Ranbaxy’s Manufacturing Woes Deepen; FDA Invokes AIP Against Paonta Sahib Facility

By Kurt R. Karst –      

Earlier today, FDA announced that the Agency was taking the unusual step of invoking its Application Integrity Policy (“AIP”) against Ranbaxy Laboratories Limited’s (“Ranbaxy”) Paonta Sahib manufacturing facility in India.  FDA takes such regulatory action under the Agency’s AIP procedures when FDA believes that a company’s actions raise significant questions about the integrity of data in marketing applications. 

According to FDA’s AIP letter to Ranbaxy, the Agency “has determined that [Ranbaxy] submitted untrue statements of material fact in abbreviated and new drug applications filed with the Agency.  These findings concern the submission of information, such as from stability test results in support of pending and approved drug applications, from the Ranbaxy Laboratories Limited site located at Paonta Sahib, Sirmour District, Himachal Pradesh, India . . . .”  FDA’s AIP letter asks Ranbaxy to cooperate with the Agency to resolve the questions of data integrity and reliability, which would include implementing a Corrective Action Operating Plan to provide assurance of the integrity and reliability of data from the Paonta Sahib facility.  Importantly, FDA notes in the AIP letter that:

In accordance with FDA policy, the Agency will assess the validity of the data and information in all of Ranbaxy's affected applications which contain data developed at the Paonta Sahib site. . . .  This means that the Agency does not intend ordinarily to conduct or to continue its normal substantive scientific review (including review of data and labeling) of any such pending application or supplement, or of any new application or supplemental applications filed after the date of this letter, that contain data developed at the Paonta Sahib site, during a validity assessment of that application.

FDA’s latest enforcement action against Ranbaxy follows the Agency’s September 2008 issuance of two Warning Letters and an import alert concerning drug products manufactured at several Ranbaxy manufacturing facilities, including Paonta Sahib.  In addition, as we previously reported, Ranbaxy has been under investigation by FDA and the Department of Justice, and has been scrutinized by Congress.  It has been reported that Ranbaxy’s troubles with FDA were one factor that led to the introduction of the 2008 FDA Globalization Act (“FDAGA”), which, as we recently reported, has been reintroduced in the 111th Congress.  FDAGA includes provisions for FDA inspections of manufacturing facilities, requirements for risk management plans, detailed supply chain requirements, greater recall authority for FDA, country of origin labeling, and requirements for testing of purity and identity for drug products, among many others.