Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the familiar routine of online meetings, calls, and deadlines has predictably returned. But you know, the world — such as it is — continues to spin. So what can you do but try to give it a nudge in a better direction. To make this happen, we are brewing cups of stimulation. Our choice today is toasted almond caramel. Please feel free to join us. Meanwhile, here are a few tidbits to get you going. We hope you have a grand day and, as always, do keep in touch. Our settings are now adjusted to accept telegrams and postcards. …
The owners of a drug wholesaler have been indicted for their alleged role in a conspiracy to distribute misbranded and diverted HIV pills, the latest effort by federal authorities to target a widespread scheme to pump the medicines into the U.S. pharmaceutical supply chain, STAT says. Patrick and Charles Boyd, who own Safe Chain Solutions, along with a broker, Adam Brosius, were indicted for allegedly buying more than $90 million of “heavily discounted” prescription medicines from a handful of black-market suppliers. Prosecutors said the diverted drugs — mostly HIV pills — were often obtained through unlawful buybacks in which previously dispensed bottles were bought from patients
The U.S. Food and Drug Administration’s power to make important regulatory decisions is in question after a Supreme Court decision weakening the ability of federal agencies to interpret ambiguous statutory measures, STAT explains. The ruling could mean headaches not just for the teams of lawyers and scientists at the FDA, but for drug and device makers the agency regulates. While the court decision is not expected to have major implications on the FDA’s bread and butter task — approving individual drugs and devices — it could open up many of the agency’s regulatory efforts to legal challenge, leading to the one thing industry hates more than a bad policy: uncertainty.
