the practice of combining disease awareness communications with reminder or product-claim advertisements (sometimes referred to as “bookending”). In general, the draft guidance explained, in considering whether two communications together qualify as promotional labeling or advertising, FDA would consider whether the pieces are perceptually distinct in use of graphic, visual, thematic or other presentation elements, and whether the pieces are presented in close physical or temporal proximity. The 2004 draft also, however, reiterated certain earlier FDA statements on disease awareness communications. Together with FDA correspondence, these earlier statements (discussed below) provide some evidence of FDA’s position on the distinction between properly executed disease awareness materials and materials that “effectively promote” a drug or medical device and are therefore submit to the promotion rules. FDA’s Pre-Guidance Approach to Disease Awareness Materials In September 1985, FDA’s Division of Drug Advertising and Labeling (the predecessor entity of the Division of Drug Marketing, Advertising, and Communications (DDMAC) and Office of Prescription Drug Promotion and (OPDP)) issued a “Clarification of FDA Policy on ‘Institutional,’ ‘Corporate,’ or ‘Health Message’ Advertising Practices.” The September 1985 document was revised in June 1988, in a further document entitled “Institutional/Disease Oriented Advertisements.”
In March 1997, FDA announced1 it was replacing both of these documents. The Agency indicated that the 1988 document would remain in effect until it could be revised and incorporated into a consolidated guidance document addressing both unbranded and preapproval communications. That document was never issued, but FDA did issue the 2004 draft guidance, which has been a source of guidance for manufacturer for more than a decade.
Now that the 2004 draft has been withdrawn, advertisers are left to evaluate the risk of proposed disease awareness materials based on the 1985 and 1988 documents and relevant enforcement letters. According to those letters, disease awareness materials are subject to regulation as promotion if they “effectively promote” a specific drug or medical device (see selected relevant letters linked below). It remains unclear whether any of the withdrawn draft guidance remains consistent with the views of FDA personnel or if the entire guidance effectively has been disavowed by the withdrawal. FDA cited the 2004 draft guidance in a 2012 notice announcing research into the effect on consumer perceptions and understanding of adding disease outcome information to branded promotional materials. FDA’s decision to withdraw the draft guidance could relate to planned follow-up actions on this research (e.g., new guidance on disease information in branded materials). Selected Relevant Letters:
- Letter from DDMAC to Novartis Pharmaceuticals Corp. (Apr. 21, 2010)
- Letter from DDMAC to Pfizer Inc. (Jan. 10, 2005)
- Letter from DDMAC to Schering Corp. (Aug. 18, 2000)
- Notice of Withdrawal, 80 Fed. Reg. 26,059 [http://www.gpo.gov/fdsys/pkg/FR-2015-05-06/pdf/2015-10477.pdf]
- FDA, Draft Guidance: “‘Help-Seeking’ and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms” [http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070068.pdf]
- Experimental Study: Disease Information in Branded Promotional Material, 77 Fed. Reg. 37051 [http://www.federalregister.com/Browse/AuxData/E4BEE9F7-615F-4805-B781-0D0F7FEA6345]