February is nearly over. Traditionally, February has never been my favorite month. The short days start getting on my nerves, the weather is usually unpleasant – the brisk winds that were so refreshing in October are downright bone-chilling by February. But this February, I took a vacation and readership of the blog has really zoomed up. A good February all around! Thanks everyone.
- FDA Approves Genzyme's Synvisc-One for Osteoarthritis of the Knee - The company announced approval of Synvisc-One™ (hylan G-F 20), a product intended for the relief of pain associated with osteoarthritis (OA) of the knee. Synvisc-One is the only single-injection viscosupplement approved for the treatment of OA knee pain in the United States.
- FDA Slams Ranbaxy – The FDA took some sweeping action against Ranbaxy this week that may have reverberations for a long time. The U.S. Food and Drug Administration today announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008. The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products. The affected applications are for drugs that fall into three categories:
- Approved drugs made at the Paonta Sahib site for the U.S. market;
- Drugs pending approval at the FDA that are not yet marketed; and
- Certain drugs manufactured in the United States that relied on data from the Paonta Sahib facility.
“Companies must provide truthful and accurate information in their marketing applications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The American public expects and deserves no less.” To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only. 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 (CAOP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.When the AIP is implemented, the FDA stops all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility.“The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy,” said Deborah Autor, director of CDER’s Office of Compliance. “Today’s action reflects the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health.” On Sept. 16, 2008, 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 Unit facilities due to violations of U.S. current Good Manufacturing Practices requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect.
In response to the FDA action, the company issued the following brief statement:
- Ranbaxy has just received a letter and information indicating that all pending and approved ANDAs from Ranbaxy's Paonta Sahib facility have been added to a list maintained under a policy entitled "Application Integrity Policy" or "AIP". Ranbaxy will analyze the letter and other information fully and respond appropriately in a timely manner. The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing. No products from Ranbaxy’s other manufacturing facilities are included in the AIP. Ranbaxy will continue to co-operate with the USFDA. Further, no effort or action will be spared to timely protect key ANDAs from Paonta Sahib, which include some First to File applications.