FDA Policy/General

Manchin Critical of Woodcock in Top FDA Post

FDA’s controversial decision to provide accelerated approval to Biogen’s Alzheimer’s drug illustrates the need to disrupt the status quo at FDA and nominate someone other than acting commissioner Janet Woodcock, Senator Joe Manchin (D-WV) said in a 6/17 letter to President Biden. Noting the scientific community’s uproar second-guessing the drug’s benefits and the resignations of three advisory committee experts (see story) in protest over the approval, Manchin said “(h)aving a permanent agency head in charge to answer patients and doctors questions on this approval, as well as assure the general public ofthe FDA’s commitment to public health, is imperative, and Dr. Woodcock is not the right person to lead the FDA. This approval underscores the fact that more of the same leadership at the agency is not the answer.”

Manchin’s letter also pointed to the ongoing opioid and drug overdose crisis as another reason for a change in FDA leadership. “The FDA has played a critical role in this overdose epidemic by overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995 — and Dr. Woodcock has been there for all of it,” Manchin wrote in the letter. “Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic. It is blatantly clear that we must do more to address the drug epidemic that is impacting every American.”

Additionally, Manchin said that as the agency recovers from the strain on resources during the Covid-19 emergency and resumes its focus on approvals of new vaccines, drugs, medical devices, and other new treatments, “doctors and patients should feel confident in the agency tasked with overseeing their wellbeing. The FDA needs new leadership to be accountable for new drug approvals and to address the public health consequences of widely-available prescription opioids, as well as the numerous other health concerns facing our country. Ihope the Biden Administration will examine the consequences of Dr. Woodcock’s leadership and appoint someone more suited to lead our country out of this devastating pandemic.”

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