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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.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
