FDA STUDY TO FOCUS ON HOW COUPONS AFFECT CONSUMERS' IDEA OF DRUG RISKS IN DTC ADS
The FDA plans to conduct a study on how coupons and other price incentives affect consumers' perceptions of drug risks and benefits in direct-to-consumer (DTC) print ads.
Research has shown that consumers rate a product more favorably when they are simply given a gift certificate or a coupon for that product or service, the FDA said in a recent notice seeking comments on the proposed study.
"Based on this body of consumer research, the inclusion of coupons or other price incentives in DTC ads may impact consumers' perception of the risks and benefits of the prescription drug," the agency said.
Such coupons may pose no problem for simple products, the FDA said. "For more complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send different signals," the agency added. "These signals may foster consumer misperceptions about the advertised prescription drug product by exploiting general beliefs."
Therefore, prescription drugs promoted with coupons or free trial offers may be seen as more widely indicated, more appropriate and/or less risky than they really are, the FDA said.
"Inclusion of a mechanism that affects consumers' perception of the product's risks is especially problematic in reminder ads because this type of ad contains no accompanying risk information," the agency continued. "Furthermore, coupons and price promotions may imply superior drug efficacy."
To justify future regulatory changes, the FDA said it needs to have better empirical data about consumers' perceptions of the information in both DTC full-product and reminder advertisements. The FDA also wants to know how inclusion of such promotional devices can affect consumers' perceptions of the risks and benefits of advertised prescription drugs.
For a copy of the notice on the proposed study, published in the Federal Register, access http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0610-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0610-n000001.pdf). Comments are due April 7.