Drugs

FDA Denies Petition Seeking New Opioid Moratorium

FDA has denied a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on approval of any new or reformulated opioids. The petition said that in the past two decades, and most recently on 11/2/18, FDA has approved new opioids or reformulation of existing opioids when previously known risks of the drugs exceeded their known benefits. “These approvals violated FDA’s current drug approval requirements for ensuring safety and effectiveness,” the group said, “and deviated from the principles articulated by the National Academies that concluded that FDA had failed to adequately ‘incorporate public health considerations into opioid-related regulatory decisions.’”

The petition said the moratorium it sought should not be lifted until the agency has implemented the elements recommended in a 7/2017 report by the National Academies for inclusion in “a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the deadly opioid crisis in the U.S.”

In a 9/6 denial letter, FDA said it cannot impose such a moratorium because its regulations require it to consider each application “on its merits according to a statutorily defined process...FDA is legally bound to apply this governing statutory and regulatory framework to all NDAs, including an application for a new opioid product. In doing so, FDA determines whether ach NDA meets applicable standards for safety and effectiveness. In applying these standards, FDA evaluates whether the benefits of the drug outweigh its risks and approves the drug if all applicable standards for approval are met.”

FDA also said it is committed to exploring whether additional authority from Congress is needed to address the opioid epidemic. “Furthermore, a moratorium on the approval of new opioid drug products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market,” the agency’s letter said.

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