STAT+: Pharmalittle: We’re reading about Roche accusing U.S. of ‘blackmail,’ a ruling on skinny labels, and more
Article excerpt
Roche has accused the U.S. government of "blackmail" over drug pricing policies, according to reporting on pharmaceutical industry tensions. The accusation centers on what the company views as coercive negotiation tactics. Meanwhile, the Supreme Court has ruled on "skinny labels", the practice of selling drugs with limited prescribing information to avoid certain regulations. Drugmakers and patient advocacy groups are also pushing the FDA to suspend a fast-track review program created under former commissioner Marty Markary that grants expedited approval vouchers for rare disease treatments. The competing pressures reflect ongoing friction between the pharmaceutical industry and regulators over drug access, pricing, and approval timelines.
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 includes promenading with the official mascots, catching some live musical vibes, and looking in on the Pharmalot ancestor. We also hope to squeeze in yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Summer is closing in so this may be an opportunity to book a getaway, find some fab beach gear, or compile a challenging reading list. You could hit the pause button and catch up on your naps. Or maybe there is time to hang with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
Leaders at the U.S. Food and Drug Administration listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary, STAT tells us. The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.
Meanwhile, the FDA has launched a safety study of the mifepristone abortion pill, a step that could pave the way for the Trump administration to restrict how it is distributed and used, The Wall Street Journal reports. The study marks a victory for antiabortion groups and Republican members of Congress, who have demanded action from the administration to crack down on the pill’s use. In recent months, antiabortion allies had lost patience with assurances from administration officials that a study would be conducted. The effort is expected to take about six months, meaning it likely will not be completed before the midterm elections.
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