Overnight Health Care – Presented by Kidney Care Partners – FDA chief’s exit casts cloud over vaping crackdown | Agency approves ketamine-like drug for depression | Senators want probe into abuse of minors at HHS facilities

Welcome to Wednesday’s Overnight Health Care, where we learned a little more about how Scott Gottlieb sees the future after his resignation…

 

Gottlieb says youth vaping crackdown will continue

FDA Commissioner Scott Gottlieb sent out shockwaves Tuesday by announcing his resignation.

We had the good fortune of having Gottlieb at an event hosted by The Hill this morning, where he said he thinks work on his signature initiatives will continue.

Gottlieb said his departure won’t have any impact on the agency’s crackdown on youth vaping.

“I’m very confident of that, and I’m very confident that we’re going to continue with this policy over the next month, including the policy that we’ve been formulating,” Gottlieb said.

Gottlieb has proposed limiting the sales of most flavored e-cigarettes to age-restricted, in-person locations, effectively ending sales at gas stations and convenience stores.

“I think there is widespread recognition that this is a major public health crisis. I think for the vaping community and the tobacco industry this is an existential threat,” he said.

Read more here.

 

 

 

 

But despite Gottlieb’s assurances, anti-tobacco groups are worried his departure comes at a difficult time. They say there are questions about whether the agency will be as aggressive cracking down on tobacco companies and teenage vaping. The Hill’s Jessie Hellmann has more on that.

 

Uncertainty over FDA vaping crackdown

What the groups are saying: “He is leaving at a uniquely sensitive time,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “If his departure means the promises he’s made don’t get adopted, then literally an entire generation of kids is at risk.”

“I don’t think I ever remember a public official leaving at a time when there is more at stake that will impact whether his legacy is one of extraordinary achievement, or of not doing anywhere near enough,” Myers added.

Analysts see his exit as good news for the industry:

Tobacco stocks went up after Gottlieb’s announcement, and analysts say his departure is likely good for the industry. “We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives,” Wells Fargo analyst Bonnie Herzog said in an email to clients.

More on that here.

 

Feinstein, Grassley call for investigation into sexual abuse of minors at HHS facilities

Sens. Chuck Grassley (R-Iowa) and Dianne Feinstein (D-Calif.) are calling on the Department of Health and Human Services (HHS) inspector general to investigate reports of rampant sexual abuse against children in government facilities at the southern border.

“We respectfully request that you open an investigation into the alleged widespread and long-term pattern of sexual abuse against unaccompanied children in HHS facilities and reports that these cases of sexual assault are not being appropriately investigated,” the senators wrote in a letter to Inspector General Daniel Levinson.  

“Immigrant families and children kept in federal custody deserve to be treated with basic human dignity and respect, and should never be subjected to these forms of abuse,” they added.

HHS “is currently reviewing the correspondence referenced,” a spokesperson for the agency said in a statement to The Hill on Wednesday.

Read more here.

 

Grassley hits pharma on Creates Act

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is not having any of pharma’s talk about modifying his signature drug pricing bill.

“Big pharma’s talking out of both sides of their mouth,” Grassley told reporters on Wednesday. “They want to adjust it to satisfy them; we’re moving ahead the way it is right now.”

The Creates Act would crack down on gaming techniques drug companies use to delay competition from cheaper generic drugs.

Multiple drug company CEOs said they supported the bill at a Finance Committee hearing last week, but the trade group PhRMA later said it wanted the bill to be “modified” to cut down on “frivolous litigation.”

 

More Grassley… Chairman open to an out-of-pocket cap in Medicare

The top Democrat on the committee, Sen. Ron Wyden (Ore.), has a bill to cap seniors’ out of pocket costs for drugs in Medicare, and has spoken to HHS Secretary Alex Azar about it.

Grassley said he has not spoken to Wyden about it but is open to the idea.

“We need to look and see if that’s possible, [if] what it costs is going to be possible, at what level do you set it and all of these things would be pretty negotiable, I’d think would have to be negotiable,” Grassley said.

“There’s kind of been a general assumption expressed that there ought to be some sort of cap,” he added.

 

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FDA approves use of ketamine-like drug to treat depression

The Food and Drug Administration (FDA) has approved a ketamine-like nasal spray drug to help drug-resistant depression.

Spravato is made from a chemical called esketamine, which is similar to ketamine, a popular club drug. This is the FDA’s first approved use of esketamine.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, the FDA’s acting director of psychiatry products, in a Tuesday news release.

Spravato will not be given directly to patients for home use, according to a pharmaceutical spokesperson. Instead, patients will use it under the observation of a health care provider.

Read more here.

 

What we’re reading

With Gottlieb’s resignation, the Trump administration loses its backroom whisperer on Capitol Hill (Stat News)

Scott Gottlieb was one of the few Trump officials taking on the opioid crisis. Now he’s out. (Vox.com)

Bernie Sanders attacks Donald Trump over proposed cuts to Medicaid, Medicare, disability fund (PolitiFact)

 

State by state

Illinois lawmakers push for Medicaid managed care reform (Chicago Sun-Times)

Health care providers protest against Cuomo’s proposed Medicaid cuts (Watertown Daily Times)

 

From The Hill’s op-ed page

Trump, GOP continue to undermine protections for people with pre-existing conditions