Drugs

FDA Deploying Staff to Puerto Rico to Help Manufacturers, Residents

FDA is deploying additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically necessary drugs and devices, as well as assist with public health needs after Hurricane Maria decimated the island. “There are many challenges ahead, but much of the hurricane response over the next few days will rightly focus on life-saving measures,” FDA commissioner Scott Gottlieb is quoted in a release as saying. “The agency stands ready to support the federal government’s overall response in whatever way we can — be it providing support through our U.S. Public Health Service Commissioned Corps officers, or FDA’s civilians who have volunteered to support the efforts led by the Department of Health and Human Services and the Federal Emergency Management Agency (FEMA).”

Gottlieb notes that it may take months to restore electricity to the island. “As the relief effort moves into recovery, we are committed to working closely with local and federal partners, as well as the food and medical product industries, to address the immediate and long-term consequences of the storm,” he says. “Like many federal agencies, the FDA has an important role to play by ensuring the safety of, among other things, medical products, blood, and the food supply—all of which have the potential to be destroyed or become contaminated by flood waters, further jeopardizing the health and safety of Americans.”

FDA has been challenged by recent storms that hits areas where there are a significant number of farmers, food distributors, and medical product manufacturers, including Houston, Florida, and now Puerto Rico and the U.S. Virgin Islands. “In fact, we identified and have begun outreach to approximately 10,000 firms potentially impacted by hurricanes Harvey and Irma,” Gottlieb says. Now, attention is shifting to areas affected by Hurricane Maria. So far, he says, about 350 staff have been deployed or are being to deployed to storm-affected areas.

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