On February 29, 2012, the Food & Drug Administration (FDA) issued a notice soliciting comments on its intent to conduct research entitled “Experimental Study: Examination of Corrective Direct-to-Consumer (DTC) Television Advertising.” FDA issued the notice pursuant to the Paperwork Reduction Act of 1995, which requires federal agencies interested in collecting information to first publish notice of the proposed collection of information in the Federal Register and grant the public sixty days to comment on the proposal. FDA’s proposed research will examine how corrective advertising may impact consumer misperceptions about drug product safety and efficacy. It also follows, FDA’s December 9, 2011, notice announcing its intent to collect information for a “Experimental Study of Comparative Direct-to-Consumer Advertising.”
Corrective advertising is one remedy FDA may request in response to what it perceives to be false or misleading advertising for a prescription drug. According to FDA, researchers and policymakers currently lack exhaustive empirical literature regarding the various impacts of corrective DTC advertisements on prescription drug consumers. FDA intends for the proposed study to examine how variations in corrective advertising may impact consumers’ misleading product beliefs.
Comments regarding the proposed “Examination of Corrective Direct-to-Consumer Television Advertising” will be accepted until April 30, 2012. More information regarding the proposed study and request for comments is available here.