I thought I woke up in a dystopian 1984 world when I saw an article on the low number of warning and untitled letters issued to drug companies in 2017. Written in the NY Daily News on 12/11/17 the article bemoaned the fact that only three letters were issued in 2017 compared to eleven in 2016. Somehow the lack of violations bothered the authors and DTC critics he quoted.
Drug companies complying with FDA regulations in this dystopian world is now somehow a bad thing. Something must be amiss because we all know drug companies are trying to hoodwink consumers with rampant false claims. Where are all the letters? Noted drug company critic, and former FDA Commissioner Dr. David Kessler is quoted in the piece as saying that the lack of letters “certainly raises questions.” Yes, comrade drug maker your clean record is very suspicious. We are very concerned you did not commit any crimes.
The article points out that there are only 60 FDA staff to review 75,000 promotional pieces. Therefore, the implication is that many deceptive pieces must be slipping through the cracks of an understaffed agency. That might be a legitimate concern but please provide any evidence that violative ads are airing undetected. FDA has the resources to watch all the television ads. In fact, maybe it would take about 120 minutes of one staffer’s time to review every ad on air. Oh, the workload required to watch those ads must be so stressful that no Federal agency can be expected to accomplish this task.
Can FDA miss something out of the 75,000 pieces submitted? Yes, there may be some sales aids or long pieces missed but not in anything seen in mass media. I think the author and Dr. Kessler can sleep at night knowing that wildly false and misleading claims are not being made in DTC Ads. I do not see FDA complaining that false claims are a major concern.
Critics of DTC will not be satisfied until our legislators ban it, or make DTC more difficult to do. Making it harder to do is certainly a policy goal of many on Capitol Hill. In fact, if the Dems retake Congress in 2018 we can expect the usual anti-DTC bills to make it to a vote. Ending tax deductibility of DTC, putting a moratorium on ads for new drugs for three years, and forcing drug makers to disclose prices in ads, are all recent proposals.
The same media outlets that rail against drug companies in their news coverage are also the leading purveyors of drug ads. That must be an interesting conflict between the business and editorial side. They should be careful what they wish for because if DTC is legislated away who will sponsor network and cable news? Think about that Wolf Blitzer!
Good is good and the three letters issued are a sign that drug companies know how to comply with DTC regulations. Drug companies complying does not fit the critics narrative therefore it must be a sign of bad enforcement. Only George Orwell could envision such a scenario.