Drugs

FDA Returns Hi-Tech’s DMAA

As ordered by a Georgia federal court, FDA has returned to Hi-Tech Pharmaceuticals over $19 million worth of DMAA (1,3-dimethylamylamine), a food additive that FDA has said is illegal to use. The product was seized over 18 months ago as part of agency enforcement action against companies marketing dietary supplements containing DMAA. Although the ingredient was returned, Hi-Tech still cannot market products containing it, pending further court action.

While many companies removed their products containing DMAA, Hi-Tech filed a suit against FDA and expects to receive a ruling from the 11^th Circuit Court of Appeals soon.

Hi-Tech CEO Jared Wheat has said the FDA seizure was “an extreme act of overreach” that violated the Administrative Procedures Act and the Fifth Amendment due process clause. Wheat claims the government investigation and prosecution of his company has included the systematic concealment of significant exculpatory evidence that would have independently corroborated the company’s defense and its experts’ testimony, and seriously damaged the testimony and credibility of key government witnesses.

“This is not about negligence,” Wheat says. “This is not about incompetence. This is about intentional wrong-doing.”

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