WASHINGTON _ Two more letters opposing pricereview commissions and rebate requirements for drugshave been sent to Democratic leaders in the House andSenate. Earlier this week, 29 representatives sent a letterexpressing similar sentiments to House Majority LeaderRichard Gephardt (D-Ill.).Eight Democratic senators wrote to Senate Majority LeaderGeorge Mitchell (Maine) on July 28 urging him to excludehealth care provisions that they argued would stifleinnovation. The letter, authored by John Kerry(Massachusetts), also was signed by Jeff Bingaman (NewMexico), Dianne Feinstein (California), Harris Wofford(Pennsylvania), Barbara Mikulski (Maryland), PaulSarbanes (Maryland), Joseph Lieberman (Connecticut), andBill Bradley (New Jersey).Meanwhile, almost the entire Democratic delegation fromMassachusetts (six representatives out of eight) sent a letterto Gephardt on July 26 arguing that certain provisions inHouse bills would decrease investment in thebiotechnology industry. They noted that, with 142companies investing $2.4 billion in research anddevelopment last year, Massachusetts has a largerbiotechnology industry than the entire European Union.The letter was signed by Reps. Joseph Kennedy, BarneyFrank, Edward Markey, Richard Neal, John Olver andMartin Meehan.Mitchell and Gephardt are working in closed-door sessionsto craft final versions of health care reform bills for theirrespective chambers. Mitchell is attempting to meld billsfrom the Senate Finance and Labor and Human ResourcesCommittees while Gephardt is forging a single piece oflegislation from bills produced by the House Ways andMeans Committee and the Education and LaborCommittee.Gephardt's bill will be introduced on the House floorFriday and Mitchell's bill could be introduced in the Senateby the middle of next week.It's unclear how letters might influence Gephardt orMitchell, if at all. The letters were signed by theDemocratic faithful _ most of whom have alreadycommitted to vote for the party's final bill. None of thesenators or representatives who have opposed price controlmeasures has said that the issue will be a show-stopper. Inother words, no one has put a vote on the line forbiotechnology, the ultimate commitment in the zero-sumgame of health care reform.Letters Part Of Broad StrategyNevertheless, Genzyme Corp.'s vice president forgovernmental relations, Lisa Raines, told BioWorld that theletters are part of a broader, cumulative strategy. Rainessaid that several lawmakers, including Neal, Kennedy andHouse Rules Committee Chairman Joe Moakley (D-Mass.),plan to reinforce the message of the letters in privatemeetings with Gephardt. (Moakley wrote a letter toPresident Clinton on May 12 opposing a breakthrough drugcommittee.)"The letters are not going to change the outcome all bythemselves," Raines said. "But the Mitchell letter wassigned by some of the most liberal members of the Senate.That shows we've got political support as an industryamong those who generally support governmentintervention."In addition, Raines noted that several members of theMassachusetts delegation to the House were co-sponsors ofa single-payer, Canadian style health care bill introducedearlier this year. "These letters may not be a breakthrough,but they represent a meaningful and symbolic advance forus," said Raines.Neither of the two Senate committee bills Mitchell ismelding contains drug price review mechanisms.Nonetheless, the senators urged Mitchell not to includesuch measures at the last minute in his final bill.In their letter to Mitchell, the senators promoted analternative government mechanism, proposed by Sen.Edward Kennedy (D-Mass.), to evaluate the cost-effectiveness of drugs and other medical services. Kennedy,who chairs the Labor and Human Resources Committee,replaced a proposed Breakthrough Drug Committee in hisbill with a three-year study of new and existing medicaltechnologies to be conducted by the Agency for HealthCare Policy and Research (AHCPR), an arm of theDepartment of Health and Human Services."This alternative has broad bipartisan support," the senatorswrote Mitchell. "By contrast, drug price controls andrebates have not passed either Senate committee and woulddivide Democratic senators."The Mystery BillThe outlines of Mitchell's bill are still unknown. SenateRepublican leader Robert Dole called it "the mystery bill"at a health care conference sponsored by the AmericanEnterprise Institute on Thursday. "Mitchell won't introducethat bill unless he has a majority," predicted Dole. But hewarned that Republicans won't support it unless it takes amarket-based approach to health care reform.The letter to Gephardt from six Massachusettsrepresentatives objected to the following provisions inHouse bills:y The Advisory Council on Prescription Drug Prices, asproposed in the Education and Labor bill. The letter saidthe council would review the prices of breakthrough drugs(drugs that represent significant therapeutic advances) andthus would discourage research and developmentinvestment in those drugs.y Authorization for Medicare to negotiate unlimited rebatesfor new products (vs. a standard, predictable 15 percentrebate) and exclude them from coverage if the manufacturerdoes not reach agreement with Medicare on a rebate(another provision of the Education and Labor bill). Theletter supported the concept of rebates but wanted limits seton the amount of that rebate to remove uncertainty forinvestors.y A mechanism in the Ways and Means bill that wouldtransfer the limited number of drugs currently covered byMedicare, including a number of biotech drugs, into thenew Medicare outpatient drug program. The transfer wouldsubject the biotech drugs to rebate requirements.The Massachusetts representatives also supportedKennedy's AHCPR proposal as an alternative to theoffending drug pricing provisions. n
-- Lisa Piercey Washington Editor
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