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Announcement
Posted on 05.30.02
CERTs to FDA: We Can Help
By Pat French
More drugs become available for use each year. This translates into a greater probability of dangerous interactions among the various treatments, and greater difficulty on the part of busy healthcare providers to keep up with them. Changes in the healthcare systems, advertising, and insurance programs also affect how the risk of therapies is communicated and perceived.
When information about a medical product's safety or effectiveness emerges or changes, the FDA has only a few ways to communicate it to the public and healthcare providers, such as "Dear Healthcare Provider" letters and "black-box" warnings on product labels. Many consider these methods inadequate, given that recent studies have shown that physician prescribing and patient monitoring change only slightly when these methods of communication are used.
On May 22, CERTs was one of several participants in a public hearing sponsored by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). The hearing was part of the agency's ongoing effort to reduce the risks involved with the use of medical products, also a primary goal of CERTs, and to develop new and effective tools to manage risk.
The hearing, titled "Risk Management of Prescription Drugs," sought to:
- receive public input about how better to minimize the risks associated with prescription drugs;
- identify collaborators for development and implementation of new tools to reduce risk;
- better understand the strengths and weaknesses of existing risk-management tools, to aid in refinement or creation of tools; and
- receive input about way to assess the effectiveness of risk-management tools.
CERTs was represented by Dr. Rob Califf, director of the CERTS Coordinating Center. CERTs had a particular interest in this hearing, given how closely the purpose of the meeting ties in with the ongoing CERTs effort known as the Risk Series.
A collaboration between CERTs and the Agency for Healthcare Research and Quality (AHRQ), FDA, and the Pharmaceutical Research and Manufacturers of America (PhRMA), the Risk Series consists of expert meetings that aim to set priorities for the study of current and innovative approaches and tools to better understand and manage pharmaceutical risks. The first meeting of the Risk Series, held in 2001, covered the topic of communicating risk, a critical part of minimizing risk. Four more meetings are planned on the topics of risk assessment, benefit assessment, risk communication and the media, and risk management.
Califf spoke for about 20 minutes, and described how the past, present, and future CERTs efforts could reinforce and support the CDER's efforts. Specifically, he described how policy changes in risk management should reflect robust research, and how CERTs is performing research that can inform such policies.
Links:
Original announcement
about the hearing.
Dr. Califf's comments.