Drugs

FDA, HHS Cuts Can Hurt Trial Oversight: Caplan

NYU Grossman School of Medicine ethicist Arthur Caplan says he is concerned that reductions in force at FDA and HHS can adversely affect clinical trial oversight and participant protections. In a Medscape video, Caplan says, “I am extremely worried about what’s been taking place at FDA and at HHS in terms of oversight and willingness to make sure that subjects are informed, that the risks and benefits of studies make sense, and even having enough people to approve studies or know where to go if somebody thought somebody had not treated them properly in the study.”

Caplan notes that the HHS Office for Human Research Protections “was hollowed out. That’s a group of people who launch investigations when there is a problem, and make sure that when people say they have a human subjects committee in place to monitor what’s going on with research, that they really do. They certify them. They have been downsized in a way that is dangerous.”

He also points out that the former HHS Secretary’s Advisory Committee on Human Research Protections was disbanded, and all the members were let go. “It’s not clear why,” Caplan writes, “but those were some of our best experts on how to ensure human subject safety in research.”

He also describes a “cleaning out” at FDA that affects its responsibility to get the information that lets people use drugs, medical devices, and vaccines safely, knowing that they will work.

“Many patients do want to get into clinical trials,” Caplan concludes, “and they do want access to new and novel drugs that may not have approval yet. They may face roadblocks. We have to make sure that the cuts that have been made at FDA do not harm them or their ability to access new drugs, and that human subject protections don’t weaken. If anything, we want to make sure that surveillance remains vigilant.”

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