Drugs

FDA Ordered to Speed U.S. Drug Manufacturing

President Donald Trump signed 5/5 an Executive Order directing FDA to cut the amount of time it takes to approve domestic drug manufacturing plants by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with domestic manufacturers to provide early support before facilities come online. “We don’t want to be buying our pharmaceuticals from other countries,” Trump said in a White House statement, “because if we’re in a war, we’re in a problem. We want to be able to make our own.”

FDA was told to increase fees for and inspections of foreign manufacturing plants, and to improve enforcement of active pharmaceutical ingredient source reporting by foreign drug producers, and to consider publicly displaying a list of facilities that do not comply.

The order also has requirements for the Environmental Protection Agency and other federal agencies to speed the process for permitting and constructing domestic drug manufacturing facilities.

The statement says estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as five to 10 years, “which is unacceptable from a national security standpoint.” It says the Executive Order “will speed up timelines for building domestic pharmaceutical manufacturing sites by reducing regulatory barriers to construction.”

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