A US Congressional committee is set to investigate whether the US Food and Drug Administration (FDA) knowingly allowed Indian pharma giant Ranbaxy to distribute allegedly suspect drugs in the US.
Questioning the FDA’s role in permitting the continued sale of drugs “suspected of being fraudulently approved and manufactured in gross violation of Good Manufacturing Practices (GMP),” two Democratic lawmakers on Thursday indicated that a House committee would soon start a formal investigation.
The House Committee on Energy and Commerce will investigate the Ranbaxy drug approvals and potential violations of GMP regulations, panel chairman John D Dingell and Bart Stupak, who chairs its oversight and investigations subcommittee said.
Federal prosecutors earlier this week demanded Ranbaxy turn over documents that allegedly show the company fabricated data on its drugs submitted to the FDA. The agency has declined comment on the matter because it is an ongoing investigation.
“If these allegations are true, Ranbaxy has imperilled the safety of Americans in a manner similar to the generic drug scandal we uncovered twenty years ago,” Dingell said. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”
Dingell and Stupak have been investigating the FDA's inspections of foreign drugmakers in the aftermath of safety problems with Baxter International Inc.'s blood thinner heparin.
Stupak said the Ranbaxy case “may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them.”