Merck is developing a research protocol to evaluate consumer understanding of direct-to-consumer television ads for prescription drugs, the company announced.

The drug maker will use the research tool internally but also plans to make it widely available to other pharmaceutical manufacturers and their advertising agencies. Merck said it would be open to working with other manufacturers on the project.

"This really is in response to what I think everyone would agree is a need for data, objective data, around the issue about whether or not consumers recall and understand TV advertising," Consumer Marketing Manager Ed Slaughter explained.

Merck has been receiving "technical assistance" from FDA's Division of Drug Marketing, Advertising & Communications on the development of the protocol.

"We share the FDA's desire to provide useful information to patients about prescription drugs," the company said in a recent release. "We believe that having this type of data will help everyone involved make informed decisions about television advertisements that have been submitted for review."

Merck plans to use the research tool to provide quantitative consumer comprehension measurements to FDA at the time proposed ads are submitted for review.

In a statement, DDMAC Director Thomas Abrams said, "While we don't know if development of this protocol will result in any changes to DDMAC's current review of policies, if successful, the protocol could be a useful tool for facilitating review of prescription drug advertisements intended for broadcast on television."

Merck said it first approached DDMAC about the research plan in August 2005 and that development is still in the "early stages." Merck plans to complete a pilot study by the end of April, which could mean that the research protocol could be finalized by the end of the summer, Slaughter said.

The initial study design being evaluated involves exposing consumers to a cluster of ads for a range of products, one of which being a drug, much the way a viewer would see them at home. Participants would then be asked standardized questions to determine their recall and comprehension of essential information.

The questions will address risk and benefit information, as well as information about the drug's target population, to determine if there is fair balance in the ad.

AstraZeneca is expected to release the results from a similar consumer research survey in early 2006. The survey is attempting to gauge consumer reaction to risk information delivered by a voiceover or by an actor looking directly at the camera, and when directed to visit a website or a magazine for more information (¹ Also see "AstraZeneca Questions Value Of DTC Ads, But Is Still Launching New TV Spots" - Pink Sheet, 14 November, 2005., p. 13).

Merck's initiative to develop a standardized research tool comes amid increasing debate over the benefits and drawbacks of DTC ads for drugs.

The company has been less outspoken than some drug makers about adopting internal DTC policies. For example, Pfizer and Bristol-Myers Squibb have announced internal procedures that include six- and 12-month moratoriums on ads for new products, respectively.

Nonetheless, Merck said it implemented most of the principles that were adopted by the Pharmaceutical Researchers & Manufacturers of America in August long before the trade group acted on them. Those policies included voluntarily submitting new ads to FDA for review and waiting for feedback prior to airing the spots, the firm said.

PhRMA's DTC advertising principles, which went into effect Jan. 1, ban TV reminder ads and recommend tailoring ads in an educational manner (² Also see "PhRMA DTC Principles Compliance To Get Independent Panel Review In 2007" - Pink Sheet, 8 August, 2005., p. 8).

During a recent Drug Information Association workshop on drug marketing, DDMAC Social Science Analyst Kathryn Aikin applauded a new TV spot for Merck/Schering-Plough's cholesterol drug Zetia (ezetimibe), which features a "doctor dramatization."

However, despite recent efforts by industry to develop more educational ads, criticism has continued. At a public hearing on the topic in November, advocacy groups urged further evaluation of DTC ads (³ Also see "Is A Picture Worth A Thousand Words? – FDA Evaluation Of DTC Images Urged" - Pink Sheet, 14 November, 2005., p. 15).

DDMAC Director Abrams recently noted that the omission of risk information in DTC ads continues to be a pressing issue (⁴ Also see "Win, Lose Or Yawn: Is Industry’s DTC Policy Working?" - Pink Sheet, 27 February, 2006., p. 19).

Merck DTC Research Tool Under Development With Input From FDA

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