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September 1, 2017 0

The FDA is starting the process of possibly reducing the required number of risks presented in television ads. They have opened a docket to solicit public input on 8 questions they raised. I expect this process to be lengthy as speed has never been a guiding principle of the FDA’s Office of Prescription Drug Promotion (OPDP). They are taking their usual approach of being extremely cautious in making changes to their risk disclosure guidance.

Bob Ehrlich
“OPDP already has enough data.. to issue a revised guidance…”
-Bob Ehrlich

This is not the only area of a slow pace in recognizing the changes in consumer communication. They have, for years now, failed to recognize the role of DTC in social media and delayed any useful guidance that recognizes how consumers actually use the Internet. Thus, it is still prohibited to actually use a drug name and indication without the fair balance, as if consumers do not know how to click through to get more information.

Their own recently published research showed that less risk presentation is better for consumer comprehension and retention. For them that finding is the start of a rigorous research process to see if their hypothesis that “less is more” in risk presentation should be implemented in terms of changing their guidance.

Some conclusions are obvious and action is sometimes better than continued study. While I know OPDP is deliberate in making any changes to guidances, we have had broadcast ads for 20 years already. That is slow even by government standards. It is painfully apparent that DTC ads are presenting way too many risks and that litany approach is ridiculed by satirists and critics. Consumers complain about the many risks presented and have been for years. What does FDA do about it? They seem to want more and more studies so they can come out with a “perfect” guidance. This attitude is hurting consumers. A whole generation will have watched DTC ads with too much confusing risk information before FDA finally acts. OPDP already has enough data and should have the people with the judgement skills to be able to issue a revised guidance today.

Studying how risks are presented in DTC ads made sense in 1997 in the introductory DTC broadcast period. For them to just begin to study reducing the number of risk disclosures after 20 years is both puzzling and concerning. OPDP frequently says as a reason for slow progress on studies is that they have constrained human and budgetary resources. Yet they have managed to conduct several studies on things that many in the drug industry find tangential and not actionable. They should have focused more on this area as comprehensible risk presentation is critical information for consumers. They must develop a better strategic focus on what are their priorities for DTC research. If you look at their research web page, you see a lot of projects that seem to be all over the map that may satisfy the curiosity of their researchers but has no actionable benefit to consumers.

I am sure they will get a mountain of feedback from their docket request and they will meticulously wade through that to use as a basis for new studies. I personally know some of the researchers at OPDP and they are top notch professionals. Maybe they are as frustrated as I am. They must be caught in the bureaucratic ways of government, however, to be taking so long to resolve the risk disclosure issue. Maybe it is time for OPDP to move things along or get new leadership. No one in the private sector would still have a job after taking 20 years to resolve such a fundamental issue. Sadly, OPDP is allowed to operate in a different universe of accountability.

Bob Ehrlich