FDA's halloween scare

The agency's Monday meeting on "candy-like" drug products wasn't a party, despite participants being offered gummy teeth as a lunch snack from a dentist. They spoke passionately about the potential benefits of sedating kids for dental work with medicated gummy bears. Not everyone was convinced.

Most speakers at Monday's meeting stressed the potential pitfalls of these products, like accidental overdose, Nick Florko reports. Several speakers emphasized that there are several, albeit less-fun ways to medicate kids who can't swallow pills, ranging from intranasal to rectal administration. Some emphasized, too, that children should simply be taught to swallow pills.

It's unclear what, if any, regulatory action will come out of the meeting. There's also not great data on the size of the "candy-like" drug market, though one speaker from the United Kingdom highlighted how these products are increasingly being offered in new forms, including films that resemble Listerine breath strips and classic flying-saucer-like wafers. Read more on the debate (and snacks) from Nick here.

Drug imports

Are we there yet?

For those of you who hoped that today, after two filed lawsuits and more than 1,000 days of deliberation, the Food and Drug Administration would finally tell Florida Gov. and would-be president Ron DeSantis whether his state may import Canadian prescription drugs, my colleague John Wilkerson has some frustrating news for you: You're going to have to wait a bit longer.

In August, government lawyers told a federal judge that the FDA would make a decision on Florida's drug import plan by today, regardless of whether state officials met the FDA-imposed Aug. 28 deadline for submitting additional information on its import plan. Florida missed that deadline and instead filed an amended plan. That tactic bought more time. Florida submitted the new plan Oct. 20, and the FDA said it could, just maybe, finish reviewing the updated plan within 60 days of receiving it. However, the agency added that the updated plan might raise more questions.

Florida also lowered the estimated savings from drug importation from $150 million annually to $100 million.

on the hill

Senate panel slates major health legislation

The Senate Finance Committee plans to vote Nov. 8 on legislation that includes substance misuse and mental health policies, reforms to drug middlemen's business practices, and extensions to provider payment policies in Medicare and Medicaid, Rachel Cohrs and John Wilkersons scooped late Friday.

The legislation would package together versions of health care policies that the committee has been working on for some time, according to five health care lobbyists.

Among the bills are a provision that would make it easier for state Medicaid programs to cover services for prisoners with substance use disorders; Medicaid and Medicare payment extensions; and reforms to pharmacy benefit managers.

surprise billing

Plenty of surprises in the doctor-hospital deadlock

Physician staffing firms, flailing in the wake of a federal law banning surprise bills, are demanding extra payment from hospitals to stay afloat. Hospitals, desperate for doctors to staff their facilities, have little choice but to comply, STAT's Tara Bannow reports.

Physician subsidies are up 20% from last year, according to for-profit hospitals' earnings calls. It's apparently just as bad for not-for-profit hospitals too. It's happening partly because companies like Envision, which employ the doctors that staff many emergency departments and operating rooms, can no longer pad their bottom lines by "balance" billing patients for anything their insurance doesn't cover. The No Surprises Act banned that practice at the beginning of 2022.

For patients, that law has mostly eliminated enormous surprise bills. On the other hand, as Tara writes, it played a big role in Envision's bankruptcy and the folding of American Physician Partners. Get into the details with Tara here.

in the weeds

How much [regulated, celebrated] weed is too much?

It's been nearly 10 years since Colorado legalized recreational marjuana use. The state is a pioneer in supplying and regulating the drug, so it's no surprise they are dealing with the fallout of an easily accessible and sometimes problematic system. But what happens next?

The Colorado cannabis industry has generated over $2 billion in tax revenues that have funded building public schools and setting up bullying prevention programs, STAT's Nick Florko reports from Denver. Youth cannabis rates have not skyrocketed. Neither has crime.

It sounds ideal, especially as other states weigh similar plans. But, as Nick writes, a decade later, Colorado is still grappling with several major public health, business, and equity questions that could determine whether its efforts are a lesson in innovative public policy or in one state's hubris to think it could single-handedly unwind the consequences of the decades-long war on drugs. Read more from Nick.

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