Originally published January 8 2009
FDA Investigated Over Knowledge of Fraudulent Conduct by Drug Company Ranbaxy
by David Gutierrez, staff writer
(NaturalNews) Two Democratic representatives have launched an investigation into whether the FDA knowingly allowed the drug company Ranbaxy to sell products in the United States that had not been manufactured according to proper legal standards.
Ranbaxy is the largest drugmaker in India by sales.
John Dingell, chair of the House of Representatives Energy and Commerce Committee, and Bart Stupak, head of the committee's investigations subcommittee, sent a letter to the FDA asking it to provide all documents relating to its pre-approval inspections of generic drugs manufactured by Ranbaxy, including the names of all FDA staff members who participated in those inspections. The representatives have also requested a list of all suppliers of raw materials for Ranbaxy products and the names of the laboratories where the products were tested.
The House seeks to know, the lawmakers said, if the FDA "knowingly allowed drugs suspected of being fraudulently approved and manufactured in violation of Good Manufacturing Practices to continue being sold by Ranbaxy Inc. in the United States."
The move came after a legal motion filed on behalf of the FDA in July stated that the agency knew that Ranbaxy had been accused of fraudulent conduct 18 months prior, but had not taken any action to remove its products from the market.
"If true, these statements would call into serious question whether the leadership of the agency ... have met even the minimum requirements of due diligence," Dingell and Stupak said.
A total of 141 Ranbaxy products have received FDA approval to date, while another 98 have been submitted for approval. Due to the "FDA's alleged lack of action to remove these suspect products from the market," the House committee is reviewing each of these approvals individually.
The FDA has promised to respond directly to Dingell and Stupak's letter. Ranbaxy, meanwhile, denies all wrongdoing and says that is cooperating with an investigation by U.S. authorities.
Sources for this story include: www.reuters.com; www.business-standard.com.
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