Drugs

Appealing a CRL in Court May be Worth It: Attorneys

Attorneys Douglas Farquhar and Sara Koblitz (Hyman, Phelps & McNamara) say that while FDA consistently maintains that a complete response letter (CRL) is not a final agency action and thus cannot be appealed in court, a recent case their firm was involved in may have at least opened a way to a court challenge. Writing in their firm’s FDA Law Blog, the two describe the issues and delays involved in using agency administrative processes to challenge CRLs.

They discuss a suit filed by Nostrum Laboratories in D.C. federal court seeking judicial review after FDA agreed to allow a two-way crossover study to establish bioequivalence for generic theophylline, the company conducted the studies, and then the agency requested a new, time-consuming, and expensive four-way crossover study.

FDA asked that the suit be dismissed on the ground that the CRL is not a final agency action. The government also refused to produce the administrative record, meaning the company could not determine if there were documents not in its possession that could bolster its arguments.

Nostrum argued that the CRL is a final agency action since the company refused to make the changes it requires and thus FDA has inherently refused to approve the application. The attorneys say the company argued that if a sponsor will not make the changes FDA demands to approve an application, and because the CRL states that the application cannot be approved “in its present form,” the CRL constitutes an order of FDA subject to court review.

The court declined to grant the FDA motion to dismiss the suit, the post says, and will allow the agency to raise the issue before a merit panel of the same court. “While the court has not decided whether a CRL is final agency action,” the attorneys write, “the decision suggests that appealing a CRL will not automatically lead to dismissal without any evaluation of the merits of the case. Importantly, in this case, where FDA refused to provide the administrative record that would reflect any underlying determinations by the agency with respect to the Nostrum prior approval supplement and the necessary bioequivalence testing, Nostrum now gets to review that administrative record … to establish that the underlying CRL is final agency action, and was unlawful.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome