PRNewswire - November 15, 2004

India's pharmaceutical problems were already in the news earlier this year when in response to a massive counterfeiting problem, the Indian Senate passed a law allowing for the death penalty for convicted counterfeiters.

Now earlier this week, New Dehli-based Ranbaxy took all of its antiretroviral products off the market due to safety concerns. These drugs had been endorsed for use by Rep. Henry Waxman (D-CA) and Sen. Ted Kennedy (D-MA), "pre-qualified" by the World Health Organization and distributed to thousands of patients in 30 African countries by the relief agency, Doctors Without Borders.

Nearly $2 million of the Global Fund monies went to buy Ranbaxy drugs with U.S. taxpayers funding nearly 40 percent of Global Fund's budget.

Additionally, Congress funds close to 25 percent of the WHO's budget, which endorsed the products in 2001 despite absence of clear evidence that these generics were safe.

According to Kerri Houston, Vice President of Policy for Frontiers, "A coalition of activists led by Doctors Without Borders and prominent members of Congress like Rep. Waxman argued for the widespread use of these now dubious medicines, leaving the U.S. taxpayer vulnerable to footing the bill for lawsuits. Even more egregious is that through Global Fund funding, we have paid out nearly $1 million for unproven drugs for suffering Africans."

"Will the Global Fund, Doctors Without Borders and WHO be immune from product liability claims in U.S. Courts? This immunity will likely apply to NGO drug purchases but may not shield the U.S. government from tort claims as there is ample evidence on the record -- thanks to careless politicians -- that the U.S. believed that these drugs should be handed out en masse in Africa."

This spring, the Bush Administration insisted that the President's $15 billion emergency plan for HIV/AIDS purchase only "tested" products but said it would expedite the FDA approval process for less expensive generics. In a letter to Sec. Tommy Thompson in July, Rep. Waxman criticized the Administration's "new initiative to review promising AIDS drugs for international use" and said these drugs were safe and needed to be on the market "immediately."

Houston concluded, "Congress must quickly review how our tax dollars have been abused by WHO and Global Fund. It also needs to turn to healthcare experts and not Members of Congress to determine safety and efficacy of a particular drug."

"The health of patients and the proven safety and effectiveness of medicines in any market must be the primary concern."

SOURCE Frontiers of Freedom

Web Site: http://www.ff.org

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PR041131

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