In 2003, Congress passed the President’s Emergency Plan for AIDS Relief (PEPFAR), which targeted the prevention, treatment, and care of people living with HIV/AIDS in Africa, Asia, and the Caribbean. PEPFAR is now the single greatest supporter of treatment for AIDS in the developing world.
PEPFAR policy dictated that it could only purchase prescription drugs approved by a stringent regulatory authority, such as the U.S. Food and Drug Administration. However, the most commonly used drugs in the AIDS-affected regions before PEPFAR were generics not approved or available in the United States. Showing flexibility rare for a regulatory agency, FDA created an innovative approach that was considered by many to be a game changer: tentative approval.
By the Numbers
The game-changer: Tentative approval
A drug application with tentative approval must show that the product meets the same standards as drugs approved for the U.S. population. As a result, existing products that meet all FDA quality, safety and scientific standards are approved as generic drugs and are eligible for purchase with PEPFAR funds.
Tentative approval has lead to more than 150 antiretroviral drugs being integrated into many PEPFAR treatment programs.
Through the efforts of FDA and its world-wide partners, the United States directly supports life-saving antiretroviral treatment for more than 3.9 million men, women and children worldwide.
Not the only breakthrough
To streamline production, FDA pulled together manufacturers interested in producing the needed products and explained, step-by-step, how to submit applications and set up manufacturing processes to be successful. The agency expedited these applications, travelled around the world to inspect facilities and made sure there were systems in place to produce quality HIV drugs.
FDA initiatives also helped to revolutionize treatment for resource-poor settings by simplifying HIV/AIDS treatment.
The agency approved applications for fixed-dose combinations and co-packaged products. Both were significant innovations because they reduce the number of pills taken each day. Some can even be dispersed in water for children who are not able to swallow tablets.
Because these drug products are easier to manage – for both patients and health workers – patients are more likely to take their medicines properly, at the right dose and for the scheduled length of time.
Before the passage of PEPFAR, only 50,000 people in Sub-Saharan Africa were receiving treatment for HIV/AIDS. And the typical cost of antiviral treatment for one person was $10,000 per year; now the cost has come down to under $200 per person, enabling over 200,000 more people to receive treatment under the PEPFAR program.
President's Emergency Plan for AIDS Relief (PEPFAR) About FDA's PEPFAR program, including a listing of medicines approved and tentatively approved in association with the program. FDA: More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief[ARCHIVED]
FDA news release (7/23/2012)
- FDA is Proud to Have Helped PEPFAR Reach its Latest Milestone: More than 150 Drugs Now Available Worldwide to Help Treat HIV/AIDS
FDA Voice blog (7/27/2012)