A host of drug companies have had drug applications turned down by the FDA because the agency didn't like what inspectors found at the CMOs they relied on to produce their drugs. One of those, Korea’s Mezzion, has now lashed out, suing Dr. Reddy’s for fraud, saying the Indian drugmaker hid problems at a plant that the FDA hit with a warning letter.
Mezzion said Tuesday that it had filed the case in New Jersey state court alleging that Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations, while it was not, and that Dr. Reddy's misconduct “was the sole reason given by the FDA” to deny approval of Mezzion's NDA for udenafil for the treatment of erectile dysfunction. It cites a warning letter that Dr. Reddy’s received in 2015 for three plants in India.
Mezzion said it is seeking “millions of dollars in damages” to cover the the cost of the delay while it looks for a new manufacturer and goes back through the submission process with the FDA for the drug.
A Dr. Reddy’s spokesman Tuesday said the company was unable to comment at this point.
The warning letter that Dr. Reddy’s received highlighted a host of problems, but several centered on a lab that the agency said the drugmaker had hidden from it for years. In it, inspectors found records showing the company had repeatedly tested APIs for impurities, never recording failed tests, and only showing the FDA those that showed the batches had passed.
Of the 14 complete response letters (CRLs) issued by the FDA last year, six of them were primarily issued because of manufacturing issues the FDA had concerns about and several of those were because of problems with CMOs. Just this month, North Carolina-based Cempra said the FDA had issued it a CRL for its new gen antibiotic. The FDA’s primary concern was over the need for a much broader clinical study. But Cempra said that the FDA also noted that manufacturing deficiencies at its API makers, Wockhardt and Hospira, would have to be resolved before the drug could be considered again for approval.