Risk Management: FDA Announces New Risk Communication Advisory Committee & AHRQ Issues User’s Guide to Patient Registries

The Supreme Court once famously characterized the risk-benefit analysis for approving new drugs as follows: “[A] drug is effective if it fulfills, by objective indices, its sponsor’s claims of prolonged life, improved physical condition, or reduced pain. . . .  [A] drug is unsafe . . . if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit.”  For the latter half of the 20th Century and the beginning of the 21st Century, attention was primarily focused on the drug efficacy component of this equation.  Beginning with the withdrawal of VIOXX (rofecoxib) from the market in 2004, and most recently, safety concerns raised about AVANDIA (rosiglitazone), however, there has been a seismic shift in FDA’s and Congress’ focus on drug safety and risk management.   

FDA recently announced plans to create a new Risk Communication Advisory Committee.  The committee will be designed to:

provide advice to the Commissioner or designee on strategies and programs designed to communicate with the public about both the risks and benefits of [FDA]-regulated products so as to facilitate optimal use of these products.  The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities.  It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products.

FDA also issued a Federal Register notice requesting nominations for membership on the committee.  FDA hopes that the committee will, among other things, “help FDA better understand the communication needs and priorities of the general public.”  Only time will tell, of course, if the creation of such a committee will have any long-lasting effect on minimizing drug product risk. 

The Agency for Healthcare Research and Quality (“AHRQ”) also recently published a report, titled “Registries for Evaluating Patient Outcomes: A User’s Guide.”  A summary of the report is available here.  The document is “a handbook that [serves] as a reference for establishing, maintaining, and evaluating the success of registries created to collect data about patient outcomes.”  FDA defines a patient registry as:

an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons exposed to a specific medical intervention who have either a particular disease, a condition (e.g., a risk factor) that predisposes [them] to the occurrence of a health-related event, or prior exposure to substances (or circumstances) known or suspected to cause adverse health effects.

Registries are an important risk minimization tool, and are highlighted in FDA’s risk minimization plan announced in March 2005.  There, FDA commented that “[t]hrough the creation of registries, a sponsor can evaluate safety signals identified from spontaneous case reports, literature reports, or other sources, and evaluate factors that affect the risk of adverse outcomes, such as dose, timing of exposure, or patient characteristics.”  Given the focus on the development of Risk Evaluation and Mitigation Strategies (so-called “REMS”) in the Senate-passed version of the FDA Revitalization Act, and if such legislation is enacted, the use of patient registries will likely increase.  As such, the AHRQ handbook could be a very valuable tool for industry.

RELATED READING:

• FDA, Guidance for Industry: Establishing Pregnancy Exposure Registries
• FDA Presentation on Patient Registries