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Today in health care lawmakers are on the verge of getting rid of the Pentagon’s COVID-19 vaccine mandate. But first, an outside panel released a scathing critique of the FDA’s food safety program.
Welcome to night health care, where we follow the latest developments in policies and news concerning your health. For The Hill, we are Nathaniel Weixel and Joseph Choi. Did someone forward this newsletter to you? Register here or in the box below.
Panel suggests changes in direction for food program
The Food and Drug Administration (FDA) needs a major overhaul to put one person in charge of its food safety program, according to an outside agency review commissioned in the wake of the infant formula crisis.
The FDA has come under fire from lawmakers and food safety advocates for its handling of an infant formula shortage that has left parents scrambling.
- The agency has long faced criticism that it is not giving enough resources to the food security program.
- The independent report recommended either establishing a food safety agency that would be separate from the FDA or establishing better and clearer lines of command within the existing agency.
Critics said the FDA was too slow to respond to multiple reports of contamination at Abbott Nutrition’s infant formula manufacturing plant, then committed a number of missteps that exacerbated a national formula shortage. infants that is still being felt today.
According to the Reagan-Udall Foundation report released Tuesday, “The absence of a single, clearly identified person to lead the Human Foods program negatively impacted organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil.”
The report criticizes the FDA for a food program that is too slow and risk-averse, which “compromises the agency’s willingness to act in enforcement or policymaking.”
Learn more here.
Maker of Narcan: the OTC nasal spray accelerated by the FDA
Emergent BioSolutions Inc., the maker of narcotic overdose treatment Narcan, said on Tuesday that the Food and Drug Administration (FDA) had accepted its request for priority review of its overdose nasal spray as an over-the-counter over-the-counter product. ).
“The application has received priority review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available over-the-counter in the United States. The Prescription Drug User Fee Act target date is March 29, 2023,” the company said.
- Naloxone, sold under the brand name Narcan, is a drug given to reverse the effects of a suspected opioid overdose. The drug can be administered nasally and through an auto-injector.
- Narcan can be purchased without a prescription at most pharmacies in all US states and territories, but it is generally not available over the counter. It is usually bought “behind the counter (BTC), which means a person has to speak to a pharmacy employee in order to get the medicine.
In November, the FDA issued a notice encouraging naloxone manufacturers to contact the agency to begin discussions about switching the drug from BTC to OTC.
“We are currently of the preliminary opinion that naloxone nasal spray up to 4 milligrams (mg) and naloxone auto-injector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed on OTC drug labeling without the supervision of a healthcare professional,”
the FDA said.
Learn more here.
ELON MUSK MEDICAL DEVICE COMPANY FACES POLL Amid COMPLAINTS
Neuralink, the medical device company owned by Elon Musk, is being investigated by a federal agency for alleged animal welfare violations, Reuters reports.
Neuralink, which launched in 2016, is developing a brain implant to help paralyzed people walk again. Musk announced this month that the company could place the implant device in a human brain for a clinical trial in about six months.
The U.S. Department of Agriculture (USDA) Inspector General’s Office opened the investigation at the request of a federal prosecutor, Reuters reported, citing sources. Investigators are reportedly looking into potential violations of animal welfare law.
Records and employee interviews obtained by the newswire alleged a number of botched animal testing in an effort to speed development of the technology.
But employees say the death toll is higher than it should be, largely due to increased pressure from Musk to speed up development, the report said.
Learn more here.
CDC HEAD: FLU SHOTS “A VERY GOOD MATCH” FOR THIS YEAR’S STRAINS
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky told reporters on Monday that the updated flu vaccines generated this year appear to be “a pretty good match” for the most prevalent flu strains.
“We are looking in real time at how well we think the flu matches what is circulating. And right now, the good news is it looks like it’s a pretty good match,” Walensky said, discussing this year’s version of the annual flu shot.
She added: “I want to emphasize that the flu shot can save lives and most importantly, there is still time to get vaccinated to be protected against the flu this season.”
This year’s flu season started in October and since then there have been around 8.7 million cases, 78,000 hospitalizations for flu-like symptoms and 4,500 related deaths, according to the government health agency.
Learn more here.
Lawmakers agree to repeal of vax military warrant in defense bill
Congress is poised to use the annual defense policy bill to eliminate the Pentagon’s COVID-19 vaccine mandate.
In a compromise with Republicans, House Democrats allow language in the National Defense Authorization Act (NDAA) that repeals the coronavirus vaccine mandate for U.S. service members a year after it was signed into law, Ranking member of the House Armed Services Committee, Rep. Mike Rogers (R-Ala.) confirmed to The Hill on Tuesday.
The bill, which outlines how an $847 billion Department of Defense top line will be allocated in fiscal year 2023, is tentatively expected to be released late Tuesday or early Wednesday and voted on by the House on Thursday, Rogers said. .
Asked if he thought the tongue would stick around amid all the last-minute jostling over the bill, Rogers replied, “Yes.”
- Republican lawmakers have for months pushed back against the Pentagon’s mandate for the COVID-19 vaccine, which Secretary of Defense Lloyd Austin first instituted in August 2021.
- Since then, thousands of active duty service members have been fired for refusing fire, according to the latest Pentagon figures.
The compromise is effectively a loss for the White House and the Pentagon, which have both opposed using the NDAA to repeal the vaccine mandate.
Learn more here.
WHAT WE READ
- Employers use patient assistance programs to offset their own costs (Kaiser Health News)
- Congress Aims Drug Addiction Too Low, Lawyers Charge (Stat)
- Some schools are closing to stem flu outbreaks – but is that a good long-term solution? (ABC News)
STATE BY STATE
- Blue Shield to lay off hundreds of California workers, many in the Sacramento area (The Sacramento Bee)
- Southern Illinois Health hospitals are enforcing visitor restrictions due to the spread of disease (WPSD)
- Mississippi medical marijuana patients, professionals on the lookout for scams and other complications (WLOX)
THE OP-EDS HILL
That’s all for today, thanks for reading. Check out The Hill’s healthcare page for the latest news and coverage. Until tomorrow.
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