Senate Committee Passes Rx Drug Patent Reform Bill

The Senate Health, Education, Labor and Pensions Committee yesterday "surpris[ingly]" voted 16-5 to approve a bill that expands access to generic drugs, the New York Times reports. The bill, which was supported by all committee Democrats, five Republicans and one Independent, would amend a provision in the 1984 Hatch-Waxman law that allows brand-name drug companies to receive an automatic 30-month patent extension from the FDA when they file a lawsuit against generic drug makers for alleged patent infringement. Critics say that some brand-name drug manufacturers use the law to delay generic competition by filing numerous patents with the FDA. The companies then file patent infringement lawsuits and receive the 30-month extensions. Under the measure approved yesterday, brand-name drug makers would be allowed only one 30-month extension for patents that were listed when the FDA first approved the drug (Pear, New York Times, 7/12). The bill also would prevent brand-name companies from paying generic manufacturers to keep their products off the market and would allow generic companies to legally challenge "frivolous patents," including "superficial changes" in a treatment's color or physical design intended only to "stifle competition" (McGinley/Lueck, Wall Street Journal, 7/12).

The legislation, which was originally proposed by Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.) and amended yesterday by Sens. John Edwards (D-N.C.) and Susan Collins (R-Maine) to "ensure bipartisan support," is a "victory for patients and a defeat for the special interests who have been exploiting loopholes" in the Hatch-Waxman law, Sen. Edward Kennedy (D-Mass.) said (New York Times, 7/12). Collins added that the bill should stop brand-name companies' ability to "stack" multiple patent extensions, which can delay a generic drug "indefinitely" (Wall Street Journal, 7/12). But Republicans who voted against the bill said that it could "lead to a blizzard of lawsuits" by generic companies against brand-name drug makers. For their part, brand-name drug makers say that the legislation would reduce "incentives for the discovery of cures and treatments." Alan 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" (New York Times, 7/12).

The Wall Street Journal reports that yesterday's legislation's approval by the committee "underscores a major shift in the politics of the already superheated" debate on prescription drugs, as lawmakers are now concerned with drug prices and not just prescription drug coverage for seniors. The Journal adds that drug costs "top the list of voters' concerns," and all five Republicans who voted in favor of the bill are up for reelection this year (Wall Street Journal, 7/12). The generic drug bill is "likely to be the vehicle for a long-awaited debate on prescription medicines" in the Senate, the Times reports (New York Times, 7/12). Senate Majority Leader Tom Daschle (D-S.D.) has said that floor debate on a bill to add a prescription drug benefit to Medicare will begin Monday. The Senate is currently considering two bills: one, sponsored by Sens. Bob Graham (D-Fla.) and Zell Miller (D-Ga.), would cost as much as $500 billion over eight years, and a rival bill, sponsored by a "tripartisan group" of senators, would cost $330 billion over 10 years (California Healthline, 7/11). By debating a Medicare prescription drug benefit bill separately from the generic drug bill passed yesterday, Democrats believe the generics bill can "overcome a filibuster" that a Medicare bill alone would likely generate, the Hartford Courant reports (MacDonald, Hartford Courant, 7/12).