TORONTO _ Vice President Al Gore's chief domestic policy advisorGreg Simon said that the Clinton administration's primary goal forhealth care reform, universal coverage, is inextricably linked to costcontainment. And he made clear that, in the administration's view, costcontainment is not the same as price controls.Simon made the remarks here on Tuesday night in his keynote addressto the Eighth International Biotechnology Meeting & Exhibition,sponsored by the Biotechnology Industry Organization (BIO). In hisspeech, he indirectly acknowledged recent political defeats for some ofthe President's schemes to contain health care costs, such asestablishing a breakthrough drug committee. "Sometimes we win abattle, sometimes we lose a battle," he said.But Simon said he believes that the biotechnology industry shares theadministration's goal of containing costs in the health care system."There are many good proposals, the best of which have come from thebiotechnology industry, on how to achieve this (cost containment),"said Simon.A case in point: In recent negotiations between Senate Labor andHuman Resources Chairman Sen. Edward Kennedy (D-Mass.) andGenzyme Corp. of Cambridge, Mass., Genzyme persuaded Kennedy todelete the breakthrough drug committee from his version of health carereform and substitute instead a study of how new medical technologiesimpact the health care system, society and patient outcomes. Thecompromise could allay the government's fears about uncontrolledcosts and give industry a chance to prove its claims about the cost-effectiveness of its products.In his speech, Simon told the crowd of at least 1,500 BIO members andmeeting attendees mostly what they wanted to hear. His depiction ofthe Clinton administration's deep commitment to and support forbiotechnology was somewhat at odds with the industry's vigorouscriticisms of government policy in the last year, including charges thatthe President's Health Security Act as originally written might havekilled off the entire industry.But Simon methodically chronicled what he says the Clinton-Goreadministration has done to foster biotechnology, including supportingbasic research, promoting technology transfer, providing incentives forprivate investment in the sector, protecting intellectual property,building a policy-making structure within the administration,promoting "regulatory certainty" and addressing global challenges.He said the administration has proposed a 4.7 percent increase for theNational Institutes of Health's (NIH) budget in "a time of shrinkingbudgets" elsewhere in the government, as well as increased funding forthe Human Genome Project (HGP) and for a new center to studygenetics. The administration vows to fight for the increases during theappropriations fight in Congress.Calling technology transfer the "bedrock of our technology policy,"Simon pledged that a solution to the controversy surroundingreasonable pricing clauses in NIH Cooperative Research andDevelopment Agreements (CRADAs) could be found in a meeting tobe chaired by NIH Director Harold Varmus and scheduled for July."We want to accelerate the development of these CRADAs, rather thanretard the growth," said Simon.In its first budget, the Clinton team extended the research anddevelopment tax credit into 1995 and hopes to make it permanent,according to Simon. In addition, the administration has implemented atargeted capital gains rate for investment of seed money and capital insmall businesses held for a number of years."Most importantly for all sectors of the economy, we have followed apolicy that has led to a reduced national debt, steady growth and lowinflation, which is good for business," said Simon.Administration Supports Patent Law ChangesIn the critical area of intellectual property protection, the administrationsupports pending legislation that will change 200 years of patent law toallow for patenting of a process that produces a novel or non-obviousproduct. Biotechnology advocates say it will prevent foreign piracy ofthe fruits of American research and development.A recent meeting between Gore and the President of Argentina on howthat nation could beef up its patent protection of pharmaceuticalsresulted in a law that was introduced and is now making its waythrough the Argentinian political process. "Countries that do notprovide intellectual property protection will not reap the rewards ofinvestment," Simon told the audience. He said that a hemisphericconference between Latin American countries and the U.S. is plannedto discuss biotechnology research and development.Citing NIH's Varmus, HGP director Francis Collins, Office ofTechnology Assessment chief Jack Gibbons, FDA commissioner DavidKessler and others, Simon said "I think we (the Clinton administration)have the best team you could assemble on biotechnology." Further,Simon predicted that the newly created Science and TechnologyCouncil (on par with the Economic Council and Security Council in theWhite House organizational structure) will tend to issues crucial to theindustry.Simon said he was most proud of the Clinton administration's strides increating an open, accountable regulatory process with timetables thatwill encourage planning and spur innovation. "The whole point of ourregulatory process now is to empower citizens to be part of the process. . . and to let companies speak for themselves as well," said Simon."The FDA has, in the process of this open system, approved bST(bovine somatotropin) and the Flavr Savr tomato after very many openand well-publicized meetings."(Many consumer and educational groups, such as the EnvironmentalDefense Fund and the Union of Concerned Scientists, and activistorganizations, such as Jeremy Rifkin's Pure Food Campaign, haveattacked the FDA and the administration for bungling the establishmentof clear review and labeling policies for genetically engineered food.)Although the FDA is currently considering instituting a pre-marketnotification policy for makers of genetically engineered food products,Simon said the new policy need not be a burden to companies.Meanwhile, the U.S. Department of Agriculture has expedited thereview of field trials for genetically engineered crops, implemented anelectronic tracking system and provided the public with environmentalassessments of herbicide-resistant squash, as well as other products.Simon also asserted that the FDA, with the help of the user feeprogram, is nearing its goal of reviewing new drug applications withinone year of submission.Finally, to help biotechnology meet the looming challenge ofovercoming trade barriers to compete in global markets, Simon saidthat the Clinton administration is actively working on regulatoryharmonization. "We want mutual acceptance of data and expeditedapproval processes that don't create a new barrier as products crossnational lines," said Simon. "We are trying to create a free globalmarket for biotech so there are no trade barriers posing as regulatoryhurdles."Simon concluded his address by noting that consolidation and businessfailures will inevitably be a part of biotechnology's future, as they havebeen for every industry. "The challenge is, how to keep it to aminimum, how to bend the twig in the best way for the growth of thetree," he said. "Like generational changes, these changes will renewand refresh both industry and society and that is why we welcomethem.""Biotechnology has great treasures to offer humanity, each one ofwhich the world has cleverly hidden, precisely for you to discover. Wein this administration admire your energy as discoverers and encourageyou in your quest."
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.