We’re reading about FDA adcomms, Kenvue lobbying about Tylenol

We’re reading about FDA adcomms, Kenvue lobbying about Tylenol


And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to shop for a new tool to help us manicure the Pharmalot grounds, catch up on our reading, possibly enjoy a soiree, and of course, hold a listening party with Mrs. Pharmalot. So far, the rotation will include this, this, this, this and this. And what about you? Summer may be nearing an end but time still remains to enjoy the great outdoors. If weather does not permit, perhaps this is an opportunity to get a head start and winterize your castle. You could also lounge about and stream a moving picture or two. Or catch up with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

U.S. Food and Drug Administration leaders are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield agency decisions from public scrutiny, KFF Health News tells us. The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research. He relayed the message Tuesday at a meeting of health care product makers and Wednesday to an FDA advocacy group. In addition to being redundant, Tidmarsh said advisory meetings on specific drugs were “a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions.” Tidmarsh said committees would still be consulted on general issues like how to regulate different classes of drugs. But meetings on specific drugs were mainly useful, he said, because they allowed the public to see how the FDA worked.

Novo Nordisk’s new chief executive officer Maziar Mike Doustdar is calling workers back to the office as the Ozempic maker struggles to catch up with Eli Lilly in the hyper-competitive obesity market, Bloomberg News says. Office-based employees will need to come in five days a week starting Jan. 1. The move comes a day after Doustdar announced the drugmaker, which is headquartered in Denmark, would slash its workforce by 11%. Novo did not previously have a global policy on working from home, a common perk for Danish employees. The company had prized work-life balance, with employees in its home market frequently taking much of the month of July off and leaving the office by 4 p.m. to see to personal obligations. Before this week’s layoffs announcement, Doustdar also fired newly hired employees who had not yet started their jobs — some within days of when they were scheduled to begin — cut bonuses, and began a hiring freeze. Doustdar has called for a “performance culture” to catch up with Lilly, which has taken the lead in the U.S. obesity market.

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