Drugs

2 Compounding Pharmacists Sentenced in Tainted Drugs Case

Two drug compounding pharmacists from Alabama have been sentenced to 12 and 10 months in prison for their roles in distributing adulterated drugs that were compounded at the now-defunct Advanced Specialty Pharmacy doing business as Meds IV. David Allen, the former pharmacist-in-charge of Meds IV, and William Timothy Rogers, the former president of the pharmacy, had pleaded guilty in March to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act. Allen and Rogers were sentenced to 12 months and 10 months in prison, respectively.

As alleged in the government’s information, Meds IV compounded various drugs for human use, as well as an intravenous total parenteral nutrition (TPN) product. The government says an amino acid used in compounding the TPN was adulterated because it was contaminated with Serratia marcescens. This bacterium can cause bloodstream infections, and tainted products were linked to nine deaths at various Birmingham-area hospitals, according to the government.

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