FDA looks beyond balance in study of efficacy info

Share this article:
Having analyzed the presentation of risk information in DTC ads and product labeling, FDA is looking at how the potential benefits of prescription drugs are communicated.

The agency gave notice in a June 16 Federal Register post of a study looking at the presentation of clinical efficacy information in professional labeling and print ads.

“Beyond the balance requirement, limited guidance and research exists to direct or encourage sponsors to present benefit claims that are informative, specific and reflect clinical effectiveness data,” said the notice.

The study will look at how presentation of clinical effectiveness information affects both consumer and physician perceptions of safety and efficacy, “and particularly, how consumers make (risk/benefit) judgments in response to variations in the efficacy presentations in the ‘display' page of a DTC print ad.”

The consumer portion of the study, featuring display pages for fictitious overactive bladder and benign prostatic hyperplasia drugs, will test perceptions of treatment versus prevention claims, placebo data and framing, using “mixed framing,” which provides the number of people who did not benefit from the drug as well as the number who did, as well as the single, positive frame typical of data presentation in drug advertising.

“Only a few studies have actually measured this missed approach, although risk communication guides recommend the use of mixed framing to create more accurate perceptions,” said the notice.

The physician portion will examine physician perceptions of clinical efficacy information in the prescribing information using varying claim types and placebo rates for the fictitious OAB and BPH drugs.

A public comment period on the study is in effect through August 16.
Share this article:
close

Next Article in News

Email Newsletters

More in News

Gilead reaps huge HCV sales, payer fury

Gilead reaps huge HCV sales, payer fury

Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also ...

Bayer drug gets orphan label

Bayer drug gets orphan label

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

Lilly's cancer drug ramu granted gastric indication

Lilly's cancer drug ramu granted gastric indication

Ramucirumab received FDA approval today in advanced gastric cancer, a nod that could translate into $600 million in peak sales.