Senate Committee Postpones Vote on Prescription Drug Patent Law Reform
Democrats on the Senate Health, Education, Labor and Pensions Committee yesterday postponed a vote on a bill that would increase access to lower-cost generic drugs and decided to resume negotiations with Republicans, who support legislation more favorable to brand-name pharmaceutical companies, the AP/Detroit Free Press reports (Carter, AP/Detroit Free Press, 7/11). The bill, introduced last year by Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.), would eliminate a provision in the 1984 Hatch-Waxman law that allows brand-name drug companies to receive a 30-month patent extension from the FDA when they file lawsuits against generic drug makers for alleged patent infringement. The Schumer-McCain legislation has support from most Democrats, some Republicans and Business for Affordable Medicine, a coalition of governors, labor unions and employers. Brand-name drug companies oppose the legislation (Pear, New York Times, 7/11).
However, the committee also may consider a rival bill, sponsored by Sens. John Edwards (D-N.C.) and Susan Collins (R-Maine), that would not eliminate the 30-month patent extensions but would reduce the number of cases in which brand-name drug companies could receive the extensions. The bill also would eliminate a 180-day market exclusivity period for the first company that receives approval to market a generic drug "if the first generic approved fails to come to market" within 180 days (Rovner, CongressDaily, 7/10). Committee Chair Edward Kennedy (D-Mass.) said, "It was suggested we might take the afternoon and see if we cannot engage members and their staffs [in negotiations]. It seems to me that is a sensible and responsible suggestion." Kennedy planned to reconvene the committee today and vote on compromise legislation, although Democrats have said they have the votes to pass the Schumer-McCain bill "if negotiations fail."
Senate Majority Leader Tom Daschle (D-S.D.) said yesterday that the Schumer-McCain bill could help spur debate in the Senate on a Medicare prescription drug benefit, which he said that he may add as an amendment to the bill or other prescription drug legislation (AP/Detroit Free Press, 7/11). Daschle has said that floor debate on a bill to add a prescription drug benefit to Medicare will begin next Monday. The Senate will consider two bills (Rovner/Fulton, CongressDaily/AM, 7/11). One bill, sponsored by Sens. Bob Graham (D-Fla.) and Zell Miller (D-Ga.), would establish a Medicare prescription drug benefit at an estimated cost of as much as $500 billion over eight years. Under the legislation, which has the support of many Democrats, seniors would pay a $25 monthly premium with no deductible, a $10 copayment for generic drugs and a $40 or $60 copayment for brand-name treatments. The government would cover 100% of seniors' annual out-of-pocket prescription drug costs that exceed $4,000. Low-income seniors would pay reduced premiums, and the bill would exempt Medicare beneficiaries with annual incomes less than 135% of the federal poverty level from premiums and copayments (California Healthline, 6/12).
The tripartisan group, which includes Sens. Charles Grassley (R-Iowa), Olympia Snowe (R-Maine), Orrin Hatch (R-Utah), John Breaux (D-La.) and James Jeffords (I-Vt.), has proposed a rival bill similar to legislation passed last month in the House that would allow seniors to purchase prescription drug coverage directly from private insurers (California Healthline, 7/10). Under the $330 billion, 10-year bill, Medicare beneficiaries would pay a $35 monthly premium, and the government would cover 50% of seniors' annual out-of-pocket prescription drug costs up to $2,000 or $2,500, no costs between $2,000 or $2,500 and $3,700, 90% of costs that exceed $3,700 and 100% of costs that exceed $6,000 (CongressDaily/AM, 7/11).
The Senate HELP Committee yesterday also voted 16-5 to approve a bill that would require private health plans to cover tests for colon cancer for individuals ages 50 and older and for high-risk patients, the New York Times reports. "Overwhelming scientific evidence indicates that with early detection, we can save lives, and millions and millions of dollars," Kennedy, who co-sponsored the bill with Sen. Jesse Helms (R-N.C.), said. However, opponents of the legislation said that the bill would increase health care costs. "Every time we increase the cost of health insurance, we throw people into the ranks of the uninsured," Sen. Tim Hutchinson (R-Ark.) said (New York Times, 7/11). Sen. Bill Frist (R-Tenn.) added, "This puts Congress on the slippery slope of micro-managing and mandating every aspect of clinical care" (CongressDaily, 7/10).
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