Washington, DC — If you work in the pharmaceutical industry, you’ve probably been asked the big, exasperated question just about anyone who’s had to use healthcare communications asks: Why do you do it that way?? The tiny fine print, the long lists of complications, the challenging language. Ugh.
It’s the FDA, we say. We’re required to do it that way.
The well-intentioned quest to protect consumers, actually created a system that can feel impossible to understand. Luckily, there are lots of people trying to make it better – from agencies, to brand managers, to the FDA itself.
Here are four initiatives that could fundamentally change how people learn about life-changing medications:
1. Rethinking the 60-Second Spot: The pharmaceutical industry spent $3.1 billion on television advertising in 2012 (the latest year available from Pew Charitable Trusts), much of it on those long lists of seeping, scary side effects. This year, the FDA is considering shortening those required disclaimers to help consumers better understand the risks, in part by not overwhelming them or creating “laundry lists” they simply tune out.
One key solution being tested is limiting the risks to those that are “serious and actionable,” and adding a disclosure to alert consumers that there are other product risks not included in the ad.
Doctors are divided on the issue. Many say that the pharmaceutical industry should be required to educate consumers. The FDA’s research with 1500 consumers is going to try to determine just what education really works in direct-to-consumer advertising.
2. Making Comparison Easier for Consumers: The FDA has also taken on longer term (3 – 5 year) consideration of a communication tool designed to rethink fair balance by simplifying the content and delivering detailed benefits with more stratified risks.
The Drug Facts Box prototype was created by Dartmouth researchers Dr. Woloshin and Dr. Schwartz with the goal of making it as easy to understand the health impact of drug as it is to understand the diet impact of a bag of potato chips.
The research team took the results of two randomized trials on how well drug fact boxes worked on several hundred people to the FDA. The studies indicated that most people presented with comparative risk and benefit information were able to identify the more effective of two drugs. The results held for random samples as well as for special populations, like people with less than a high-school-level education.
3. Getting Specific About Social: Years after the initial hearings on the matter, the FDA has begun releasing digital and social media guidance that’s surprisingly specific and actionable.
In 2013, they provided direction on how to deal with unsolicited requests. Then, earlier this year, provided detailed guidelines on pharma-created or -sponsored social and digital destinations, particularly who is responsible for content and how both brand and user-generated content should be reviewed. At least one more set of social media guidance is expected this July.
4. Double-Checking Generic Equivalency: Up to 80% of the drugs used in the U.S. today are actually generics. Often consumers are given these replacements automatically by pharmacists without any discussion about how they compare to the original innovator drug. In a new series of reviews, the FDA is asking: Just what are those consumers getting?
The current definition of bioequivalence is broad: Generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name – that’s a 45% range in drugs that are labeled as being the same. There are other allowed differences, too. Like, the drugs have to use the same active ingredient, but the other ingredients and fillers can be different and of lower quality. The biggest impact of those differences seems to be impacting the rate and amount of absorption.
In 2012, the FDA withdrew approval of a generic version of Wellbutrin when it found it was not in fact “bioequivalent” to the name-brand version. Following that action, the FDA is taking more steps to make sure consumers know what they’re buying, looking at the actual formulations of a wide-range of generics, including immunosuppressants, antiseizure medicines and drugs for treating attention deficit hyperactivity disorder.
Posted by: Leigh Householder