Thompson Negotiating With Drug Companies to Purchase Anthrax Antibiotics; Sees No Need to Override Cipro PatentHHS Secretary Tommy Thompson said on Saturday that he would consider invoking a federal law allowing generic drug makers to bypass Bayer's patent on Cipro, the only drug approved by the FDA to treat inhalation anthrax, the Washington Post reports. The move would allow the generic companies to produce the antibiotic for the government. "We are looking at the patent issue very closely," Thompson said (Vedantam/Chea, Washington Post, 10/20). However, he said that at present "there was no need" to override Bayer's Cipro patent. "We have plenty of Cipro right now," he said (Pear, New York Times, 10/20). Tony Jewell, an HHS spokesperson, said that agency officials "do not believe" that breaking the patent is necessary, adding, "It would not save money to break the patent." Bayer supplies the government with Cipro at a discounted price of $1.83 per tablet. Thompson said Saturday that he has negotiated with Bayer and other drug companies to purchase about 1.2 billion doses of antibiotics to treat 10 million Americans for 60 days in the event of an anthrax outbreak. Federal health officials last Friday said Cipro makes up only about 8% of the pills that the government plans to purchase. The remainder will be generic versions of other antibiotics such as penicillin and doxycycline (Washington Post, 10/20). Sen. Charles Schumer (D-N.Y.), who has asked Thompson to override Bayer's patent on Cipro, said that Thompson "wants to negotiate between Bayer and the generic companies, to get an amicable agreement" under which Bayer would allow the companies to manufacture Cipro. Bayer's patent on the drug expires in December 2003 (New York Times, 10/20). The company has "mounted a defense against attempts" to allow the sale of a generic version of Cipro (Washington Post, 10/20).
Legal, Political Questions
Thompson said last week that he did not "have the power or legal authority" to allow generic drug companies to bypass Bayer's patent and manufacture Cipro (Kaiser Daily Health Policy Report, 10/17). However, Philippe Bennett, head of intellectual property practice at Coudert Brothers law firm in New York, said that the government does have the legal authority to "find alternative suppliers other than the patent owners to meet the needs of the welfare of the country." According to Alfred Engelberg, a retired intellectual property lawyer who wrote a brief for Schumer about the proposal, the government's "reticence to order generic Cipro stemmed from a larger concern": a "clas[h]" with nations in Asia and Africa over their right to acquire generic drugs for AIDS and other diseases. "If the United States is seen as issuing a compulsory license when it has a health emergency, it can hardly argue to the rest of the world that third-world countries can't exercise a similar right when they have an emergency," he said (Washington Post, 10/20).
In related news, federal health officials said last Saturday that they have asked the FDA to approve the use of the anthrax vaccine for patients already exposed to the bacteria, CDC Deputy Director David Fleming said. Health officials said that the vaccine "would be useful" to treat patients exposed to anthrax strains with resistance to antibiotics and in patients who "could not tolerate" antibiotics (New York Times, 10/20). Meanwhile, the Gilmore Commission, a federally appointed advisory panel on terrorism chaired by Virginia Gov. James Gilmore (R), is expected to recommend that the government build and operate a national facility to develop vaccines against biological agents. The commission, which plans to release its third annual report to the president and Congress in December, may release an executive summary as early as this week. The Wall Street Journal reports that the commission will likely ask the government to contract with a private pharmaceutical company to operate a national vaccine facility to help "avoid some of the chronic shortages" of vaccines against biological agents. In addition, the commission plans to recommend increasing public health laboratories' capacity to detect biological attacks, standardizing lab employees' training and improving coordination among government and private labs. According to the Journal, the plan could "help reduce some of the delays and confusions that have arisen over the recent anthrax cases" (Caffrey, Wall Street Journal, 10/22).