Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits

Posted 12 September 2012 | By Alexander Gaffney, RAC 

Advertisements for over-the-counter (OTC) pharmaceutical products routinely discount the risks associated with a product instead of presenting the same "fair balance" approach mandated for prescription products, say researchers.

Writing in the Journal of the American Medical Association (JAMA), lead researcher Jeremy Greene explained that often when prescription drugs achieve OTC status, the drug's risks disappear from the advertising.

"A commitment to fair balance in drug promotion is clearly lost when a drug moves from prescription-only to over-the-counter status," said Greene.

The changes come from a difference in which agency acts as the primary regulator of the advertising.

Prescription drug products are primarily overseen by the US Food and Drug Administration (FDA), which uses its Office of Prescription Drug Promotion (OPDP) to keep tabs on branded advertising. However, once products are changed over to OTC status-something that happens once a drug can prove it is generally regarded as safe and effective, and is able to be used by consumers without the oversight of a doctor-the advertising is primarily overseen by regulators with the Federal Trade Commission (FTC).

FTC's rules are different than FDA's. FDA requires branded drug sponsors to exhibit "fair balance," so called because the advertisement must devote equal time, space and prominence to a drug's risks as well as its benefits. FTC, meanwhile, only requires that a "reasonable consumer" be able to determine the truthfulness of the advertisements, and does not have the same "fair balance" rule as FDA.

Broader Audience, Fewer Warnings

Greene's research looked at four drug products now available to consumers without a prescription: loratadine (Claritin), omeprazole (Prilosec) orlistat (Alli) and cetirizine (Zyrtec). After being made OTC, more of the drugs touted their respective benefits (97% versus 83%), while significantly fewer drugs explained the safety risks associated with the product (11% versus 70%).

The lack of warnings could lead some consumers to believe the drugs are safer than they really are.  Greene pointed to the overuse of the OTC painkiller ibuprofen, which can cause stomach ulcers and liver failure when used in excessive amounts or for extended periods of time, as an example.

Greene and his colleagues also found that the generic names of products were often left off of OTC advertising, which he called troubling.

"The generic name is a very powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places," he told Reuters in a subsequent interview. "It's concerning to us that the consumer is left without that information."

Greene's research was supported by a grant from CVS CareMark.

Read more:

JAMA - Changes in Direct-to-Consumer Pharmaceutical Advertising Following Shifts From Prescription-Only to Over-the-Counter Status

Reuters - Ads lose balance when drugs become over-the-counter

Med Page Today - When Drugs Go OTC, Risks Get Fewer Mentions

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