
How is it mid-November? I think of all of the things that need to get done by the end of the year and then try and pull out the productivity schemes (5 choices, pomodoro, eat the frog, etc.) I’ve learned over the years. The problem is that none of these create more time, just make…

Caught my Eye Cool Idea, But. The Food and Drug Administration (FDA) puts announced a new pilot prioritization program for the review of Abbreviated New Drug Applications (ANDAs) to support generic manufacturing in the U.S. I mean it sounds good, except… there are three criteria for applicants: Only 9% of API manufacturers are in the…

Feeling Owl Right? No? As I look at my calendar, I’m feeling a little antsy about the week ahead. Everything is positive, even great, but it feels like a gauntlet. The other significant factor is the upcoming September 29th Most Favored Nation (MFN) deadline. This date marks 60 days since the seventeen letters went out…

Next week we’ll have our first glimpse of the Medicare Part D premiums for 2026; I expect them to be pretty awful. The Part D redesign shifted additional liability onto plans without changing enough of the premium calculation. Some articles next week will say it is unintended consequence; I think it is an intended one…
This week I’ve repeatedly spoken to groups about the President’s Executive Order (EO) on Most Favored Nation (MFN) pricing and I feel a little vulnerable. I am often “authentic” in my explanations. I recognize that to many people I seem biased on a lot of issues but, in my defense, I find most politics maddening…

Some days I sit down the pottery wheel and I pull 4 bowls or vases in a row that are fantastic. Other days (like, oh, this Sunday and Wednesday) it all collapses. Here is hoping that all of us get better at staying centered and not collapsing. I’d Prefer Not. The 2026 Medicare Advantage and…

Tariffic. This week Eli Lilly announced they were investing at least $27 billion in US manufacturing, which is pretty cool. Was it to buy favor with the new Administration? It certainly does not hurt. I get the allure of manufacturing in the United States. If a country wanted to hurt us, they could stop sending…

Some days you eat the bear and some days the bear eats you. Looking at Canada? No, not like that. JAMA featured a supply chain shortage look at the U.S. versus Canada. While not all of the lessons from Canada carry over (more flat bureaucracy because of connections between regulators and facilities) – they do…

A relatively quiet week around these parts. I think everyone is so ASCO’d and BIO’d that policy is taking a quick breather. A PDAB will do you. The National Pharmaceutical Council put out a nice round-up comparing four prescription drug affordability boards. The chart is my favorite part – Extra, extra. Elevance Health, a health…

Ruling It. Yesterday afternoon, the Centers for Medicare & Medicaid Services released the MA/Part D final rule. Personally, most of it was not up my alley but I did read over the changes to the changes to an approved formulary sections. In December 2022, CMS proposed allowing immediate substitution of interchangeable biosimilars or branded biologics…