Drugs

U.S. Should OK Discovery in FCA Materiality Cases: Analysis

Three Fried Frank attorneys say that if False Claims Act (FCA) cases that look at the materiality of the claims being made, the government should be required to provide full discovery to the parties. However, they write in a Washington Legal Foundation Legal Opinion Letter, in some recent cases, the Department of Justice has opposed defendants’ attempts to obtain from federal agencies evidence that would tend to show that the violations were not material to the agency payment of claims.

“While the government understandably may not want the curtain drawn back to reveal the actual agency record for the claims at issue as well as similar claims,” the attorneys write, “the government has no grounds to oppose such discovery once an FCA litigation has commenced. In fact, DoJ itself should evaluate the agency record as part of its litigation diligence before it launches FCA litigation or makes an intervention and/or dismissal decision in a qui tam (whistleblower) suit. The options are simple: the government can either allow an FCA matter to proceed and open up the agency to materiality discovery, or the government can shut the suit down. There is no third option. DoJ cannot properly allow an FCA case to be litigated but then deny legitimate discovery on this topic.”

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