Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus again, but our spirits remain sunny, nonetheless. Why? We recall a bit of insight from the Morning Mayor, who taught us “Every day should be unwrapped like a precious gift.” To celebrate the notion, we are firing up the trusty tea kettle for a cuppa ginger honey and invite you to join us. Remember, a prescription is not required. So no need to mess with rebates or regulatory requirements. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …
U.S. Food and Drug Administration Commissioner Marty Makary believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring, doubling down on a push that has been questioned by some in the pharmaceutical industry, CNBC tells us. Makary said the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He noted the agency is going through “the proper regulatory processes” to update OTC monographs, which are the rulebooks that determine which drugs can be sold without a prescription. He explained that the FDA is looking at “basic, safe” prescription drugs like nausea medications and vaginal estrogen, which is used to treat menopausal symptoms like dryness and pain. And he framed the effort as another way to lower drug costs, a key priority of the Trump administration.
Meanwhile, the FDA plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products, the Associated Press notes. Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Marty Makary and a top deputy, Vinay Prasaid, wrote in a New England Journal of Medicine piece published Wednesday. The move is the latest example of Makary and his team changing longstanding FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines. Dropping the two-trial requirement, they wrote, reflects modern advances that have made drug research “increasingly precise and scientific,” and they predicted the shift would lead to “a surge in drug development.”Continue to STAT+ to read the full story…