Drugs

Grand Jury Indicts Freedom Pharma Owner, Employees

A federal grand jury has returned an indictment charging two Florida residents and one North Carolina resident with manufacturing and distributing performance-enhancing drugs in violation of FDA regulations. William Bagwell (Petersburg, FL), Cole Leggett (Clearwater, FL) and Robert Nicholson-Gould (Lexington, NC) allegedly conspired to manufacture and distribute various unapproved prescription drugs to customers throughout the U.S. Bagwell was owner of Freedom Pharma and the other two worked at the company, which was not registered with the agency as a drug manufacturer. “The drugs, which include, dehydrochloromethyltestosterone, drostanolone enanthate, exemestane, methandienone, nandrolone decanoate, oxandrolone, oxymetholone, sildenafil, stanozolol, tadalafil, tamoxifen citrate, testosterone, and trenbolone, were misbranded and introduced into interstate commerce,” a Justice Department release says.

The defendants were each charged with one count of conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and one count of conspiracy to violate the Controlled Substances Act. They each face up to five years in prison and a fine up to $250,000 for the conspiracy to violate the Federal Food, Drug, and Cosmetic Act charge; and up to ten years in prison and a fine up to $250,000 for the conspiracy to violation the Controlled Substances Act charge.

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