FDA Policy/General

29 Groups Oppose Woodcock Nomination Over Opioids

Some 29 advocacy groups, led by Public Citizen and Physicians for Responsible Opioid Prescribing, are urging the Biden administration not to appoint acting commissioner Janet Woodcock as commissioner of FDA. In a 1/27 letter to incoming HHS officials, the groups say that in her role as CDER director for more than 25 years, “Woodcock presided over one of the worst regulatory agency failures in U.S. history. Since 1999, more than 500,000 Americans have lost their lives to opioid-related overdoses, and millions of Americans have developed opioid use disorder from use of prescription opioids.”

The letter references a 2017 statement by the President’s Commission on Combatting Drug Addiction and the Opioid Crisis that the crisis was caused in part by “inadequate oversight by FDA.” And it says the National Academy of Sciences, Engineering, and Medicine (NASEM) called on the agency to overhaul its opioid policies.

“In 2019, Woodcock’s failure to implement NASEM’s opioid recommendations prompted calls for his dismissal from the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Public Citizen,” the groups write…. In the face of mounting criticism of FDA over its opioid decision-making, Woodcock has maintained a defensive posture, refusing to acknowledge past mistakes.”

The letter charges that Woodcock and the division she supervised consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state attorneys general, and victims of the opioid crisis. “Recent reports that the pharmaceutical industry enthusiastically supports Woodcock’s candidacy for FDA commissioner do not surprise us because she consistently put the interests of opioid makers ahead of public health,” the groups conclude. “If Woodcock is nominated for and confirmed as FDA commissioner, all hope will be dashed that FDA would begin to base opioid decisions on the best available science, correct past harmful opioid decisions, and finally implement the NASEM recommendations.”

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