Drugs

Time to Challenge Whistleblower Law?

Writing for Washington Legal Foundation, two Fried, Frank attorneys say the time may be right to look again at constitutionality of the False Claims Act’s (FCA) qui tam (relator or whistleblower) provisions that allow a whistleblower to independently prosecute a False Claims Act case on behalf of the United States and to be awarded up to 30% of any government recovery based on the whistleblower’s claims. The attorneys say that interest in challenging the constitutionality of the provision waned following a 2000 Supreme Court decision in Vermont Agency of Natural Resources v. United States ex rel. Stevens. In that decision, the court unanimously held that whistleblowers have Article 3 standing, even though they suffer no injury themselves, because they are “assignees” of a portion of the government’s FCA claim, they say.

The attorneys note that in recent years, court decisions have questioned the wisdom of qui tam enforcement, at least in many circumstances where the interests of the qui tam relator conflict directly with the interests of the executive branch and the public interest. “These opinions may form a basis for courts to revisit the constitutionality of this private enforcement of the government’s rights and remedies …,” the attorneys write.

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

Read more

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