Drugs

Raw Deal Enforcement Case Hailed

FDA deputy commissioner for global regulatory operations and policy Howard Sklamberg and deputy commissioner for foods and veterinary medicine Michael Taylor say that a fall 2015 enforcement action against Raw Deal, Inc., a New Jersey dietary supplement manufacturer illustrates the agency’s “careful field work, close teamwork, and skillful investigation that are hallmarks of FDA’s criminal enforcement.” Writing in an FDA Voice blog post, the two said that Raw Deal owner and president Barry Steinlight pled guilty in 9/2015 to one count of conspiracy to commit wire fraud involving a scheme to introduce adulterated and misbranded products into interstate commerce. He was sentenced to 40 months in prison and ordered to forfeit $1 million in profits from the scheme.

On 12/21, the two write, the company’s former executive vice president, Catherine Palmer was sentenced to one year probation and a criminal forfeiture of $100,000 after pleading guilty to obstructing an FDA investigation.

“The convictions arose from illegal practices by the firm, which included manufacturing adulterated and misbranded products by using fillers to cut costs, reusing returned and contaminated products, and falsifying batch records and certificates of analysis,” Skalmberg and Taylor wrote. The post reviews four years of investigations and enforcement activities that were undertaken by the agency before criminal charges were filed by the Justice Department.

“This case is just one example of FDA enforcement in action,” the post says. “Companies are given the opportunity to correct violations, but if they don’t, there are serious consequences. Indeed, during the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and $694,131,579 in fines and restitutions.”

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