Senate Passes Amendment To Expand Access to Generic Drugs
The Senate yesterday voted 94-1 to approve a proposal that would speed the market entry of generic drugs by eliminating some patent extension practices used by brand-name drug manufacturers, the Washington Post reports. The proposal was passed as an amendment to a Senate bill (S 1) to add a prescription drug benefit to Medicare (Goldstein/Dewar, Washington Post, 6/20). The measure, passed last week by the Senate Health, Education, Labor and Pensions Committee as a separate bill (S 1225), would amend the 1984 Hatch-Waxman Act to allow brand-name companies only one 30-month stay in cases where the brand-name company claims patent infringement by a generic drug company. Currently, brand-name companies can obtain multiple 30-month stays from the FDA to keep generic competition from the market. Also under current law, the first generic drug to come to market has 180 days of exclusivity, which has led some brand-name companies to pay generic drug makers to not bring their product to market. The bill would eliminate the 180 days of exclusivity for any generic drug company that enters such anticompetitive deals or fails to come to market in a timely manner (California Healthline, 6/12). The measure would also allow generic drug makers to file counterclaims against patent infringement lawsuits by brand-name companies (Espo, AP/Newark Star-Ledger, 6/20). Sen. Orrin Hatch (R-Utah), one of the authors of the Hatch-Waxman Act, cast the only dissenting vote (Lueck et al., Wall Street Journal, 6/20).
The measure "builds on" new FDA regulations announced by President Bush last week, the Los Angeles Times reports (Hook, Los Angeles Times, 6/20). Those regulations will allow brand-name pharmaceutical companies to receive only one 30-month delay in patent infringement cases and will make brand-name pharmaceutical companies that make alleged false claims in the patent process liable for criminal charges (California Healthline, 6/13). However, unlike the Senate measure, the Bush rule does not eliminate the 180-day exclusivity provision or allow counterclaim lawsuits by generic drug makers (AP/Newark Star-Ledger, 6/20).
Sen. Charles Schumer (D-N.Y.) one of the proposal's sponsors, said the changes would save consumers between $60 billion and $70 billion over the next 10 years and could shrink Medicare costs by $18 billion to $20 billion. He said the plan would do away with the "frivolous patents, lawsuits and legal mumbo-jumbo" used by brand-name drug makers to delay generics from coming to market (Pear/Toner, New York Times, 6/20). Sen. Judd Gregg (R-N.H.), also a sponsor of the measure, said it would make "generic drugs more available to consumers on a faster time frame" but would not limit "innovation in our brand-name [drug] companies." Jeff Trewhitt, spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "It is important that the tilt in incentives not be given to the generics industry, since it is the innovative brand-name industry that researches and develops new medicines that patients need."
According to the Los Angeles Times, the measure was approved as part of the broader Medicare reform bill because "[s]ome have complained that the Medicare bill, although it provides new insurance for drug expenses, would do little to solve the related problem of soaring prescription drug costs." Although a similar measure passed the Senate last year but died in the House, the bill's Senate sponsors are more optimistic this time around. They have changed the bill to include provisions sought by Republicans, including one limiting lawsuits by generic drug makers. Still, the outlook in the House is "uncertain," according to the Los Angeles Times (Los Angeles Times, 6/20). Rep. Billy Tauzin (R-La.), chair of the Energy and Commerce Committee, is working on a generic drug amendment to the House Medicare bill that he said would have a "comparable provision, probably not exactly the same." The House is set to debate its Medicare bill next week (Wall Street Journal, 6/20).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.