The Way Drug Ads Disclose Potential Risks May Be About to Change

The way drugs and medical devices are advertised on television is, understandably, closely regulated by the FDA. Companies can’t just make claims without evidence to support their statements and have long been required to report risks and potential side effects as they tout the benefits of their drugs. It’s an area of contention between the FDA and so-called “big pharma” (a term used generally to refer to the leading drug manufacturers and their interests). The FDA is keen to ensure televised ads give a fair account of the pros and cons of a medication. Pharmaceutical companies are, of course, eager to downplay any potential risks associated with their drugs – or at least to present their products in the best light possible.

Last week, the FDA announced it was moving forward with plans to re-evaluate how prescription drug risks are disclosed during televised advertisements. It could be great news for consumers – if the FDA is actually able to make effective changes.

FDA and Pharmaceutical Companies Work Together with Different Goals in Mind

It’s been more than a year since the FDA first proposed to review the current rules, issuing a public notice that, in part, criticized the already extensive list of potential risks that companies place in their advertisements. How can long lists of risks be a problem? The FDA explained:

“There is concern that as currently implemented in ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.”

In short: no one’s paying attention to the detailed list of problems or the lengthy lists are scaring patients away from potentially helpful treatments. The FDA’s probably right to be concerned about this. If lists of risks are too long, consumers may simply ignore them or fail to spot the actual risks posed by an individual drug among the “boilerplate” risks associated with any and all modern medications. On the other hand, the FDA does recognize that, for some viewers, current risk disclosures don’t go far enough to adequately warn individuals about prescription drugs’ side effects. So, in its notice, the FDA proposed requiring drug companies to stress “serious and actionable” risks while providing viewers with other means of learning about all possible risks.

That was one year ago and, this being the FDA, things have moved slowly. Big pharma, critical of the original proposal to add even more warnings to televised ads, has made some concessions, and now a detailed study will compare current ads with modified versions to see which leads to less confusion and more understanding of risks among viewers. At the heart of the study, which may extend to thousands of subjects, is one question: If viewers are warned about only the serious risks and told where they can find further information, will they ultimately understand more or less about the drug?

To be fair, the FDA has stood its ground in certain areas. After one pharmaceutical trade group argued that real ads – ones that people may have already seen on television – should be avoided for fear of viewer bias and individuals’ preconceived notions, the FDA pointed out that the costs of creating entirely new ads was too high. Instead, real ads will be shown alongside modified versions – though the FDA has publicly welcomed trade groups’ input and announced that a survey of participants will gauge how familiar they are with certain drugs, allowing the agency to control, to a degree, any bias or favoritism.

This is how the game is played between the FDA and pharmaceutical companies. Cooperation is needed on all sides, but the two groups clearly have different goals. At Pfizer Inc.’s request, the FDA has agreed to delete a question that asked viewers if a condition was “easy to treat” using the advertised drug. The agency conceded that ads would not normally provide enough information to make such a call. At Eli Lilly & Co.’s request, the FDA also removed a question deemed irrelevant to the subject – but kept several others, albeit with modification.

Consumer Groups Respond to Drug Risk Study

If the FDA faces criticism from big pharma on one side, it faces equally harsh treatment from the other – and this time, it’s consumer advocacy groups voicing their concerns. Consumers Union wrote to the FDA last year to oppose the proposed study, which, in its view, could lead to less information being shared directly, limiting consumers’ choices.

“A drug’s side effects are usually rattled off at warp speed during a television or radio ad. While consumers might be alarmed at the list of reactions that have been documented, the FDA’s concern should not be whether an ad negatively affects consumers’ perception of the drug. On the contrary, these ads should motivate consumers to ask their doctor about all possible side effects of a drug before taking it. Doctors can help patients determine if they are vulnerable to any of the side effects identified.

According to the FDA, the length of a ‘major statement’ (statement of side effects) can be long and result in reduced understanding of the risks by the consumer and minimize the most important risks. The proposal seeks to study how to limit this list of risks but fails to define ‘serious and actionable’ – this should be publicly clarified prior to doing such a study.”

For consumer groups, the concern seems to be that there’s already so much information to digest about prescription drugs, taking some away (and therefore requiring the viewer to search for it themselves) may leave more patients less informed. There’s also the concern that even current televised ads are failing to convey, clearly and succinctly, the real risks of certain medications. After the FDA proposed the new study and sought feedback, one consumer noted that even the speed and clarity of announcements in ads needed to improve. Responding, the FDA noted that the comment was “interesting” but not necessarily relevant to the risk disclosure study.

Study Results Should Bring Slow Change

When all’s said and done, the actual results of the study will ultimately affect whether any changes will be made to televised prescription drug ads. If viewers are more confused by the modified ads, coming away less informed than before, then it’s hard to see how the FDA could justify changing current rules. Even if viewers ultimately prefer being told only of serious risks, with clear instructions on where to find further information, it seems likely that pharmaceutical companies and consumer groups will be watching the FDA with interest.

Things don’t move quickly at the FDA and, when it concerns something as important as risk disclosure, it would take an overwhelming one-sided response from the study (unlikely) along with across-the-board agreement between all parties involved (near impossible) for adjustments to be swift. Taking a closer look at pharmaceutical television ads, though, may very well be a good thing. Risk disclosure matters, and changes to how we’re told about potential dangers in televised ads need to be made only when there’s a proven benefit. With so many opinions and interested groups, perhaps the one good thing to come out of this will be an increased awareness of how drug risks are disclosed and how the average viewer actually responds to drug ads.