"There was tremendous concern at the beginning that antiviral medications bought by PEPfAR would be limited to branded drugs, purchased from the U.S. pharmaceutical industry," said Dr. Charles Carpenter, professor of medicine in the Warren Alpert Medical School of Brown University and a physician at The Miriam Hospital.
The FDA subsequently agreed to evaluate and to give tentative approval, when appropriate, to qualifying foreign-made generic antivirals so that they could be bought by PEPfAR and used exclusively overseas. The program also expanded drug availability by developing a sophisticated supply chain management system to anticipate demand. In addition, over time the FDA has lowered the costs it charges foreign drug companies to test their generics.
"We are now providing HIV medications for more than 3 million people, hopefully 4 million soon, and are buying them for the least cost possible," Carpenter said.
Carpenter and Dr. Kenneth Mayer, a professor at Harvard Medical School and adjunct professor of epidemiology at Brown, are co-authors on the paper.
PEPfAR is now facing the challenge that many people have HIV infections that are resistant to the first-line and second-line antiretroviral drugs available as generics. PEPfAR has not yet approved and gained access to many of the drugs that make up a second and third line of antiviral defense in a generic form.
"I don't know how long that's going to take, but I do know that Ambassador Goosby is working very hard to achieve that end," Carpenter said.
For other major global health efforts, Carpenter said, what PEPfAR's experience has to teach will v
|Contact: David Orenstein|