• There are 19 drugs on the market that had accelerated approval from the Food and Drug Administration but whose confirmatory trials are marked as delayed as of April, including trials that are both past their due dates and behind schedule, according to a Bloomberg analysis of FDA databases. The analysis also found seven accelerated approval drugs with studies behind schedule but were not marked as delayed because the company has submitted some data. (Bloomberg)
• Planned Parenthood is asking for significant reforms to the U.S. judicial system after the Supreme Court overturned Roe v. Wade last year and a federal judge in Texas suspended the FDA’s approval of the abortion pill mifepristone, including an end to single-judge divisions, an expansion of the Supreme Court and setting term limits for justices. (Axios) Nikki Haley, a GOP 2024 presidential candidate, said on CBS’ “Face the Nation” that it is “not realistic” for candidates to promise a federal abortion ban because of the 60-vote threshold required in the Senate, noting that they are “not even close to that on the Republican or the Democrat side,” adding “why try and divide people further?” (Axios)
• FDA advisers voted 8-6 to recommend that the FDA approve Sarepta Therapeutics Inc.’s gene therapy treatment for Duchenne muscular dystrophy, a first for the agency if approved. (NPR News) Meanwhile, the FDA approved Astellas Pharma Inc.’s drug to treat moderate to severe hot flashes caused by menopause, providing women who do not want to take hormone therapy with another option. (CBS News)
• The Group of Seven nations plans to agree this week on a global vaccination program to distribute vaccines to developing countries, with plans to invest in vaccine production and purchasing, vaccine storage and training for health workers to prepare for future health emergencies, according to a report from Japan’s Yomiuri newspaper. Some G-20 nations such as India and international groups including the World Health Organization and World Bank would also participate in the program, according to Japanese government sources. (Reuters)

“Sharp increase” in crimes against abortion clinics post-Roe

Axios

A U.S. Experiment on Single-Payer Care Just Ended

Margot Sanger-Katz, The New York Times

The system for one disease, Covid, had similarities to “Medicare for all.”

CDC sets first target for indoor air ventilation to prevent spread of Covid-19

Brenda Goodman, CNN

The agency had advised people to ventilate indoor air before, but this is the first time a federal agency has set a target – five air changes per hour – for how much rooms and buildings should be ventilated.

CVS will shut down clinical trials unit that it launched during Covid

Drew Armstrong, Endpoints News

CVS Health is shutting down the clinical trials business that it launched just two years ago, part of an effort to focus on its core business.

Covid Tests to See Reduced Coverage by Employer Health Plans

Sara Hansard, Bloomberg Law

Employers are likely to cover Covid-19 tests on a more limited basis or with cost-sharing requirements now that the public health emergency has ended.

Americans in most states will no longer receive Covid exposure alerts on phones

Annika Kim Constantino, CNBC

Since 2020, nearly 30 states have used a Bluetooth system developed by Apple and Google to track the spread of Covid infections and send push alerts to any smartphone user who came in close contact with a person who tested positive for the virus.

FDA Blood Donor Policy for Gay Men Perpetuates Stigma Concerns

Celine Castronuovo, Bloomberg Law

The FDA’s updated blood donor screening policy falls short of eliminating obstacles for members of the LGBT community wishing to donate, public health researchers and advocates say.

A recalled Gerber powdered baby formula was distributed to some US retailers after the initial recall notice, company says

Ashley R. Williams, CNN

A Gerber infant formula under voluntary recall for possible contamination with a germ that can seriously sicken babies was distributed to some US retailers even after the initial notice, according a release shared by the US Food and Drug Administration.

Progress on reducing infant and maternal deaths has stalled, WHO warns

Erin Blakemore, The Washington Post

A combined 4.5 million deaths occurred among mothers and infants worldwide in 2020, the agency reports.

North Carolina’s governor vetoed a 12-week abortion ban, setting up an override fight

The Associated Press

The veto by Gov. Roy Cooper launches a major test for leaders of the GOP-controlled General Assembly to attempt an override vote after they recently gained veto-proof majorities in both chambers.

Historically Black medical schools ask for funding increase

The Associated Press

Representatives from several Black medical schools met with Sen. Bernie Sanders (I-VT) to share their concerns around funding and training.

FDA issues marketing denial for 6,500 flavored e-cigarettes

Reuters

The U.S. Food and Drug Administration (FDA) on Friday issued marketing denial orders to 10 companies which collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products.

Abortion bans are unpopular. Republicans are passing them anyway.

Shefali Luthra, The 19th

In some cases, anti-abortion legislators have been forced to backtrack from some more restrictive proposals. In others, they’ve tried to subvert the lawmaking process to avoid blowback.

Abortion pill battle threatens America’s ‘gold standard’ drug approval process

Colin Meyn and Joseph Choi, The Hill

With oral arguments in the Texas lawsuit set to begin next week, the implications of how the 5th Circuit Court of Appeals rules are far-reaching.

Kansas governor vetoes measures to aid anti-abortion centers, limit health officials’ power

John Hanna, The Associated Press

Kansas’ Democratic governor on Friday vetoed Republican legislation that would have provided a financial boost to anti-abortion pregnancy centers and prevented officials fighting outbreaks of contagious diseases from prohibiting public gatherings or ordering infected people to isolate themselves.

Facing high death rates, Black expecting parents seek out Black doulas

Justin Wm. Moyer, The Washington Post

These Black doulas focus on a community that faces higher maternal mortality rates yet has long struggled to find advocates to address their birthing needs.

From fusion to retooling cancer trials, Eric Lander wants his new group to ‘go after big problems’

Megan Molteni, Stat News

Science for America, or SfA, launched quietly last summer, with a mission to go after existential issues such as climate change, cancer, pandemic preparedness, and reimagining how research gets done in this country.

How to Get Your Health Insurance to Cover Ozempic and Other Drugs Used for Weight Loss

Anna Wilde Mathews and Peter Loftus, The Wall Street Journal

If you want to take one of the buzzy drugs like Ozempic or Wegovy to lose weight, the toughest part may be finding a way to pay for it.

Hospital-insurer tussle in Arizona puts care denials front and center

Bob Herman, Stat News

Hospitals and health insurance companies feud over prices when contracts are up for renegotiation. But this particular instance indicates that other insurance terms — like retrospective reviews of whether an emergency department visit was necessary or no payment for basic procedures — are reshaping these fights and possibly making them even more combative.

Thousands face Medicaid whiplash as rules change

Arielle Zionts, CBS News

The federal government estimates 15 million Americans will lose coverage under Medicaid or the Children’s Health Insurance Program because they no longer qualify or because of paperwork issues.

‘Stunning’ change to United’s colonoscopy coverage roils physicians and patients

Angus Chen, Stat News

When gastroenterologists learned in March that UnitedHealthcare plans to barricade many colonoscopies behind a controversial and complicated process known as prior authorization, their emotions cycled rapidly between fear, shock, and outrage.

The Shadowy Financial Empire Built Around Liberty HealthShare Is Showing Signs of Strain

David McSwane and Ryan Gabrielson, ProPublica

Beers family members built a “conglomerate” by selling a Christian alternative to traditional health insurance. They’re now scrambling for cash, even though they received millions in PPP loans that were later forgiven.

How a green card freeze will exacerbate the nursing crisis

Kelly Hooper, Politico

The stream of international nurses coming to work in the United States could soon slow to a trickle because of a backlog of green card petitions at the State Department.

GAO: 340B program netted savings and provided benefits for low-income patients

Tyler Patchen, Endpoints News

As pharma companies and industry groups seek limits on the 340B program, a new report from the GAO examined hospitals that received the pandemic’s eligibility exception and some of the savings generated for hospitals that participate in the program.

HCA workers at 5 hospitals vote to strike

Mari Devereaux, Modern Healthcare

The strike, set to start May 22, would involve around 3,000 SEIU-UHW members working at HCA’s Good Samaritan Hospital and its Regional Medical Center in San Jose; Los Robles Medical Center in Thousand Oaks; West Hills Hospital in West Hills; and Riverside Community Hospital in Riverside.

As More Hospitals Create Police Forces, Critics Warn of Pitfalls

Renuka Rayasam, KFF Health News

Nearly 30 states have active or proposed laws authorizing independent hospital police forces. Groups representing nurses and hospitals say the laws address the daily realities of patients who become aggressive or agitated. But critics worry about unintended consequences.

The $100,000 signing bonus: What hospitals are doing to woo workers

Mari Devereaux, Modern Healthcare

To fight severe staffing shortages and lessen the use of contract labor, hospitals are updating their strategies to recruit and retrain front-line employees.

A ‘reckoning’ in healthcare: The climate crisis and what the industry can do about it

Anastassia Gliadkovskaya, Fierce Healthcare

Fierce Healthcare talked with Gary Cohen, the president and co-founder of Health Care Without Harm, about the way healthcare is addressing its role in climate change.

How the nursing shortage may lead to gaps in sexual assault care

Katheryn Houghton, KFF Health News

As many as 80% of U.S. hospitals don’t have sexual assault nurse examiners, often because they either can’t find them or can’t afford them. Nurses struggle to find time for shifts, especially when staffing shortages mean covering long hours. Sexual assault survivors may have to leave their town or even their state to see an examiner.

This telehealth program is a lifeline for New Mexico’s pregnant moms. Will it end?

Sarah Jane Tribble, KFF Health News

A federal program in remote New Mexico has helped hundreds of pregnant mothers stay healthy, but it’s running out of time and money despite a growing national maternity care crisis.

Promising new Alzheimer’s drugs face questions about real-world benefit

Caitlin Owens and Oriana González, Axios

Promising clinical trial results from another new Alzheimer’s drug haven’t put to bed questions about how much the treatments actually benefit patients, and whether their strong points outweigh their safety risks.

Lawmakers call on FDA to create more uniformity in rare disease drug reviews

Zachary Brennan, Endpoints News

A group of Democrats and Republicans from both the House and Senate recently sent a letter to FDA Commissioner Rob Califf requesting that the agency establish a task force to identify strengths and challenges for reviewing rare disease therapies and to publicly issue recommendations on better alignment across the agency.

AI May Be on Its Way to Your Doctor’s Office, But It’s Not Ready to See Patients

Darius Tahir, KFF Health News

Giant corporations like Microsoft and Google, plus many startups, are eyeing health care profits from programs based on artificial intelligence.

Masimo’s CEO on battling Apple for the health wearable market

Lizzy Lawrence, Stat News

Masimo isn’t just battling Apple in the courts. It’s hoping to battle the technology giant for share in the wearable market. So far Masimo sells a $500 “advanced health tracking” watch and is planning to launch a $1,000 smartwatch in the fall.

Sorry, the government’s not paying for your therapy app

Ruth Reader and Ben Leonard, Politico

New treatments for chronic conditions like opioid addiction, ADHD and insomnia are here and they’re on your smartphone — not in a pill bottle. But the government won’t pay for them, even as tech entrepreneurs insist to Congress and the Biden administration that their digital therapeutics are the next big thing.