(CN) – A federal judge lambasted the FDA on Wednesday over the “slipshod” and “lackadaisical” approval it gave a drugmaker under investigation for tainted products.
It has been nearly two years since Ranbaxy Laboratories reached a $500 million deal, the largest of its kind at the time, to settle criminal and civil charges related to adulterated drugs made in India and distributed in the United States.
While Ranbaxy was still under investigation, the Food and Drug Administration granted “tentative approval” to five of the pharmaceutical company’s abbreviated new drug applications (ANDA).
Those applications concerned the manufacture of generic drugs at the same Indian facilities later admittedly involved in making the adulterated drugs.
When these tentative approvals prevented other drugmakers from putting their wares on the market years later, the FDA revoked two of the five tentative approvals it granted to Ranbaxy. It stated that the approvals, for heartburn medication esomeprazole and retinitis treatment valganciclovir, had been granted “erroneously.”
Ranbaxy challenged this determination with a federal complaint, but U.S. District Judge Beryl Howell in Washington upheld the agency’s decision Wednesday.
“Although the FDA’s practices, which apparently led to these errors, raise grave concerns, the federal defendants’ interpretation of the relevant portions of the Food, Drug, and Cosmetics Act as permitting the rescission of the erroneously issued tentative approvals is reasonable,” the judge said.
Howell called plaintiff’s interpretation of the law “untenable” and would make the statute “patently absurd.”
“By plaintiffs’ logic, the FDA could not withhold tentative approval of an ANDA even if the FDA knew it had withdrawn approval for the pioneer drug or that the ANDA contained an untrue statement of material fact,” the judge said.
It would also mean the FDA had no power to deny tentative approval to an application that clearly could never win final approval – “an applicant could state in its ANDA that it planned to manufacture a generic drug in an outhouse behind the applicant’s house using a child’s chemistry set.”
The court also noted the record’s silence on whether, before it granted the tentative approvals, the FDA considered compliance at Ranbaxy’s facilities with current good manufacturing practices (CGMP).
“The slipshod nature of this approval process, especially considering the long-existing policy in place designed to prevent approval of applications for drugs manufactured in non-CGMP compliant facilities, is disturbing,” Howell said. “Instead, 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. 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.”
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