Overnight Health Care – Brought to you by Carequest – FDA decides to sell over-the-counter hearing aids

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Welcome to Tuesday night health care, where we follow the latest policy developments and news affecting your health. Subscribe here: thehill.com/newsletter-inscription.

Looking for dating tips to mingle during the pandemic? General surgeon Vivek MurthyVivek Murthy More than a third of eligible seniors have received boosters, White House says, confusion reigns over rollout of vaccine boosters CDC director partially cancels panel and approves boosters MORE gives advice on Hinge Pandemic Dating Resource Page.

The Food and Drug Administration (FDA) has taken a step forward to make hearing aids available without a prescription for people with mild to moderate hearing loss.

For The Hill, we are Peter Sullivan ([email protected]), Nathaniel Weixel ([email protected]) and Justine Coleman ([email protected]). Write to us with tips and comments, and follow us on Twitter: @ PeterSullivan4, @NateWeixel and @ JustineColeman8.

Let’s get started.

FDA releases long-awaited hearing aid proposal

The FDA is proposing a rule to offer a new class of over-the-counter hearing aids in an effort to improve accessibility and lower the costs of the devices for Americans.

The agency announced his proposal On Tuesday, this would allow certain over-the-counter hearing aids to be sold directly to the millions of adults who have “experienced mild to moderate hearing loss”, once it is finalized.

Officials expect proposed regulation to “likely” enable the sale and availability to the public of less expensive hearing aids, thereby increasing competition in the market. Hearing aids can cost thousands of dollars and typically aren’t covered by traditional health insurance or private insurance, and advocates argue that making them available over the counter can dramatically lower the price.

The FDA proposal implements the Over-the-Counter Hearing Aid Act, which was enacted as part of the FDA Reauthorization Act of 2017.

Of course, the rule is only a proposition and a major setback is expected from hearing aid manufacturers and audiologist groups.

Reaction of senators: Sense. Elizabeth warrenElizabeth WarrenAmerica May End Poverty Among Her Elderly Citizens Senate GOP Says It Will Help Bail out Biden Fed Chairman Wrong recusal rules lock up valuable Pentagon leaders MORE (D-Mass.) And Chuck grassleyChuck Grassley Lawmakers pay homage to Colin Powell’s Senate GOP signals that they will help bail out Biden Fed Chairman Fill the Eastern District of Virginia MORE (R-Iowa), which introduced the 2017 law, called the FDA proposal “tremendous news” in a joint statement.

“We have just passed a major regulatory hurdle for over-the-counter hearing aids,” Senators said. “Soon, millions of people with mild to moderate hearing loss will finally have lower-cost hearing aid options – and more options mean more competition in the market, further reducing costs for consumers.”

Read more here.

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SCOTUS WILL NOT BLOCK THE VACCINE MANDATE

On Tuesday, the Supreme Court left a vaccine requirement for Maine healthcare workers untouched, pushing back another legal challenge targeting COVID-19 vaccination warrants.

Denial by justice Stephane BreyerStephen BreyerBreyer: Supreme Court is “fallible”, but has “served rather well” the Supreme Court of the United States considers the power of Kentucky AG to defend the restriction of abortion The heresy of Justice Alito MORE, which handles Maine’s emergency claims, was issued “without prejudice,” meaning applicants can file another claim if circumstances change.

The challengers, a group of Maine healthcare workers, have sought to block a vaccine requirement announced by the government in August. Janet MillsJanet Mills Appeals court rejects request to block Maine vaccine mandate for health workers Judge rules Maine can ban religious exemptions to health care vaccine mandate Collins to approve LePage in return candidacy from the Governor of Maine PLUS (D). The statewide mandate, which applies to employees of hospitals, nursing homes and other healthcare facilities, is expected to take effect next week.

The lawsuit was brought by a Christian group called Liberty Counsel, which said it represented some 2,000 employees opposed to the warrant on religious grounds. While medical exceptions to Maine’s vaccine requirement are recognized, religious exemptions are not.

Tuesday’s decision comes after the Supreme Court dismissed challenges similar to the vaccination mandate by New York City public school teachers and a group of Indiana University students.

Read more here.

Levine was sworn in as the openly transgender four-star first officer in the Health Corps

Assistant Secretary of Health, Ministry of Health and Social Services Rachel LevineRachel LevineHHS launches new office of climate health Delta variant raises fears of worsening mutations Biden appoints first openly gay woman as U.S. ambassador MORE was sworn in as an admiral in the US Public Health Service Commissioned Corps on Tuesday, becoming the first openly transgender person to serve as a four-star officer in one of the country’s eight uniformed services.

With his new title, Levine will assume a leadership role in the public health service, a team of more than 6,000 people responding to public health crises and natural disasters. The body also helped support vaccinations during COVID-19.

Levine is the first openly transgender four-star officer in the public health corps or in the uniformed service of the army.

“I stand on the shoulders of those older LGBTQ people who came before me, both known and unknown,” Levine said during his swearing-in. “May this appointment today be the first of many to come as we create an inclusive future.”

Levine was previously the Pennsylvania health secretary. She was confirmed by the Senate in March for her role as deputy secretary, on a majority party line vote of 52-48. Meaning of republican. Susan collinsSusan Margaret Collins Senators call on Biden administration to fund program that helps people pay their heating bills McConnell receives wake-up call from GOP Republicans are today’s Dixiecrats MORE (Maine) and Lisa MurkowskiLisa Ann Murkowski Anti-Trump Republicans back vulnerable Democrats to prevent GOP takeover GOP rallies around Manchin, Sinema McConnell receives GOP wake-up call PLUS (Alaska) seconded his nomination.

Read more here.

CDC: EFFECTIVE VACCINE AGAINST YOUTH HOSPITALIZATION

The Pfizer-BioNTech COVID-19 vaccine has been shown to be 93% effective against hospitalizations of 12 to 18 year olds, according to research from the Centers for Disease Control and Prevention (CDC) when the delta variant was predominant.

Researchers calculated the vaccine’s effectiveness using data from 464 hospital patients, including 179 with laboratory-confirmed COVID-19 and 285 virus-free controls, at 19 pediatric hospitals between June and September.

Of the 179 COVID-19 patients, only 3% were fully vaccinated, while the vast majority had not received any dose of the COVID-19 vaccine.

Of the unvaccinated COVID-19 patients, 77 were admitted to the intensive care unit, 29 received resuscitation and two died. None of the six patients vaccinated against COVID-19 went to intensive care or received intensive care.

Importance: The CDC study sought to add to the “limited” real-world data on the vaccine’s effectiveness in 12 to 18 year olds. He concluded that the efficacy was aligned with the results of Pfizer’s previous clinical trial which found 100% efficacy against symptomatic COVID-19 in 12 to 15 year olds.

Despite the efficacy, adolescents have the lowest vaccination rates among vaccine-eligible age groups, with 46 percent of those 12 to 15 years old and 53 percent of 16 to 17-year-olds fully vaccinated, according to the CDC.

Read more here.

COVID-19 pill raises concerns over global fairness

Concern is growing among advocates that Merck’s promising new COVID-19 treatment pill could worsen the inequalities between rich and poor countries that have been exposed during the coronavirus vaccine rollout.

The vast majority of COVID-19 vaccines have been distributed to people in wealthy countries. Vaccination rates are below 10% in more than 50 poor countries, according to the World Health Organization (WHO), while many rich countries have vaccination rates above 70%. And experts fear the distribution of the new drug will follow a similar trend.

Merck’s antiviral pill, molnupiravir, is treatment for people who are already infected, not prophylactic. But the drug appears to prevent those infected from being hospitalized and dying and could be another important tool countries can use alongside vaccines.

Unlike vaccine makers, Merck has already taken steps to proactively address global access issues by licensing its technology to five generic manufacturers in India. This move is unusual, as it comes before the brand name drug was even cleared in the United States.

Under the agreements, Merck will license these manufacturers to supply molnupiravir to India and more than 100 low- and middle-income countries at a much lower price than the branded version.

Lawyers and experts have said the licensing deals are encouraging, but they hope for more effective measures.

Read more here.

WHAT WE READ

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STATE BY STATE

  • If COVID-19 cases continue to decline, Pritzker wants to ‘remove some mask warrants’ in time for the holidays (Chicago Tribune)
  • Colorado college campuses have become COVID vaccine islands, with lower case rates than surrounding areas (Colorado Public Radio)
  • Helena Hospital says doctors are “threatened” by officials over demand for ivermectin (Hélène Independent Record)

OP-EDS IN THE HILL

That’s all for today, thanks for reading. Check out The Hill’s healthcare page for the latest news and coverage. See you on Wednesday.

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