Drugs

Sen. Bernie Sanders Places Hold on Califf Nomination

Sen. Bernie Sanders (I-VT) has placed a hold on FDA commissioner-nominee Robert Califf’s confirmation because of his close ties to the pharmaceutical industry and lack of commitment to lowering drug prices. Sanders’ hold comes on the heels of a separate hold placed by Sen. Edward J. Markey (D-MA), who called for immediate reforms to the agency’s approval process for opioid painkillers (see earlier story).

“I also strongly believe that at a time when millions of Americans cannot afford to purchase the prescription drugs they require, we need a leader at the FDA who is prepared to stand up to the drug companies,” Sanders said in a statement. “We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.”

Sanders is bothered by Califf’s past ties to the pharmaceutical industry. “He ran a multimillion-dollar clinical research center at Duke University that received more than 60% of its funding from the pharmaceutical and medical device industry,” Sanders said. “And his financial disclosure form last year listed seven drug companies and a device maker that paid him for consulting and six others – including Merck, Novartis and Eli Lilly – which supported his university salary.”

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