Pill bottle

We see the advertisements on the television, the music plays and people start barbequing, playing frisbee with their dogs, or walking through their neighborhood greeting neighbors with a smile.  A voiceover describes some medical condition, and then, they tell you that there’s a drug that may help.  After about thirty seconds of hearing about how the drug could treat a specific condition, the voice starts to tell you all the things that may go wrong.  In the pharmaceutical industry, this is called “fair balance.”  It’s the required warning statement describing the most common or serious side effects that were discovered during the clinical trial program for the drug.  If you have not completely tuned out during the ad, you may start to wonder whether the side effects are even worth the risk.  In cases where you might benefit from the use of that drug product, you may be inclined to ask your doctor whether the drug you heard about is right for you. 

What many patients don’t know is that the US is one of very few countries in the world that allows direct-to-consumer drug advertising. The reason? Most patients do not have the understanding necessary to weigh the benefits and risks presented in drug advertising.  However, healthcare providers (HCPs) themselves may not have any additional helpful information for patients who ask them about a particular drug.  HCPs that are likely to prescribe any particular medications will have access to the drug’s full prescribing information (PI) and sales materials or other aids developed by drug manufacturers.  These materials are intended to help the HCP understand the clinical risk and benefit data that was collected in during the clinical trials leading to a drug product’s FDA approval.  With the time constraints that many HCPs face in their practices, they may not spend much time looking over these materials.  Instead, they may feel pressure to prescribe the drug their patients ask for, or they may just remember that a product sales representative gave a presentation to the office the week before and assume that’s good enough.  According to the FDA, there is a gap in understanding what really drives HCP prescribing decisions, especially when drugs include “boxed warnings”

Although all drug labelling is required to provide a complete description of the product’s risks and benefits, “boxed warnings” are required on any drug product that poses a serious life-threatening risk to patients.  On August 8, 2019, the FDA issued a request for comment on a proposed research study intended to collect valuable insights on how information contained in “boxed warnings” is perceived by providers.  The FDA’s proposed study will investigate HCPs’ awareness, perceptions, and beliefs about the benefits and risks when an FDA-approved product includes a boxed warning in its PI.  According to the announcement, the FDA plans to conduct one pretest survey with 25 voluntary participants and one main survey with 1,156 voluntary participants asking the following questions:

  1. What awareness, knowledge, and beliefs do HCPs have regarding boxed warning information for a prescription drug or class of drugs?

  2. When making prescribing decisions, how do HCPs consider boxed warning information about a potential treatment? How does boxed warning information factor into their assessments of a drug’s potential benefits and risks to their patients?

  3. How do HCPs communicate with their patients about boxed warning information?

  4. What factors (e.g., experience treating a condition) are associated with HCPs’ awareness, knowledge, and beliefs about boxed warning information?

The FDA has spent significant resources in understanding how consumers and HCPs understand and use important safety information included in drug product labelling. The FDA’s Office of Prescription Drug Promotion has established an ongoing research program dedicated to understanding and improving medical decision making related to prescription drugs.  A complete list of the research projects completed to date can be found here on the FDA’s website.  This is an opportunity or HCPs to help shape the FDAs understanding of what is most helpful to HCPs when making decisions about drugs that may pose significant safety risks for patients.

Comments on the proposed research study are due by October 7.  Please contact us if you would like our help in submitting a comment or if you need our assistance with review of your medical product advertising and promotion.