December 17, 1998: Bert Spilker, Pharmaceutical Research and Manufacturers of America
Response to AHRQ on CERTs
We at the Pharmaceutical Research and Manufacturers of America (PhRMA) read with interest the call for nominations of topics for study and ideas for implementation of the Centers for Education and Research on Therapeutics (CERTs), to be established by the Agency for Health Care Policy and Research (AHCPR) in conjunction with the Food and Drug Administration (FDA). We applaud the efforts of the Agency in their endeavor to establish such centers and submit the following general comments and suggestions as you begin your development process:
- The activities listed appear to focus primarily on clinical attributes of drugs and biologicals, including prevention of adverse events. We recommend the Agency consider expanding the focus beyond clinical effects to more formally include economic and humanistic aspects of drugs and biologicals. We recommend specifically that you include the term "outcomes" in the required activities. While it is implied in the content, it would be useful to remind the larger research community of the importance of measuring the impact of process of care measures included in the request.
- The CERTs will be most useful with a clearly focused agenda. To that end we suggest that the CERTs identify a few focused areas of research, and that between one third and one half of the budget be directed to educational activities around this focused agenda.
- While we agree with the statement made by your Administrator in the December 2, 1998 issue of the Blue Sheet on page 12 that "The idea that we are going to improve the utilization of pharmaceuticals with $1 million or $2 million is silly," we do, however, strongly believe that the initial funds for CERTs still present an ideal opportunity to begin the research that will be needed to underpin AHCPR's and FDA's eventual effort to accomplish what now appears to be unattainable, i.e., to improve the utilization of pharmaceuticals.
- Underutilization of pharmaceuticals mentioned above (e.g., Why do many post heart attack patients fail to receive beta blockers when we have known for almost two decades that they confer protection against another heart attack, as well as sudden cardiac death? Why do many patients with diabetic kidney failure not receive ACE Inhibitor medication?) is an issue demanding attention. Another avenue by which the CERTs could begin to address the underutilization of pharmaceuticals would be to launch a series of research projects to document the true extent of underutilization and the number of lives and money that could be saved if this were corrected. Eventually, epidemiological, sociological and economic tools could be used to further investigate this issue and educate health care professionals.
We appreciate the opportunity to participate in the CERTs process and we would be happy to work with the agency's CERTs program on the issues above as well as any other aspects of this new program wherein you think we might be helpful. We recognize, of course, that additional resources must be allocated to the CERTs program so that it may accomplish, not only its current modest objectives, but more ambitious goals in the future. Finally, we wish you and the Agency every success in bringing to life this very important new program.
Bert Spilker, Ph.D., M.D.
Senior Vice President of Scientific and Regulatory Affairs
Pharmaceutical Research and Manufacturers of America
1100 15th Street NW, Suite 900
Washington, DC 20005
Telephone: (202) 835-3540
Fax: (202) 835-3597