FDA Policy/General

FDA Worried About Sole-sourced Products from Puerto Rico: Gottlieb

FDA commissioner Scott Gottlieb says the agency is very concerned about 13 “sole-sourced” drug products that are made in Puerto Rico and could be in short supply after Hurricane Maria. During a 10/3 House Energy and Commerce Health Subcommittee hearing (see earlier story), Gottlieb was asked to provide additional details on the condition of regulated industry following his visit to the island 9/29.

"The loss of access to these drugs and devices could have significant public health consequences,” he said at the hearing. “These are important medicines... These are HIV medicines, chemotherapeutics and injectable drugs that are hard to manufacture.” There are also some sophisticated devices that are only made on the island that the agency is also monitoring, he added.

Restoring the capacity at drug and device facilities in Puerto Rico is a priority for the area’s recovery and economy, Gottlieb said. “These sites directly employ about 90,000 residents of Puerto Rico and represent about 30% of the island’s GDP," he said. “If we don't get these facilities back online in a timely way or they decide to relocate after this disaster, it would jeopardize the island’s economic future.”

A lack of fuel for employees to get to work and to run generators while the plants are off the electrical grid are top concerns, Gottlieb said. Then, there is concern about resources and supplies these companies need in order to turn out product, he added.

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