Regulatory Focus™ > News Articles > Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores

Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores

Posted 13 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that it plans to move forward with a proposed study on direct-to-consumer (DTC) advertising first announced in August 2012 regarding the use of composite scores in advertising and whether consumers have sufficient understanding to allow for their use.


Composite scores are essentially a collection of clinical endpoints combined into a single overall score. For example, an allergy drug might use a composite score that measures a patient's runny nose, congestion, nasal itchiness and sneezing.

But if the concept is clear to regulators and health professionals, FDA still has a question: Do consumers understand these advertisements?

Prior research on the subject is "scant" according to regulators, and FDA's study, announced in August, intends to find an answer.

The study is specifically intended to assess whether patients understand that though a drug may have a better composite score than a competitor's product, it is not necessarily better in every single area reflected in its composite score. For instance, one hypothetical allergy drug might have a higher overall composite score, but its competitor could still be better at treating a patient's nasal congestion.

"Because most DTC prescription drug ads do not explicitly state that they used composite scores to demonstrate efficacy or they provide little explanation of how these scores are calculated, it is also important to understand whether consumers recognize how composite scores are used for measuring drug efficacy," FDA wrote in its August 2012 Federal Register notice.

Regulators added that their preliminary research indicated that consumers generally fell into one of two groups:  those who said they would appreciate drug advertising including information about the composite score, and those who felt that the ads already provided sufficient information to inform their choices.

Two Proposed Studies

FDA proposed two separate studies to assess the use of composite scores. The first, a 1,600-person Internet survey, is meant to assess a participant's understanding of composite scores and what they mean for a drug's safety and effectiveness, with a particular focus on patients who may not be well-educated.

The second study will involve 1,602 subjects and will include three different presentations of information: an ad with no information about a composite endpoint, a list of symptoms treated by the drug that make up the composite endpoint, and an explicit definition of a composite score.

Half of the second group will also be given an educational intervention, which FDA said should allow it to see if consumers receiving a plain explanation of the information from a presenter affects comprehension of the score. FDA said it plans to use the example of a decathlon to illustrate the concept for study participants.

"In that event, athletes compete in 10 events, such as the long jump, the shot put, and the 50-yard dash.  An athlete may not win all events, but if he or she wins some and performs well enough in others, he or she may be the winner based on a combination of scores for each event," explained FDA.

Feedback from Industry

FDA said it received a number of comments from industry regarding the proposed study. In one comment, it was brought up that perhaps FDA should look at the use of composite scores in mediums most likely to be viewed by consumers, such as television or other video ads. FDA responded that "Because this is the first study to our knowledge that specifically examines the understanding of composite scores, we have chosen to examine them in the context of magazine ads" due to their prevalence.

Another comment questioned whether the study was even necessary given that there is a layer of protection between consumers and the dispensing of a drug in the form of physicians. If consumers aren't the ones prescribing the drug, should FDA really care how they understand composite scores? Yes, answered FDA in its Federal Register posting.

"We agree that the health care professional is the prescriber and that the consumer or patient has a layer of protection before consuming prescription drugs," FDA wrote. "However, direct-to-consumer advertising is directed at consumers before they talk to their health care professionals--in fact, driving consumers to their health care professionals is a primary goal of DTC ads. If sponsors choose to communicate with consumers in such a manner, then it makes sense to examine the understandability of their messages."

In response to another question, FDA said it plans to make the results of the study available to the public in a "timely manner" on the agency's webpage for the Office of Prescription Drug Promotion (OPDP).

FDA also said it had shifted around the number of proposed study participants in the second study, narrowing the number of pretest participants from 600 to 462, but increasing the number of participants in the main study from 1,602 1,740. The overall hours to complete the study have also been decreased from 1,519 hours to 1,321 in total.

Tags: DTC, study

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