Much important discussion of late about possible new categories for Rx-to-OTC switching – namely erectile dysfunction medicines and statins. But how does this impact consumer information? Consider the impact of the FDA-to-FTC switch.
The FDA requires prescription drug advertising to provide consumers with a "fair balance" of risks and benefits. The FTC, on the other hand, holds drug advertisements to the same standards as other consumer products, requiring a "reasonable" standard of truthfulness.
What’s the impact on how these products are presented to consumers?
According to a new study, when prescription drugs become available over-the-counter, advertisements for the medications are less likely to tell consumers about the potential harms and side effects. This according to Dr. Jeremy Greene, an associate professor in the history of medicine department and the department of medicine at Johns Hopkins University (study published in the September 12th issue of the Journal of the American Medical Association).
Greene and his colleagues analyzed print and broadcast advertisements for four commonly used drugs that were heavily marketed to consumers as prescription drugs and then approved for sale over-the-counter.
The drugs included loratadine (brand name: Claritin, sold over-the-counter since 2002), omeprazole (brand name: Prilosec, went over-the-counter in 2004), orlistat (brand name: Alli, Xenical, sold over-the-counter since 2007), and cetirizine (brand name: Zyrtec, sold over-the-counter since 2008).
When the drugs were available only by prescription, 70 percent of the ads mentioned potential harms. After the drugs were available over-the-counter, only 11 percent did, the investigators found.
After drugs became available over-the-counter, only about half of print and broadcast advertisements mentioned a drug's generic name, compared to 94 percent of ads when drugs were prescription-only. Knowing a drug's generic name can help consumers make sure they're not taking more than one medication that has it as a component, risking overdose, Greene explained.
Greene believes that the FDA should be given authority to regulate marketing of over-the-counter drugs, or perhaps the FTC should adopt guidelines similar to what the FDA requires.
Rather than asking either underfunded agency to take on more work (for which they are neither staffed nor suited), perhaps OTC advertisers should consider what they could do to better educate consumers. After all, a key FDA consideration in approving an Rx-to-OTC switch is whether consumers understand key communication objectives of the label, relating to directions for use, contraindications, in-use warnings and precautions.
Knowledge is power.