A nonprofit in Philadelphia can open a safe injection site for intravenous drug users; clinical trial sponsors could be deemed noncompliant for not posting their data; Mallinckrodt Pharmaceuticals agrees to pay $1.6 billion in ongoing opioid crisis lawsuit.
Late Tuesday saw District Court Judge Gerald A. McHugh issue his final ruling on permitting nonprofit Safehouse to open its proposed safe injection site in South Philadelphia, reports The Hill. Opponents claimed the site would violate federal law, specifically the Controlled Substances Act, and “facilitate illegal drug use.” Proponents, meanwhile, tout that the medical personnel staffing the site will be able to connect their clients to social services and provide medical care—including naloxone, if needed—and clean needles. Judge McHugh previously ruled in October 2019 that Safehouse’s proposal would not violate federal law.
With claims of inconsistent reporting of clinical trial data to ClinicalTrials.gov, a federal judge from New York’s Southern District has ruled that previously unpublished clinical trial data must be released, according to Stat News. Two chief complaints from the lawsuit’s plaintiffs, a New York University journalism professor and a former FDA associate commissioner, are that the FDA has not fined trial sponsors and the National Institutes of Health has not withheld grant funding for not releasing the data, despite transparency requirements. A deadline for posting the data has not been determined.
With thousands of lawsuits on the docket, the pharmaceutical behemoth and Attorney General Xavier Becerra of California jointly announced tentative plans for the $1.6 billion to be put into a trust over 8 years, says The New York Times. The US division of Mallinckrodt will also file for Chapter 11 bankruptcy under the plan. According to the CDC, close to 218,000 people died from opioid overdoses between 1999 and 2017, with the death rate 5 times higher in 1999 than 2017. Similar offers from Johnson and Johnson and McKesson remain in limbo.