FDA Coming to a Mall Near You?

The FDA plans to interrupt about 1,800 "self-identified, moderately overweight" shoppers at malls to survey them on the content and format of the brief summary in direct-to-consumer (DTC) print ads, according to a notice published today in the Federal Register ["Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs"; DOCID:fr25ap06-80]

This is what a "brief summary" statement looks like in a typical print ad:




A mall is probably an ideal place to find moderately overweight consumers. But you gotta wonder what incentives FDA plans to offer people to spend 20 minutes reading this stuff? Perhaps a coupon for a free Big Mac!

Current FDA regulations require every risk in an advertised drug's approved labeling to be included in the brief summary, which my friend Harry Sweeney rightly pints out is "neither brief, nor a summary" (see "Communicating Risk: Let the Dialog Begin" in the April 2006 Issue of Pharma Marketing News).

One thing the FDA intends to study is its "less is more" idea: ie, is a "short list" of side effects better than a "long list"?

The number of side effects will be varied to create "short" and "long" levels as follows:

Short: "Side effects include a, b, and c. This is not a complete
list. Talk to your doctor for more information."
Long: "Side effects include a, b, c, d, e, f, g, and h. Talk to
your doctor for more information."

The Coalition for Healthcare Communication (CHC), which recently submitted a petition to the FDA seeking to simply the communication of risk information in broadcast, print, and Internet DTC ads (see "DTC without the Risk"), should be interested in the proposed FDA survey of consumers. In its petition, the CHC suggested that a short list is best.

The CHC has been doing its own survey about drug safety and DTC. Unfortunately, the results of their survey do not support the "learned intermediary" premise of their petition to the FDA. Here are some results of that survey:

1. Drug prescribers are keenly aware of the safety issues surrounding every drug they prescribe. 68% of respondents disagreed with this statement, 18% agreed, and 20% were unsure.

The CHC believes that patients should rely on their physicians as "learned intermediaries" and not on DTC advertising for communicating drug risk details. If this survey is any indication of how "learned" physicians are, then we are in big trouble.

2. Most patients think drugs are safe if prescribed by their doctors. 89% agreed and 9% disagreed.

3. Most patients read, understand and pay strict attention to the warnings that are given by their doctors and/or that are contained in product inserts and pharmacy literature. 91% disagreed and 7% agreed.

This result suggests that patients need to be exposed to warnings about drug side effects in multiple ways, not just through their physicians.

4. Most doctors are careful to be sure that patients understand the possible side effects of drugs being prescribed. 84% disagreed, 7% agreed.

It seems that despite these indications that physicians are not prepared to take up the slack, the FDA intends to have less risk information in DTC print ads and force consumers to rely more on physicians to communicate the details. The FDA survey will no doubt support that effort.