Drugs

FDA Monitoring Drug Shortages After Pfizer Tornado

FDA says it is working with Pfizer to monitor more closely the drug shortages impact of a 7/19 tornado that severely damaged Pfizer’s large sterile injectables site in Rocky Mount, NC. The company reported that no employees were harmed by the twister. Drug shortage expert and senior pharmacy director at University of Utah Health Erin Fox told CBS News that the damage “will likely lead to long-term shortages while Pfizer works to either move production to other sites or rebuilds.”

According to Pfizer, the Rocky Mount site is one of the largest sterile injectables facilities in the world, with more than 1.4 million square feet of manufacturing space on 250 acres. “Nearly 25% of Pfizer's sterile injectables used in U.S. hospitals are produced at the site,” it says. “At this facility, a wide range of products are produced, including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers. These products are available in small volume presentations, such as ampules, vials and syringes.”

Online images of the damage show roofs peeled back exposing the inside of inventoried products. The plant stores large quantities of medicine that were tossed about, Nash County Sheriff Keith Stone told CBS. “I've got reports of 50,000 pallets of medicine that are strewn across the facility and damaged through the rain and the wind,” Stone said.

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