Nicholas Florko

Hello, D.C. Diagnosis readers. It was great to see some of you this weekend in Austin at the annual meeting of the Association of Health Care Journalists. I came away from the confab with tons of story ideas, and a lot of pride in this job. If you attended, I hope you came away feeling the same. I also hope you ate your weight in migas tacos like I did. I’m at nicholas.florko@statnews.com.

Earmarks are back, and one state’s health care industry is cashing in

Missouri hospitals, medical schools, and health clinics have benefited especially from Congress’ decision to bring back earmarks, the controversial process where lawmakers can direct federal funds to specific projects in their states, STAT’s Rachel Cohrs reports. Rachel’s sleuthing reveals that of the 10 biggest health-focused earmarks, five went to Missouri institutions.

So why exactly did Missouri benefit so handsomely from the new policy? A very influential senator. All of the high-profile Missouri earmarks were requested by Sen. Roy Blunt, the top Republican on the Senate’s health care-focused appropriations committee.

But Missouri isn’t the only state benefiting from the new policy. The biggest health care earmark of all actually went to another southern institution: the medical school at the University of Alabama at Birmingham. The school’s $76 million earmark was requested by the state’s Republican Sen. Richard Shelby.

More from Rachel here.

Bad news for fans of FDA advisory committees

If you’re an FDA nerd like me, you’ve probably sat through your fair share of FDA advisory committee meetings, those day-long debates between professors and FDA officials about statistical analysis, pharmacokinetics, and clinical study designs. There’s no way around it: They’re boring. But they provide an unparalleled window into the FDA’s decision making process for drugs and devices that could mean the difference between life and death.

If you’re a fan of those advisory committee meetings, this new study in Health Affairs might concern you. The FDA is using the advisory committee system far less than it did a decade ago, the new study found. In 2010, the FDA was asking for experts’ advice for roughly half of its drug approval decisions, but by 2021, that number dropped to just six percent.

In a new story for STAT, my colleague Ed Silverman unpacks why experts say the FDA’s “I got this” attitude is a growing problem. The story also includes hints of why the FDA might be less and less keen to convene these experts – fresh with some pretty spicy criticisms of the process that were lobbed by FDA Commissioner Robert Califf during this week’s AHCJ confab.

Got questions about Congress’ new insulin idea? We’ve got (some) answers

The next four weeks are going to be a crucial sprint that could determine the fate of a new insulin pricing proposal championed by Sens. Jeanne Shaheen (D-N.H.) and Sen. Susan Collins (R-Maine), my colleague Rachel Cohrs reports.

The make-or-break issue is whether Senate Majority Leader Mitch McConnell (R-Ky.) will let 10 of his GOP caucus members support the narrow insulin pricing policy to get it across the finish line. On one hand, it’s a wildly popular idea; on the other, passing the bill would be a win for vulnerable Democratic incumbents, particularly Sen. Raphael Warnock (D-Ga.), in an election year. A McConnell-aligned super PAC has already reserved $37 million in ads this cycle in Georgia alone, its spendiest target of the cycle. We’ll be in the hallways asking lawmakers what they think, and accepting tips as always.

The road ahead is paved with difficult, if not impossible, politics. But it’s also worth examining whether this policy could even work. Would drugmakers actually lower their prices voluntarily? Who would it actually help? Would premiums go up? Here's what we know right now.

The highlights of Rob Califf’s recent speaking tour

The FDA commissioner has been busy with public appearances in recent days — he had his first formal appearance before Congress, he joined us at AHCJ, and he spoke to a conference in Atlanta about his plans to tackle the opioid crisis. Here’s what caught our eye.

On Aduhelm: The commissioner was pressed on the FDA’s controversial decision to approve Biogen’s Alzheimer’s drug Aduhelm over the objections of its expert panel.

Califf argued that the FDA overruling an advisory committee vote isn’t unusual, and he sparred with a reporter who suggested that Medicare officials at CMS “countered” the FDA when they decided to limit access to Aduhelm to patients enrolled in clinical trials.

“I don’t think it’s an appropriate framing of the question to say that our decision was countered by CMS,” Califf said, adding that the FDA and CMS use different standards to determine whether they will, respectively, approve a drug and pay for it.

I also asked CMS Administrator Chiquita Brooks-LaSure if she expected CMS to more frequently limit coverage of drugs approved through the FDA’s accelerated approval pathway. She insisted that those decisions will be “very rare.” Read more here.

Related: UnitedHealthcare restricts coverage of Aduhelm, following Medicare’s decision.

On importation: I asked Califf about whether he wants to see the FDA finally let a state import drugs from Canada. I’m curious because a number of states in recent months have asked the FDA for permission to do just that, and Califf has been skeptical of the idea in the past. But he declined to say whether he still feels negatively about importation now that he’s in the FDA’s top job. Instead, he argued that the FDA will judge those importation requests by the standards it set out in its 2020 importation regulation.

“My opinion is irrelevant,” Califf said. “We have a law and a rule and that’s what we will go on.”

He also sparred with another reporter who asked for an update on the FDA’s deliberations over the most high-profile importation request, which was filed by the state of Florida in Nov. 2020. “Come on, you know I can’t comment on pending applications,” Califf said. When the reporter asked for a general timeline for when the agency would decide on applications, Califf shot back that a general timeline “is not useful.”

On opioids: Califf also emphasized during the AHCJ conference that the agency needs to tackle the growing trend of mail order fentanyl and methamphetamine, and he foreshadowed that he wants to push for the greater use of technology to help FDA inspectors at mail facilities who are often tasked with finding these drugs. The remarks come on the heels of similar comments Califf made at the annual Rx and Illicit Drug Summit in Atlanta on April 20.

Califf has been not-so-subtly requesting that Congress give the FDA more authority to be more selective when deciding which opioid applications to approve. He said during the April 20 meeting that the FDA needs additional authority to only approve opioids that are proven to be safer than what’s currently on the market. He made a similar pitch to Senate appropriators during a committee hearing last week.

The faces of the latest telehealth lobbying blitz

Health tech companies are spending big to expand the sort of care patients can receive in their homes through telehealth, but, as my colleague Mohana Ravindranath writes in a new story for STAT, what type of care will eventually be offered will largely depend on whether Medicare will pay for these services. That means, of course, that there’s a growing list of lobbyists and lawmakers in Washington who are laser focused on convincing Medicare it should pay for these services. Read more here.