The 71-page opinion from Howell not only chastises Ranbaxy for attempting to hide and skirt around its manufacturing problems to seek approval for the ANDAs, but also criticizes the FDA for approving the ANDAs and waiting more than six years to notify Ranbaxy that the ANDA approvals would be revoked.
The lawsuit was filed by Ranbaxy after the FDA rescinded its approvals of the two ANDAs in November 2014 and subsequently accepted ANDAs from Endo Pharmaceuticals, Dr. Reddy’s and Teva. The agency claimed that the tentative approvals were granted in error.
Back in 2006 the FDA began an intensive investigation into Ranbaxy’s manufacturing facilities that eventually led to a criminal investigation, consent decree and $500m fine. But the FDA did not revisit any of the ANDAs tentatively approved in 2007 and 2008, including the valganciclovir and esomeprazole ANDAs cited in the lawsuit, until 2014, which is when they were rescinded.
“A rushed and confused approval process, conducted with lackadaisical regard for an important public health policy, contributed to an error that took the FDA more than six years to discover,” Howell said. “Such a consistent failure of policies and procedures is stunning, but it does not indicate a change in policy. The Court finds that the FDA did not alter its policy regarding conditioning tentative approval on CGMP compliance and, instead, clearly erred when it tentatively approved the plaintiffs’ ANDAs for esomeprazole and valganciclovir.”
Howell points to two specific regulations that require the FDA to reject an ANDA for tentative or final approval if the agency finds that the facility in which the ANDA drug is to be manufactured is not in compliance with cGMP.
But Howell didn’t place all of the blame on the FDA’s error, noting the agency “was stymied at nearly every turn by the plaintiffs in the agency’s attempt to discover the extent of CGMP violations at the Paonta Sahib facility. As previously noted, it took over a year for the plaintiffs to turn over audit reports that the FDA had made clear were needed to complete a review of the plaintiffs’ compliance with CGMP... The initial summaries the plaintiffs did turn over deceived the FDA into believing that all of the issues identified in the 2006 Warning Letter were resolved.”
The judge also points to a warning letter from the FDA in 2006 that contained details finding that certain drugs from the Paonta Sahib facility “show much lower potencies in these batches within approximately three to six months of release, and well before their expiration dates,” as well as findings of “several abnormalities” among antiretroviral drugs shipped by Ranbaxy to African nations under the PEPFAR program.
“In sum, the FDA should have recognized its errors earlier, but its failure to do so was caused in substantial part by the plaintiffs’ own malfeasance to which they eventually pleaded guilty criminally and paid $500 million in fines,” Howell concludes.