A study of advertising for drugs that have made the switch from prescription to over-the-counter status found that the presentation of risk information plummeted once the products advertised escaped the purview of the FDA.
The study, which was reported in the Journal of the American Medical Association, looked at print and broadcast ads—133 in all—for four products in the 24 months before and six months after they went OTC. Those products were Schering-Plough's Claritin (loratidine, which went OTC in 2002); AstraZeneca's Prilosec (omeprazole, OTC as of 2004); GSK's Alli (orlistat, OTC in 2007); and McNeil's Zyrtec (cetirizine, 2008). The study found that while the presentation of the products' benefits ticked up a notch after the switch, going from 83% to 97%, presentation of their potential harms plummeted, going from 70% to just 11%.
“With the exception of print advertisements for orlistat, no post-switch advertisements mentioned contra-indications or adverse effects,” wrote the study's authors. After the switch to OTC, just half of ads mentioned the generic name of the drug, compared to nearly all for the prescription-only period.
The study's authors noted that after an OTC switch, regulatory authority over the advertising of a drug switches from FDA to the FTC, which “holds drug advertisements to the same standards as any consumer product: it applies a ‘reasonable consumer' standard of truthfulness and non-deception that does not require any balancing of potential benefits and harms.”
FDA advertising standards, they argued, are inconsistently enforced and frequently inadequate, but “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 of 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.”
Four of the study's authors were at Brigham and Women's Hospital, while a fifth researcher works for CVS Caremark. The study's lead author, Dr. Jeremy Greene, is now at Johns Hopkins University.