Drugs

Gottlieb Expects Improvements in PR Drug Supplies

FDA commissioner Scott Gottlieb says he expects a shortage of IV saline fluids related to the hurricane destruction in Puerto Rico will improve early this year, with continuing improvements in the weeks ahead. In an online update, he says Baxter, a leading producer of IV saline fluids, has indicated that all its Puerto Rican facilities have returned to the commercial power grid.

In addition, he says, other companies that manufacture products that were on the agency’s initial list of drugs that are considered critical and at risk of potential shortages because they were largely or entirely manufactured in Puerto Rico are now on the power grid.

The agency has been in frequent communication with hospitals, healthcare providers, and health system organizations about the burden the drug shortages have placed on them and the efforts they have taken to mitigate them, Gottlieb says. He says the agency will continue to engage with them and provide them information to support their management of the shortages.

“Given the improvements we’ve seen over the last few weeks,” he concludes, “I’m optimistic that supplies of IV saline and amino acids will increase over the next few weeks and the stress of the shortage will begin to abate, even if the shortages will not be fully resolved immediately. That said, the production situation in Puerto Rico remains fragile. As many risks and challenges remain and there are still shortages affecting patient care, we’ll continue to take all possible steps to help improve shortage situations.”

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