FDA Affirms Permissive Comparative Claim Policies, While Establishing Foundation for Restrictive Guidance
Food and Drug Administration (FDA) officials recently affirmed that prescription drug manufacturers may make comparative promotional claims regarding price, dosing, and indications without head-to-head clinical trial data. At the same time, published social science research from the Office of Prescription of Drug Promotion (OPDP) suggests that FDA policies will become more restrictive in the future. For example, FDA could seek to limit comparative claims to generic products that have been found interchangeable with, or at least comparable to, their innovator counterparts.
On May 7, 2014, OPDP announced plans to study the extent to which comparative price promotion might mislead consumers and physicians. In passing, the Federal Register announcement stated that current OPDP policy allows price comparisons when accompanied by “context that the relevant drugs may not be comparable in terms of efficacy and safety and that the acquisition costs presented do not necessarily reflect the actual prices paid by consumers, pharmacies, or third-party payors.”1 Similarly, in a scientific journal article published on August 28, 2014, OPDP representatives affirmed that FDA currently “permits some comparisons based on labeled attributes” of two drugs, such as dosing and indications.2 The lack of data from comparative trials ordinarily precludes such claims in prescription drug promotion, a fact highlighted by a recent OPDP untitled letter that objected to claims based on differences in product formulation and delivery system.3 The Federal Register and journal statements nonetheless make clear that manufacturers may lawfully proceed in the absence of such data provided the statements are appropriately qualified and the compared attributes carefully selected.
FDA’s statements—which are consistent with earlier agency pronouncements—make clear that not all comparative claims are subject to the same restrictive regulatory approach.4 Yet FDA has also, in these same publications, appeared to lay groundwork for future restrictions, almost certainly to be articulated in guidance under development. Both the May 7 announcement and the scientific journal article concerned research by OPDP social scientists examining the potential for even truthful comparative claims to mislead. According to the latter publication, fictitious advertising comparing product dosing, indications, or mechanism of action skewed consumer perceptions of the relative safety and efficacy of the compared products, although the results were mixed.
These research results will inform OPDP’s approach to guidance on prescription drug comparative claims, which has been highlighted in OPDP’s guidance development plans for several years.5 Although current policy gives manufacturers latitude to make a range of comparative statements about their prescription drug products, the continued development and implementation of a social science research agenda points up the importance of continued monitoring of FDA actions and focused engagement with agency officials on these issues. FDA’s focus on the safety and efficacy of compared products suggests that agency policy ultimately could seek to prohibit comparative claims, except for generic drugs and interchangeable follow-on biologics found essentially the same in safety and efficacy as their innovator analogs. Such a policy would be consistent with prior statements by other senior FDA officials questioning the validity, in the absence of impracticably large head-to-head trials, of comparative claims among innovator products within a therapeutic or pharmacologic category.6
2 Amie O’Donoghue, et al., Effects of Comparative Claims in Prescription Drug Direct-to-Consumer Advertising on Consumer Perceptions and Recall, Social Science & Medicine 120 (2014): 1-11.
3 Untitled Letter to Cipher Pharmaceuticals Inc., Re: Lipofen (fenofibrate capsules, USP) for Oral Use (Sept. 11, 2014).
4 See, e.g., Warning Letter to Henry McKinnell, Chairman of the Board & CEO, Pfizer Inc., Re: Zyrtec (cetirizine HCl) Tablets, Syrup, and Chewable Tablets (Apr. 13, 2005) (stating that “FDA does not object to the dissemination of truthful, non-misleading statements about approved indications”).
5 See, e.g., Thomas Abrams, Director of OPDP, OPDP Update on Oversight of Prescription Drug Promotion (Sept. 16, 2013).
6 See, e.g., Robert Temple, A Regulator’s View of Comparative Effectiveness Research, Clinical Trials 9 (2012): 56-65.
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