Drugs

Supplement Company Owner Sentenced in Steroid Case

The Justice Department says the owner of MedFitRX, now known as MedFit Sarmaceuticals, a sports supplement company based in Cary, NC, has been sentenced to one year and one day in federal prison after pleading guilty to introducing unapproved new drugs into interstate commerce. A department statement says that Brian Parks previously pleaded guilty in a Virginia federal court to one count of distributing unapproved new drugs with the intent to mislead and defraud FDA and consumers.

In pleading guilty, the department says, Parks admitted that from 6/2017 to 9/2019 he and his company unlawfully distributed synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids.

The statement says FDA has long warned against the use of such synthetic steroids, saying they have been linked to life-threatening reactions including liver toxicity, and have the power to increase the risk of heart attack and stroke.

In connection with his sentence, Parks forfeited $350,000.

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

Read more

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