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Executive Summary

The National Institutes of Health is not interested in setting the prices of drugs that it helps to develop, National Institute of Allergy & Infectious Diseases AIDS Division Director Daniel Hoth, MD, asserted at a Dec. 2 congressional briefing on efforts to streamline the drug approval process. The briefing was sponsored by the FDA Council in Washington. Aside from being unqualified to assess costs such as those involved with manufacturing experimental products, NIH is not inclined to participate in price setting, Hoth said. AIDS is a difficult and expensive area in which to focus R&D investment, he explained, and NIH price actions could inhibit future investment. NIH Director Bernadine Healy, MD, testified at a recent congressional hearing that the agency is designing a "fair pricing" framework for pharmaceutical products licensed from the federal government ("The Pink Sheet" Nov. 25, T&G-8). Hoth reported that many NIH officials are worried that the agency's involvement in the AZT patent dispute might make HIV research even less attractive to industry in the future than it already is. In a May 28 statement, NIH asserted a co-inventor claim for AZT stating that "NIH believes that investigators at the National Cancer Institute should have been named as co-inventors of the AZT-related patents issued to Burroughs Wellcome" ("The Pink Sheet" June 3, T&G-1). Healy indicated that NIH supports Barr Labs' April challenge of the Burroughs Wellcome AZT patent. NCI's Cancer Therapy Evaluation Program Associate Director Michael Friedman, MD, told the meeting that one company with which he has worked has invested "millions" of dollars to manufacture an experimental drug without knowing whether it will prove to be at all effective. Another company, Freedman said, has priced a new anticancer agent "very reasonably" and in line with preexisting therapies. John Cohrssen, associate director of the Vice President's Council on Competitiveness, contended that the council, in developing proposals for accelerated drug approvals, was motivated solely by the desire to have new therapies reach patients faster. Cohrssen said the Council did not consider its proposals from the perspective of how or whether they would benefit the pharmaceutical industry.

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