The FDA has approved 18 products for market from generic drug manufacturer Ranbaxy Laboratories, even though the company is currently being investigated by Congress for making substandard products and conspiring to fraudulently cover it up.
“Allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information,” the Department of Justice said.
The Department of Justice is investigating claims that Ranbaxy, India’s largest drug manufacturer, produced HIV medication that contained insufficient active ingredients or was adulterated with other ingredients. These drugs were then used to treat patients in Africa.
Other drugs are also suspected of containing active ingredients in concentrations that are either too low or too high. The company also stands accused of attempting to conceal manufacturing procedures that do not meet FDA standards and of forging documents relating to U.S. government investigations of its practices.
Finally, Ranbaxy is being investigated for falsifying data suggest that its generic drugs are absorbed into the body in a similar fashion to brand-name products. This proof is an essential part of the process of gaining FDA approval for a generic drug without going through large clinical trials.
In July, Congress also began a probe into why the FDA had not taken action against Ranbaxy, even though it had known for months of allegations against the company. As part of this probe, the FDA was asked to provide information on every FDA-approved Ranbaxy product and the approval process that it went through.
Former FDA Deputy Commissioner Mary Pendergast has criticized the FDA’s failure to take action against Ranbaxy and its products.
Because the FDA “wouldn’t be confident of the accuracy and reliability of the information in the applications,” Pendergast said, “they might be approving a product that ought not be approved.”