Simplify the DTC roll call of side effects? Yes, please, drugmakers tell FDA

We've all encountered the long list of side effects at the end of a pharmaceutical TV ad or YouTube video. A disembodied voice rattles off a list of problems, citing a number of potential risks associated with a drug.

In February, the FDA announced that it wanted to see whether paring down that litany would help consumers understand the risks better. The agency asked for comments about its plans for a study, and now, the pharma industry is weighing in, Regulatory Focus reported. The unsurprising verdict? Drugmakers like the idea.

"Shorter or less complex warnings may be more effective at communicating risk information in an understandable way compared to longer, less focused warnings," said pharmaceutical trade group PhRMA (as quoted in Regulatory Focus).

The FDA planned to recruit 500 people for a pilot study and 1,500 for a main event that would examine consumers' response to a shorter list of safety risks. Patients in the main study would have one of three medical problems, and would view one of four different versions of an ad for products to treat their condition. Some of the ads would resemble the existing format, while others would include shorter side-effects lists, with an "additional risks apply" addendum. After watching the ad, participants would answer a questionnaire to determine their understanding of the risks.

"Our hypothesis is … providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks," the FDA said in a statement in the Federal Register.

A shorter risk statement could motivate patients and healthcare providers to seek additional information--a more effective way to educate consumers, PhRMA said in its comments. Pfizer ($PFE) also responded favorably to the proposed study, saying that it was "much-needed" and that it could provide "serious benefits" to the consumer.

However, companies and industry groups had a few things to say about the study's methodology. Pfizer said questions that asked respondents to think about what "other people" might do in response to the ad were unnecessary, and also recommended nixing items related to the persuasiveness of the ad and drug quality, Regulatory Focus reported.

This is not the first time the FDA has addressed risk statements in direct-to-consumer advertising. In 2012, the agency conducted a study to see whether "distracting images" in DTC ads would affect consumers' perception of a drug's risk. The FDA expected to find that the images had an adverse effect, but the study determined that the graphics did not detract from a patients' understanding of a product.

- read the Regulatory Focus story
- here's the Federal Register article (PDF)

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