FULL DISCLOSURE OF COLLABORATIVE INDUSTRY/ACADEMIA
FULL DISCLOSURE OF COLLABORATIVE INDUSTRY/ACADEMIA could be prerequisite to funding from the National & Institutes of Health, House Small Business/Regulation Subcommittee Staff Director Steve Jenning, suggested at a Nov. 23 presentation on research-related conflict of interest issues. Expecting "that there will be a number of suggested policy changes coming down the pike," Jenning noted "foremost among them [likely would be] a requirement that NIH grant recipients at least disclose to the NIH, when they receive a grant or before they receive a grant, what kinds of collaborative agreements" have been entered previously. The briefing was sponsored by BIO. The Congressional aide noted that this type of disclosure is already happening as institutions attempt to prevent difficulties that might arise when seeking funding from both the federal government and industry. The Scripps/Sandoz agreement has been the catalyst for the renewed attention to corporate/institution agreements ("The Pink Sheet" March 15, p. 8). By an "informal vetting process," institutions such as Massachusetts General Hospital have been meeting with NIH before signing proposed agreements with outside companies to pre-empt any potential problems, Jenning said. Consequently, such meetings have "chilled some discussions," he noted. Public Health Service conflict-of-interest guidelines directed at institutions may follow the awaited individual conflict-of- interest guidelines that are expected to be released in mid- December, Jenning indicated. "After the conflict-of-interest procedures for individual researchers, there's a fair chance that there's going to be a... follow-up set of guidelines aimed at institutions," Jenning stated. Moreover, although intended to apply to individuals, Jenning believes that the "statutes could be written broadly to speak to...institutional conflicts of interest." As it now stands, NIH policy standards are being set by the institute's action on the Scripps/Sandoz agreement, which NIH counsel has found to be inconsistent with the Bayh-Dole amendments, Jenning noted ("The Pink Sheet" June 21, p. 8). In spite of NIH measures to present standards in terms of conflict of interest, Jenning stated that the institute should not be "charged with being the grant policing agency," as is currently the case. Rather, he explained that according to Bayh-Dole, the "Commerce Department is supposed to be taking a role in this -- one that they've avoided up to now." Jenning said he expects a more active participation on the part of Commerce as "part of the change that we expect to occur...with the new Administration." "I think it's almost counter to NIH's mission to be a tough cop on the beat regarding drug pricing," he continued. "Their mission is to create technologies, discover interesting new agents and then get them out the door and...it's going to be very difficult for them to do both, and we're not really suggesting at this point that they do do both; we look for another agency to share part of that burden." Drug pricing has been a major concern of Jenning's subcommittee chair, Rep. Wyden (D-Ore.), who on March 11 introduced the "Federal Research Product and Commercialization Act" (HR 1334). The legislation would require that NIH and federally supported research institutions negotiate a pricing formula for products developed through commercial agreements with industry prior to entering those agreements ("The Pink Sheet" March 22, T&G-2).
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