FDA Moves Towards a Less Risk-Averse New Day

It’s been more than 10 years since the FDA provided official direction on risk information for print. This month, based on social science research and perhaps a bit of common sense, new FDA regulations are asking the industry to focus on only the most important potential side effects and simplify the language. Or in the words of the FDA, “a conversational tone or language designed to engage the reader may be useful.”

The revised draft guidance goes so far as to provide ideas on layout, font, white space and the use of “attention-drawing symbols” to further help with consumer interest and comprehension.

For anyone who’s ever had to explain to a non-industry friend why we in pharma insist that our ads contain laundry lists of phrases such as, purple urine or gas with oily discharge, these revisions are most encouraging news.

A New Regulatory Trend?

Although this update is focused on the brief summary, this less-is-more trend has some promising implications.

For starters, it’s bound to open the door for re-evaluating fair balance in print and even on TV. In turn, pharma ads could become more financially feasible, with less space needed for the extensive list of risk information. And certainly with the potential to be more engaging and relevant to consumers.

The new regulations admit that “minor risks detract from, and make it difficult for, consumers to… retain information about the more important risks.” Apparently people remember that they’re likely to grow a third arm before they retain information about the possibility of a better quality of life.

With the go-ahead to eliminate the odd, minor risks there’s hope for less side-effect backlash. Having to mention some of the unusual side effects has kept more than a few marketers from communicating with consumers altogether. The new recommendations could change that and help get those messages out to people who could benefit from these products.

Within the new update, the FDA speaks admiringly of the clear, succinct OTC Drug Facts label and its usefulness and credibility with consumers. The FDA referred to this as an example for pharma to follow.

Perhaps with a sensible amount of clearly stated risk, pharma, too, could be inching toward the unchartered territory of credibility and respect.

The Risk of Fewer Risks

But before we get too carried away, the new guidance does leave room for subjectivity. Internal regulatory teams are going to have a field day with recommendations like: “include information that would affect a decision to prescribe or take a drug” and “incorporate measures that can be taken to prevent or mitigate harm” among others. There is also the possibility that without the comfort of a boatload of risk information, med-legal teams may become skittish and more conservative with what they will allow from the creative and messaging.

But let’s stay hopeful. The FDA seems to be looking at pharma ads a bit more through the lens of non-pharma ads, as a means to engage and start the conversation rather than to be the be-all, end-all.

There will always be a lot of people and a lot of official product information standing between a consumer and a prescription medication—ready to educate on the finer details, the major and minor risks. But print and TV ads are not the place and it seems that the FDA may be acknowledging this.