Drugs

Vanda Says FDA Disclosed Trade Secrets to Competitors

Vanda Pharmaceuticals is charging that FDA disclosed trade secrets from NDAs for the company’s Fanapt (iloperidone) and Hetlioz (tasimelteon) to companies submitting ANDAs for approval to market generic forms of the two drugs. In a 5/1 case filed with the United States Court of Federal Claims, Vanda says it supplied FDA with the highly confidential information in its NDAs “in reliance on FDA’s promise to maintain strict confidentiality of this information. To this day, details of the manufacturing process Vanda actually uses to manufacture the active ingredients for its drugs and those drugs’ formulations remain strictly confidential.”

The company says it obtained documents through Freedom of Information Act requests that show “FDA blatantly and forthrightly relied on data in one of Vanda’s drug applications and then disclosed that information to Vanda’s competitors. All the while, FDA continued to refuse to release the same information to the public, on the basis that it constituted trade secrets or confidential commercial information. And FDA’s misconduct does not appear isolated. The material available thus far through public record requests demonstrates that FDA routinely directly or indirectly discloses confidential portions of drug sponsors’ applications to competitors seeking to market generic knockoffs.”

FDA asks the court to:

declare that FDA’s disclosure of confidential information contained in an NDA to ANDA applicants constitutes a taking for purposes of the 5th amendment to the U.S. Constitution;
declare that the United States has taken Vanda’s proprietary information without providing just compensation in violation of the 5th amendment to the U.S. Constitution;
declare that the United States has breached an implied-in-fact contract by failing to maintain the confidentiality of Vanda’s trade secret and confidential commercial information;
award to Vanda just compensation and damages for the taking and breach in an amount to be determined at trial;
award Vanda its costs and reasonable attorney’s fees incurred in this action; and
award Vanda such other and further relief as the court deems just and proper.

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