By Arun Kumar, IANS,
Washington : 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 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 indicated.
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 imperiled 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.”
“One of the great reforms to come out of the generic drug scandals was the institution of pre-approval inspections,” said Stupak said.
“We learned from investigating contaminated heparin that such inspections were dispensed with in the case of the active pharmaceutical ingredient manufactured in China, which resulted in a public health disaster,” the two lawmakers said.
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.
The drug, which was recalled after being linked to dozens of deaths, contained an ingredient made by a Chinese manufacturer. The FDA said it never inspected the Chinese plant due to a bureaucratic mix-up involving a factory with a similar-sounding name.
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.”
Last year, FDA employees seized paper and electronic documents from Ranbaxy’s headquarters in New Jersey. The company markets generic versions of popular medications, including Merck’s blockbuster cholesterol pill Zocor.
“Now it appears that such inspections in India – the second largest supplier of drugs to the United States – may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them for marketing to American patients,” Stupak said.
“If that is the case, then the American people should not have to wait until January for change and this Administration should clean house at the FDA now,” he said.
Dingell and Stupak said they were responding to information contained in a case filed by the Department of Justice July 3 with the Maryland District Court.
The motion on behalf of FDA alleges a “pattern of systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information” a failure to timely report the distribution of out of specification drugs and attempts to conceal violations of GMP regulations.
Specific allegations under investigation include fabricating bio-equivalence and stability data to support Abbreviated New Drug Applications (“ANDAs”) filed with FDA for generic drugs…”