Drugs

PA Firm Settles False Claims Case for $4 Million

Lehigh Valley Technologies (LVT) has agreed to pay $4 million to settle False Claims Act allegations that it designed a scheme to avoid paying fees to FDA associated with NDAs. A Justice Department news release says the Allentown, PA, firm is a drug company that develops and commercializes certain human drug products.

The release says the law provides that FDA can waive the prescription drug user fee associated with an NDA for a small business applicant submitting its first application. LVT had received a waiver in 2010 for its oxycodone HCl NDA, the department says. When it wanted to submit two NDAs relating to potassium chloride for oral solution, it would have had to pay over $2 million in PDUFA fees.

However, the government says, the company paid two other companies to submit NDAs in their own name. The LVT payment was contingent on FDA granting waivers to the two companies. “LVT prepared and controlled all of the submissions that the companies made to FDA relating to the NDA approval,” the release says. “Neither LVT nor the companies disclosed to the government the agreements despite the government’s request for such information. Not knowing of the agreements, FDA granted fee waivers and approved both NDAs.”

The case was investigated by the FDA Office of Criminal Investigations.

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