FDA to pharma: Scrap that fine-print risk info in DTC ads

Look for some big changes next time you run across a magazine ad for Crestor or Viagra or any of the brands on heavy rotation. The FDA has decided that its long-standing disclose-all policy on side effects was wrong. Way wrong.

As Regulatory Focus reports, the agency now says pharma advertisers should capsulize information on a drug's risks, focusing only on the "most important" potential side effects rather than the full page of fine print that now accompanies some direct-to-consumer ads.

"FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements, an approach in which risk-related sections of the [prescribing information] are presented verbatim, often in small font," the agency said in new guidance on risk disclosures in DTC ads.

Here's why: The FDA knows that people often flip past that fine print completely. In fact, 40% of consumers say they usually don't read any of the so-called brief summary of drug risks in print ads, the agency says.

Plus, the FDA has studied how people respond to risk information in ads, comparing a simplified approach with the usual lay-it-all-out-there advertising. Focusing in on the most common and most serious risks helped consumers understand the products better.

The FDA also wants drugmakers to translate the legalese on their drugs' official labels into plain English for advertising purposes. "Do not use," rather than "This use is contraindicated in," for example, RF says. The idea, again, is to help consumers understand the risks. After all, the official labeling isn't written for the general public; it's aimed at medical professionals.

Drugmakers are free to experiment with formatting, the agency says. Any "readable format" is OK, though the agency recommends Q&A's and "Drug Facts" boxes. Include the "clinically significant" info. Leave out "less pertinent information."

As RF points out, the guidance raises many questions about how to put the FDA's suggestions into practice. The agency is taking comments for 90 days. But in general, the industry has welcomed 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," PhRMA said when FDA first raised the idea last year.

- read the RF article
- get the FDA guidance (PDF)