Rise and shine, everyone, another busy day is on the way. We can tell by the steady stream of vehicles passing under our window and the outsized number of emails arriving in our inbox. But busy is generally a good thing, yes? So to help things move along as smoothly as possible, we are firing up the trusty coffee kettle and brewing another cup of stimulation. Our choice today is the ever-yummy gingerbread, of all things. Please feel free to join us. And meanwhile, we have assembled a few items of interest for you to peruse. As always, we hope you have a meaningful and productive day. And of course, do stay in touch. …
Merck filed a lawsuit against the U.S. government, seeking an injunction of the drug-price negotiation program contained in the Inflation Reduction Act, which it argues violates the Fifth and First Amendments to the U.S. Constitution, Reuters reports. The lawsuit, which was filed in the U.S. District Court for the District of Columbia, argues that under the law, drugmakers would be forced to negotiate prices for drugs in the government’s Medicare health insurance program at below market rates. Merck asserts this violates the part of the Fifth Amendment that requires the government to pay just compensation for private property taken for public use.
U.S. Food and Drug Administration Commissioner Robert Califf has made clear he would like to do away with voting at advisory committee meetings, but Richard Pazdur, director of the FDA Oncology Center of Excellence, took issue with his boss, STAT says. Although the FDA has no obligation to follow what advisory committees recommend, the votes help, Pazdur said at the American Society of Clinical Oncology annual meeting. “I think we need to vote,” he said. “We have to make a binary decision at FDA whether to or not to approve. If we are going in one direction, and we hear a unanimous vote against — we have to pause. You have to step back and say, were we wrong on this?”
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