In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, leaving consumers more confused than informed.

Now the pharmaceutical industry is weighing in on FDA's call for comments, supporting both its call for additional research and its goal of easing current requirements.

Background

At present, companies are required to present the benefits and risks of a drug using a "fair balance" approach that gives equal weight to both the benefits of taking the drug and the risks to the consumer who takes the drug. In addition to the "major statement" of risks-those risks most commonly associated with the drug-companies are also required to present other major risks that may occur considerably less frequently but to potentially devastating effect, up to and including death.

But in a February 2014 Federal Register announcement, FDA expressed concern that the advertisements now contain too much information, and that the information-dense advertisements might be doing more harm than good. For example:

• Could the extensive requirements paint an otherwise safe drug as overly risky?
• Might consumers be subject to such a cavalcade of risks that they are no longer able to determine which are worth listening to?
• Might others stop taking a drug or avoid seeking a physician's care for unwarranted fear of a drug's side effects?

For now, it's hard to say without data-data that FDA says it's now looking to obtain.

"Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks." FDA wrote in its announcement. "We will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes."

FDA said it is possible that the major statement in future advertisements might be limited to only those risks which are both "serious and actionable" while including an additional warning to consumers that additional risks exist (One possible default disclosure: "This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it.").

Industry Praise for Proposal

But as required by law, FDA is also seeking public comments on whether its proposed studies (a 500-person pilot and a 1,500-person main study) are necessary and proper.

And to that question, the pharmaceutical's resounding response thus far seems to be a resounding, "Yes, and thank you."

Comments submitted by the pharmaceutical trade group PhRMA, for example, note that "Shorter or less complex warnings may be more effective at communicating risk information in an understandable way compared to longer, less focused warnings."

By shifting some of the information-seeking burden to consumers and healthcare providers, PhRMA said the advertisements might be able to be more effective at educating consumers.

The Washington Legal Foundation (WLF), a prominent pro-industry law group which frequently represents trade groups, also hailed the potential shift, saying it would be in the best interests of its clients' First Amendment rights to free speech.

"The First Amendment permits FDA to require risk disclosures in DTC advertising only to the extent that FDA can demonstrate that such disclosures are necessary to serve the agency's interest in ensuring that consumers are not deceived by the advertisement," WLF wrote in its comments to FDA. "Moreover, any mandated disclosures must be narrowly tailored to serve that interest. Thus, a risk disclosure requirement is not constitutionally permissible if a briefer disclosure would be better (or at least equally well) understood by an average consumer."

Pfizer also put its support behind the proposed study, calling it much-needed and capable of providing consumers with "serious benefits."

Adverse Comments

But not all comments were supportive. The consumer group Consumers Union panned the proposed study, saying that FDA shouldn't be concerned with how a consumer perceives a drug's actual side effects.

"A drug's side effects are usually rattled off at warp speed during a television or radio ad," the group wrote in its comments. "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."

Industry groups and companies also offered a range of ideas on how the proposed study might be improved.

Several comments said FDA had poorly defined what a "serious" risk was versus a non-serious one. Other proposed questions in the study ask respondents to think about what "other people" might do in response to the ad-questions Pfizer said were unnecessary and un-empirical.

Other questions related to the persuasiveness of the ad, drug quality and the ease with which a person might treat their condition with a drug were also recommended by Pfizer for deletion.

PhRMA, meanwhile, said FDA should avoid using "existing advertisements" in its study for fear that they might taint the responses of the test and control groups if they already possess high levels of awareness and understanding about the product.

A full list of comments may be found on FDA's Docket.