Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop the world, such as it is, from spinning. So this means one thing: time to dig in to the tasks at hand. On that note, we have assembled a menu of tidbits to help you get started. Meanwhile, we have also fired up the coffee kettle for another cup of stimulation. Our choice today is orange creme. We hope your day is simply smashing and, as always, do keep in touch if something saucy arises. …
A new fight is brewing over the Medicare drug price negotiation program after the Trump administration proposed to consider an additional form of drugs for price cuts, spurring more legal and policy concerns from the pharmaceutical industry, Bloomberg Law explains. The proposal would allow the Centers for Medicare & Medicaid Services to select a fixed-dose combination drug for negotiations if the agency determines it does not have a “clinically meaningful difference” compared to its original drug with the same active moiety or ingredient. Fixed-dose combinations contain multiple medications in a single dosage form to help simplify treatment for patients. The pharmaceutical industry has been resisting the proposal, raising questions about the government’s legal authority and statutory basis to implement it. If finalized, the move could be a problem for Merck’s Keytruda, Bristol Myers Squibb’s Opdivo, and Johnson & Johnson’s Darzalex — top cancer drugs that could be picked for price cuts with their fixed-dose combinations.
Despite Trump administration efforts to shrink the U.S. Food and Drug Administration, Senate appropriators unanimously advanced a funding bill last Thursday that maintains agency funding in fiscal 2026 at roughly the same level as in fiscal 2025, Politico notes. The Senate Appropriations Committee bill, which advanced by 27-0 vote, funds the agency at $7 billion, comprised of $3.6 billion in taxpayer funds and $3.4 billion in user fee revenues. That sets up a showdown with the House, which advanced a party-line FDA spending bill out of committee last month that funds the agency with $6.8 billion in total funding, in line with what President Trump asked Congress to provide to the agency. Both measures are set for floor action, but there is still no broader funding agreement in place to keep federal agencies running beyond the Sept. 30 government shutdown deadline. Congress could resort to a stopgap funding patch in the fall.
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