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 still shaping up as we weigh our options. So far, we plan to catch up on our reading and promenade with the official mascots. We also plan to hold another listening party — this is a weekly event, you know —where the rotation will likely include this, this, this, this and this. And what about you? Depending on where you live, you may be able to enjoy the great outdoors with a walk in the park or a long drive to nowhere. If cold temperatures are an issue, you could enjoy a good book or stream a show or two on the telly. Or maybe cook a nice meal. Well, whatever you do, have a grand time. But be safe. And a quick reminder — we will see you on Tuesday, since there is a long weekend on this side of the pond due to a holiday that commemorates civil rights. Remember those? Enjoy, and see you soon….
More than half a dozen major drugmakers are participating in the Trump administration’s speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what they see as potential legal risks, Reuters tells us. Under the FDA Commissioner’s National Priority Voucher Program unveiled in June, U.S. Food and Drug Administration chief Marty Makary can issue approval decisions in one to two months on a limited number of drugs deemed critical to public health or national security, or if they were manufactured in the U.S. or offered at low prices. But pharma executives and advisers said one chief concern is that a two-month review could fall short of the scientific rigor needed to evaluate a medicine’s safety and efficacy. That could undermine the credibility of the FDA decision and create more legal risk for a drugmaker if patients experience serious side effects post-approval.
President Trump released a hodgepodge of health care policies that would create new price-control power over pharmaceutical companies, but that otherwise would not fundamentally overhaul America’s existing system, as he faces mounting pressure to address the cost of insurance and care, STAT explains. The most consequential provisions could be proposals to extend lower international drug prices to all Americans, make more prescription drugs available over the counter, and send at least some health insurance subsidies directly to enrollees. But many of those moves would require action from Congress. Part of the new health plan also includes provisions to expand access to drugs. The administration wants to make more prescription drugs available without seeing a doctor. Some high-dose NSAIDs and drugs for stomach ulcers should be available over-the-counter at pharmacies or through TrumpRx.Continue to STAT+ to read the full story…