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 drugs 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 while all that information may be required, regulators now seem increasingly concerned that its inclusion may be doing more harm than good. Could the advertisements, which sometimes span several minutes, be portraying an otherwise helpful and generally safe drug as overly dangerous?
And 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. But these critiques have long been raised by pharmaceutical marketers, and now in at least one medium, FDA says it’s prepared to listen.
In a Federal Register announcement on 14 February 2014, FDA said it is considering the possibility that it should “limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad.” FDA floated 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.” The agency says it plans to investigate the effectiveness of those disclosures, which it is calling a “limited risks plus disclosure” strategy, in upcoming studies it will conduct. “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. “We will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes.”
The agency’s planned study will involve participants over the age of 18 assigned to one of four groups:
? Version one will present the full major statement without the disclosure regarding additional risks.
? Version two will include the full major statement plus the disclosure about additional risks.
? Version three will include an abbreviated statement of risks without the disclosure about additional risks.
? Version four will include an abbreviated statement of risks as well as the disclosure about additional risks.
FDA anticipates a total of 500 participants taking part in an initial pilot study, with an additional 1,500 participants taking place in the main study.
REFERENCE: Regulatory Focus; 14 FEB 2014; Alexander Gaffney