WASHINGTON _ Sen. Edward M. Kennedy (D-Mass.), introducedan amendment Wednesday to remove the Clinton Administration'sproposed breakthrough drug council from his version of the health carereform package.The committee adjourned Wednesday night without finishingdiscussions of the proposal, but it is expected to stand when membersresume their work this morning.Kennedy is chairman of the Senate Labor and Human ResourcesCommittee, one of five key committees in the health care reformdebate. Barbara Mikulski (D-Md.) co-sponsored the amendment.Kennedy's amendment included a proposal which would direct thefederal Agency for Health Care Policy and Research to conduct studieson the impact of medical technology on patients, society and the healthcare system. The proposal was developed by Genzyme Corp., ofCambridge, Mass.Kennedy's amendment still faces several potential traps. Chief amongthese is the debate that will occur on the Senate floor once the bill isreported out of the Labor and Human Resources Committee. There,"any type of price control amendment could be offered," ChuckLudlam, vice president for government relations for the BiotechnologyIndustry Organization, told BioWorld."We have no indication that anyone is going to do that, but Sen. DavidPryor [D-Ark.] just might," Steve Push, vice president for corporatecommunications at Genzyme, told BioWorld. Pryor has been a strongproponent of price controls.Another danger is that "proposals for other forms of price controlmight surface," Ludlam told BioWorld. These could includeamendments to impose price controls on licensees of the NationalInstitutes of Health (NIH) or on NIH grantees. "So it's an importantevent for the chairman of the Senate Labor and Human Resourcescommittee to decide this should be stricken from the bill."Kennedy's action cheered venture capitalists, to say the least. "That'sgreat news," said Brook Byers, a partner at Kleiner, Perkins, Caufield,& Byers, of Menlo Park, Calif. "If I had to think of something thatwould make my day, it would be Ted Kennedy doing this."Byers says his firm, which provided venture capital for 35biopharmaceutical companies, reduced its rate of biotech start-ups by50 percent after the breakthrough drug committee was first proposed,and that the committee's potential death could reverse this trend.But even if the breakthrough drug committee dies, provisions allowingthe Secretary of Health and Human Services to blacklist pricey drugsfrom Medicare are still alive."Some people feel that Medicare needs to have some authority torefuse to pay for drugs if they are excessively priced, or the programwill not be fiscally responsible," said Lisa Raines, vice president forgovernment relations, Genzyme Corp.The blacklisting provision has been scored by the CongressionalBudget Office as saving money, a fact that will make it all the moredifficult to remove. "As for the breakthrough drug committee, nobodysuggested that it would save the government money, and that made iteasier to eliminate," said Raines.Peter Drake, executive vice president and director of research, VectorSecurities, praised Genzyme president Henri Termeer, and theMassachusetts Biotechnology Council for their role in influencingKennedy on the breakthrough drug committee. "The MassachusettsBiotechnology Council is a well-organized and very effective lobbyingorganization," he told BioWorld.
-- David Holzman Special to BioWorld Today
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