Congress
Senators push back pharmacy benefit manager reform
It's go time for the Senate HELP Committee's PBM reforms: the panel will markup legislation this morning that makes some pretty major changes to the industry.
Already, it seems like the industry's scored a win: now, the legislation won't won't go into effect until 30 months after the bill is made law, pushing the slate of changes to November 2025 at the absolute soonest, according to changes shared with D.C.D. co-writer Rachel Cohrs.Previous language would have triggered the reforms at the start of 2025.
The bill due before the Senate's health committee this morning would require PBMs to pass 100% of rebates from drugmakers to health plans and ban spread pricing amid other measures designed to boost transparency around the industry middlemen. There's a host of amendments up for consideration today, too, as my colleague John Wilkerson reports, so nothing's set in stone.
The package has center stage, considering it's sponsored by HELP Committee Chair Bernie Sanders (I-Vt.), ranking member Bill Cassidy (R-La.) and others, but senators will also mark up bills aimed at boosting generic drug competition and clarifying market exclusivity for rare disease drugs.
Tobacco
Anti-tobacco groups rally against new vape bill
It might seem like new legislation to crack down on makers of disposable vapes like Puff Bar would have easy support from anti-tobacco advocates. But tobacco control groups are opposing a new bill, alleging it's a play by big tobacco companies to refocus FDA's energy off their (also popular) vapes, STAT's Nick Florko writes.
Those groups can't prove that tobacco companies like RJ Reynolds are behind the bill, dubbed the Disposable ENDS Product Enforcement Act, but they've pointed to nearly identical language in a Reynolds petition filed with the FDA just days earlier, and lobbying by both the North Carolina maker of Vuse vapes and Juul. Disposable vapes are popular with kids but those two popular brands can't be ignored, anti-tobacco advocates argue.
What's striking, as Nick notes, is that the legislation is sponsored by a group of Democrats typically aligned with those organizations, like Florida Rep. Sheila Cherfilus-McCormick, whose office said Reynolds had not lobbied them. Reynolds told Nick it supports the bill but denied it had any role in writing the legislation. Read more.
The courts
SCOTUS sets up for Chevron debacle
The U.S. Supreme Court signaled Monday that it's ready to hear arguments to limit a sweeping doctrine that favors federal agencies over courts in areas where regulatory oversight is unclear. The looming debate could have massive ramifications for health agencies already under fire in court cases surrounding Obamacare and the abortion pill approval.
One sentence in a fishery-related order released Monday set off the prospect that the four-decade-old concept known as Chevron deference could soon be dismantled or narrowed — a longtime conservative priority aimed at reining in agencies like HHS and EPA. As soon as this fall, the justices will hear arguments in Loper Bright Enterprises v. Raimondo on "Whether the Court should overrule Chevron or at least clarify that statutory silence concerning controversial powers expressly but narrowly granted elsewhere in the statute does not constitute an ambiguity requiring deference to the agency."
This panel of judges has entertained limiting Chevron in previous cases but backed away, like in last year's ruling on AHA v. Becerra. That case could have imperiled everything from drug market exclusivity to ACA subsidies (I wrote a rundown at my last job). But SCOTUS kept that decision narrow — Loper indicates they are ready to hear new arguments.
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