FDA Approves Generic ARV Drug Combination
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POLITICS AND POLICY
FDA Approves Generic Antiretroviral Drug Combination, Allowing
PEPFAR to Purchase Drugs for Use in Developing Countries
FDA on Tuesday announced that it has approved a generic version
of a "widely used" co-packaged antiretroviral drug regimen, a
move that is "expected to expand AIDS treatment in the develop-
ing world" by allowing the President's Emergency Plan for AIDS
Relief to purchase the drugs, the AP/Yahoo! News reports. The
approval of the regimen, which is made by South Africa's Aspen
Pharmacare, is the first time FDA has approved a generic
HIV/AIDS drug manufactured by a foreign pharmaceutical company.
The regimen includes a generic version of GlaxoSmithKline's
fixed-dose combination Combivir, which contains the antiretrovi-
ral drugs lamivudine and zidovudine, and a version of Boehringer
Ingelheim's Viramune, known generically as nevirapine, which As-
pen packages together. Although FDA in December 2004 approved a
generic antiretroviral made by Woodcliff, N.J.-based Barr Labo-
ratories, its approval of Aspen's generics is seen as a "major
advancement" because the combination is "so widely used as a
first-line therapy," according to the AP/Yahoo! News (Agovino,
AP/Yahoo! News, 1/26).
Aspen completed its marketing application on Jan. 13, and FDA
completed its expedited review within two weeks because the co-
packaged regimen has "great public health significance," accord-
ing to FDA Acting Commissioner Lester Crawford (FDA release,
1/25). The Bush administration also waived the $500,000 applica-
tion fee under its new FDA fast-track review program announced
in May 2004 (McNeil, New York Times, 1/26). According to Mark
Isaac, vice president of the " target="_blank"Elizabeth Glaser
Pediatric AIDS Foundation, the estimated cost of the regimen
could be between $20 and $30 per person per month. He added that
the foundation currently pays $55 per person per month for the
brand-name drugs included in the regimen.
PEPFAR Use
The Bush administration previously has been criticized by
HIV/AIDS advocates for "refusing" to purchase drugs for PEPFAR
that had not been approved by FDA, according to the AP/Yahoo!
News (AP/Yahoo! News, 1/26). PEPFAR is a five-year, $15 billion
program that directs funding for HIV/AIDS, tuberculosis and ma-
laria to 15 focus countries, including Botswana, Ethiopia, Cote
d'Ivoire, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Af-
rica, Tanzania, Uganda, Zambia, Haiti, Guyana and Vietnam (Kai-
ser Daily HIV/AIDS Report, 1/24). Some advocates alleged that
the administration policy was an attempt to boost the profits of
U.S. pharmaceutical companies "at the expense" of HIV-positive
people in developing countries, the AP/Yahoo! News reports
(AP/Yahoo! News, 1/26). Although Tuesday's approval brings PEP-
FAR "more into line" with international initiatives that have
"long advocated the use of cheaper generics," the co-packaged
regimen will not be sold in the United States because it would
violate U.S. patents, the Washington Post reports.
Safety Concerns
Although the pharmaceutical industry previously has raised con-
cerns about the safety of generic antiretrovirals, FDA's ap-
proval of Aspen's co-packaged regimen "set concerns... to rest"
about generic drugs, according to Mark Grayson, spokesperson for
the Pharmaceutical Research and Manufacturers of America, the
Post reports. Grayson also "rejected the notion" that the phar-
maceutical industry has "voiced safety concerns as a way to keep
less-expensive drugs from being purchased with U.S. money," ac-
cording to the Post. "It wasn't a way to keep the drugs off the
market," he said, adding, "It was a way to make sure people got
the appropriate medicines... People in Africa deserve safe and
effective medicines." According to Murray Lumpkin, acting deputy
commissioner for FDA international and special programs, the FDA
approval process also involved inspections of Aspen's facility
in South Africa. Lumpkin said that the facility met "all of our
safety, efficacy and manufacturing standards" (Vedantam, Wash-
ington Post, 1/26).
Positive Reaction
FDA's approval "partly answered criticism" from some HIV/AIDS
groups who have advocated for the purchase of generic drugs un-
der PEPFAR, according to the Wall Street Journal. The approval
"opens the door -- as promised by" U.S. Ambassador Randall To-
bias, head of the State Department's Office of the Global AIDS
Coordinator, and former HHS Secretary Tommy Thompson -- that
PEPFAR "would be able to buy these drugs, and more people can
benefit from treatment," UNAIDS Executive Director Peter Piot
said (Lueck, Wall Street Journal, 1/26). Jamie Drummond, execu-
tive director of DATA, said, "This is obviously a positive and
much anticipated step forward in the global battle against AIDS.
America's contribution to the fight against AIDS now has the po-
tential to go farther, treat more people with safe and effective
drugs and keep more people alive by making it easier for pa-
tients to take medicine" (DATA release, 1/25).
Criticism
However, the "praise for the FDA action was not unanimous," ac-
cording to the Post. Medecins Sans Frontieres "questioned the
need" for FDA approval because the regimen already has been
"widely endorsed" by some international health groups, the Post
reports. "It sends a strange signal that the FDA should be the
arbiter of drug safety for African governments," Rachel Cohen,
U.S. director of MSF's Campaign for Access to Essential Medi-
cines, said, adding that the United States should support the
World Health Organization's certification program. "We should
not have to go down this road to begin with. It is a curious
time for FDA to be boasting about its ability to monitor drug
safety given recent scandals around Vioxx and other products,"
Cohen said (Washington Post, 1/26). "Confusion has been sown and
precious resources wasted as the administration unnecessarily
insisted on brand-name drugs," Paul Zeitz, executive director of
the Global AIDS Alliance, said. "This approval, a full two years
after the president's declaration of a global AIDS emergency, is
a positive development. But, the product that was approved is
not a fixed-dose combination, and, as a result, is not as easy
to take. Also, the company would not have gotten its drug ap-
proved without cozy relationships with several brand-name compa-
nies, something not all producers of essential, generic medica-
tions enjoy. As a result, this might not be replicated any time
soon" (GAA release, 1/26).
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