Law Allowing Government to Buy Drugs Made ‘Outside Normal Patent Process’ Should be Used for Anthrax Antibiotic, Schumer Says

Sen. Charles Schumer (D-N.Y.) on Oct. 16 questioned whether German drug maker Bayer AG can meet the demand for the antibiotic Cipro, the only drug approved by the FDA to treat inhaled anthrax. He has asked HHS Secretary Tommy Thompson to "invoke" a federal law that allows the government to purchase products for official use from manufacturers "other than the patent holder." Under the law, only the government would purchase Cipro manufactured "outside normal patent processes." Many patients fearing bioterrorism have "inundated" doctors with requests for Cipro prescriptions, and the Bush administration plans to request funding from Congress to increase antibiotic supplies to allow the government to treat 12 million Americans for 60 days (Adams, Wall Street Journal, 10/17). "Given that there is now only one manufacturer, there is real concern that we have enough Cipro to deal with any potential future crisis," Schumer said (Bernstein, Los Angeles Times, 10/17). He added, "So if we invoke this statute, we can greatly increase our supply of Cipro and greatly reduce the cost to the government by about 50%" (Sheehan, AP/Philadelphia Inquirer, 10/17). According to Schumer, generic drug makers Par Pharmaceuticals, Ranbaxy Pharmaceuticals and Teva Pharmaceuticals could manufacture 60 million pills per month if given approval. (Fritz, St. Petersburg Times, 10/17). Barr Laboratories Inc. also said that the company "stood ready to assist" in the production of Cipro. The Journal reports, however, that HHS Secretary Tommy Thompson appeared "hesitant" to support the proposal. "Our lawyers don't believe I have the power or legal authority to do so," he said (Wall Street Journal, 10/17). In addition, Bayer would likely "fight such a move" (Appleby, USA Today, 10/17). Bayer has filed suit against two drug makers, including Mylan Laboratories, to prevent them from manufacturing a generic version of Cipro after the patent expires in 2003. The Federal Trade Commission has also investigated charges that Bayer "improperly" paid Barr $200 million to stop the firm from manufacturing a generic version of Cipro (St. Petersburg Times, 10/17).

Working 24/7
Bayer plans to triple production of Cipro to meet increased demand in the aftermath of a number of recent anthrax exposures, the Wall Street Journal reports. Bayer, which says it has filled "every order to date from the U.S. government," plans to operate facilities 24 hours a day, seven days a week and resume production at a plant in Germany (Adams, Wall Street Journal, 10/17). Bayer says that "there is no overall shortage" of the drug even though some pharmacies and wholesalers "have been unable to fill every" order for Cipro "immediately." According to Karen Dawes, senior vice president of marketing at Bayer, the company will increase production to 200 million pills per three months, up from 60 pills per three months before Sept. 11. HHS spokesperson Kevin Keane "welcomed" Bayer's decision to boost production. He said that Cipro accounts for 8% to 10% of the national stockpile of antibiotics (Peterson/Pear, New York Times, 10/17).

Treatment Alternatives
Meanwhile, although Cipro has become the "drug of choice" for anthrax treatment, several other "widely available and less expensive" antibiotics would "very likely work as well," the New York Times reports. The FDA approved Cipro last year to treat inhaled anthrax, but in the past, the agency had approved penicillins and tetracyclines to treat anthrax "generally." The drugs treat cutaneous and gastro-intestinal anthrax and would likely "work against" inhaled anthrax. "Everyone is focusing on Cipro, and that is giving the false impression that it is the only drug that would work against anthrax," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said (Kolata, New York Times, 10/17). However, the Washington Post reports that Cipro "may be more effective" against some strains of anthrax that have a resistance to other antibiotics. Mohammad Akhter, executive director of the American Public Health Association, said that doctors should treat a patient exposed to anthrax with Cipro and shift to other drugs only when they determine that the anthrax does not have a resistance to them (Vedantam, Washington Post, 10/17).