2004S-0233 - Solicitation of Comments on Stimulating Innovation in Medical Technologies
FDA Comment Number : EC7
Submitter : Dr. Allan Korn Date & Time: 09/14/2004 06:09:11
Organization : Blue Cross and Blue Shield Association
Health Care Association
Category :
Issue Areas/Comments

August 20, 2004

Division of Dockets Management
Food and Drug Administration
Via e-mail: http://www.fda.gov/dockets/ecomments

Docket #2004S-0233

The Blue Cross and Blue Shield Association (BCBSA) is pleased to respond to the ?Solicitation of Comments on Stimulating Innovation in Medical Technologies? published in the Federal Register on May 24, 2004 (Federal Register Vol. 69, No. 100). BCBSA is an association of 41 independent Blue Cross and Blue Shield Plans (?Plans?) providing health benefits to almost 92 million members, one in three Americans. BCBSA also provides scientific information on new technologies through BCBSA?s Technology Evaluation Center (TEC), jointly operated with Kaiser Permanente. Technology assessments developed by TEC are available to all users on the web at http://www.bcbs.com/tec/index.html. TEC is also an AHRQ Evidence-based Practice Center.

HHS has expressed the concern in the solicitation that ?new discoveries in basic sciences are not rapidly translating into new medical products for patients.? A statistic is cited indicating that only one in five products that reach the clinical testing stage ever make it to marketing. There are two processes that limit the transformation of scientific discovery into clinical products that benefit patients. The first is the transfer of basic research from the laboratory to product development and testing in clinical trials. The second is the adoption of the outcomes of clinical trials into mainstream clinical practice. A key barrier to diffusion of effective new technologies is the dearth of quality information that can be used by decision-makers- physicians, payers, health plans, and consumers- ?to make well-informed decisions regarding alternative strategies for diagnosis and treatment of common clinical conditions.? We agree that ?the current clinical research enterprise in the United States is not consistently producing an adequate supply of information to meet the needs? of decision-makers.

Please see the attachment for the remainder of our comments which do not fit in this space.