NIH PROPOSED CRADA CONFLICT-OF-INTEREST POLICY

Executive Summary

NIH PROPOSED CRADA CONFLICT-OF-INTEREST POLICY will adversely affect the ability of a company to complete commercial development of a National Institutes of Health invention, Association of Biotechnology Companies Exec VP Bruce Mackler (D.C. law firm Mackler, Cooper and Gibbs) told the association's annual meeting in Washington March 29. The proposed NIH policy would require a one-year hiatus between an NIH researcher's involvement in a CRADA (cooperative research and development agreement) and that researcher's employment with a sponsoring firm on a consulting basis. During Q&A following a presentation by NIH Director James Wyngaarden, Mackler asserted that the proposed policy will prevent companies from getting a researcher's assistance in solving such problems as process design and quality control, which contract R&D agreements do not typically cover. "I think NIH has to be sensitive to that -- if they want, under the Technology Transfer Act, to transfer the technology -- implementing into a manufacturing process is also part of the transfer," Mackler said. Responding, Wyngarden said NIH will consider the issue in developing its conflict-of-interest policies. "I don't know the answer," he said, "but I take the point." ABC outlined its position on CRADAs in a March 22 letter to NIH Office of Invention Development Director Reid Adler. The letter suggests that a "better approach" to the one-year CRADA/consulting hiatus plan would be "documentation of the circumstances surrounding both, with approval procedures, and not allowing them to occur simultaneously." The proposed "restrictions on CRADAs and consulting undercut NIH's interest in allowing the public to benefit rapidly from its work and its interest in collecting royalties on behalf of the federal government and NIH inventors," the letter states. "Further," the letter adds, "it seems innappropriate to work with a company toward commercial development of a product and then require the NIH personnel involved to abandon the company during one of the most difficult and expensive stages of commercial development."