Senate Committee Targets Generic DrugTrade Agreements, Canada Overrides Cipro Patent
The Senate Judiciary Committee yesterday approved a bill that would force drugmakers to disclose agreements with generic manufacturers that "keep less expensive" treatments off the market, CongressDaily reports. Sponsored by Sens. Patrick Leahy (D-Vt.) and Charles Schumer (D-N.Y.), the bill is aimed at firms like Bayer AG, which has a patent until 2003 for the antibiotic Cipro, thought to be the "most effective" anthrax treatment. Under the legislation, drug makers would be required to disclose to federal officials financial arrangements that keep generics off the market (Rovner/Fulton, CongressDaily, 10/18). In addition, the Federal Trade Commission's oversight powers on drug patents would be "extended" (Hallam, Bloomberg, 10/18). A federal judge could also "void agreements" that "limit" the production of generic drugs (Harmon/Pear, New York Times, 10/19). Leahy said, "This bill will ensure that law enforcement agencies can take quick and decisive action against companies that are driven more by greed than by good sense." He added that had the bill been passed when it was first introduced last year, "generic alternatives to Cipro might have been on the market today." But a spokesperson for the Pharmaceutical Research and Manufacturers of America said the industry "has concerns" over the bill, since it "singles out one particular industry's agreements for scrutiny." CongressDaily reports that Schumer is also sponsoring a "broader" bill that would make it "easier" to get generic treatments on the market (CongressDaily, 10/18).
Meanwhile, Canada yesterday took the "unusual step" of "overid[ing]" Bayer's patent on Cipro and ordered one million tablets of a generic version from a Canadian manufactuer, the New York Times reports. While Bayer "condemned" the action and said it could meet demand for the drug, Paige Raymond Kovach, a spokesperson for Health Canada, said, "These are extraordinary and unusual times. Canadians expect and demand that their government will take all steps necessary to protect their health and safety." Toronto-based Apotex Inc. said it will make the drugs in a method that does not infringe on Bayer's patent and does not expect Bayer to file a patent infringement lawsuit, because such an action would be "a public relations nightmare." Bayer, however, said it is "prepared to consider all options to defend [its] patents." Schumer said he had called HHS Secretary Tommy Thompson to "renew his plea that the United States follow Canada's lead." But the White House said it was "unmoved" by Canada's action and was not considering breaking the patent, the Times reports (New York Times, 10/19).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.