Health Care – FDA: Juul must stop selling vapes
Your Amazon Alexa might someday be able to mimic the voices of your dead relatives, which is about as morbid as it is interesting. Cue “Black Mirror” intro.
In health care news, Juul’s in trouble after the FDA finally acted on the company’s marketing application.
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FDA bans sale of Juul e-cigarettes
The Food and Drug Administration (FDA) said Thursday that it is banning the sale of Juul e-cigarettes, a major blow to the company that was blamed for the youth vaping epidemic.
- The agency said Juul did not prove that keeping its products on the market “would be appropriate for the protection of the public health.”
- Consumers who already bought and currently use Juul pods won’t be restricted, the FDA said.
The move is part of a broader FDA review of the vaping industry as the agency decides which products to allow on the market. The FDA has authorized some e-cigarette applications in the past year, but they have not been the products with major market share.
Safety concerns: The FDA’s action was not related to youth vaping.
The agency said the marketing denial was because the company provided “insufficient and conflicting data” about potentially harmful chemicals leaching from its e-liquid pods.
But it’s hard to overlook: FDA Commissioner Robert Califf in a statement indicated Juul “played a disproportionate role in the rise in youth vaping.”
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Califf said.
Juul is no longer among the top brands favored by kids, since it no longer sells fruit-flavored cartridges. According to the government’s annual National Youth Tobacco Survey, fewer than 6 percent of current high school-age youth said they prefer Juul.
Panel OKs Moderna two-dose vaccine for kids 6-17
An advisory panel for the Centers for Disease Control and Prevention (CDC) on Thursday gave the green light to Moderna’s vaccine for kids 6-17, bringing it closer to becoming the second vaccine in the U.S. eligible for use in children.
The CDC’s Advisory Committee on Immunization Practices (ACIP) on Thursday unanimously endorsed Moderna’s vaccine for use in those between the ages of 6 and 17.
CDC Director Rochelle Walensky is likely to sign off on the committee’s recommendation, as the agency almost always follows ACIP’s endorsements.
Currently, the only COVID-19 vaccine authorized for use in children between 6 and 17 is Pfizer’s two-dose mRNA vaccine.
- Walensky has already signed off on the committee’s previous recommendation that Pfizer’s and Moderna’s coronavirus vaccines be administered to children under the age of 5, with administration of these reduced doses having already begun.
- While a majority of U.S. adults and older children are believed to be fully vaccinated against COVID-19, a minority of eligible young children can currently say the same. The most recent CDC data shows 29.5 percent of children between 5 and 11 are fully vaccinated.
HARRIS MEETS WITH DEMOCRATIC STATE AGS ON ABORTION RIGHTS
Vice President Harris met with Democratic attorneys general from seven states on Thursday about abortion rights as the White House prepares for a Supreme Court ruling overturning the landmark abortion ruling Roe v. Wade.
- Harris spoke with attorneys general from Wisconsin, Nevada, Illinois, California, Delaware, New York and Washington state at the White House Thursday afternoon about protecting abortion rights.
- “I asked these attorneys general to meet with us knowing that they have a pivotal role to play in defending women’s reproductive freedom and their rights to make decisions about their own bodies,” Harris said in brief remarks to reporters at the start of the meeting in the vice president’s ceremonial office.
Harris, who has been a leading voice for the White House on the abortion issue, and other officials have convened a series of meetings with abortion rights advocates, groups, state officials and other stakeholders over the past several weeks in preparation for the Supreme Court ruling, which will come any time between now and the end of June.
NYC MAKES VAX OPEN TO PEOPLE POSSIBLY EXPOSED TO MONKEYPOX
The New York City Department of Health and Mental Hygiene on Thursday abruptly announced it would be offering vaccines to New Yorkers who may have been exposed to monkeypox.
In a statement, the department said adult men who have sex with men and have had sex with multiple or anonymous partners in the past 14 days will be eligible to receive smallpox vaccines believed to also be effective against monkeypox.
- The vaccine being made available to New Yorkers is the Jynneos smallpox vaccine, administered in two doses four weeks apart.
- The doses will be administered at the Chelsea Sexual Health Clinic, which will be open Sunday through Thursday from 11 a.m. to 7 p.m.
According to the most recent data from the Centers for Disease Control and Prevention (CDC), more than 150 monkeypox cases have been confirmed across 24 U.S. states and territories. New York has confirmed 22 cases so far.
Limited walk-ins to receive vaccines will be accepted, but appointments — which can be made here — are preferred. As of Thursday afternoon, no appointments are available.
Birx: Downplaying COVID led to ‘false sense of security’
Deborah Birx, the former White House Coronavirus Response Coordinator, told a House committee on Thursday that the Trump administration failed to communicate the seriousness of COVID-19 early on in the pandemic, leading to inaction and a false sense of security throughout the government.
- Testifying before the House select Subcommittee on the Coronavirus Crisis, Birx said a clear and concise message on the seriousness of the COVID-19 virus was needed at the start of the pandemic, noting that data coming from China and Europe had already indicated the risks of the pathogen even before it reached the U.S.
- The “continued communication of underplaying the seriousness of this pandemic” ultimately resulted in “inaction early on I think across our agencies, but also created a false sense of security in America,” Birx said.
“You cannot contain a virus that cannot be seen. And it wasn’t being seen because we weren’t testing,” she said.
Weak start: Birx said the White House was already behind in its efforts to respond to the coronavirus pandemic in several ways early on, such as believing that the virus could be tracked through symptomatic cases when the risk of asymptomatic viral spread had already been known from other pathogens.
“I think from the very beginning, CDC believed this could be tracked through symptoms only and didn’t prepare for asymptomatic community spread or develop the data and the infrastructure to track that,” Birx said.
WHAT WE’RE READING
- Wearables are collecting a flood of data. An ambitious new study of pregnancy aims to prove that’s valuable for health (Stat)
- Fauci says he’s ‘example’ for COVID-19 vaccinations (Associated Press)
- They searched online for abortion clinics. They found anti-abortion centers (New York Times)
- U.S. monkeypox response mirrors early coronavirus missteps, experts say (The Washington Post)
STATE BY STATE
- Trump’s legacy looms large as Colorado aims to close the Hispanic insurance gap (Kaiser Health News)
- House speaker adds another Medicaid expansion plan to the mix (NC Health News)
- Protect yourselves: Virus detected in Michigan mosquitoes (The Detroit News)
THE HILL OP-EDS
- Just get the damn shot
- Expediency v efficacy: Reexamining the FDA’s accelerated drug approval process
- Counterproductive federal nicotine limits will only increase harm
That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you tomorrow.
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