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DTC in Perspective: FDA Very Busy in DTC Research

April 1, 2016 by Bob Ehrlich0

The FDA is becoming very active in DTC research. By my count they have identified ten studies that are in process to be fielded. Their glacial pace of completing their studies is well known so I am not sure when these ten will be completed and published. I know the people doing the studies are well qualified professionals who are hampered by government procedures that slow down the process. They go through numerous mandated public comment periods and have to get budget approval from Office of Management and Budget bureaucrats. It is unfortunate that after 20 years of DTC, FDA is still doing basic research that should have been done 15 years ago.

Bob Ehrlich
“FDA needs to…better communicate the…results.”
-Bob Ehrlich

FDA is doing some important studies and some that I question for their usefulness. On the positive side they are doing an important study on shortening the risk statement to focus on the major risks rather than the long litany of risks in many ads. They are also doing important work in the area of price discussion in DTC ads. FDA is also studying how to convey quantitative clinical information in understandable visuals. A fourth study which is important is how to measure the impact of superimposed text on the screen, as to size, contrast to background, and use on mobile devices.

FDA is also doing a major consumer attitude study on DTC, which was last done in 2002. This is long overdue and might be the most important of all their proposed studies. With all the criticism from payers, politicians, and physicians it is critical to get comprehensive consumer feedback.

There are a few studies I find less useful. One is measuring DTC television ads impact on the hard of hearing. One can assume that anyone who cannot hear well will have trouble with the audio and have less comprehension. This is one of those studies without a practical purpose. What are drug makers supposed to do differently? Are they supposed to have special ads for the hearing impaired?

Another study is one done with teens on ADHD drugs. Does it matter what teens take away from DTC ads? Their parents and physicians are the gatekeepers. Again what is a drug maker supposed to do when advertising ADHD drugs? Are they expected to make sure teens understand risk/benefit?

One thing FDA needs to do is better communicate the research results to the DTC community. Their findings should be announced and summarized in user friendly formats. It is ironic that an agency dedicated to improving consumer communication does a mediocre job of organizing and releasing their data. They need to have an easy to understand summary chart of each study with objectives, findings, conclusions, and next steps. No business person would accept the current way of communication and neither should FDA. Hopefully their web site will be better run and targeted to the people who actually are expected to act on their research.

Bob Ehrlich


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