WASHINGTON _ The political tide here continues to turn against theconcept of a breakthrough drug committee. Rep. John Moakley (D-Mass.) wrote a letter to President Clinton on May 12 arguing that acommittee to review prices of breakthrough drugs could "irreparablydamage America's preeminence in biotechnology."Moakley's move is significant because he is chairman of the HouseRules Committee which will choreograph the scope and timing ofdebate _ as well as the voting procedures _ for any health carereform bill that makes it to the House floor."The political prospects for deleting this provision (the breakthroughdrug committee) are looking good," a Moakley aide told BioWorld."We'd like to have the issue worked out before any legislation reachesthe Rules Committee."The aide said that Moakley wrote the letter to Clinton primarily "in hiscapacity as representative from the ninth district of Massachusetts"rather than as chairman of the Rules Committee. Massachusetts ishome to 142 biotechnology companies that employ 17,600 people.Nevertheless, Moakley is chairman of the Rules Committee and thatmay carry significant political weight as the debate over reforming one-seventh of the nation's economy rages on.Three House committees with jurisdiction over health care reform _Energy and Commerce, Education and Labor and Ways and Means _may produce separate legislation. All three bills would then advance tothe Rules Committee which will set the terms of debate andreconciliation, with input from the House leadership."If a biotechnology company cannot charge for a breakthrough drug, aprice commensurate with the extraordinary risks its investors tookwhen they financed the research that resulted in that drug, then allindustry research could go unfunded," Moakley wrote to Clinton. "Thenet result: biotechnology companies would cease to exist as a source ofbreakthrough drugs. And there is no possible way for me to quantifythat loss . . ."Moakley said he had discussed the proposed breakthrough drugcommittee extensively with his constituents in the biotechnologyindustry. He concluded that the breakthrough drug committee wouldhave several unintended adverse effects:y it would impose pricing constraints on a high risk entrepreneurialindustry when such constraints have been historically imposed only onlow risk, slow-innovating ventures such as public utilities;y it would divert capital away from biotechnology to industries inwhich the risks and returns are commensurate;y it would decrease research and development spending for new waysto diagnose, prevent, treat and cure difficult medical conditions such asAIDS and cancer;y it might add to rather than reduce overall health care costs fortreatment and prevention of diseases for which no satisfactory therapiesyet exist;y American jobs would be lost and American leadership inbiotechnology would be surrendered to Japan and Europe.Opposition To Committee Is PriorityAccording to Carl Feldbaum, president of the Biotechnology IndustryOrganization (BIO), opposing the breakthrough drug committee hasbeen the number one priority of his group in recent months. "I amhopeful that we can put the breakthrough drug committee to bed, onceand for all," he said. The concept, a panel of experts that would reviewthe prices of new or breakthrough drugs and make public declarationsabout whether or not they were "reasonable," first surfaced in theClinton administration's Health Security Act last September. It alsoappeared in a health reform bill sponsored by Rep. Fortney "Pete"Stark (D-Calif.) that was voted out of a Ways and Means subcommitteeearlier this year.Administration officials have maintained that the committee was notintended to damage the biotechnology industry but rather to hold downcosts in the health care system. "The administration wants to protectconsumers and to provide access to prescription drugs at affordableprices," said Lorrie McHugh, a White House health care spokeswoman."We feel we put forth a good approach to achieve accessibility andaffordability."Feldbaum credited BIO members from Massachusetts, including MarkGoldberg of the Molecular Biology Research Institute in Worcester andGabriel Schmergel, CEO of Genetics Institute in Cambridge, forsuccessfully pleading the industry's case with Moakley. "Our goal allalong has been to convert neutral individuals into friends of theindustry and friends into champions," said Feldbaum. "Moakley hasbecome a champion." n

-- Lisa Piercey Washington Editor

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