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Committee Backs Expansion of Access to Low-Cost Drugs
By a vote of 16 to 5, a Senate committee approved a bill today that would greatly expand access to low-cost generic versions of prescription drugs. The full Senate plans a free-swinging election year debate on drug prices next week. Even supporters said they were surprised by the lopsided vote on the bill, the first major setback in years for the industry that manufactures brand-name prescription drugs sold in the United States and around the world. Ten Democrats, 5 Republicans and one independent supported the bill, while 5 Republicans voted against it. All the Republicans who voted for the bill are up for re-election this year. Senator Edward M. Kennedy, Democrat of Massachusetts, the committee chairman, hailed the outcome, saying, "This is a victory for patients and a defeat for the special interests who have been exploiting loopholes" in existing law to delay competition by makers of generic drugs. The bill is likely to be the vehicle for a long-awaited debate on prescription medicines next week in the Senate, where efforts to write a prescription drug bill for Medicare recipients have been stymied. Members of both parties plan to offer amendments to authorize coverage of prescription drugs under Medicare, the federal health insurance program for 40 million people who are elderly or disabled. Today's vote was in the Senate Committee on Health, Education, Labor and Pensions. Another panel, the Finance Committee, has authority over Medicare, but has been unable to reach agreement on Medicare drug benefits. Republicans like Senator Judd Gregg of New Hampshire said they feared that the bill approved today would lead to a blizzard of lawsuits by generic drug companies challenging patents on brand-name medicines. Under current law, a maker of brand-name drugs can often get a 30-month delay in federal approval of generic drugs by filing a lawsuit that alleges infringement of its patents. Critics say that some companies have delayed generic competition for years by repeatedly seeking 30-month delays. The bill approved today would allow a single 30-month delay, to protect patents listed at the time a brand-name product is approved by the Food and Drug Administration. Brand-name drug companies adamantly opposed the measure, saying it would reduce patent protections for their products, thus reducing incentives for the discovery of cures and treatments. Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, said, "This legislation undermines the patent system that has brought us a cure for polio, four new medicines to combat Alzheimer's disease, a breakthrough treatment for leukemia and every AIDS treatment we have now." The Republicans who voted for the bill were Susan Collins of Maine, Tim Hutchinson of Arkansas, Pat Roberts of Kansas, Jeff Sessions of Alabama and John W. Warner of Virginia. Today's vote was a victory for Senators Charles E. Schumer, Democrat of New York, the chief sponsor of the bill, and John McCain, Republican of Arizona, the principal co-sponsor. An amendment devised by Ms. Collins and Senator John Edwards, Democrat of North Carolina, to balance the interests of generic and brand-name companies, ensured bipartisan support. When Mr. Schumer and Mr. McCain introduced an earlier version of the bill two years ago, experts on the drug industry dismissed it as a quixotic effort to rewrite arcane patent laws. But the two senators translated the issue into dollars and cents, saying patients, employers and insurers could cut drug costs at least 30 percent whenever they used generic medicines rather than brand-name ones. The House passed a bill to add drug benefits to Medicare last month. House Republican leaders deflected bipartisan efforts to rein in drug prices. But the House leaders said they might return to the issue if the Senate passed a bill addressing drug costs. When their efforts to write a Medicare drug bill stalled, senators seized on the generic drug legislation as a way to provide relief to consumers. In an interview, Mr. Schumer said his bill affected everyone who used prescription drugs and "does not cost the government anything." By contrast, the Medicare bills would provide direct assistance only to the elderly and the disabled, and would generate large federal costs, ranging from $370 billion to $700 billion or more over 10 years. Mr. Schumer said his bill took "a free-market approach," trying to drive down drug prices through greater competition, not through price controls or regulation. Kathleen D. Jaeger, president of the Generic Pharmaceutical Association, said some brand-name companies had blocked generic competition by claiming patents on incidental features of their products — for example, the grooves cut into the surface of a tablet or the brown bottle in which a medicine was packaged. Under the bill approved today, Ms. Jaeger said, generic drug companies could file suit in federal court to challenge such patents. FAIR USE NOTICE: This page contains copyrighted material the use of which has not been specifically authorized by the copyright owner. Global Action on Aging distributes this material without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. We believe this constitutes a fair use of any such copyrighted material as provided for in 17 U.S.C § 107. 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