Limiting Disclosure of Drug Side Effects in TV Commercials

The FDA's comment period ended last month on the topic of "limited risks plus disclosure strategy" for drug advertising. In a change under consideration by the FDA, drugs would be classified according to one of three "risk" levels: severe, serious, or actionable. In addition to this level of risk disclosure in TV commercials, instead of requiring full listings of side effects to be announced, notice would be given that the list is incomplete and that patients need to discuss full details with their health care provider.

AskaPatient poll respondents' opinions on this possibility mirror the sentiments expressed by consumers and doctors during the federal regulatory comment period: They feel that the FDA should not pursue this option. Respondents overwhelmingly believe that consumers need all of the risk information disclosed in drug advertisements. In fact, many respondents think that drug ads don’t belong on TV at all. The AskaPatient poll question, "Should the FDA allow abbreviated (instead of complete) lists of risk warnings in TV commercials for prescription drugs?" received 118 responses. 81% responded "no" to the question. Complete Poll results.

While the FDA does not review advertisements in advance of their broadcast or publication, if the FDA finds advertisements to be illegal or misleading, they will send the company a warning letter. So far in 2017, only three such warning letters have been issued. These include warning letters related to advertisements for Contrave (weight loss drug), Conzip (pain relief drug), and Zolpimist (oral spray sleep aid similar to Ambien). The FDA posts the warning letters issued by the “Office of Prescription Drug Promotion” and the related offending promotional materials on their web site. In 2016, eleven such letters were sent and in 2015 there were nine warning letters sent.

Spending on direct-to-consumer advertising for pharmaceuticals continues to increase each year. Here are the three most heavily advertised drugs in the U.S., along with their patient satisfaction scores:

Spending amounts are in millions; from Kantar Media Satisfaction rating scores from AskaPatient.com 1=LOW (I would not recommend taking this medicine.) 5=HIGH (this medicine cured me or helped me a great deal.)