How long does it take for the US Food and Drug Administration (FDA) to get a study up and running? For at least one previously-proposed study on promotional advertising, nearly two years.
Since September 2010, FDA has been looking to conduct a study on consumers to assess the effects of promotional offers in direct-to-consumer prescription drug print advertising. In its 22 September 2010 Federal Register posting, FDA proposed the study as a way to look at how coupons, free-trial offers, discounts and money-back guarantees were affecting consumer habits.
"Coupons and free trial offers may send different signals" to consumers regarding the appropriateness and performance of prescription products," FDA explains on its website. "In situations where little information about the product is available or when consumers are unmotivated to seek further information, consumers may use price as a heuristic cue to ascertain the quality of a product."
This represents something of a challenge for the agency, FDA wrote.
"While the Federal Food, Drug and Cosmetic Act (the FD&C Act) provides FDA with authority to regulate prescription drug advertisements that are false or misleading, the FD&C Act does not provide FDA with the authority to regulate the pricing of prescription drugs," explained FDA in the 2010 posting. "FDA is merely interested in studying the effects, if any, of the presence of various promotional offers in DTC advertisements on consumers' perceptions of product risks and benefits, and recognizes that it does not actually regulate the dollar or other incentive amount of coupons, price incentives, or rebate offers with respect to how they affect the price of prescription drugs or biological products."
The 2010 proposal received comments from a number of companies and individuals, including PhRMA, Bausch+Lomb, Community Catalyst and McKesson.
In its statement to FDA, PhRMA wrote it was "concerned that the study, as currently envisioned, will not yield information that is relevant to FDA's regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced."
"Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand," explained PhRMA, "it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted."
Community Catalyst meanwhile supported the study, saying it predicted "the results of the study will show that the promotional offers negatively impact the division-making process of consumers by inflating the perceived benefits and diminishing concerns about risks."
"If this is the case, we support FDA action to ban the use of coupon promotions for prescription drugs," Community Catalyst concluded.
FDA Moves Forward
In September 2011, FDA published two proposed study designs: one to test different types of promotional advertising in patients suffering from insomnia and another to test the same advertising's affect on patients with high blood pressure. Both studies will have an online survey component, while the first will incorporate a mall intercept component as well.
"We will test how the offer type affects their recall of the benefit and risk information, their perceptions of the benefits and risks of the drug, their perceptions of the incentive, and their behavioral intention to look for more information about the product and try the product," explained FDA.
Both studies will assess five variables: free trial offers, buy-one get-one free offers, money-back guarantees and a "no offer" control variable.
FDA did not submit the proposed study to the Office of Management and Budget (OMB) until September 2011-nearly a year after the study was first proposed. OMB is in charge of approving or rejecting any proposed collections of information.
In a 26 June 2012 Federal Register posting, FDA announced it had received approval from OMB and plans to go ahead with the study. In a statement on its website, FDA said it anticipates the study being completed at some point in 2013.