Drugs

Hi-Tech Pharma Sues FDA on Action Against Supplements

Hi-Tech Pharmaceuticals says it has sued FDA in DC federal court claiming that the agency “bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.” The complaint states that DMHA has existed in the food supply for many years. “Hi-Tech and the industry have sold millions of bottles of dietary supplement products containing this ingredient without any serious adverse event reports,” it says. Hi-Tech claims that DMHA is a natural constituent of the walnut tree and Kigelia Africana fruit.

Last month, FDA sent Hi-Tech a Warning Letter dealing with four of the company’s dietary supplements containing DMHA. In response, the company said the letter represents agency “bullying” attempts to “quasi ban a product by Warning Letter rather than rulemaking” and “is not the law.” The Warning Letter questioned whether DMHA is a new dietary ingredient under provisions of the law and says it is not generally recognized as safe under its conditions of use in the dietary supplements.

Hi-Tech says its lawsuit seeks a court order to stop “FDA's campaign of intimidation” and that “if the agency has scientific evidence which brings the safety of DMHA into question, that it disclose same and engage in the formal rule making process to ban the ingredient.”

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