Health Care — Review recommends changes for FDA food program

by Nathaniel Weixel and Joseph Choi - 12/06/22 6:21 PM ET

Leave it to Ticketmaster to unite Republicans and Democrats: Bipartisan members of the House Energy and Commerce Committee want a briefing about the company’s Taylor Swift debacle.

Today in health, lawmakers are on the verge of getting rid of the Pentagon’s COVID-19 vaccine mandate. But first, an outside panel released a scathing review of FDA’s food safety program.

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Sign up here or in the box below.

Panel suggests leadership changes for food program

The Food and Drug Administration (FDA) needs major restructuring to put a single person in charge of its food safety program, according to an outside review of the agency commissioned in the wake of the infant formula crisis.

The FDA has come under fire from lawmakers and food safety advocates for the way it handled an infant formula shortage that left parents scrambling.

The agency has long faced criticism that it doesn’t give enough resources to the food safety program.
The independent report recommended either establishing a food safety agency that would be separate from the FDA, or establishing better, 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 baby formula manufacturing plant, and then made a number of missteps that exacerbated a nationwide shortage of baby formula that is still being felt today

According to the report from the Reagan-Udall Foundation released Tuesday, “the lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil.”

The report faulted FDA for a food program that is too slow and risk-averse, which “compromises the agency’s willingness to act in enforcement or policy development.”

Read more here.

Narcan maker: OTC nasal spray fast-tracked by FDA

Emergent BioSolutions Inc., the maker of narcotic overdose treatment Narcan, said on Tuesday that the Food and Drug Administration (FDA) has accepted its application to grant priority review of its overdose nasal spray as an over-the-counter OTC) product.

“The application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023,” said the company.

Naloxone, sold under the brand name Narcan, is a drug administered to reverse the effects of a suspected opioid overdose. The drug can be administered nasally and through an autoinjector.
Narcan can be bought without a prescription at most pharmacies in all U.S. states and territories, but it is typically not available OTC. It is usually bought “behind-the-counter (BTC) which means a person must speak to a pharmacy employee in order to get the drug.

In November, the FDA issued a notice encouraging naloxone makers to get in contact with the agency to start discussions on switching the drug from BTC to OTC.

“It is our preliminary opinion at this time that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed in nonprescription drug labeling without the supervision of a healthcare practitioner,”

said the FDA.

Read more here.

ELON MUSK MEDICAL DEVICE COMPANY FACES PROBE AMID COMPLAINTS

Neuralink, the medical device company owned by Elon Musk, is under investigation from 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 this month announced 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 probe at the request of a federal prosecutor, Reuters reported, citing sources. Investigators are reportedly looking at potential violations of the Animal Welfare Act.

Records and employee interviews obtained by the newswire alleged a number of botched animal tests in the pursuit of accelerating development of the technology.

But employees say the number of deaths is more than it should be, largely because of increased pressure from Musk to speed up development, according to the report.

Read 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 shots generated this year seem to be “a very good match” for the most prevalent strains of influenza.

“We look in real time as to how well we think the influenza match is to what’s circulating. And right now, the good news is that it looks like it is a very good match,” said Walensky, discussing this year’s version of the annual flu vaccine.

She added, “I want to emphasize that the flu vaccine can be life-saving and importantly there is still time to get vaccinated to be protected against flu this season.”

This year’s flu season began in October, and since then, there have been approximately 8.7 million cases, 78,000 hospitalizations for flu-like symptoms and 4,500 related deaths, according to the government health agency.

Read more here.

Lawmakers OK military vax mandate repeal 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 are allowing language into the National Defense Authorization Act (NDAA) that repeals the coronavirus vaccine mandate for U.S. service members a year after it was enacted, House Armed Services committee ranking member Rep. Mike Rogers (R-Ala.) confirmed to The Hill Tuesday.

The bill, which lays out how a $847 billion Defense Department top line will be allocated in fiscal year 2023, is tentatively set to be released late Tuesday or early Wednesday and voted on by the House Thursday, Rogers said.

Asked if he believes the language will stick amid all the last minute jostling over the bill, Rogers replied: “Yes.”

Republican lawmakers for months have pushed back on the Pentagon’s COVID-19 vaccine mandate, which Defense Secretary Lloyd Austin first instated in August 2021.
Since then, thousands of active-duty service members have been discharged for refusing the shots, according to the latest Pentagon numbers.

The compromise is effectively a loss for the White House and Pentagon, which have both opposed using the NDAA to repeal the vaccine mandate.

Read more here.

WHAT WE’RE READING

Employers use patient assistance programs to offset their own costs (Kaiser Health News)
Congress has its sights set too low on addiction, advocates charge (Stat)
Some schools close to stem flu outbreaks — but is it a good long-term solution? (ABC News)

STATE BY STATE

Blue Shield to lay off hundreds of California workers, including many in Sacramento area (The Sacramento Bee)
Southern Illinois Health hospitals implement visitor restrictions due to spread of illnesses (WPSD)
Mississippi medical marijuana patients, professionals on the look out for scams and other complications (WLOX)