Tobias Testifies on PEPFAR Progress to House Subcommittee, Says FDA Expected To Approve More Generic AIDS DrugsFDA likely will approve more generic AIDS drugs in the next few months, allowing them to be included in the five-year, $15 billion President's Emergency Plan for AIDS Relief, U.S. Ambassador Randall Tobias, head of the State Department's Office of the Global AIDS Coordinator, said on Wednesday before the House Foreign Operations Subcommittee, Reuters reports (Willard, Reuters, 3/2). HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including fixed-dose combination drugs -- to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce FDCs to improve access to drugs in remote areas in severely affected countries and ensure the drugs' safety (Kaiser Daily HIV/AIDS Report, 5/17/04). FDA in January approved a generic version of a widely used co-packaged antiretroviral drug regimen made by South Africa's Aspen Pharmacare. The regimen includes a generic version of GlaxoSmithKline's fixed-dose combination Combivir, which contains the antiretroviral drugs lamivudine and zidovudine, and a version of Boehringer Ingelheim's Viramune, known generically as nevirapine. The move allowed PEPFAR to purchase the drugs (Kaiser Daily HIV/AIDS Report, 1/26).
During Wednesday's testimony, Tobias said that he "expects" FDA to approve more generic antiretrovirals in the "coming months," according to Reuters. "We have put a lot of effort into hand-holding with generic companies around the world to encourage them, so my guess is in the next few months we will see more generics approved," Tobias said, adding, "The first company to apply was approved, ... and we expect more." However, some AIDS advocates still say that FDA is "moving too slowly" on approving generic antiretrovirals, which can cost $140 per patient annually, compared with $470 per patient annually for brand-name drugs, according to ActionAid, Reuters reports. In addition, some HIV/AIDS advocates are "skeptical" about the role of FDA because the World Health Organization already has its own prequalification process for generic drugs, Reuters reports. "Cost-effectiveness is very important, but the Bush administration's process has turned out to be anything but fast track," David Bryden, communications director for Global AIDS Alliance, said, adding, "It has yet to provide any meaningful results, and the (Aspen Pharmacare) drug in question is still not in use in any of the affected countries" (Reuters, 3/2).
PEPFAR Progress, Budget
Tobias also said that the amount President Bush requested for PEPFAR in his proposed fiscal year 2006 budget would keep it "on track" to meet its five-year goal of spending $15 billion, VOA News reports (Robinson, VOA News, 3/2). Last month, Bush released his proposed FY 2006 budget, which included $3.2 billion for the third year of PEPFAR, $300 million of which would go to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Kaiser Daily HIV/AIDS Report, 2/8). Although PEPFAR funding has increased "steadily" during its first three years, Tobias said there have been no "major upward turn[s] in the battle" against the HIV/AIDS pandemic, according to VOA News. "I wish I could report to you that the world has turned the corner on HIV/AIDS or that the hard part is behind us. But even with the encouraging results you will see in our first annual report, it is very true that we have a very, very long way to go," he said (VOA News, 3/2).
Although Tobias testified that PEPFAR is "on pace" to hit spending and treatment targets -- two million people treated and seven million new HIV infections prevented -- some House Democrats "voiced discomfort" with the program's emphasis on abstinence as a prevention method, according to CQ HealthBeat (CQ HealthBeat, 3/2). The HIV/AIDS prevention component of PEPFAR is based on the "ABC" method -- which stands for abstinence, be faithful, use condoms -- an approach that Tobias said has received "growing endorsement" from experts and is called a "proven ... centerpiece" of HIV prevention, VOA News reports (VOA News, 3/2). However, Rep. Jesse Jackson (D-Ill.) said that PEPFAR could "put ideological limits on funds" and that condom use has been "de-emphasized" because of the administration's emphasis on abstinence, according to CQ HealthBeat. Rep. Steven Rothman (D-N.J.) asked Tobias what he believed was the most effective HIV prevention method. When Tobias responded that he "would not chose any particular method," Rothman asked, "Why wouldn't it be productive to know which one (method) is most effective? I find it startling you don't know which is most effective" (CQ HealthBeat, 3/2).
Changes to Policy?
During Tobias' testimony, other House members said that elements of the law (PL 107-248) authorizing PEPFAR "might need revision," according to Washington File. Because the law stipulates that the U.S. contribution to the Global Fund not exceed 33% of total contributions, Rep. Jim Kolbe (R-Ariz.) said that other countries might "over rely" on U.S. donations. However, Tobias said that he "wouldn't favor changing that" because urging other countries to increase their contributions to the fund is an "important task ahead," Washington File reports (Porter, Washington File, 3/2). He added that actual contributions to the fund, compared with pledges, are "still lagging," saying that it is too early to say whether the United States will be able to provide its full contribution to the fund, according to VOA News (VOA News, 3/2). Other representatives also questioned PEPFAR's dispersal formula, which calls for 55% of overall funds to be devoted to treatment -- 75% of which should be spent on the purchase and distribution of antiretrovirals and the remaining on related care. Several subcommittee members said that such dispersal decisions should be made by health care providers, not U.S. lawmakers, Washington File reports. "The goal of the program is to save lives, not hit percentages," Rep. Mark Kirk (R-Ill.) said. He added that PEPFAR's funding formula has become "impractical" as generic drugs have become more widely available, according to Washington File.
Other subcommittee members questioned PEPFAR's focus on 15 countries because they said HIV is spreading at a "fierce pace" in other nations not included as focus countries under the program, Washington File reports (Washington File, 3/2). "Swaziland has an adult HIV [prevalence] rate of 38.8%, Lesotho 28.9%, Zimbabwe 24.6% and Malawi 14.2%. All of these nations are nonfocus countries," Jackson said, adding, "In fact, of the top four countries with the world's highest adult HIV [prevalence] rates, only one of them is considered a focus country. What is the administration's plan to (keep) up the commitment to combat the spread of HIV/AIDS in nonfocus countries?" Tobias responded that the United States has not "lost sight of need" in other nonfocus countries, VOA News reports. He added that, "generally speaking," U.S. aid to such countries has increased and that they also receive assistance from the Global Fund, according to VOA News (VOA News, 3/2).