Healthy Skepticism Library item: 15147
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Grogan K.
Ranbaxy facility in India falsified data, claims FDA
Pharma Times 2009 Feb 26
http://www.pharmatimes.com/WorldNews/article.aspx?id=15393
Full text:
The US Food and Drug Administration has stated that a facility owned by India-based Ranbaxy Laboratories “falsified data and test results in approved and pending drug applications”.
The agency has suspended reviews of any products whose file contains data from Ranbaxy’s Paonta Sahib facility. Deborah Autor, the director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said that the agency’s investigations “revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications.”
She added that the FDA has invoked its has invoked its “application integrity policy”. This means that the agency will stop “all substantive scientific review of any new or pending drug approval applications” that contain data generated by the Paonta Sahib facility. Janet Woodcock, director of the CDER, said that “companies must provide truthful and accurate information in their marketing applications. The American public expects and deserves no less”.
The agency did note, however, that to date, it has no evidence that the drugs linked to the Paonta Sahib facility “do not meet their quality specifications”. Also the FDA “has not identified any health risks associated with currently-marketed Ranbaxy products”.
Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency “to resolve the questions of data integrity and reliability”. This would include implementing a ‘corrective action operating plan’ which includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.
In September last year, the FDA issued two warning letters and instituted an ‘import alert’ barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and Batamandi facilities. The agency took that measure due to alleged violations of US current Good Manufacturing Practices requirements and that action, which barred the commercial importation of 30 different Ranbaxy generics into the USA, remains in effect.
In a filing to the Bombay Stock Exchange, Ranbaxy said it will analyse the letter it has received from the FDA “and respond appropriately in a timely manner”.
