FDA Defends Framework As It Dismisses Advocacy Group’s Petition To Put Moratorium On Opioid Approvals
Public Citizen says the agency displayed “dangerously deficient oversight” when it approved opioids during a growing crisis. The FDA denied the request for a moratorium, pointing to the framework and guidance it has developed in the years since. In addition, the FDA argued that it is not permitted under federal law to impose a moratorium on approving new medicines. In other news: a judge knocks down Purdue Pharma's efforts to dismiss public nuisance claims and the AMA is urging states to be proactive on opioid abuse treatment.
FDA Rejects Bid For Moratorium On Opioid Approvals
As public health officials struggle to address the ongoing opioid crisis, the Food and Drug Administration has rejected a petition filed by a consumer advocacy group calling for the agency to impose a moratorium on the approval of any new or reformulated opioids. In arguing for the moratorium, Public Citizen maintained last March that the FDA displayed “dangerously deficient oversight” and that none of more than two dozen opioids approved between 2009 and 2015 provided benefits that outweighed the risks. As noted at the time the petition was filed, two drugs — Opana ER and Dsuvia — were singled out as examples. (Silverman, 9/9)
U.S. Judge Allows Public Nuisance Claim In Opioid Trial
The U.S. judge overseeing nationwide litigation concerning the opioid epidemic on Monday rejected Purdue Pharma LP's effort to dismiss claims that its activities caused a public nuisance. U.S. District Judge Dan Polster in Cleveland ruled six weeks before the first scheduled federal trial over the epidemic, in a case brought by Cuyahoga and Summit counties in Ohio. (9/9)
AMA Urges States To Improve Opioid Abuse Treatment Access
The American Medical Association and Manatt Health urged states on Monday to step up their game to ensure residents have adequate access to opioid use disorder treatments. In a new report, the two organizations zeroed in on the efforts of four states that have particularly innovative strategies: Colorado, Mississippi, North Carolina and Pennsylvania. The report focused on reducing access barriers in Medicaid and state-regulated commercial health plans. (Bannow, 9/9)