Overnight Health Care — Presented by Better Medicare Alliance — Juul CEO steps down amid public outrage | Altria, Philip Morris call off merger | FDA chief says agency ‘should have acted sooner’ on teen vaping

Welcome to Wednesday’s Overnight Health Care.

Washington has been dominated by Speaker Nancy Pelosi (D-Calif.) launching an impeachment inquiry against President Trump and there’s been plenty of speculation that the move could derail the congressional agenda for the rest of the year. But at least one Democrat is publicly optimistic about working with Trump on lowering drug prices. That Dem is Nancy Pelosi.

Meanwhile, there’s plenty of vaping news, starting with a big executive shakeup at Juul, two tobacco giants, Altria and Philip Morris, calling off a potential merger, and the head of the FDA admitting the agency could have moved faster to regulate e-cigarettes. 

We’ll start with Juul…

 

Juul CEO steps down amid public outrage over vaping

The CEO of Juul Labs stepped down Wednesday as the company faces a growing public outcry over the health risks of vaping, particularly among teens.

Juul also said it was halting all print, broadcast and digital advertisements in the U.S., effective immediately. The company also said it will refrain from lobbying the Trump administration on its draft guidance to ban most flavored vaping products, and will fully support and comply with the policy, which is expected in the coming weeks.

Kevin Burns will be replaced by K.C. Crosthwaite, an executive from Altria. The move could bring additional scrutiny to Altria’s acquisition of 35 percent Juul, a move that raised eyebrows among some officials and public health advocates when it was first announced.

Hill scrutiny: “Juul took Big Tobacco’s money and used Big Tobacco’s slick playbook to hook kids on addictive e-cigarettes and dangerous and deceptive vaping products. With a Big Tobacco executive now at its helm, Juul’s transformation is complete. It’s never been clearer: FDA must act to protect children from this insidious vaping industry,” said Sen. Richard Blumenthal (D-Conn).

The company is currently being probed by a House Oversight subcommittee, and lawmakers on the committee have threatened to subpoena Juul if the company doesn’t turn over documents by next week, including the contract with Altria.

Read more on Juul here.

 

 

Also, Altria and Philip Morris are no longer talking about a merger…

 

Altria, Philip Morris call off potential merger amid vaping crackdown

 Tobacco giant Philip Morris has called off talks of an impending $200 billion merger with Altria, the companies said Wednesday, amid the nationwide crackdown on vaping products and electronic cigarettes.

Instead, the companies said they will focus on launching IQOS, the “heat not burn” tobacco product from Philip Morris that gained FDA approval earlier this year.

“After much deliberation, the companies have agreed to focus on launching IQOS in the U.S. as part of their mutual interest to achieve a smoke-free future,” André Calantzopoulos, CEO of Philip Morris International, said in a statement.

The companies announced in late August they were considering a merger. Philip Morris separated from Altria in 2007.

Read more here.

 

New York state sued over flavored e-cig ban 

The Vaping Technology Association, the trade group representing e-cigarette companies (but not Juul), is suing New York over its ban on flavored e-cigarette products. 

They are seeking a preliminary and permanent injunction, arguing the rule is executive overreach and arbitrary and capricious. 

“Not only will the state’s arbitrary and misguided measure do nothing to address the marketing issues about which the state has complained, it is one of the worst examples of government overreach,” said Tony Abboud, executive director of the VTA. 

“Banning flavors for vapor products, while leaving all flavored combustible products on shelves, can only entice all users to smoke more.” 

Context: New York state health officials voted this month to ban sales of most flavored e-cigarettes, citing rising youth vaping rates. Michigan has also banned flavored e-cigarette sales and Massachusetts has banned sales of all e-cigarette products. 

 

FDA chief: Agency ‘should have acted sooner’ to curb teen vaping

The Food and Drug Administration (FDA) “should have acted sooner” to stop the epidemic of youth vaping, the agency’s acting commissioner told House lawmakers Wednesday.

“In retrospect, the FDA should have acted sooner, we should have begun regulating these devices sooner,” Ned Sharpless said. “But we’re going to catch up.” 

Sharpless said the agency is working to finalize guidance that will force e-cigarette manufacturers to submit their flavored products for review. When that happens, all current flavored e-cigarettes — except tobacco– will be removed from the market.

Background: FDA gained the authority to regulate tobacco products in 2009, but it wasn’t extended to vaping products until 2016. When the Trump administration took over in 2017, then-FDA commissioner Scott Gottlieb enacted a plan to reduce nicotine levels in traditional cigarettes and saw e-cigarettes as a potential tool to help people quit.

The FDA has come under fire recently from lawmakers and public health groups for its seeming unwillingness to regulate the vaping industry, even as teen use has skyrocketed. 

Sharpless noted that no e-cigarette product in the United States is on the market legally but pushed back on the notion that the administration is instituting a ban. 

“FDA is not banning flavors. Rather, FDA intends to enforce existing law,” Sharpless said.

Read more on the FDA chief’s testimony here.

 

Meanwhile, Georgia is reporting a vaping-related death 

State health officials in Georgia are reporting vaping-related deaths, bringing the nationwide toll to at least 10. 

Georgia health officials said the patient had a history of “heavy nicotine vaping”, but no reported history of vaping THC, the psychoactive component of cannabis. 

As of last Thursday, 530 cases of vaping-related lung illnesses had been reported to the Centers for Disease Control and Prevention. The agency is expected to update the numbers tomorrow.

The CDC said most patients reported vaping THC, but some vaped both THC and nicotine or only nicotine. 

Health officials do not yet know what is causing the illnesses and haven’t identified any specific e-cigarette or vaping products that are linked to all cases.  

But the CDC is warning people not to buy products off of the street or black market. 

 

And some news on drug prices…

 

Pelosi still hopes Trump will work with Dems on drug prices

House Democrats might have opened an impeachment inquiry against President Trump, but Speaker Nancy Pelosi (D-Calif.) still wants to work with him to lower drug prices. 

“I certainly hope so,” she told reporters when asked if Trump and Democrats can still work together to lower drug prices. 

Context: Pelosi unveiled her signature bill to lower drug prices last week, and is counting on Trump’s support to get it through the Senate. But congressional Republicans have denounced the bill as “socialism,” darkening the prospects for any bipartisan action on it. 

Trump on Pelosi: While Trump hasn’t commented on drug prices specifically, he said on Wednesday that he no longer considers Pelosi to be Speaker. Which could make working with her a little difficult. 

Trump on Wednesday said Pelosi had been taken over by the “radical left.” “Nancy Pelosi, as far as I’m concerned, unfortunately she’s no longer the Speaker of the House,” the president said.

 

 

What we’re reading 

Employer health insurance is increasingly unaffordable, study finds (The New York Times)

Opioid defendants air concerns ahead of federal trial in Ohio (The Wall Street Journal)

Valerie Jarrett turns to pushing women’s health to the forefront (Pittsburgh Post-Gazette) 

Health insurance costs surpass $20,000 per year, hitting a record (Bloomberg)

 

State by state

Juul’s spending on proposition to overturn SF’s e-cigarette ban soars (San Francisco Chronicle)

Some small Texas towns are declaring themselves ‘sanctuary cities for the unborn’ (Texas Tribune)

Public comment sought on Georgia doctors who don’t meet obligations (Atlanta Journal Constitution)

 

From The Hill’s opinion page: 

Vaping and your health — a clue to what’s causing the mystery outbreak and what we can do

Showing consumers health care pricing could lower costs