'Medicare For All' drives the week

It’s a big week for "Medicare For All"— and though it might not sound like it, that means it’s a big week for drug pricing. Those progressive proposals wouldn’t just shake up the countries’ insurance system, they would also drastically rework the country’s drug pricing system.

At least one witness at today’s hearing on the idea, the Center for Economic and Policy Research’s Dean Baker, told STAT he plans to highlight lower drug prices as a result of Medicare For All as “probably the biggest single area for potential savings.”

If you need more proof of how the fight over drug pricing and Medicare For All are intertwined: See my dispatch from yesterday’s Medicare For All rally outside of PhRMA headquarters, where one popular Medicare For All advocate led the crowd in a chant of: “I hate PhRMA.” The story.

So, how would Medicare for All impact drug prices?

Both the Senate M4A bill, sponsored by Sen. Bernie Sanders (I-Vt.), and the House version, sponsored by Rep. Pramila Jayapal (D-Wash.), would require the government to directly negotiate with drug makers and ultimately set up a national drug formulary. The bills differ slightly in how they direct the government to set up that formulary: Sanders’ bill simply says that the formulary should “encourage best practices in prescribing and discourage the use of ineffective, dangerous, or excessively costly medications when better alternatives are available,” while Jayapal’s bill directs the government to consider a slew of factors, including: comparative effectiveness, the budgetary impact of covering a drug, the number of alternatives and, strangely enough, global sales and R&D investment for the drugs.

One big difference: I was struck by how the two bills handle a stalemate where the government and drug makers can’t agree on the price paid for a drug. Sanders’ bill would direct the government to just pay the lowest price paid by other government programs like the Department of Veterans Affairs. Jayapal’s bill has a slightly bigger stick: If negotiations fell through the government could let a lower priced competitor come on the market, via so-called competitive licensing. If this sounds familiar, it’s because it’s the same idea behind Rep. Lloyd Doggett's (D-Texas) Medicare negotiation bill.

A floor vote on drug pricing legislation? Before Memorial Day?

The House Judiciary Committee is marking up four drug pricing bills today — bringing House Democrats one step closer to a floor vote on some kind of drug pricing legislation. Both progressive activists and drug lobbyists all told STAT that they expect a floor vote before Memorial Day, with two lobbyists telling STAT they expect a vote within the next two weeks. Buckle up!

The four bills are: The CREATES Act, which is meant to incentivize generic competition; the “Preserve Access to Affordable Generics and Biosimilars Act,” which would ban so-called pay-for-delay agreements; the “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act,” which would crack down on abuses of FDA citizen petitions; and the “Prescription Pricing for People Act of 2019,” which would direct the FTC to study the role of pharmacy benefit managers.

Can Ned Sharpless command a room of lawyers like Gottlieb?

Acting FDA Commissioner Ned Sharpless is slated to give the keynote address at the annual confab of food and drug lawyers known affectionately as FDLI on Thursday. It’s one of Sharpless’ first high-profile public appearances since taking the job earlier this month — and it could be a big one. At last year’s FDLI keynote Gottlieb, delivered a more than 5,000 word manifesto that spilled the beans on the administration's plan to eliminate drug rebates (talk about making news.)

What Sharpless will chose to focus on remains to be seen. He’s made it clear that he’s eager to support FDA’s work on nutrition, and has committed to modernizing how FDA regulates dietary supplements, even calling a public meeting on the topic, scheduled for next month. FDA lawyers love debating the gray areas of the agency’s portfolio, so the audience would likely be overjoyed to hear Sharpless’ take on those topics.

But the most important question: Will Sharpless command the sprawling well-dressed conference room like Gottleib once did? Sharpless already seems to have his lawyer jokes honed: During his first address to FDA staff he joked that the “thorny problems” of “electronic nicotine delivery systems (ENDS), gene therapies, CBD oil, genetically modified animals, cell cultured meat (and pet food)” all played a role in why “we have so many lawyers around.” He’s not exactly George Carlin, but it’ll do ...

What else you need to watch this week:

The Energy and Commerce health subcommittee will hear today from Jim Matthews, the head of the congressional medicare advisors known as MedPAC. It’ll be a chance for Matthews to pitch lawmakers on the drug pricing ideas endorsed by his commission, and for lawmakers to get Matthews’ take on the Trump administration’s proposals.

Patients for Affordable Drugs is holding a congressional briefing today at 3:30 about the Trump administration's international pricing index. HHS drug pricing guru John O’Brien is slated to speak, along with drug pricing experts Peter Bach, Avik Roy, and Rena Conti. (The event, sadly, is restricted to congressional staff.)

PhRMA is holding its annual researcher fly-in today, too. The group is expected to fly in more than 60 researchers who will meet with lawmakers to espouse the work being done in drug industry labs. (Good timing!)

For CRISPR nerds, the American Society of Gene & Cell Therapy is holding its annual meeting this week, through Thursday. For those not into reading scientific abstracts, there will be panels on the FDA’s regulation of the technology, as well as discussions on paying for the costly treatments. I’ll be watching to see if there’s any mention of CRISPR babies, given the group just last week wrote to HHS Secretary Alex Azar to urge the administration to support a moratorium on so-called germline editing.

Worth your time

Bloomberg dives deep into the "U.S. Rural Health Network," a two-year-old nonprofit mysterious to rural health officials, funded by dark money, and best known for pushing back against proposals to lower drug prices. — Lev Facher

In state legislatures, Juul claims to support legislation raising tobacco-purchase ages to 21. Public health advocates who've watched them ban cities from restricting vape sells tell a different story, Sheila Kaplan writes in the New York Times. — Lev Facher

STAT sat in on a drug pricing debate some 400 miles away from Washington, at Harvard. And the distance wasn’t the only thing that made this one stand out from the typical D.C. conversations. — Erin Mershon

The Atlantic has a fascinating look at “loopers,” biohackers with diabetes who tweak discontinued insulin pumps to largely automate their diabetes management. — Nicholas Florko