Study Examines Impact of FDA Drug Risk Communications

A recurring topic here at MassTortDefense is the role of hazard communications in product safety, and the related issues of a consumer reading, heeding, or relying on such warnings.  This is particularly true in the area of prescription drug litigation, focused on over at Drug and Device Law.

So, that makes a recent study in Medical Care interesting reading: Dusetzina, et al.,  Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review.

The paper reviews the literature of the past 20 years on the impact of FDA drug risk communications on medication utilization, health care services use, and health outcomes.  These 50 or so studies covered roughly 16 therapeutic classes; most used medical or pharmacy claims and a few examined patient-provider communication, decision making, or risk perceptions.

The authors concluded that although some FDA drug risk communications had immediate and strong impacts, many had either delayed or no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes, according to the authors.

Although not the focus of the article, the findings are relevant to those of us who need to think about the learned intermediary doctrine, preemption, and other legal warning doctrines.

FDA To Hold Meeting on Risk Communication Strategies

The Food and Drug Administration’s Risk Communication Advisory Committee will be holding a public meeting on April 30, 2009, and May 1, 2009, at the Center for Drug Evaluation and Research Advisory Committee Conference Room, in Rockville, MD. On both days the Committee will discuss the Agency’s draft risk communication strategic plan and will be asked for comment and further advice on strategic priorities for research on effective risk communication.

That draft plan describes FDA’s strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their own health and well-being. FDA has been looking to improve how it produces communications about the risks and benefits of regulated products, as well as how it oversees those communications produced by regulated entities. For example, as the Internet and emerging technologies have both enabled and fed the public’s demand for greater transparency and communication frequency, the traditional waiting periods for FDA guidance have given way to communication in real time. Designing a contemporary risk communication strategy is key to FDA’s efforts to reposition itself to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology.

Effective communication supports both optimal use of medical products and safe consumption of foods to maximize health. The IOM report on The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006) focused on drug safety, but also highlighted communication more generally, referencing FDA’s mission of helping the public get the accurate, science-based information it needs. In response to an IOM recommendation, FDA launched its Risk Communication Advisory Committee in 2007 to give advice about FDA’s risk communication approaches for all FDA-regulated products.

The FDA has begun to identify research needs in this area, including on the broad topics of:

  • When and what to communicate
  • Reaching the audience (dissemination)
  • Ensuring audience understanding
  • Motivating audiences
  • Evaluating effectiveness of communications