Drugs

FDA Wins Vanda Trade Secret Case

The U.S. Court of Federal Claims has granted the federal government’s motion for summary judgment in a case in which Vanda Pharmaceuticals alleged that FDA improperly disclosed the company’s trade secrets and confidential commercial and proprietary information to competitors seeking approval of generic drugs. In a 1/18/2024 decision, the court had granted in part and denied in part FDA’s motion to dismiss the company’s complaint for lack of subject matter jurisdiction and failure to state a claim on which relief could be granted. At that time, the court declined to dismiss Vanda’s 5th Amendment takings claim. Rather, it posed several “novel” questions about whether Vanda could assert a cognizable property interest in an alternative dissolution specification that the agency proposed to the company during the drug approval process.

In its 1/22 decision granting the government summary judgment on the 5th Amendment question, the court held that Vanda failed to plead a viable 5th Amendment taking since the dissolution specifications ultimately adopted for the company’s Fanapt (iloperidone) and Hetlioz (tasimelteon) were not developed by Vanda or submitted to FDA. Instead, it said, they were generated by FDA and proposed to and accepted by Vanda during the NDA process to secure approval to market.

The court further held that the impurities testing and micronization information related to the active pharmaceutical ingredient in Hetlioz was already in the public domain at the time of FDA’s alleged disclosures.

“Vanda included the cited data in a publicly filed patent application six months before FDA reportedly used the information in reviewing ANDAs,” it said. “Accordingly, defendant is entitled to judgment on the pleadings.”

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