According to a study published in the latest “Health Affairs” journal, the success of the President’s Emergency Plan for AIDS Relief was made possible in large part by changes at the US Food and Drug Administration. Starting in 2004, FDA began expediting the tentative approval of generic drugs, allowing them to be offered through PEPFAR. The approval is considered tentative only because patents protect the brand-name drugs from generic competition in the US market.
Since 2003, much of the treatment in countries hard-hit by AIDS has been paid for by PEPFAR. FDA’s expedited approval of more than 140 generic versions of common antiretrovirals (ARVs) brought PEPFAR’s share of drug treatment costs down from $1,100 per person annually in 2004 to $335 per person in 2012.
According to the study authors, this drop in cost allowed PEPFAR to offer the drugs to millions more people. In the 15 countries that PEPFAR targets, approximately 70 percent of those who receive ARV treatment get generic versions of the drugs.
Kartik Venkatesh, the study’s lead author, said the future for generics is unclear. While most generic drugs are manufactured in middle-income countries like India, restrictions by the World Trade Organization on producing patented formulas have limited some development. The advancement of generic second- and third-generation ARVs has been slowed.
According to Venkatesh, President Obama’s 2011 commitment to provide ARVs to 6 million people worldwide by 2013 will depend on keeping drug prices down.
Date of Publication
Jessica Camille Aguirre, Shots blog
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