Bush Administration Under Pressure To Allow Purchase of Generic Combination Antiretroviral Drugs With AIDS Relief Plan Money
The Bush administration is facing "mounting pressure" to allow the purchase of generic combination antiretroviral drugs -- instead of name-brand drugs -- as part of the President's Emergency Plan for AIDS Relief, the Wall Street Journal reports. The issue is expected to be discussed on Monday at a meeting in Botswana on international standards for evaluating generic combination drugs (Lueck, Wall Street Journal, 3/25). PEPFAR, which was submitted to Congress last month, details the Bush administration's five-year, $15 billion global AIDS initiative, which seeks to prevent seven million new HIV infections, provide care for 10 million people living with the disease and provide treatment to two million HIV-positive people living in 14 African and Caribbean countries (Kaiser Daily HIV/AIDS Report, 3/4). The plan states that procurement of drugs for the initiative "will have to fit within the parameters of existing federal and international law for the protection of intellectual property rights." Ambassador Randall Tobias, head of the new State Department Office of the Global AIDS Coordinator, has said that the administration is open to the use of generics. He said that FDA, the World Health Organization, UNAIDS and other groups at the Botswana meeting will discuss principles that can be used to examine alternatives in the market (Kaiser Daily HIV/AIDS Report, 2/24).
The issue of generic combination drugs is expected to be "hotly debated" during the meeting, according to the Journal. The combination treatments in question are Cipla's Triomune and Ranbaxy Laboratories' Triviro, which have not been approved by FDA but are supported by WHO. The patent holders on each of the drugs included in the combination pills are GlaxoSmithKline, Bristol-Myers Squibb and Boehringer Ingelheim. Mark Grayson, a spokesperson for the pharmaceutical industry trade group PhRMA, said that the organization is "leaving the lobbying on the issue up to individual member companies," but he added that the group is pointing to safety concerns, according to the Journal. "You can't just mix [the drugs] together and put them on the market," Grayson said, adding, "You have no idea how it's going to work in tandem. You need to run at least a year's worth of clinical trials and testing." Mark Dybul, deputy chief medical officer in the Office of the Global AIDS Coordinator, said that the United States is "agnostic" about the issue. He said that the administration has made a "big shift" in considering for use generic medications that have not been approved by FDA, according to the Journal. "Our predilection is to use them if at all possible. The activists should be jumping up and down and saying 'Hallelujah, this is a major movement in international health,'" Dybul said.
Supporters of the generic combination therapies say that the drugs are less expensive and easier to administer because they require patients to take fewer pills, the Journal reports. Sen. Edward Kennedy (D-Mass.) recently sent a letter to Bush demonstrating his support of the generic combination drugs, and Rep. Sherrod Brown (D-Ohio) on Wednesday sent a similar letter to the White House, according to the Journal. Many international health experts warn that if the purchase of generic antiretrovirals is not allowed under PEPFAR, "treatment could be a logistical nightmare," the Journal reports. Governments and aid organizations may have to operate separate treatment programs with generic and brand-name drugs in order to keep U.S. funding separate. In addition, generic drug use advocates say that "every dollar counts" when there is a limited amount of money, according to the Journal. Peter Mugyenyi, head of the Joint Clinical Research Center in Uganda, said, "If there were enough money for everyone, we would not care which drugs. We have a moral imperative and an ethical dilemma -- how to choose among the patients who should live and who should die" (Wall Street Journal, 3/25).