Overnight Health Care — Presented by PCMA — FDA says Juul illegally marketed e-cigarettes | AMA warns against vaping after deaths | Two Planned Parenthood clinics to close in Ohio

Welcome to Monday’s Overnight Health Care. 

Congress is back with a daunting to-do list and facing a time crunch. In today’s big health news, the FDA said Juul was illegally promoting its products. Also, there’s more fallout from the Trump administration’s Title X rule, and Senate Dems have questions about the decision not to vaccinate families held in migrant detention centers.

We’ll start with the news on Juul…

 

FDA says Juul illegally marketed e-cigarettes

Federal health authorities blasted e-cigarette maker Juul on Monday, saying the company illegally marketed its products as a safer alternative to traditional cigarettes. 

In a warning letter to the company, the Food and Drug Administration (FDA) said Juul “ignored the law” and unless corrective actions are taken in the next 15 days, the agency could fine the company or even seize its products.

Why Juul is on the hot seat: The warning letter comes after the agency said it reviewed testimony made by Juul executives during a House Oversight and Reform subcommittee hearing in July.

According to the warning letter, Juul’s labeling and advertising activities deliberately misled customers by saying the products are less harmful than cigarettes and would represent a lower risk of a tobacco-related disease.

Companies need FDA approval to claim their products are less harmful than traditional cigarettes, and Juul did not have that. 

FDA is also asking Juul to turn over information about its marketing, educational programs and nicotine formula.

FDA under pressure too: Rep. Raja Krishnamoorthi (D-Ill.) began investigating Juul earlier this summer, and FDA’s letter relied heavily on testimony given during a two-day hearing he held just before recess. FDA has been investigating the company for months, but had not previously taken action. Sen. Dick Durbin (D-Ill.), the No. 2 Democrat in the Senate, has been hammering FDA for failing to take action to stop a massive surge in teen vaping, and late last week threatened to call for the resignation of acting FDA Commissioner Ned Sharpless if nothing happened. It’s unclear if the warning letter will be enough to placate the critics, but it’s certainly a start. 

Read more here.

 

 

So, will be that enough for Democrats? (Probably not.)

 

DeLauro says FDA should remove all e-cigarettes from the market after deaths linked to vaping

Rep. Rosa DeLauro (D-Conn.) is seizing on the recent spate of vaping-related illnesses to call on the FDA to do more. More than 450 people have fallen ill across 33 states, and 5 people have died. Federal health officials have asked consumers to consider not using e-cigarette products.

“From when e-cigarettes first came to market until now, FDA has continually shirked its regulatory authority and failed in its mission to protect public health,” said DeLauro, chairwoman of the Labor-Health and Human Services Appropriations subcommittee. 

 “As a consequence, today there are thousands of e-cigarette products on the market without any independent, science-based assessment of their long-term health risks, the safety of their ingredients, or their impact on youth tobacco initiation.” 

“Enough is enough: FDA must immediately enforce existing law and ban the sale of all harmful e-cigarette products that have not undergone a premarket review of their health risks.”

However, there has been no direct link to any specific products. Most patients reported using e-cigarettes containing elements of marijuana, like THC. Some patients reported using nicotine e-cigarettes as well, but the primary link was cannabis products that were often sold on the black market. 

 

American Medical Association urges public to avoid e-cigarettes after deaths 

The nation’s largest doctor’s group is urging the public to avoid using e-cigarettes until health officials figure out what’s causing vaping illnesses and deaths. 

“In light of increasing reports of e-cigarette-associated lung illnesses across the country, the AMA urges the public to avoid the use of e-cigarette products until health officials further investigate and understand the cause of these illnesses,” said AMA President Patrice Harris. 

“The e-cigarette-related lung illnesses currently sweeping across the country reaffirm our belief that the use of e-cigarettes and vaping is an urgent public health epidemic that must be addressed.” 

Harris urged the FDA to “speed up” its regulation of e-cigarettes and remove all unregulated products from the market. 

The Centers for Disease Control and Prevention is also encouraging the public not to use e-cigarettes as it continues its investigation into the 5 deaths and 450 possible illnesses tied to vaping. 

 

Two Planned Parenthood clinics to close in Ohio after funding cuts

Planned Parenthood on Monday announced that two of its clinics in Ohio will close later this month after losing state and federal funding.

The organization blamed the closures on politicians who moved to “defund” Planned Parenthood for performing abortions. Neither of the two clinics performed the procedure, Planned Parenthood said.

“Cincinnati is the last place politicians should be forcing health centers to close,” said Kersha Deibel, president and CEO of Planned Parenthood Southwest Ohio Region.

“This is the world they want to see: one where women lose access to birth control, where information about how to access abortion is held hostage, and where, if you don’t have money, it’s almost impossible to access an STI test or a cancer screening.”

The two clinics will close their doors for good on Sept. 20; the five other clinics in that part of the state will remain open.

Context: This is a win for anti-abortion advocates, who don’t support Planned Parenthood and think it should not get any state or federal funds. Planned Parenthood gave up millions of dollars in federal funding last month after the Trump administration said the group would need to comply with a new rule banning it from referring women for abortions. 

Republican state legislators in Ohio cut about $600,000 in state funding to Planned Parenthood this year after winning approval from a federal appeals court.

Read more about the Planned Parenthood closures here.

 

What we’re watching this week: 

The House Energy & Commerce Committee is holding a hearing Tuesday at 10 a.m. on several bills related to maternal health. 

The House Committee on Small Business has a hearing on Wednesday at 11:30 a.m. on the challenges faced by small medical practices.

The next Democratic presidential debates are on Thursday. 

And the Senate is set to start work this week on funding bills, including one on labor, health and human services and education.

 

Biotech lobby warns drug pricing proposals would hinder new treatments 

Speaker Nancy Pelosi’s (D-Calif.) plan to lower drug prices is expected to come out soon, and the Biotechnology Innovation Organization (BIO) did some pre-emptive pushing back on Monday. 

BIO CEO Jim Greenwood told reporters that his industry is facing the “most stiff political winds in the history of the industry.”

He warned that the smaller biotech companies he represents rely on attracting investors, and no one will want to invest in an innovative new drug if its price will be set by a third-party arbitrator, as Pelosi is proposing. “Who would invest in that?” Greenwood said. 

He emphasized a cap on patient’s out-of-pocket costs as an alternative solution. 

He said he expects the vehicle for enacting any drug pricing legislation will be the year-end government funding package. 

Bigger picture: The pharmaceutical industry is on high alert given all of the building pressures for action, from President Trump to Capitol Hill. But it remains unclear what, if anything, will actually happen, given that industry remains powerful and many congressional Republicans remain opposed to much action. 

 

Senate Dems question Trump administration’s decision not to give flu shots to some migrant families 

Sen. Elizabeth Warren (D-Mass.) and other Senate Democrats are pressing the Trump administration about its decision not to give flu shots to migrants being held at Customs and Border Protection’s holding centers. 

The senators noted that three children died in CBP’s custody, in part, from the flu. 

“This dangerous decision not to administer vaccinations for a disease that has already proven fatal to migrant children in CBP’s custody is immoral and irresponsible, placing entire communities at risk of the flu and its associated complications,” the senators wrote. 

“CBP must do more to ensure the health of migrant families under its care, and we strongly urge the agency to reconsider its plan not to vaccinate those in its custody.”

Backstory: CBP has said flu vaccinations aren’t necessary due to the “short term nature of CBP holdings.” Once children leave CBP detention centers and are transferred to the Department of Health and Human Services, they are given full medical screenings upon arrival, as well as any needed vaccinations, including the seasonal flu vaccine, an agency spokesperson said. But the transfers out of CBP custody may not happen immediately, and children have been held in overcrowded conditions that make it easy for infectious diseases to spread quickly among those who are not vaccinated. 

Flu is incredibly contagious and the Centers for Disease Control and Prevention recommends annual vaccinations for everyone older than 6 months. Pregnant women, young children and adults older than 65 are all at greater risk for flu complications. 

Read the letter here.

 

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What we’re reading

This app saves money on prescriptions ― and shows how messed up drug prices are (HuffPost)

The 2 big health care fights coming up this fall (Vox.com)

The deep-pocket push to preserve surprise medical billing (Kaiser Health News)  

 

State by state

ACLU: Kansas inmate could die without opioid-addiction meds (Associated Press) 

‘UVA has ruined us’: Health system sues thousands of patients, seizing paychecks and putting liens on homes (The Washington Post) 

New York Gov. Cuomo says he plans to ban flavored e-cigarettes amid vaping health concerns (ABC News)