Drugs

High Court Asked to Consider Gilead Case

Washington Legal Foundation (WLF) is asking the Supreme Court to review and then overturn an appeals court decision authorizing private individuals to sue drug companies for government-contracting fraud based on technical violations of federal regulations, even if FDA approved the drugs and government officials continue to buy them after investigating the allegations. WLF says the appeals court decision conflicts with Supreme Court precedent and facilitates filing of unwarranted False Claims Act fraud claims against government contractors.

In the Gilead case, a whistleblower who was fired by the company alleged that the firm was out of compliance with FDA drug manufacturing regulations. Government officials investigated the allegations but took no action, WLF says. And, it says, the drugs remain approved by the agency and the government continues to pay billions of dollars each year to purchase the drugs.

The appeals court reinstated the whistleblower’s suit, WLF says, finding that he had adequately alleged that the company defrauded the government by submitting claims for payment without informing the purchaser of its regulatory non-compliance. The advocacy group says the whistleblower failed to demonstrate that the alleged false claims are “material,” meaning that the government would not have paid the claims had it been aware of the violations.

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