Morning Consult Health Presented by the Partnership for Quality Home Healthcare: HHS Watchdog Recommends Changes to FDA’s Emergency Use Authorization Process


Essential health care industry news & intel to start your day.
September 22, 2022
Twitter Email

Today’s Top News

  • The Health and Human Services Department’s Office of Inspector General said in a report that the Food and Drug Administration’s emergency use authorization policies resulted in quality issues and false results with COVID-19 tests that quickly hit the market during the early stages of the pandemic. The HHS watchdog said the government should overhaul its EUA strategy before another pandemic occurs, advocating for a “coordinated federal effort to determine a federal testing strategy” that involves stakeholder feedback, improved communication practices with testing labs, more specific guidance on test validation and additional FDA support throughout the process. (Modern Healthcare)
  • The reformulated COVID-19 boosters from Moderna Inc. and Pfizer Inc.-BioNTech SE are expected to be available for children by the middle of next month, per the Centers for Disease Control and Prevention, with a recommendation from the agency coming as soon as early October provided the shots are authorized by the FDA. The Pfizer bivalent vaccine would be available for children ages 5-11, while Moderna’s booster is expected to be used in kids between 6 and 17, the CDC said. (Reuters)
  • Dr. Anthony Fauci said during an interview at The Atlantic Festival that President Joe Biden’s declaration that “the pandemic is over” was “semantics” and that he actually intended to convey that “we’re in a much better place with regard to the fulminant stage of the pandemic.” Fauci said the country is in a new phase where vaccines and antiviral treatments ensure that there aren’t sudden surges in the death toll, even as case counts and hospitalization rates seesaw. (The Atlantic)
  • HHS Secretary Xavier Becerra declared a public health emergency in Puerto Rico after the island was battered by Hurricane Fiona last weekend and continues to deal with flooding, power outages and other fallout from the storm. HHS’ National Disaster Medical System has sent 15 people to Puerto Rico, while another 10 from the agency’s management team are also on the island, moves that come after Biden issued an emergency declaration and charged the Federal Emergency Management Agency and the Department of Homeland Security with overseeing disaster relief. (The Hill)

Worth watching today (all times local): 

  • 8:30 a.m. FDA meeting of the Vaccines and Related Biological Products Advisory Committee.
  • 9 a.m. FDA meeting of the Oncologic Drugs Advisory Committee.
  • 10 a.m. AEI event: “Access to Obesity Care in the US: Coverage in a New Era of Treatments.”
  • 11:30 a.m. Washington Post Live event: “The real cost of unpaid caregiving and impact of the pandemic.”
  • 12:30 p.m. Axios event: “The Nation’s Mental Health Crisis,” featuring Substance Abuse and Mental Health Services Administration Administrator Miriam E. Delphin-Rittmon.

Chart Review


What Else You Need to Know


Scientists were worried about a particular variant this fall. They didn’t expect its offspring  

Erin Prater, Fortune 

Omicron spawn BA.2.75, dubbed “Centaurus,” seemed like the COVID variant to watch this summer—one with the potential to wreak unprecedented havoc later in the year.


Talk of Covid’s End Sparks Fight Over Funding, Emergency Powers

Alex Ruoff and Ian Lopez, Bloomberg Law 

The latest phase of the Covid pandemic is shaping up to be the hardest for the Biden administration as the White House faces uphill battles getting new funds and public interest for its booster campaign.


Covid Still Kills, but the Demographics of Its Victims Are Shifting 

Phillip Reese, Kaiser Health News 

As California settles into a third year of pandemic, covid-19 continues to pose a serious threat of death. But the number of people dying — and the demographics of those falling victim — has shifted notably from the first two years.


Moderna exec: ‘eager’ to collaborate with China on supplying COVID vaccines 


Moderna Inc (MRNA.O) Chief Medical Officer Paul Burton said on Wednesday the company is “eager” to collaborate with China on supplying its mRNA-based COVID-19 vaccines to the country.


Federal judge strikes down Biden administration’s Head Start vaccine, mask mandate 

Joseph Choi, The Hill 

A federal judge in Louisiana on Wednesday struck down a mandate from the Biden administration that required staffers at Head Start child care facilities to be vaccinated and to wear masks.


Senate bill aims to narrow mental health workforce shortage

Robert King, Fierce Healthcare 

The discussion draft (PDF), released Thursday by the Senate Finance Committee, is part of a larger effort by the panel to reform mental health. The legislation would also boost bonus payments for mental health providers that offer care to underserved communities. 


WHO: World “off track” in goal to reduce deaths from chronic diseases

Han Chen, Axios 

The World Health Organization warned in a report Wednesday that most countries are “far off track” in their efforts to reduce premature deaths from noncommunicable diseases (NCDs), such as cancer, diabetes and cardiovascular diseases.


With overdoses rising, a push for syringe service programs 

Sandhya Raman, Roll Call 

Experts say the spike in overdoses and diseases related to sharing needles means it’s time to revoke a longtime ban restricting federal funds for syringe exchanges. But lawmakers in both parties remain resistant to allowing taxpayer dollars to go toward clean needles and syringes for drug use.


What happens when you don’t get enough sleep? Blood samples show heart risks. 

Linda Carroll, NBC News

Cutting sleep short on a regular basis may harm immune stem cells, potentially increasing the risk of inflammatory disorders and heart disease, a small new study suggests.


Why mosquitoes were the vaccinators in a new malaria vaccine trial

Max Barnhart, NPR News 

“We use the mosquitoes like they’re 1,000 small flying syringes,” explains University of Washington, Seattle physician and scientist Dr. Sean Murphy, lead author on a paper in Science Translational Medicine released on August 24 detailing the vaccine trials.


The Fatal Error of an Ancient, HIV-Like Virus 

Katherine J. Wu, The Atlantic 

Many, many millions of years ago, an HIV-like virus wriggled its way into the genome of a floofy, bulgy-eyed lemur, and got permanently stuck.


Monkeypox has worsened stigma of skin conditions like eczema, psoriasis 

Amanda Morris, The Washington Post 

A cashier with psoriasis received daily complaints from customers at work. A traveler with eczema was escorted off a flight and questioned by airline employees. A commuter with small, benign tumors on her body was unknowingly filmed and scrutinized on social media. All of them were singled out because people mistakenly believed they had monkeypox.


To contain monkeypox, colleges must step up outreach to LGBTQ+ students, experts say

Nadra Nittle, The 19th 

Multiple colleges and universities have reported monkeypox cases, but the resources they have to fight the virus aren’t equal.


Wisconsin’s governor eyes statewide vote on ‘criminal’ abortion ban 

Zach Schonfeld, The Hill 

Wisconsin Gov. Tony Evers (D) on Wednesday called a special session of the state legislature for October in an effort to enable voters to repeal the state’s 1849 abortion ban through a referendum.


Abortion looms over 2022 state ballots

Oriana Gonzalez and Victoria Knight, Axios

Five forthcoming state ballot initiatives on abortion rights could add fissures to the fractured post-Roe landscape and the evolving patchwork of reproductive health policies.


Death Is Anything but a Dying Business as Private Equity Cashes In 

Markian Hawryluk, Kaiser Health News 

Private equity firms are investing in health care from cradle to grave, and in that latter category quite literally. A small but growing percentage of the funeral home industry — and the broader death care market — is being gobbled up by private equity-backed firms attracted by high profit margins, predictable income, and the eventual deaths of tens of millions of baby boomers.


Medicare Mental Health Bills Get Boost From House Committee

Tony Pugh, Bloomberg Law 

The House Ways and Means Committee advanced a package of legislative proposals designed to improve Medicare coverage of mental health services during a markup hearing Wednesday.


UnitedHealthcare expands fitness partnership with Peloton 

Paige Minemyer, Fierce Healthcare 

UnitedHealthcare is expanding its relationship with Peloton, making its fitness services available to as many as 10 million members.


Maternal health disparities exist across coverage types: study 

Paige Minemyer, Fierce Healthcare 

Women of color are at higher risk of maternal health complications, and those disparities persist regardless of whether they are enrolled in commercial health plans or Medicaid coverage, a new study found.


Patients Suffered at For-Profit Nursing Homes Early in Pandemic, Congress Says 

Lauren Coleman-Lochner, Bloomberg 

The report by the House of Representatives’ Select Subcommittee on the Coronavirus Crisis examined five for-profit chains operating about 850 homes with 80,000 residents during the early months of the pandemic, drawing on complaints filed against the companies. About 70% of nursing homes in the US are run by for-profit operators. 


Galvanized by Dobbs, more doctors are distributing abortion pills by mail 

Ruth Reader, Politico

Doctors at online and brick and mortar primary care companies are slowly starting to prescribe medication abortion pills via telemedicine in states where it’s still legal following the Supreme Court’s Dobbs decision ending the constitutional right to the procedure.


Rural hospitals face funding cliff

Arielle Dreher, Axios 

Rural hospitals that weathered the pandemic are facing a funding cliff, in danger of losing some $600 million in Medicare funding at the end of this month unless Congress intervenes.


HHS Publishes National Strategy to Support Family Caregivers

Bloomberg Law 

The US Department of Health and Human Services has released the 2022 National Strategy to Support Family Caregivers through the Administration for Community Living, according to a Wednesday news release.


Envision Healthcare teeters on the brink of bankruptcy 

Bob Herman, Stat News

Envision Healthcare, the large chain of outpatient surgery centers and physician staffing services for hospitals, is on the cusp of bankruptcy and likely will run out of cash by the end of next year.

Pharma, Biotech and Devices

Adderall shortage in US spreads to two more drug suppliers, impacting consumer demand

Natalie Neysa Alund, USA Today

A growing U.S. shortage of Adderall, a prescription drug taken to treat attention deficit hyperactivity disorder, has spread to two more makers of the drug.


FDA warns of cybersecurity risk with certain Medtronic insulin pumps 


The U.S. Food and Drug Administration on Tuesday warned that certain types of insulin pump systems manufactured by Medtronic (MDT.N) were vulnerable to cyberattacks and that hackers could potentially hamper insulin delivery by accessing the device.


Novartis to take U.S. drug patent case to Supreme Court 


Novartis AG (NOVN.S) plans to ask the U.S. Supreme court to uphold the validity of a patent it holds on the dosing regimen for multiple sclerosis drug Gilenya after suffering a setback in a federal appeals court ruling, the Swiss drugmaker said on Wednesday.


Biogen says ALS drug shows clinical benefit in new data analysis 

Mrinalika Roy, Reuters 

Longer-term use and early initiation of Biogen Inc’s (BIIB.O) experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) was effective in slowing disease progression, according to a new analysis by the company published on Wednesday.


Medical device, drugmakers assess operations after Hurricane Fiona 

Lauren Berryman and Kara Hartnett, Modern Healthcare 

As Hurricane Fiona reached Puerto Rico late Sunday night, flooding the archipelago and tipping its battered energy grid into a blackout, healthcare industry leaders and government agencies were bracing for impact. 


‘Poison Pill’ Threats Blamed for Medical Innovation Bill Delay

Alex Ruoff and Jeannie Baumann, Bloomberg Law 

Partisan bickering is holding up a biomedical innovation bill in the House, the legislation’s main Democratic sponsor said.

Health Technology

Genetic Tests Create Treatment Opportunities and Confusion for Breast Cancer Patients

Michelle Andrews, Kaiser Health News 

The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.


After early wins, CRISPR gene editing is about to get a lot harder

Jason Mast, Stat News

The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their livers last year, another six patients with a different strand of toxic liver DNA knocked out last week. 


Researchers show they can quickly turn CAR-T cells on and off 

Jonathan Wosen, Stat News

Researchers reported Wednesday that they could quickly and reliably turn CAR-T cells on and off in cancer patients, giving scientists an unprecedented level of control over this potent — but at times dangerous — oncology therapy.

Opinions, Editorials and Perspectives

CDC Oversells the ‘Bivalent’ Covid Shot 

Paul A. Offit, The Wall Street Journal

The Centers for Disease Control and Prevention recommends that everyone over 12 receive a “bivalent” Covid-19 vaccine as a booster dose. But only a select group are likely to benefit, and the evidence to date doesn’t support the view that a bivalent vaccine containing omicron or its subvariants is better than the monovalent vaccine. The CDC risks eroding the public’s trust by overselling the new shot.

Morning Consult