Biotechnology suffered a potentially major setback in the health carereform debate on Wednesday when Rep. John Dingle, chairman of the HouseEnergy and Commerce Committee, said that his committee was unable topass a bill.The committee's failure sprays water into the powerful Michigan democrat'sgas tank just two months after proponents of biotechnology scored amajor victory when they obtained Dingle's pledge to excise thedreaded breakthrough drug committee from his committee's health carereform package.The latest version of the breakthrough drug committee is included in areform package that the House Ways and Means Committee is expected topass today."The bill is otherwise laden and larded with price controls," as isthe only other surviving bill on the House side, that of the Educationand Labor Committee," Biotechnology Industry Organization president CarlFeldbaum told BioWorld.However, Dingle will remain a major player in health care reform. "TheHouse democratic leadership has agreed to allow Dingle a place at thetable in formulating the bill that will go to the House floor," LisaRaines, vice president for government affairs at Genzyme Corp. toldBioWorld. The final bill, she said, will be an amalgam of the billsof the Ways and Means and Education and Labor Committees, "and theinput of the chairman of the Energy and Commerce Committee. Dingleis also expected to be named as a conferee when the House and Senatemeet for Conference."Nonetheless, Feldbaum told BioWorld, "The fact that he is notchampioning his own bill, and that we are working off of a realregressive series of House bills may diminish somewhat Chairman Dingle'sability to weigh in on biotech's behalf."Additionally, "It is unclear whether [Dingle] is still bound by thecommitment he made to Lynn Schenk [D-Calif.] now that his committeehas failed to report a bill," Raines said. "The purpose of thatcommitment was an attempt to get Schenk to vote for a bill in committee."Dingle became the most powerful opponent of the breakthrough drugcommittee in April, after Reps. Schenk and Marjorie Margolies-Mezvinsky(D-Pa.) explained to him how the breakthrough committee could stranglethe industry. Feldbaum said Dingle's commitment to remove thebreakthrough committee was more than quid pro quo.In a letter to Schenk dated April 20, Dingle wrote, "You have presentedconvincing arguments for removing [the breakthrough drug] provisionfrom the bill. I do not desire to single out new or "breakthrough"drugs for draconian price regulation."But Kay Holcomb, a professional staff member on Dingle's committee,told BioWorld she did not know how Dingle would stand on the Waysand Means prescription drug commission.The new version of the breakthrough drug committee in the Ways andMeans bill is labeled the Prescription Drug Payment Review Commission.Described in just three paragraphs, "it is so vague that you canproject almost any function onto the commission without muchimagination," Feldbaum said. "It is almost as if they drafted theprovision for deniability. The inescapable interpretation is to install someversion of price controls."The Ways and Means bill contains several other provisions thebiotechnology industry opposes. First, it would slap a separate setof price controls on each sector of the health care system. Not onlywould this approach hurt sales of new drugs, but it could blockcost-saving substitutions by one sector for another, and preventpatients from receiving the best possible treatment, Feldbaum said.For example, John Wennberg, professor of medicine and director ofthe Center for Evaluative Clinical Sciences at Dartmouth MedicalSchool, explained that when a new drug comes on the market that canreplace a surgical procedure, and which costs less than the surgicalprocedure, and produces better outcomes, a sector-by-sector approachto price controls prevents substitution of the new drug for thesurgical procedure. That approach is one in which there are varyingprices for each sector of health care such as hospitals, out-patientclinics and physicians.Another provision of the Ways and Means bill would force drugmanufacturers to pay a 15 percent rebate to the Health Care FinancingAdministration for drugs used by people on Medicare, Medicaid, and theuninsured.Feldbaum told BioWorld he is now looking to the Senate FinanceCommittee to rescue biotechnology from the jaws of price controls,when the House and Senate meet in conference, which will probably takeplace after the August recess. n

-- David Holzman Special to BioWorld Today

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