WASHINGTON _ Despite some high-profile health care reformtriumphs in recent months, biotechnology industry advocates say thatlegislative dangers still lurk in at least two key congressionalcommittees: Senate Finance and House Ways and Means.And with three weeks remaining until the July 4 recess, members ofCongress and their staffs are under intense pressure."The legislation will be flying faster and more furiously with even lessconsideration for the implications because there's less time now,"Biotechnology Industry Organization (BIO) president Carl Feldbaum,told BioWorld. "We're entering a danger zone. Ideas that sound goodand are truly half-baked could take flight. This is not a reflectivelegislative period."Capitol Hill veterans said that the Senate Finance and House Ways andMeans committees are the ones to watch in the upcoming weeks.Although a total of five congressional committees will likely drafthealth care reform bills, versions from Finance and Ways and Meanscould have the most impact because of their powers to tax and raiserevenues. (The five committees that have jurisdiction over health carereform are: Senate Labor and Human Resources, Senate Finance,House Ways and Means, House Education and Labor and HouseEnergy and Commerce.)Last week, Finance chairman Daniel Moynihan (D-N.Y.) introducedhis Chairman's Mark, an outline of a bill that will be the starting pointfor the committee's legislative debate. Moynihan's Mark containednone of the provisions that the biotechnology industry has opposed,such as a breakthrough drug committee.Since the bill does not expand Medicare to include outpatientprescription drug coverage, biotechnology hot-button issues such asawarding special rebate negotiation and "blacklisting" powers to theSecretary of Health and Human Services (HHS) are irrelevant.According to Genzyme Corp.'s vice president of governmentalrelations, Lisa Raines, the lack of Medicare drug coverage is a mixedblessing for biotechnology companies."Sure, there's no objectionable blacklisting provisions, but olderAmericans still won't have coverage for their drugs," said Raines."This means that drug prices will continue to attract attention as thesingle largest out-of-pocket expense for elderly Americans." She calledolder Americans a "formidable political group" who tend to vote inelections and write letters to their political representatives.Indeed, the Finance committee counts Sen. David Pryor (D-Ark.), avocal critic of the drug industry and chairman of the SpecialCommittee on Aging, among its members. Pryor is not likely to remainsilent on the topic of drug prices during the committee amendmentprocess slated to begin today. Although the concept of a breakthroughdrug committee appears politically dead, sources say that Pryor couldoffer amendments to approach drug price controls from a differentangle.Pryor Labeled "Unpredictable""He (Pryor) is biotechnology's main concern in the Financecommittee," said Feldbaum, who added that he "could not even beginto predict what Pryor might do."One possibility: Pryor could seek to impose restrictions on the prices ofdrugs developed via technology transfer agreements between thegovernment and private sector. One way to achieve this would be tostrengthen the so-called "reasonable price clause" currently containedin all Cooperative Research and Development Agreements (CRADAs)signed by the National Institutes of Health (NIH). Pryor could tack aproposal onto health care reform legislation or introduce a separate bill.The BIO has been sounding the alarm about that type of legislationsince April."Legislation may shortly be introduced which would institutionalizethe counter-productive technology transfer practices of the NIH, thelargest government basic research agency in the U.S.," BIO warned ina recent technology transfer backgrounder. "The risk with thislegislation is not only that it would prevent NIH from reforming itscurrent practices, which many at NIH are eager to do, but that it wouldset in law a dangerous precedent that could well be applied withdisastrous results to all technology transfer programs."One Clinton administration official who asked not to be identifiedpredicted that Pryor will definitely make trouble for the drug industry.Referring to a recent compromise reached in the Senate Labor andHuman Resources Committee, he said, "There's no way Pryor is goingto buy into that Kennedy proposal to study outcomes of new medicaltechnologies instead of reviewing drug prices."Sen. Edward Kennedy (D-Mass.) deleted a provision for abreakthrough drug committee from his original health care bill andreplaced it with a three-year study of patient, societal and costoutcomes for new and existing medical technologies. The study wouldbe conducted by the Agency for Health Care Policy and Research.Kennedy's was the first and, as yet, only congressional committee totake a final vote on a bill. The committee adopted its version lastThursday with an 11 to 6 vote, insuring that the full Senate will vote onthe issue this summer.But whatever Pryor does in upcoming weeks, the Finance committee iswidely regarded as the most bipartisan and moderate of the fivecongressional committees with authority over health care reform. Manybelieve it is most likely to produce a bill that could ultimately be viablein both chambers. Likewise, if Finance is unable to vote a bill out ofcommittee, health care reform could be stalled indefinitely.The powerful House Ways and Means committee also begins mark-upsessions for its bill today. Over the weekend, Republican membersworked on drafting amendments to the Chairman's Mark, whichclosely resembles a version pushed through the Health subcommitteeby chairman Fortney "Pete" Stark (D-Calif.).The Ways and Means committee is currently chaired by Rep. SamGibbons (D-Fla.), who took over as acting chairman after Rep. DanRostenkowski (D-Ill.) was indicted on felony charges last week.According to Feldbaum, the Ways and Means bill is layered with pricecontrols."The Ways and Means bill is highly problematic for the industrybecause it contains a whole spectrum of price controls," said Feldbaum."We've got to work hard during the amendment process to get thoseprovisions deleted." One likely target of the BIO's lobbying efforts willbe the Prescription Drug Payment Review Commission which couldreview the reasonableness and rate of increases for drug prices.The House Energy and Commerce Committee, which has been stalleddue to fundamental disagreements over employer mandates, is stillsearching for a compromise on health care reform. Until a compromiseis reached, the committee won't begin marking up a bill. Although theHouse Education and Labor Committee is marking up its health carebill, few expect that the highly partisan document will survive once itreaches the full House. n

-- Lisa Piercey Washington Editor

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