Global AIDS Coordinator Tobias Defends U.S. Policy Not To Use Generic Fixed-Dose Combination Antiretroviral Drugs
U.S. Global AIDS Coordinator Randall Tobias in South Africa on Wednesday as part of a three-country, eight-day trip to Africa defended the U.S. policy not to use generic fixed-dose combination antiretroviral drugs in the President's Emergency Plan for AIDS Relief because of quality concerns, the AP/Las Vegas Sun reports (Zavis, AP/Las Vegas Sun, 4/28). Generic FDC antiretroviral drugs, including Cipla's Triomune and Ranbaxy Laboratories' Triviro, combine three different medicines into one pill that is taken twice a day and costs as little as $140 per person per year. A regimen of the same three drugs purchased separately from the companies that hold the patents would require about six pills a day and cost about $562 per patient per year. The drugs have been approved by a World Health Organization prequalification system, but U.S. officials want to ensure that the drugs will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use and are proposing guidelines for reviewing FDCs (Kaiser Daily HIV/AIDS Report, 4/9). Tobias said, "Patients ... in Africa deserve to have assurances about the safety and effectiveness of drugs in the same way that people in the United States do," adding, "It is [the U.S.] policy to buy the least expensive drugs that we can find without regard to who manufactures them or where they come from, as long as we can be satisfied as to their safety and effectiveness." He also said that the United States wants a "more transparent and stringent" review process, but he added that the process does not necessarily have to be overseen by FDA, according to the AP/Sun.
Tobias said, "Maybe [FDC] drugs are safe and effective. Maybe these drugs are, in fact, exact duplicates of the research-based drugs [sold in the United States]. Maybe they aren't. Nobody really knows." He added that the United States does not want to contribute to an increase in antiretroviral drug resistance because of "widespread or inappropriate" use of the treatments, the AP/Sun reports. Tobias said, "With the money that we are putting into this process, it is a whole new ball game. We are massively gearing up the provision of treatment in the world. ... The risks associated with doing something that ends up resulting in increasing drug resistance is quite significant." Tobias began his trip on Sunday in South Africa, visiting projects funded by the United States, and on Wednesday signed an agreement to provide $10 million over three years to the South African group Right to Care, which provides antiretroviral treatment to more than 1,000 people living with HIV, the AP/Sun reports. Tobias also met with officials and community leaders in Ethiopia and underwent a public HIV test to help combat HIV/AIDS stigma. Tobias on Wednesday traveled to Mozambique, where he will conclude his trip, according to the AP/Sun (AP/Las Vegas Sun, 4/28).
Some senior officials have said that the Bush administration is working to establish a "speedy" approval process for FDCs that could be used in developing countries in an effort to "calm a controversy" over the issue, the Wall Street Journal reports. Under the proposed process, generic FDC drug makers and brand-name drug makers would be able to go through an expedited FDA review process, which could take one to two months. According to the Journal, a senior FDA official speaking on the condition of anonymity said, "The Indian companies can apply to the FDA for approval for their new HIV drugs, and if the data they submit shows that these drugs are safe and effective, FDA could approve them," adding, "As a practical matter, the Indian companies would probably be free to market these drugs in Africa, since the innovator companies have already said they would not enforce their patents in that continent." Bush administration officials said that the faster approval process is "one option" they are examining while determining what drugs PEPFAR grant recipients can purchase, according to the Journal. The administration also is working with WHO to collect more data on the drugs, the Journal reports (Lueck, Wall Street Journal, 4/29).