Disclosing Risk in DTC Print Ads: Introducing the "Consumer Brief Summary"

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. One document was titled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”

“Our new regulatory guidance,” said Mark B. McClellan, M.D., Ph.D., FDA Commissioner at the time, “provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn't in drug promotion” (read "FDA Draft Guidance for Print DTCA: Less than Feared").

But now even NEWER evidence - and complaints from the pharma industry - forced the FDA to issue a "revised draft guidance" titled "Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs," which you can find here (Docket No. FDA-2004-D-0500).

Released on February 9, 2015, this revision was ELEVEN years in the making. Compared to that, the four years FDA took to issue draft social media guidelines was lightening fast.

The guidelines address the requirement under provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require that an advertisement for a prescription drug to disclose each side effect, warning, precaution, and contraindication from the labeling. This is referred to as the "brief summary requirement."

So what's new in the guidelines?

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