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[afro-nets] FDA Approval of AIDS Drugs - 2 items

  • From: Leela McCullough <leela@healthnet.org>
  • Date: Tue, 28 Jun 2005 11:59:51 -0400

FDA Approval of AIDS Drugs - 2 items

Uganda Bars Imports of FDA-Approved, S African-Made Generic AIDS
Drugs Because of Lack of WHO Testing, Approval
28 Jun 2005

Reprinted with permission from http://www.kaisernetwork.org

Uganda is refusing the importation of FDA-approved, South Afri-
can-made generic antiretroviral drugs, despite the fact that up
to 100,000 of the country's HIV-positive residents are in "dire
need" of the medications,...
AFP/Yahoo! News reports. Ugandan officials insist that the drugs
first must be tested and approved by the World Health Organiza-
tion and the country's National Drug Authority.
http://www.health.go.ug/National_drug.htm "For us, we have the
duty to protect our citizens from drugs that have not been thor-
oughly scrutinized," NDA Chair James Makumbi said. He added that
the issue could have been resolved if FDA had conferred with WHO
about the safety and effectiveness of the South African drugs,
AFP/Yahoo! News reports. "The WHO can always endorse the U.S.
regulator's review," he said, adding, "The United States is a
member of the WHO, if they feel that their tests are sufficient,
then they should sort that out with WHO" (AFP/Yahoo! News,

Uganda is one of four African countries -- including Ethiopia,
Nigeria and Tanzania -- that has told South African generic drug
maker Aspen Pharmacare http://www.pharmacare.co.za/ that the
company's generic drugs require safety and quality approval from
WHO despite the company's FDA approvals for its antiretroviral
drugs. Aspen also must register its drugs in each country before
the governments will approve the drugs' distribution

(Kaiser Daily HIV/AIDS Report, 6/20).

Up to one million Ugandans are estimated to be HIV-positive, and
nearly the same number have died from AIDS-related causes since
the the early 1980s (AFP/Yahoo! News, 6/23).

Aurobindo Pharma Receives Tentative FDA Approval To Produce Ge-
neric Antiretroviral Efavirenz for PEPFAR
28 Jun 2005

FDA on Friday granted tentative approval to Indian drug manufac-
turer Aurobindo Pharma http://www.aurobindo.com/ to produce the
generic antiretroviral efavirenz for use under the President's
Emergency Plan for AIDS Relief, http://www.state.gov/s/gac/
Reuters reports. Efavirenz, manufactured by Bristol-Myers Squibb
http://www.bms.com/landing/data/index.html under the brand name
Sustiva, is used in combination with other antiretrovirals to
treat HIV infection (Reuters, 6/24). http://www.hhs.gov/ HHS in
May 2004 announced plans for a new FDA fast-track review program
to speed the delivery of low-cost antiretroviral drugs -- in-
cluding fixed-dose combination drugs -- to nations covered under
PEPFAR. The expedited process is meant to encourage drug makers
to produce generic medications to improve access to drugs in re-
mote areas of severely affected countries and ensure the drugs'
safety (Kaiser Daily HIV/AIDS Report, 6/21

The tentative approval designation means the generic drug meets
FDA safety and efficacy standards but it cannot be sold in the
United States because of existing patents or exclusivity agree-
ments (Reuters, 6/24). HHS Secretary Mike Leavitt said in a
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01191.html statement
that the government is "working diligently to end the suffering
of those with HIV/AIDS," adding, "By making these safe and ef-
fective treatments available through the PEPFAR program as
quickly as possible, we are helping to combat this worldwide
problem" (FDA release, 6/24).

"Reprinted with permission from http://www.kaisernetwork.org.
You can view the entire Kaiser Daily HIV/AIDS Report, search the
archives, or sign up for email delivery at
http://www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily
HIV/AIDS Report is published for kaisernetwork.org, a free ser-
vice of The http://www.kff.org/hivaids Henry J. Kaiser Family
Foundation . 2005 Advisory Board Company and Kaiser Family Foun-
dation. All rights reserved.

Leela McCullough, Ed.D.
Director of Information Services

30 California Street, Watertown, MA 02472, USA
Tel: +1-617-926-9400 Fax: +1-617-926-1212