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.”
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.
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.
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.
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
79 Fed. Reg. 26255, 26256 (May 7, 2014).
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).
See, e.g., Warning Letter to Henry McKinnel, 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”).GLOBAL LIFE SCIENCES UPDATE
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
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.
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
If you have any questions regarding this update, please contact the Sidley lawyer with whom you usually work.
Sidley Global Life Sciences Practice
On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug
and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability,
Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and
Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology.
Globally rated as one of the top life sciences practices, our team includes former senior government officials, medical doctors and
leaders in various life sciences fields.
For further information on the Global Life Sciences Practice, please contact:
Paul E. Kalb, M.D.
James C. Stansel
M. Patricia Thayer
Michael W. Davis
David J. Zampa
To receive future copies of this and other Sidley updates via email, please sign up at www.sidley.com/subscribe
BEIJING ∙ BOSTON ∙ BRUSSELS ∙ CHICAGO ∙ DALLAS ∙ GENEVA ∙ HONG KONG ∙ HOUSTON ∙ LONDON ∙ LOS ANGELES NEW YORK ∙
PALO ALTO ∙ SAN FRANCISCO ∙ SHANGHAI ∙ SINGAPORE ∙ SYDNEY ∙ TOKYO ∙ WASHINGTON, D.C.
Sidley Austin refers to Sidley Austin LLP and affiliated partnerships as explained at www.sidley.com/disclaimer. www.sidley.com
See, e.g., Thomas Abrams, Director of OPDP, OPDP Update on Oversight of Prescription Drug Promotion (Sept. 16, 2013).
See, e.g., Robert Temple, A Regulator’s View of Comparative Effectiveness Research, Clinical Trials 9 (2012): 56-65.