FDA May Trim Some Of Those Lengthy Warnings In Prescription Drug Ads

We’re all familiar with prescription drug commercials that are basically 5 seconds about how there’s some awesome drug for your “moderate-to-severe” fill-in-the-blank condition, followed by 25 seconds of happy families playing in parks accompanied by the sound of speed-red disclosures about a vast array of warnings and possible side effects. The FDA is now looking for you opinion about whether it should look into trimming down all that fine print.

Earlier today, the FDA began seeking public comment on a proposed investigation into whether or not to ease the regulations governing the level of disclosures in prescription drug ads.

The regulations currently governing these ads require that present the product’s major risks of the advertisement. This fine print — whether spoken, as you’ll find on TV or radio spots, or printed in magazine ads — is generally referred to as the “major statement.”

The FDA says there is concern (from whom — consumers or drug makers?) that “the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.”

It also says there is a conflicting concern (again, without identifying the source of said concern) that these ads “do not include adequate risk information or leave out important information.”

Ever the peacemaker, the FDA sees a possible resolution in limiting the major statement to only those risks “that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad.”

It gives the example of an ad that would rattle off a couple of major side-effects — let’s say hair loss, weight gain, and death — that would be followed by a statement like “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it.”

The FDA hypothesizes that this format — presenting only the most dire risks, along with a disclosure that there may be others — “will promote improved consumer perception and understanding of serious and actionable drug risks.”

To test that hypothesis, it proposes a study in which participants — each of whom self-identify as having been diagnosed with one of three possible medical conditions, will be randomly assigned to view one of four possible versions of an ad.

One version will represent the current state of prescription ads with a commercial that uses the full major statement without the disclosure regarding additional risks.

A second version of the ad will include the full major statement plus the disclosure about additional risks.

The third version will include an abbreviated statement of risks without the disclosure about additional risks.

And in case you hadn’t guessed, the fourth version will include an abbreviated statement of risks and the disclosure about additional risks.

The participants will then respond to questions about information provided in the version of the ad they watched.

If you want to chime in with your opinion on this study, go to this page on Regulations.gov before April 21, 2014.

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