Washington, DC - Congressman John D. Dingell (D-MI15) released the following statement today in response to U.S. Food and Drug Administration’s (FDA) announcement that the Paonta Sahib facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications.  To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the facility and stopped all substantive scientific review of any new or pending drug approval applications that contain data generated by the facility:

“I find little solace in the fact that today the U.S. Food and Drug Administration has decided to take enforcement action against Ranbaxy.  Unfortunately, this action is long overdue, and given that it applies to only one facility, it serves as a slap on the wrist. 

“For the past three years, FDA possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior, but they continued to drag their feet while American lives were at risk.  The Ranbaxy case is yet another example of the need for significant reform at the FDA.  Insufficient funding and a lack of a clear mandate to conduct preapproval inspections led us to this situation.  Last month, I introduced H.R. 759, the FDA Globalization Act.  H.R. 759 would provide FDA adequate funding and require pre-approval inspections.  I look forward to working with my colleagues to make sure H.R. 759 becomes law.  I also look forward to working with President Obama to ensure FDA has new leadership that will take seriously its mission to protect the public health.” 

# # #