WASHINGTON _ Health and Human Services (HHS) SecretaryDonna Shalala announced on Monday the appointment of Clifton Gausas administrator of the Agency for Health Care Policy and Research(AHCPR). Gaus will replace departing administrator J. Jarrett Clinton.The national debate over health care reform has turned a spotlight onAHCPR, a relatively obscure arm of the Public Health Service (PHS)that supports and conducts health services research. In response toCongressional calls for review of drug prices, biotechnology industryadvocates have proposed that AHCPR is the best qualified agency toconduct cost-effectiveness studies of new medical technologies,including drugs.Indeed, a recent health reform proposal crafted by Sen. EdwardKennedy (D-Mass.) and Genzyme Corp., of Cambridge, Mass.,replaced a breakthrough drug committee with a three-year, AHCPR-sponsored study of medical technologies. Biotechnology industryrepresentatives have championed AHCPR as a governmental arbiter ofcost-effectiveness over the FDA. The industry has vigorously opposedthe idea of expanding the FDA's role to consider the cost of new drugs_ its current mandate is confined to judging safety and efficacy.However, with a 1994 budget of only $154 million and with limitedpersonnel in its technology assessment division, AHCPR is notequipped to conduct large scale studies of cost-effectiveness for newand existing medical products. The agency will need significantly moreresources in order to assume a leadership role. Shalala said that, underGaus, AHCPR will expand its efforts to provide lawmakers with "theobjective information and technical advice needed to reform thenation's health care system.""Most of the health care reform proposals under consideration by theCongress will greatly expand the role of AHCPR in research and policydevelopment," said HHS Assistant Secretary for Health Philip Lee. "Iexpect the agency, under Dr. Gaus' leadership, to vigorously meetthese new challenges."Gaus spent the last year as Lee's senior advisor on health care reform atHHS and held positions in academia and at the HHS's Health CareFinancing Administration prior to that.NIH CRADA Meeting Set For July 21A long-awaited meeting that will allow industry to air its views on thestandard "reasonable pricing" clause inserted into National Institutes ofHealth (NIH) Cooperative Research and Development Agreements(CRADAs) is set for July 21.CRADAs have been a hot-button issue for biotechnology executives,who claim that the clause is deterring companies from collaboratingwith the government to commercialize potentially valuabletechnologies. Congress enacted the Federal Technology Transfer Actof 1986 to spur federal laboratories to cooperate with private industrythrough CRADAs. In 1989, in response to pressure from Congress andconsumer advocates, a pricing clause was added to NIH CRADAs.The clause states that HHS "has a concern that there be a reasonablerelationship between the pricing of a licensed product, the publicinvestment in that product, and the health and safety needs of thepublic. Accordingly, exclusive commercialization licenses granted for[NIH-owned] intellectual property rights may require that thisrelationship be supported by reasonable evidence."Both public and private statements by NIH officials suggest that theagency is flexible on the issue of removing the clause from futureCRADAs _ the biotech industry's goal. One NIH source who askednot to be identified said that technical development coordinators andscientists there view the clause as both a toothless _ it has never beenenforced _ and an unnecessary constriction on private-public sectorcollaborations."Most people here feel that drug prices, if they are to be controlled,should not be controlled at the CRADA stage in the process," said thesource. "Only a minuscule number of CRADAs yield actual products,anyway. This is needless regulation."Numerous case studies of CRADAs, ranging from basic researchcollaborations to those involving advanced clinical trials, will bepresented on July 21 to a 17-member panel of government and industryrepresentatives.Consumer advocacy and public policy groups, including Ralph Nader'snon-profit organization, The Center for the Study of Responsive Law(CSRL), have criticized the NIH for not including a consumerrepresentative on the CRADA panel."Dr. Varmus denied our request to participate in the CRADA forum[he] only wanted industry and government panelists," said James Love,director of economic studies at CSRL's Taxpayer Assets Project. "Wewere dismayed by the lack of balance in the forum. This, however, istypical of the agency. NIH sees itself as a partner with industry, and hasbecome highly sympathetic of the industry views on issues such asdrug pricing and reporting requirements."In a draft mandate dated July 7, NIH director Harold Varmus directedthe CRADA panel to consider the following questions: "Given themandates of NIH to support research and to transfer the results of thatresearch to advance the public health, should the `reasonable pricing'clause be used by NIH as a mechanism to reflect the public investmentin NIH-supported research in the products brought to market throughNIH/private sector collaborations? Does the clause strike theappropriate balance between these dual mandates? What othermechanisms are available to NIH to achieve this goal?"Concerned organizations and individuals are invited to present theirviews at the meeting or submit written views of any length to the NIHCRADA panel. Requests for a 5-minute presentation time slot orwritten views should be sent to: Harold Safferstein, TechnologyTransfer Branch, National Institute of Allergy and Infectious Diseases,NIH, Building 31, Room 7A-32, 9000 Rockville Pike, Bethesda, Md.20892 (Fax number: 301-402-7123).Medical Device User Fee Act IntroducedOn Tuesday, Sen. Edward Kennedy (D-Mass.) and Rep. HenryWaxman (D-Calif.) introduced the Medical Device User Fee Act of1994. The legislation is patterned on the Prescription Drug User FeeAct of 1992, which was supported by the pharmaceutical andbiotechnology industries as a means of boosting the FDA's income toenable speedier review of product applications.Kennedy referred to the Drug User Fee Act in a statement announcingthe Device User Fee Act. "With the help of the new resources availablethrough prescription drug user fees, the FDA has hired new reviewersto come closer to the goal it has set of cutting review times in half. Thepharmaceutical industry has worked closely with the FDA to ensurethat the user fees are implemented in a fair and timely manner," saidKennedy. "The legislation I am offering today provides a similaropportunity for the medical device industry."The Medical Device User Fee Act authorizes the FDA to collectapproximately $100 million over the next five years for activitiesdirectly related to the FDA review and approval process for devices.The funds will not be available for any other purpose or priority.Premarket submissions (known as 510(K) submissions) that seek FDAapproval for substantial equivalence to existing devices and arefrequently submitted by small companies would carry a $3,200 user feeprice tag. For new device regulatory submissions that include clinicaldata (known as premarket approval (PMA) applications), the FDAwould charge a user fee of $52,000. (Prescription drug user fees are setas high as $100,000 for submissions involving clinical trial data.) n
-- Lisa Piercey Washington Editor
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