Last week, the FDA announced plans to conduct two studies designed to explore how consumers understand and interpret efficacy representations made in “direct-to-consumer” (“DTC”) advertising for prescription drugs. See Notice.

Clinical endpoints and composite scores

Before introducing a new drug into the market, pharmaceutical companies must prove the safety and efficacy of that drug through well-controlled clinical trials. The efficacy of some drugs can be determined using a single clinical endpoint. However, the efficacy of many drugs is measured using multiple endpoints, e.g., where a drug is intended to treat a condition that has multiple symptoms.

The results from individual clinical endpoints are sometimes combined into an overall “composite score.” A composite score is a single measure of how well a drug performs based on a combination of factors.

Although one drug may have a significantly better composite score than another drug that treats the same condition, the drug may not be significantly more effective (or effective at all) for treating a particular aspect or symptom of the condition.

Consumers and composite scores

Last fall, the FDA convened a focus group “to better understand how consumers understand the concept of composite scores.” According to the FDA, the work showed few consumers are familiar with composite scoring or its use in clinical trials, and most consumers “had difficulty correctly interpreting efficacy information that was based on composite scores.”

The FDA stated that these findings suggest that further research is needed to understand how the use of complex information influences consumer perceptions of drug efficacy.

FDA to study direct-to-consumer marketing

To address this, the FDA proposes to conduct two web-based studies of approximately 1,600 adults each. The first study will explore:
  • Whether consumers understand how efficacy is measured for specific drugs.
  • How well consumers understand the concept of composite scores.

The second study will examine:

  • Whether DTC ads based on composite scoring influence consumer perception of drug efficacy and risks.
  • How DTC ads can best deliver composite endpoint information to “maximize consumer comprehension and informed decisionmaking [sic].”

Proposal criticized

 The FDA proposal is not without its critics. Pharmaceutical blog, Pharmalot, has quoted Arnie Fried, a former FDA associate chief counsel, as noting: “Once again, the fact that FDA is only now proposing to study the use of composite scores in DTC advertising suggests that its conclusions about the misleading nature of various claims based on aggregate data, or based on a disaggregation of the aggregate data, are not empirically validated.”

Public comments on the proposed studies may be submitted to the FDA by October 22, 2012. See Notice.

Source: 77 Fed. Reg. 51027 (Aug. 23, 2012).


This article was prepared by Kathy Grant ((kgrant@fulbright.com / 210 270 7182) and Saul Perloff (sperloff@fulbright.com / 210 270 7166) of Fulbright’s False Advertising Practice.