Is FDA Laying the Groundwork for a Broad Shift in the Way it Regulates DTC Drug Advertising?

Does the US Food and Drug Administration (FDA) have some big changes in the works for the way in which it regulates drug advertising? A review of a slew of studies the agency has proposed in the last two years indicates that maybe-just maybe-it is.

Since 2012, FDA has proposed a torrent of studies targeting niche aspects of the way in which drug promotional activities, and especially TV-based advertising aimed at consumers, are regulated.

A brief overview of those studies is as follows:

• In January 2012, FDA announced that it planned to carry out a study on corrective direct-to-consumer (DTC) advertising. Corrective advertising is used when FDA feels that an advertisement has incorrectly portrayed a benefit or risk of the drug, and is meant to explicitly state how the previous advertisement was wrong. The two-phase study is set to look at variables of message exposure, similarity of original and corrective ads and the length of time between exposure to the original and corrective ad. The study got OMB approval in April 2013.
• In October 2012, FDA said it wanted to conduct a study on how DTC advertising affects prescribing healthcare professionals, and in particular their prescribing habits. While prescribers have traditionally been physicians, this role is increasingly being assumed by nurse practitioners, who have in turn become the focus of advertising efforts by the pharmaceutical industry. Previous studies did not assess their role in the advertising and prescribing ecosystem, and FDA said its new study wants to assess their role much more closely. The study got the go-ahead in April 2013.
• In May 2013, FDA said it wanted to conduct a study on how so-called "composite scores" are used in DTC advertising. The scores are essentially a collection of clinical endpoints combined into a single overall score. FDA said it wants to know if consumers actually understand what the scores mean, and how it might affect their assessment of the risks or benefits of a drug.
• In July 2013, FDA announced it was looking at a previous study to assess how consumers find health information online, including how they use social media, blogs, chat rooms and pharmaceutical company websites. FDA said it hoped to "look at the relationships between [selected] variables and perceived risk, perceived benefit, behavioral intention, and source credibility."
• In October 2013, FDA said it wanted to study how kids interpret drug advertising, and whether a new approach was needed to ensure that advertising (e.g. for acne drugs) advertised their benefits and risks in such a way that adolescents could adequately understand them. Kids, FDA noted, aren't exactly renowned for their recognition of risk.
• In November 2013, FDA released a request for information indicating that it was looking for partners with whom to conduct behavioral research on how consumers and healthcare providers interpret promotional materials and labeling.
• On 29 November 2013, FDA released a Federal Register notice indicating that it wanted to conduct an eye tracking study to assess how consumers view DTC prescription drug advertisements on TV. Regulators said they wanted to assess how some elements could distract from the advertisement, and thus a consumer's perception of risk or benefit.

Taken together, the proposed studies could indicate coming changes in FDA's regulatory approach toward advertising, presumably wide in scope but targeted in effect. One can assume that FDA isn't in the habit of spending money on studies just to satisfy its curiosity; rather, the studies are presumably to validate a hypothesis with the unstated intent of informing future regulatory actions.

The proposed and ongoing studies are also relatively unique in one respect: We can recall no other area that has been subject to even a single proposed behavioral study that is not related to drug advertising.

In other words, this might be one area worth keeping a close eye on.