Drugs

Court Says Warning Letter Can be Final FDA Action

In a first-time decision, a Florida federal court has ruled that a citizen petition denial can turn an FDA Warning Letter into final agency action that can be challenged in court. Attorney Peter Dickos (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the case involved two Warning Letters issued to Hybrid Pharma. The company submitted a citizen petition asking the agency to rescind the letters. FDA denied the petition, and Hybrid sued it. FDA moved to dismiss the case, but the court held that Hybrid had standing.

FDA argued that Hybrid’s complaint could only be attacking the agency’s petition decision, although the complaint did not allege anything wrong or unlawful about that decision.

According to Dickos, the Hybrid suit mainly alleged that the Warning Letters were improperly issued in the first place. FDA said the Warning Letters were not reviewable because they were not final agency action. The court rejected the agency’s position, saying that the Warning Letters were the reason Hybrid submitted its petition, and in denying the petition, FDA had made its final determination on the issuance of the letters.

“This ruling will be of high interest to other companies who find themselves reputationally, financially, or otherwise aggrieved by a Warning Letter,” Dickos writes. “Of course, to follow Hybrid’s workaround, those firms would first have to be willing to endure the agency’s notorious delays in responding to a citizen petition, and might even, as Hybrid did here earlier, have to sue the agency for unreasonable delay to get FDA to respond to the petition in the first place. (They’d also have to separately establish standing, like Hybrid did here.) But once they get their likely petition denial, those firms might well seek to have their day in court, too. And FDA may have to face the prospect that, one way or another, its Warning Letters might not remain forever unreviewable.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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