A litmus test for states' drug pricing power

Colorado could soon cap how much the state will pay for Amgen's autoimmune drug Enbrel — in what would be the first such move from a state prescription drug affordability board. Affordability boards have been around for years, but they've been slow to actually act on lowering costs for patients.

Last week, Colorado's board declared that Enbrel, which costs more than $46,000 per year per patient, per the state's claims database, is unaffordable for Colorado patients. Friday, the board will begin to discuss whether it wants to move forward with setting an upper payment limit for programs including Medicaid and commercial payers in the state. The same drug is also subject to Medicare's drug price negotiation program.

Novartis' arthritis and psoriasis drug Cosentyx and J&J's Stelara are next up for the committee to consider. The board recently decided that Vertex Pharmaceuticals' Trikafta and Gilead's HIV drug Genvoya were affordable, due to patient assistance programs. More on state drug affordability boards here.

legal watch

Quadruple header: IRA edition

Mark your calendars for a doozy of a court hearing on March 7 — a federal judge in New Jersey will be hearing oral arguments in *four* challenges to Medicare's new drug price negotiation program, brought by Johnson & Johnson, Bristol Myers Squibb, Novo Nordisk, and Novartis. I'll be heading up to Trenton to cover the hours of arguments.

The cases run the gamut of arguments the industry is making against the Inflation Reduction Act: that it's unconstitutional because it violates the First, Fifth, and Eighth Amendments, and that Medicare violated the Administrative Procedure Act.

The judge hearing the arguments, Zahid Quraishi, is a Biden appointee and is the first Muslim American federal judge in U.S. history. This will be the second round of oral arguments following AstraZeneca's first hearing in Delaware, which didn't go too well for them.

oversight

Democrats tell FDA to get it in gear on trial diversity

Key House Democrats are urging the Biden administration to hurry up with its guidelines for including patients of color in clinical trials for drugs and medical devices. They're already nearly two months late.

Congress in late 2022 passed a law requiring companies to give the FDA their plans for diversifying clinical trials. That law cannot take effect without guidance to industry from the agency. And while an FDA spokesperson said the guidance is a high priority, Democrats want the agency to move faster. Historically marginalized populations are underrepresented in many clinical trials, and at least one report shows that Black patient participation has declined over the last decade. More on the agency's new power, and experts' skepticism that it will use it well, here.

influence

A new O'Day at PhRMA

oday

Sarah Gonzalez for STAT

PhRMA announced a new board chair yesterday: Gilead CEO Daniel O'Day. He will lead the board through a pivotal election year. He replaces Novartis' Vas Narasimhan.

O'Day has been an active political donor, giving to Sen. Kyrsten Sinema (I-Ariz.) frequently. He's also donated to Sens. Bill Cassidy (R-La.), Marsha Blackburn (R-Tenn.), and Tim Kaine (D-Va.) and Reps. Buddy Carter (R-Ga.), Lisa Blunt Rochester (D-Del.), Nanette Barragán (D-Calif.), Larry Bucshon (R-Ind.).

Many pharma lobbyists will acknowledge their prospects of watering down the IRA are grim for the rest of this year, but that could change if Republicans take control of the Senate or White House in 2025.

capitol hill

Democrats take new tack on drug shortages

Democrats on the House Oversight Committee are taking a different tack on their probe of drug shortages, and requesting briefings from Pfizer, Teva, and Sandoz, each of which make key drugs in shortage.

The health care system has been struggling with the scarcity of 15 cancer drugs, including three commonly used generic cancer treatments made by Pfizer and its subsidiaries—carboplatin, cisplatin, and methotrexate. Teva makes Adderall, a treatment for the attention deficit/hyperactivity disorder that has experienced shortages. Sandoz is a top manufacturer of powder amoxicillin within the U.S. market. Antibiotics like amoxicillin are 42% more likely to experience shortages than other prescription medications, according to Democrats on the committee.

Instead of going to drug makers, oversight Chair James Comer (R-Ky) is investigating the FDA's handling of drug shortages.

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