Drugs

Court Allows 1 Vanda Claim Against FDA

The United States Court of Federal Claims has denied in part and granted in part an FDA motion to dismiss a Vanda complaint against the agency for lack of subject matter jurisdiction and failure to state a claim upon which relief can be granted. The decision says the case involves the question of whether an innovator drug company can assert a viable 5th Amendment takings claim and/or a breach of an implied-in-fact contract based on a government official’s alleged disclosure, whether intentional or inadvertent, of claimed trade secrets and confidential commercial information to competitors seeking FDA approval of generic drugs.

The case involves Vanda’s Fanapt (iloperidone) tablets indicated to treat schizophrenia in adults, and Hetlioz (tasimelteon) capsules that treat non-24-hour sleep-wake disorder. The company’s suit says that as FDA considered and approved several ANDAs for generic forms of the two drugs, the agency illegally shared information with the generic manufacturers.

The court denied FDA’s request to dismiss the 5th Amendment taking claim. FDA had argued Vanda’s claims failed to plead a viable taking under the law of the Court of Claims. The court found that FDA review and approval of NDAs and ANDAs falls squarely within the scope of its statutorily authorized duties, even if certain acts were taken during the review process that were ultimately found to be unlawful.

The court granted, however, FDA’s motion to dismiss Vanda’s breach of contract claim as either an implied-in-law contract outside the court’s jurisdiction or an improvidently pleaded claim that is factually implausible as a matter of law. It also granted FDA’s motion to dismiss claims involving one of the generic manufacturers because they are time-barred.

FDA was told to file an answer to the order by 2/1.

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’

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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