Healthcare – FDA commissioner faces Congress on infant formula issue

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In health care today, FDA commissioners face baby formula shortages on Capitol Hill, and CDC advisors recommend boosters for children ages 5-11.

Welcome to Overnight Wellness, we’re following the latest updates on policies and news that affect your health. For The Hill, we are Peter Sullivan, Nathaniel Weixel and Joseph Choi. Has anyone forwarded this newsletter to you? Subscribe here.

FDA chief: Formula shortage may ease within days

The head of the U.S. Food and Drug Administration (FDA) told a House panel on Thursday that baby formula shortages will begin to ease in the next few days, but had few answers on how the agency would allow manufacturing plants with known safety concerns to continue operating. months without intervention.

FDA Commissioner Robert Califf is the first administration official to answer questions about formula shortages in Congress, which recently caught the attention of lawmakers. Now facing pressure from frustrated families, these lawmakers have not found an easy solution.

Part of the scarcity is the closure of a manufacturing plant operated by Abbott Nutrition. The factory has been closed since February after four babies fed formula produced at the factory were hospitalized with a rare bacterial infection.

The FDA announced earlier this week a preliminary consent agreement with Abbott to restart production pending safety upgrades and certification.

“I’m happy to say that we’ve made very significant progress in reopening our factories,” Calif told members of the House Appropriations subcommittee, “I think we’re on track to open factories in the next week to two weeks, probably Two weeks out of the country.”

Califf said increased production by other manufacturers and new authorizations for imported formula meant “we should see an improvement in a few days.”

However, he conceded that “it will be a few weeks before we get back to normal.”

read more here.

Harris meets with abortion provider

Vice President Harris spoke with a group of abortion providers Thursday who she said are serving “on the front lines” of the “fight for women’s rights.”

Harris held a virtual meeting with doctors, nurses and reproductive rights advocates working in states with particularly strict abortion laws, including Oklahoma, Texas and Kansas. News broke earlier this month that the Supreme Court had drafted an opinion that would overturn Roe v. Wade, a landmark 1973 ruling protecting a woman’s right to abortion.

“We cannot deny that this decision will have a real and immediate impact on the women of our country,” Harris said. “So, here I am today, standing with doctors, nurses and leading advocates against this war on women’s rights. front line.”

Harris noted that her remarks came less than an hour after lawmakers in Oklahoma approved a bill that would effectively ban all abortions unless it’s to save the life of a pregnant woman, or the pregnancy is intended for The results of the rape reported by the authorities.

Harris called Oklahoma’s law “outrageous, and it’s just the latest in a string of extreme laws across the country. Several medical professionals who joined us today are seeing how these laws aimed at punishing and controlling women are coming to an end.” Influence.”

read more here.

Senators unveil bill to avoid future formula shortages

A group of Senate Democrats introduced a bill on Thursday to protect families who rely on infant formula and other sources of essential nutrition from future shortages.

The Protect Infants from Formula Shortages Act also requires manufacturers to notify the U.S. Food and Drug Administration (FDA) of potential supply disruptions, thereby protecting the availability of these products and giving the agency time to prevent or mitigate potential shortages.

The proposed bill would also direct formula manufacturers to develop risk management plans for their product offerings and increase FDA inspection authority.

The bill was introduced by Senators Bob Casey (D-Pa.), Sherrod Brown (D-Ohio), Elizabeth Warren (D-Mass.), Tammy Duckworth (D-Ill.) and Kirsten Gillibrand (DN.Y.).

In a statement, Casey said Congress had a “responsibility” to address the issue, adding that they must do everything they can to ensure parents have formula on the shelves.

“I’m introducing the Protect Infants from Formula Shortages Act to avoid another massive disruption to the supply of life-saving and life-sustaining formula and other products,” Casey said.

read more here.

CDC investigates cases of unexplained hepatitis in children

The Centers for Disease Control and Prevention (CDC) is currently investigating 180 childhood hepatitis cases reported in the past seven months, 71 more than the cases reported earlier this month.

In a statement, the CDC stressed that while this appears to be a large increase in cases, most of which are “retrospective,” the agency investigated patients as early as October 2021. Not all detected cases are recent, the agency noted, and some may end up not even relevant to the current investigation.

“Furthermore, no deaths have been reported since February 2022, and the proportion of patients requiring liver transplantation has declined from 15% to 9% since May 5,” the CDC said.

Since the CDC began investigating unexplained pediatric hepatitis cases, it has been speculated that an adenovirus connection may be involved due to the high rate of detection of adenovirus in affected patients.

Adenovirus has been found in almost half of children with unexplained hepatitis, the CDC said in its update, saying it “continues to be a strong clue” as a potential cause.

The agency added that childhood hepatitis remains a rare disease. However, parents should still be aware of potential symptoms. These include vomiting, dark urine, and light-colored stools. One of the most noticeable symptoms of hepatitis is jaundice, the yellowing of the skin.

read more here.

CDC consultant recommends boosters for children ages 5-11

On Thursday, an independent advisory panel from the Centers for Disease Control and Prevention recommended a booster shot of the Pfizer-BioNTech vaccine for children ages 5-11.

The recommendation comes two days after the U.S. Food and Drug Administration (FDA) issued it Expand authorization Pfizer’s COVID-19 booster shot for children in this age group.

CDC Director Rochelle Walensky is likely to sign off on the recommendation later today. Children who received their first dose of the vaccine at least five months ago will be eligible.

During the ACIP’s five-hour meeting on Thursday, health officials kept citing data that found booster doses for children in this age group were safe and effective in reducing hospitalizations and deaths.

While pediatric hospitalizations rose to record numbers during the omicron surge, parents have proven hesitant to vaccinate their children.

According to the latest data from the U.S. Centers for Disease Control and Prevention, about 36 percent of U.S. children ages 5-11 are partially vaccinated, and nearly 29 percent are fully vaccinated.

Read more here.

what are we reading

  • Montreal sees 17 suspected cases of monkeypox as numbers rise in Europe (statistics)
  • In the rural low-income areas of the country, how do you find infant formula when there is nowhere to be found? (19th)
  • The CDC says COVID vaccine-associated myocarditis is much lower in children than in adolescents (Reuters)


  • This rural Red Southern county is a vaccine success story. no longer(Kaiser Health News)
  • Counties that support Trump continue to suffer higher COVID deaths (NPR)
  • Here’s how the abortion clinic prepared for Roy’s fall (Associated Press)

That’s all for today, thanks for reading.Check out Hill’s Healthcare Page Get the latest news and coverage. See you tomorrow.

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