Drugs

Senators Reintroduce Opioid Studies Bill

U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) have reintroduced their bipartisan FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act, which would require an advisory committee to review the “controversial enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids and ensure opioids are only marketed for uses where they are both safe and effective.”

FDA has been approving new painkillers “based on improper studies that skew results in favor of approval,” a news release from the lawmakers says. “The methodology they're using was cooked up in private meetings with drug makers. The time for outside experts to examine the use of enriched enrollment randomized withdrawal is long overdue.”

The legislation would also require FDA advisory committee reviews of opioids currently approved using the EERW methodology, and require the National Academy of Sciences to conduct a study on EERW and its effectiveness in proving the efficacy of opioids in treating chronic pain.

Manchin has been a staunch critic of the agency over its efforts to curb opioid use. In April, he questioned FDA commissioner Robert Califf on his “continued complicity in the drug epidemic for using the flawed EERW opioid trial methodology and allowing disproportionate pharmaceutical influence on agency decision-making.”

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