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[e-drug] FDA Approval of AIDS Drugs - 2 items

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

E-DRUG: 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 African-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 Organization and the country's National Drug Authority.

"For us, we have the duty to protect our citizens from drugs that have not been thoroughly 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, 6/23).

Uganda is one of four African countries -- including Ethiopia, Nigeria and Tanzania -- that has told South African generic drug maker Aspen Pharmacare
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 Generic Antiretroviral Efavirenz for PEPFAR
28 Jun 2005

FDA on Friday granted tentative approval to Indian drug manufacturer 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 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 -- including 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 remote 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 agreements (Reuters, 6/24). HHS Secretary Mike Leavitt said in a statement
that the government is "working diligently to end the suffering of those with HIV/AIDS," adding, "By making these safe and effective 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
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