Greene JA, Choudhry NK, Kesselheim AS, Brennan TA, Shrank W. Changes in Direct-to-Consumer Pharmaceutical Advertising Following Shifts From Prescription-Only to Over-the-Counter Status. JAMA. 2012;308(10):973–975. doi:10.1001/2012.jama.10647
Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts (Drs Greene, Choudhry, Kesselheim, and Shrank) (firstname.lastname@example.org); and CVS Caremark (Dr Brennan). Dr Greene is now with Johns Hopkins University.
To the Editor: Direct-to-consumer advertising (DTCA) can influence the use of prescription drugs.1,2 The US Food and Drug Administration (FDA) regulates prescription drug advertising, including requirements to provide consumers with a “fair balance” of risks and benefits. When prescription drugs switch to over-the-counter (OTC) status, regulatory oversight of their advertising shifts to the Federal Trade Commission (FTC). Unlike the FDA, the FTC holds drug advertisements to the same standards as any consumer product: it applies a “reasonable consumer” standard of truthfulness and nondeception that does not require any balancing of potential benefits and harms. Such a shift may be associated with changes in content.
We analyzed all print and broadcast advertisements from 4 commonly used prescription drugs that were the subject of extensive DTCA promotion before and after OTC shift: loratidine (OTC in 2002), omeprazole (in 2004), orlistat (in 2007), and cetirizine (in 2008). Television and print materials spanning 24 months before and 6 months following OTC shift for each drug were obtained from an advertising database compiled by VMS Adsight, an archiver of print and broadcast advertising media.3 The longer preshift period was required to obtain comparable numbers of prescription and OTC advertisements. Reproductions of 133 discrete advertisements were obtained, stratified by whether they appeared in print or television, and coded for descriptive characteristics, presentation of health benefits (specific indications and claims of general health improvement), and potential health harms (adverse effects, contraindications, warnings, and precautions) by 2 independent researchers. A third coder settled disagreements in 52 (13%) of 399 coding judgments. Prevalence ratios (PRs) of characteristics before and after the OTC switch were compared using the Fisher exact test and Stata statistical software version 7.2 (StataCorp). All tests were 2-tailed and the level of significance was P < .05; multiple comparisons used a Bonferonni-corrected α level of .002.
After the OTC switch, 62 of 64 (97%) advertisements described benefits of medications compared with 57 of 69 (83%) during the prescription only period (PR, 1.17 [95% CI, 1.04-1.32]; P = .01; Table). The difference was not statistically significant for individual drugs. Differences existed in the presentation of potential harms during the prescription-only period in 48 of 69 advertisements (70%) vs 7 of 64 (11%) after OTC shift (PR, 0.17 [95% CI, 0.09-0.35]; P < .001). With the exception of print advertisements for orlistat, no postswitch advertisements mentioned contraindications or adverse effects. Print and broadcast advertisements after OTC switch were less likely to mention drugs' generic names (33 of 64 [52%] vs 65 of 69 [94%]; PR, 0.55 [95% CI, 0.43-0.70]; P < .001).
Our results support and extend initial reports on the practical outcomes of the shift in regulatory oversight in drug promotion from the FDA to the FTC that accompany OTC shift.4 In addition to less presentation of potential harms, DTCA for OTC medications frequently omitted identification of drugs by their generic names, both of which are key tools for consumers seeking independent information on risks, benefits, and costs.5
These 4 products may not be representative of all prescription drugs, OTC drugs, or drugs undergoing OTC shift. Our study omitted online and radio advertisements, and advertisements may have been missed by the VMS algorithms. This analysis cannot distinguish between overrepresentation of insignificant harms in DTCA for prescription drugs vs the underrepresentation of significant harms in DTCA for OTC drugs.
The FDA's “fair balance” requirements covering prescription DTCA do not necessarily result in balanced presentations of risks and benefits, and these guidelines are known to be inconsistently enforced. However, our analysis suggests that DTCA after OTC switch presents even less information for making an informed decision, at a time when consumers must have more knowledge of whether medications' potential benefits are worth their risks and costs. Pharmaceuticals do not lose their capacity for harm after moving from behind the pharmacist's counter to in front of it; misuse of OTC drugs remains a major cause of emergency department visits, hospitalization, and death.6 Closer attention should be paid to how such drugs are promoted to consumers.
Author Contributions: Dr Greene had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Greene, Choudhry, Kesselheim, Shrank.
Acquisition of data: Greene, Brennan, Shrank.
Analysis and interpretation of data: Greene, Shrank.
Drafting of the manuscript: Greene.
Critical revision of the manuscript for important intellectual content: Greene, Choudhry, Kesselheim, Brennan, Shrank.
Obtained funding: Shrank.
Administrative, technical, or material support: Brennan, Shrank.
Study supervision: Greene, Shrank.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Greene reported receiving a STS Scholars Award by the National Science Foundation, a Junior Faculty Fellowship in Entrepreneurship Research from the Kauffman Foundation, a research grant from CVS Caremark, and royalties from Johns Hopkins University Press for a scholarly monograph entitled Prescribing by Numbers: Drugs and the Definition of Disease. Dr Choudhry reported receiving research grants from CVS Caremark, Aetna, the National Association of Chain Drug Stores, the Robert Wood Johnson Foundation, and the Commonwealth Fund. Dr Kesselheim reported receiving a career development award from the Agency for Healthcare Research and Quality, a Robert Wood Johnson Foundation Investigator Award in Health Policy Research, and serving as an expert witness on behalf of a class of individual plaintiffs against AstraZeneca alleging improper promotion of esomeprazole (Nexium). Dr Shrank reported receiving research grants from CVS Caremark, Aetna, the National Association of Chain Drug Stores, Teva Pharmaceuticals Inc, and Lilly. Dr Brennan reported holding stock or stock options in CVS Caremark.
Funding/Support: This work was supported by a research grant from CVS Caremark.
Role of the Sponsor: Dr Brennan participated in the project but CVS Caremark placed no restrictions on and had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Additional Contributions: Mary Kenneally, BA, Elaine Kilabuk, BA, Benjamin Smith, BA, and Kellie Swanton, BA, participated in the primary coding of the advertisements and Jessica Myers, PhD, conducted all statistical analyses. All of the these individuals are associated with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts, and did not receive compensation for their work.