Drugs

Industry Fights FDA on Drug Shortage Fixes: Califf

FDA commissioner Robert Califf says drug manufacturers have fought agency efforts to encourage companies to ramp up production when a shortage occurs in another company. “People don’t like to be regulated,” he said during an appearance on a Healthcare Unfiltered podcast. “But we need it for the public health.”

Califf identified three reasons for drug shortages: (1) when there is a great demand for a drug, such as the current weight loss drugs; (2) when there are federal restrictions on the amount that can be produced, such as stimulants that are scheduled; and (3) when manufacturers of inexpensive generic drugs have manufacturing issues and inspection violations. He said the vast majority of drug shortages are generics and pointed out that FDA cannot order companies to produce additional low-price generic drugs.

“We can’t prevent shortages,” he said, “but we’re getting better information and improving our inspection regimes.” Califf also said the agency is encouraging companies to invest in improving their manufacturing systems.

Asked whether clinicians understand the dynamics of drug shortages, Califf noted that he had been a busy cardiologist and doesn’t think that doctors and nurses generally should have to think about all the details involved in a shortage. “I understand why they are angry,” he said. “But it is easily explainable and we need to do a better job of explaining and reassuring that the drugs they are getting are of high quality.”

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