FDA Policy/General

Sen. Markey Places Hold on Califf Nomination

Senator Edward Markey (D-MA) has placed a hold on FDA commissioner nominee Robert Califf’s Senate confirmation, calling for immediate reforms to the agency’s approval process for opioid painkillers. “Specifically, Senator Markey is calling for the FDA’s commitment to convene advisory committees for any future opioid-approval questions; to consider addiction, abuse and dependence as part of its determinations of which opioids are ‘safe’; and to rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision,” according to a statement from the lawmaker. Last year, the agency approved a new pediatric use for OxyContin without convening an advisory committee.

“Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs,” Markey says. “The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family.”

Markey has introduced the Safe Prescribing of Controlled Substances Act, which would require prescribers of opioid pain medications and other controlled substances to undergo mandatory training on safe prescribing practices and the identification of possible substance use disorders. Additionally, he has introduced the Treatment and Recovery Investment Act to increase funding for states so they can better assist individuals with substance use disorders.

In 2014, Markey released what he says was a comprehensive plan to address the opioid epidemic. It outlines, he says, a broad range of actions – prevention, treatment and enforcement – that must work in unison to address the crisis.

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