STAT+: Pharmalittle: Merck sues U.S. to halt Medicare drug-price negotiation; FDA oncology head wants advisory panels to keep voting on new drugs
Merck sued the U.S. government, seeking an injunction to block the drug-price negotiation program contained in the Inflation Reduction Act.
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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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