D.C. Diagnosis is STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.
Has Andy Slavitt gone full socialist? And what on earth does that mean for insulin prices?
If you’re an avid follower of #healthpolicytwitter, you may have seen a pretty head-turning statement from former CMS Administrator Andy Slavitt: “Yes, I went full socialist.”
The eyebrow-raiser came after Slavitt endorsed a plan to nationalize insulin and make it a “public good” — and when I caught up with Slavitt for a brief interview, he didn’t back down. He made the argument that insulin is an essential part of life for people with type 1 diabetes, much like water. “We wouldn’t sell bottled water at $80 a bottle,” he told me. He also isn’t buying the argument that tweaks around the edges can solve the insulin affordability issue. Slavitt emphasized that the rising price of insulin was “ripe for a bold solution,” and he was quick to differentiate the drug pricing issues around insulin from “big problems” that “require more complex solutions.” (He brought up the price of CAR-T drugs as a more complex problem.)
Such a statement likely sent shivers down the spine of drug pricing lobbyists, who have done their best to steer congressional lawmakers toward tweaks around the edges rather than sweeping changes to the way America prices drugs. Combine this with the fact that Slavitt has said he’s brought up nationalization with congressional lawmakers, and you have a pretty scary situation (for drug makers, that is).
Slavitt acknowledged, too, that his embrace of nationalization is a negotiating position. (Translation: It’s not happening any time soon.) “‘All things should be on the table’ is the way you should interpret my suggestion,” Slavitt said. “I think there has to be a credible threat to the industry.” He told me he isn’t pushing specific legislation that would nationalize insulin at this point. (And per my research, no such bill even exists right now, though Massachusetts Democrat Sen. Elizabeth Warren has a bill that would direct the U.S. government to make its own generic drugs.)
“What I’m trying to add to the dialogue is a sense of urgency,” he said.
The FDA gets its marching orders
FDA nerds, rejoice! On Monday, congressional appropriators released their report language for the 2020 FDA funding bill. For the uninitiated, this is where appropriators get to not-so-subtly demand what the FDA works on next year, and also what it wants the FDA to stop doing. As is often the case, the report is long, and covers a hodgepodge of oddball issues like the weight of canned tuna, early retirement for chimps, and even pentobarbital in dog food. (Do I have your attention now?)
Here’s three not-so-oddball issues that caught my eye:
- Congress is backing stronger regulation of cosmetics and dietary supplements, and they’re willing to put up the money to support those efforts. (Or at least, they’re willing to put it into the report.) The committee has promised an additional $3 million for the FDA’s dietary supplement office and $4 million for its effort to begin actually regulating cosmetics. More funding may be coming, too, at least in the cosmetic space — appropriators are requesting a briefing on “the staffing and budget resources it would need to improve its oversight of cosmetics, including whether the agency believes user fees would help to improve such oversight.” (A friendly reminder that Congress would still have to pass these funding bills for the FDA to get these funds.)
- Appropriators seem to be softening on the FDA’s regulation of compounding. In the past, appropriators have made no bones about their gripes with the FDA’s approach toward compounding, but the tenor doesn’t seem so tense this time around. Though they’re still requesting a briefing with the FDA on the hot-button issue of “office use compounding,” appropriators also seem to be realizing that the agency isn’t going to altogether switch up their approach. For example, they applauded the FDA’s new draft agreement with states over compounding regulation, even though groups like the International Academy of Compounding Pharmacists are still pushing for sweeping changes to the agreement.
- Appropriators are leaning on the FDA about as hard as they can to get something done on CBD. The committee writes that it expects the FDA to find a way to allow CBD supplements, while also making sure there’s a reason for drug makers to put CBD drugs through the FDA approval process. If you’re thinking, “Well, how hard could that be?” then you clearly weren’t in the room Friday when the FDA heard from more than 100 speakers, all of whom had their own ideas on how to regulate CBD. The co-director of the FDA’s CBD working group, Dr. Amy Abernethy, summed it up well. She said on Twitter that she “Appreciate[s] a speaker’s observation: ‘You guys have a tough job. Good luck with that.'” She added: “Indeed.”
(Want to know more about CBD? May I suggest my dispatch from Friday’s meeting, my deep dive on the regulatory issues around CBD, or my interview with recent commissioner Scott Gottlieb?) Stay tuned for more — we aren’t done yet!
Did Novartis convince Washington to placidly accept the price of its multi-million dollar gene therapy?
So says Sloan Kettering’s Peter Bach, who argues in a new opinion piece for STAT that because Novartis had thrown out prices as high as $5 million for Zolgensma, its ultimate asking price, $2.1 million, stung less. Bach may have a point — Washington has been shockingly mum over the Zolgensma news … which, you know, isn’t normal in a town that relishes the opportunity to chide drug makers.
Speaking of Zolgensma pricing, I have to tip my hat to my former colleague John Wilkerson who has some fascinating details on how Novartis is contracting with a specialty pharmacy to administer payment plans for the drug. The move shields Novartis from being liable for Medicaid’s best price requirements — and it’s already courting controversy.
“If Novartis set a reasonable price for Zolgensma in the first place, the company would not be tied in knots trying to justify why refunds shouldn’t mean lower prices for all patients covered by Medicaid,” Jon Conradi, a spokesperson for the Campaign For Sustainable Rx Pricing, told me.
Novartis didn’t immediately comment.
The debate over expanded access is heating up again, folks!
My colleague Matt Herper sat down yesterday with Dr. Richard Pazdur, the director of FDA’s Oncology Center of Excellence, to discuss a new agency initiative that is intended to make it easier for physicians to request access to experimental cancer treatments. Don’t get too excited: It largely builds on the FDA’s existing expanded access pathway, whereby doctors can request the FDA’s go-ahead to give patients unapproved drugs, so long as the drug makers developing those drugs have also agreed to the plan. Under the FDA’s new pilot plan, the agency will launch a call center staffed by the FDA’s oncology experts that will answer doctors’ questions and even help with the requisite paperwork. Changing the expanded access process has been a goal of Pazdur for years, he told Matt. “I think this is a more equitable process,” he added.
And in case you missed it, I have a new story out about one patient’s efforts to speed up the FDA’s expanded access process — a crusade that even led them to enlist a striking coalition of lawmakers to pressure the FDA. The piece examines all the ethical issues that pop up when lawmakers start trying to pressure a government agency on a single patient’s behalf.