Senators To Announce Compromise on Bill To Improve Access to Generic Drugs
A bipartisan group of lawmakers, including Sens. Charles Schumer (D-N.Y.), Judd Gregg (R-N.H.), John McCain (R-Ariz.) and Edward Kennedy (D-Mass.), today are expected to announce compromise legislation designed to allow lower-cost generic drugs to more quickly reach the market, CongressDaily/AM reports (Rovner, CongressDaily/AM, 6/5). The compromise legislation would close a loophole that allows brand-name drug makers to delay generic versions of their drugs for 30 months each time the brand-name companies sue for patent infringement, Long Island Newsday reports. Instead, under the anticipated compromise, brand-name companies could only delay marketing for one 30-month stay in such cases (Povich, Long Island Newsday, 6/5). In addition, the compromise removes a controversial provision that was included in a bill (SB 812) that passed 78-21 in the Senate last year (McGinley, Wall Street Journal, 6/5). Last year's bill -- sponsored by Schumer and McCain -- would have allowed generic drug companies to legally challenge frivolous patents, including changes in a treatment's color or physical design, intended only to block competitors' products (California Healthline, 8/1/02). Opponents of that version said the right-to-sue provision would lead to additional lawsuits; the bill failed to pass the House. The compromise measure would allow generic companies to try to remove "inappropriate patents" by filing a counterclaim against a brand-name drug company, according to the Journal. The counterclaim could be filed after a brand-name drug maker sued a generic drug company for patent infringement.
With the elimination of the right-to-sue provision, the legislation has gained the backing of Gregg, chair of the Senate Health, Education, Labor and Pensions Committee, who last year opposed the bill, the Journal reports. Gregg said his support could expedite the bill's chance for passing the Senate again this session as well as increase its viability in the House (Wall Street Journal, 6/5). The compromise bill could be passed on its own or included in larger Medicare reform legislation, according to Newsday (Long Island Newsday, 6/5). Gregg said he expects the HELP committee to approve the measure next Wednesday, the New York Times reports. Gregg stated that the new bill would provide "access to prescription drugs more quickly, at a lower cost, without a lot of litigation, and there will still be many incentives for pharmaceutical innovation." Schumer said the legislation would provide "relief from the high prices of prescription drugs" for all U.S. consumers. Bruce Lott, spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "Current law works well, ... but we are reviewing" the bill. Kathleen Jaeger, president of the Generic Pharmaceutical Association, said her group welcomes the proposed measure. A Bush administration official said, "We are encouraged that bipartisan progress is being made" (Pear, New York Times, 6/5).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.