Citing Safety Concerns, FDA Bans Imports Of Ranbaxy Drugs Made In Two Indian Plants, Including Antiretrovirals

Main Category: HIV / AIDS
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals
Article Date: 18 Sep 2008 - 5:00 PDT

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FDA on Tuesday announced that it has banned imports of more than 30 generic drugs, including antiretrovirals, manufactured by Indian generic drugmaker Ranbaxy, citing manufacturing deficiencies at two of the company's plants, the Wall Street Journal reports. Ranbaxy manufactures generic antiretrovirals used in U.S. and in the President's Emergency Plan for AIDS Relief, as well as other generic drugs (Mundy et al., Wall Street Journal, 9/17). According to Deborah Autor, director of FDA's compliance office, FDA inspections this year found violations at Ranbaxy factories that could lead to contamination, allergic reactions and other problems, and the company has not taken proper steps to correct them (Neergaard, AP/Google.com, 9/16).

Although the ban allows U.S. Customs inspectors to stop incoming shipments of drugs from the Ranbaxy plants in Dewas and Paonta Sahib, India, FDA officials in a statement said that Ranbaxy drugs currently in the U.S. are considered safe and will not be removed from the market because there is no direct evidence that they are harmful (Satyanarayana, Detroit Free Press, 9/16). In addition, the ban will not affect drugs made at other Ranbaxy facilities around the world or in the U.S. (Cohen, Newark Star-Ledger, 9/17). Despite the ban, FDA said it will continue to permit Ranbaxy to export the drug Ganciclovir in order to avoid a shortage (Wall Street Journal, 9/17). Ranbaxy is the only manufacturer of Ganciclovir, which is used to treat an eye infection common among HIV-positive people.

FDA told consumers of all Ranbaxy drugs to continue to use the drugs because repeated testing has found no contaminated products, just the threat of them if factory conditions do not improve (AP/Google.com, 9/17). Douglas Throckmortan, a physician with FDA's Center for Drug Evaluation and Research, said that there was "no evidence of harm to consumers" and that the import ban is "a preventive action" (Brown, Washington Post, 9/17). The agency added that it will deny new approval requests for all new Ranbaxy drugs and expects other generic manufacturers to meet any supply shortages (Detroit Free Press, 9/16). In addition, Ranbaxy will not be able to export any of the banned drugs into the U.S. until the manufacturing deficiencies are resolved (Washington Post, 9/17).

Effect on PEPFAR
A spokesperson for PEPFAR said that it is "currently working through the PEPFAR interagency process and with our technical teams to evaluate the impact of today's FDA announcement on PEPFAR drug procurement and programming." The antiretroviral AZT, however, was on the list of Ranbaxy drugs banned from importation (Washington Post, 9/17).

Ranbaxy already is under investigation by the Justice Department over whether it manufactured substandard generic drugs. Ranbaxy under a U.S. government contract was paid to provide low-cost antiretroviral drugs under PEPFAR, and investigators at the Justice Department and FDA have said that some of the drugs were substandard, impotent or unstable. In addition, court filings and lawyers close to the investigation indicate that Ranbaxy manufactured documents to cover up the poorly made drugs (Kaiser Daily HIV/AIDS Report, 8/18).

Reaction
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "With this action, we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality." Rep. John Dingell (D-Mich.), chair of the House Energy and Commerce Committee, said Tuesday that FDA's action was too little, too late, adding that the agency has had credible information for three years that Ranbaxy had "engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices." The Energy and Commerce committee is conducting an investigation of FDA's handling of Ranbaxy. Dingell in a statement said, "Apparently, this FDA places administrative convenience over its mission to protect the public health" (Newark Star-Ledger, 9/17).

The Journal reports that a Ranbaxy executive in India said the company was not aware of any FDA action, and officials in the U.S. did not return calls. FDA officials said it had notified Ranbaxy of the import ban (Wall Street Journal, 9/17).

FDA's letter to Ranbaxy, a news release, a list of drugs produced by the company and other information are available online.

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