In the battle against HIV/AIDS, there’s news on two fronts regarding anti-retroviral drugs.
First, the World Health Organization released a progress report today on its “3 by 5” program. That’s the effort to provide AIDS drugs to three million people by the end of 2005. The WHO says at the close of 2004, 700 thousand people in developing countries were receiving anti-retrovirals, a 75 percent increase from 2003.
Also, there’s word today that the US Food and Drug Administration has approved some generic AIDS drugs manufactured by Aspen Pharmacare of South Africa. It means that President Bush’s 15 billion dollar emergency plan for AIDS relief, known as PEPFAR, will be able to purchase generic combination drugs made by a foreign manufacturer.
Ambassador Randall Tobias is the US Global AIDS Coordinator. From Davos, Switzerland, he spoke to English to Africa’s Joe De Capua about US efforts to provide anti-retroviral drugs to developing countries.
Ambassador Tobias says, “It was almost exactly two years ago that President Bush announced a commitment of $15 billion over five years to focus on addressing HIV/AIDS in the developing world. This is the largest commitment that any country has ever made for a single disease. And today we announced very significant progress in our programs to get people on treatment and specifically in the 15 focus countries that we are putting particular attention on, which represent 50 percent of the infections in the world. We now have 155,000 people receiving treatment and this is a significant increase in the number of people who were receiving treatment when these programs began. And it also says that we really are ahead of schedule in launching the scale-up of the president’s program.”
The US Global AIDS Coordinator also responded to the news that the FDA had approved generic combination AIDS drugs manufactured in South Africa. He says, “Last May, (Health and Human Services) Secretary Thompson and I announced at the World Health Organization meeting in Geneva that we were putting together a two-part strategy where the Food and Drug Administration would have an accelerated program for reviewing the anti-retroviral drugs manufactured by any company anyplace in the world. And I announced at the same time that if drugs were submitted and received tentative approval from the FDA, then I would use that tentative approval as evidence that those drugs would be safe and effective. And they would therefore be eligible for funding under the president’s emergency plan.” He calls the FDA approval “a very, very positive move.”
Ambassador Tobias was also asked whether this would end the debate that only expensive, patented drugs would be used for the PEPFAR program and that money, not safety, was the real issue.
He responded, “Well, I hope it does. We have been saying from the very beginning of the plan that our policy is one of buying the least expensive drugs we can buy, regardless of the country of origin or the country that’s manufacturing them…. It’s just that it’s very important that that the drugs we are buying need to work. We need to know with certainty that they represent the same kind of quality that those of us in the United States would expect to have if we had a prescription fill at our local pharmacy…and so the FDA has done exactly what they said. And in turn I’ve done exactly what I said our policy would be. So, I hope it puts that question behind us.”
To listen to or download the full interview click the links above.