NIH CRADA reasonable pricing clause removal under "serious discussion," NIH rep tells AIDS task force.

NIH CRADA REASONABLE PRICING CLAUSE COULD BE DROPPED, NIH officials say. Removal of the pricing clause from CRADA contracts is an option that is "under the most serious discussion at this point" among National Institutes of Health and Public Health Service representatives, NIH Acting Deputy Director for Science Policy & Technology Transfer Sandy Chamblee told the National Task Force on AIDS Drug Development in Bethesda, Md. on Jan. 19. Chamblee noted that at the December meetings of both the PHS Technology Transfer Board and NIH Advisory Board to the Director, participants agreed that the reasonable pricing clause in cooperative research and development agreements "should not be permitted to impede scientific collaboration" and "NIH itself is not a regulatory agency and should not take on a price-setting role."

NIH will submit a final recommendation within two to four weeks to PHS. Top HHS officials expect the CRADA pricing issue will be resolved at the department level within three to four months.

The task force approved a recommendation that "supports NIH activities related to the review of the reasonable pricing clause in CRADA agreements as a barrier to drug development," adding that it will "review NIH's final recommendations to determine if further action is necessary."

If the reasonable pricing clause is removed, NIH would still expect "some other public benefit" from industrial sponsors in cases where NIH assumed a "substantial part of the risk," Chamblee added.

In those situations, Chamblee indicated that NIH "would actually compete a CRADA, and as an element of the competition, we would require the company to identify additional benefits to the public." Such benefits could include "accessibility...[and] perhaps some sort of pricing concessions" or other creative methods, she said. Noting that there have been "a lot of anecdotes about the fair pricing clause as a barrier," Assistant Secretary for Health Philip Lee asked Chamblee: "What kind of real evidence do we have that in fact it is a barrier?"

"It's difficult to pin down precisely," Chamblee responded. "We hear from our researchers consistently...about refusal of companies to deal with them, and the fact that their research has not been able to advance [due to] lack of collaboration."

NIH Director Harold Varmus asserted that "these are not apocryphal stories," and that they are "documented." Although he noted that NIH has not conducted a "systematic survey," he maintained that NIH knows "of specific instances in which companies are not only unwilling to enter into CRADAs but are unwilling to share with NIH investigators materials that would ordinarily be made available under material transfer agreements." He stressed that this is an "obstacle to doing research generally."

NIH's most recent figures show that 10 fewer CRADAs were signed in 1994 than 1993. NIH executed 31 CRADAs in FY 1994 (ended Sept. 30), the third highest number since the beginning of the CRADA program in FY 1985. Over the ten-year period, NIH entered 237 CRADAs.

The new director of the NIH Office of Technology Transfer is Maria Freire. She will join NIH Feb. 5 from the University of Maryland, where she directs the technology development offices of the Baltimore and Baltimore County campuses.

Other options for revising the clause have also been discussed, Chamblee noted, ranging from strengthening the clause to removing the clause from certain CRADAs -- for example, those in which NIH may want to utilize a company's proprietary compound, or ones that strictly involve basic science research. Several such options were debated at the two CRADA forums held by NIH in September and July.