Medicare's next Alzheimer's conundrum

Yesterday's announcement of promising data from Eli Lilly on their latest anti-amyloid Alzheimer's treatment was big news for patients — and will add even more pressure on Medicare's unprecedented coverage restrictions.

The Alzheimer's Association and Lilly have called for the agency to ease up, and members of Congress have questioned whether the additional requirements are warranted if a drug has gained full FDA approval.

When I asked for examples of other instances when CMS had placed restrictions on coverage for fully approved medications, the agency pointed to examples that weren't quite comparable with the situation the agency is facing with Alzheimer's, one expert said. Read more about the agency's compounding conundrum in my new story out this morning.

influence

Juul execs find a friend in Congress, and start writing checks

K.C. Crosthwaite, CEO of JUUL Labs, testifies during a House Committee on Energy and Commerce hearing in 2020. (DREW ANGERER/GETTY IMAGES)

For months, the e-cigarette maker Juul has been telling anyone who will listen that the FDA wants to pull its products off the market thanks to a barrage of political pressure from Democrats in Congress. Juul appeared to be making serious headway with that argument when the House's top watchdog, the head of the House Oversight Committee, launched a probe into political pressure at the FDA's tobacco center this March.

Comer, it turns out, also got a raft of checks from Juul executives that month, my colleague Nick Florko reports. The checks came from Juul's top brass, including the company's CEO, and its chief regulatory officer, and totaled more than $10,000.

Avid D.C. readers are no stranger to lawmakers getting showered with campaign cash at opportune times. (We are looking at you Sens. Cassidy, Thune, Tillis, and Menendez) but this is a relatively new move for Juul execs, who typically aren't prolific fundraisers for Capitol Hill. Read more here.

congress

NIH in the hot seat

The Senate Appropriations Committee will grill NIH officials today about their budget request for next year, amid a highly politicized environment — but the person everyone wants to hear from most won't be appearing.

Monica Bertagnolli, NIH's heir apparent, dropped out of the hearing due to a scheduled cancer treatment, my co-author Sarah Owermohle reports. But the hearing with four other top NIH officials will offer clues to the questions Bertagnolli could face in a confirmation hearing.

Potential topics could include questions about diversity and culture at the agency, about the agency's lagging long Covid research initiative, and spending on gain-of-function research. Read Sarah's full primer on the confirmation battle ahead.

tobacco

RJ Reynolds' new snitching tactic

The tobacco giant RJ Reynolds is trying to get small vape shops in trouble if they run afoul of bans on flavored vapes, my colleague Nick Florko reports.

Two letters Nick obtained show that RJ Reynolds is threatening to sue the vape shops if they don't stop selling flavored vape products. In New Jersey, the company also copied the county prosecutor where the shop is located.

The letters highlight tobacco companies' growing frustration with the FDA's scattershot enforcement approach toward flavored vapes, leading them to take matters into their own hands. Read Nick's full dispatch here.

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