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Executive Summary

NIH CRADA SURVEY DATA WILL BE REVIEWED BY REP. WYDEN AT JUNE 17 HEARING that will examine the results of the institute's review of over 100 federally supported research institutions and their licensing agreements with private industry. National Institutes of Health Director Bernadine Healy will be the lead witness for the agency before Rep. Wyden's (D-Ore.) House Small Business/Regulation Subcommittee. NIH requested the Cooperative Research and Development Agreement (CRADA) information from its grantees in February. Each institution was asked to "describe fully your financial arrangements with the companies, what interest in research results or products the company will receive and how the agreements will affect the conduct of research and the dissemination of research results." A task force at NIH has been analyzing the agreements and will provide an assessment at the hearing. In Wyden's May 20 invitation letter to Healy, he asks her to describe "generally" NIH's findings from the survey. In addition, while noting the Scripps Research Institute's long-term technology arrangement with Johnson & Johnson and a recently signed 10-year $300 mil. agreement with Sandoz, Wyden asks: "Although it is the subcommittee staff's understanding that the Scripps technology transfer agreements may be unique with regard to their comprehensiveness, are there other matters of concern which arose from the agency's survey?" The upcoming hearing is a follow-on to a March 11 Wyden hearing that focused on the commercial agreements between federally supported labs and private industry, and the Sandoz/Scripps deal in particular ("The Pink Sheet" March 15, p. 8). In fiscal 1992, Scripps received 214 grants from NIH totaling approximately $60 mil. Following the hearing, at which Healy also testified, Wyden asked the HHS Inspector General to audit 130 patents that have been filed by Scripps as well as investigate the Sandoz/Scripps arrangement ("The Pink Sheet" March 22, T&G-2). Although the IG's review is ongoing, results may be ready for the June 17 hearing. Referring to concerns about the Scripps licensing deals voiced by Healy at the March hearing, Wyden's letter asks: "Do you still harbor doubts regarding the conformance of those agreements to the essence of the Bayh-Dole Act?...If yes, what changes will you suggest or demand as a prerequisite to the continuation of funding to this institution?" The Bayh-Dole Act governs the transfer of technology from NIH-funded research institutions to industry. Wyden also asks Healy to discuss consulting arrangements "between Scripps scientists and companies receiving Scripps technologies," noting that "there was some evidence that Scripps employees had personally enriched themselves through highly profitable ownership arrangements with some of these companies." In "your view," Wyden asks: "do these sorts of relationships offer the potential for conflict-of-interest in the case where individuals may be managing millions of dollars in federal grants?" As a follow-up: "Has NIH or [HHS] reconsidered the need for a conflict-of-interest standard?" The hearing may also discuss Wyden's April request to NIH institutes for information about their CRADAs with industry. In addition to Healy, two or three other witnesses are expected to testify. Healy's congressional testimony will most likely be her last as the NIH director. She is stepping down from the post effective June 30.

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