Health Care — FDA commissioner faces Congress on baby formula
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Today in health care, the FDA commissioner faced questions on baby formula shortages on Capitol Hill, and CDC advisors recommended boosters for kids 5-11.
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FDA chief: Formula shortages may ease within days
The head of the Food and Drug Administration (FDA) told a House panel Thursday that the infant formula shortages will begin to ease over the next few days, but had few answers for how the agency allowed a manufacturing plant with known safety issues to continue operating for months without stepping in.
FDA Commissioner Robert Califf was the first administration official to answer questions before Congress about the formula shortage, which has recently caught lawmakers’ attention. Now facing pressure from frustrated families, those lawmakers are finding no easy solutions.
The scarcity is partly due to the closure of a manufacturing plant operated by Abbott Nutrition. The plant has been shut down since February, after four infants who consumed formula made there were hospitalized with a rare bacterial infection.
The FDA earlier this week announced a preliminary consent agreement with Abbott to restart production, pending safety upgrades and certifications.
“I am pleased to say we’ve made very significant progress” on reopening the plant, Califf told members of a House appropriations subcommittee, “and I think we are on track to get it open within the next week to two weeks, most likely at the outbound two weeks.”
Califf said the combination of increased production from other manufacturers and new authority on importing formula means “we should see improvement within days.”
However, he acknowledged “it will be a few weeks before we’re back to normal.”
Harris meets with abortion providers
Vice President Harris on Thursday spoke with a group of abortion providers who she said are serving “on the front lines” of a “war on women’s rights.”
Harris held a virtual meeting with doctors, nurses and reproductive rights advocates who are working in states with particularly restrictive abortion laws, like Oklahoma, Texas and Kansas. The gathering was prompted by news earlier this month that the Supreme Court had drafted an opinion that would overturn Roe v. Wade, the landmark 1973 ruling that protects a woman’s right to an abortion.
“We cannot deny that this decision will have real and immediate effects on women around our country,” Harris said. “So, I am here today, joined by doctors, nurses and leading advocates, who are on the front lines against this war on women’s rights.”
Harris noted that her remarks came less than an hour after legislators in Oklahoma approved a bill that would effectively outlaw all abortions except to save the life of the pregnant person, or if the pregnancy is the result of a rape that was reported to authorities.
Harris called the Oklahoma law “outrageous, and it’s just the latest in a series of extreme laws around the country. Several of the medical professionals joining us today are seeing the impact of these laws that are designed to punish and control women.”
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 essential sources of nutrition from future shortages.
The Protect Infants from Formula Shortages Act would also safeguard the availability of these products by requiring manufacturers to notify the Food and Drug Administration (FDA) of potential supply disruptions, giving the agency time to prevent or mitigate potential shortages.
The proposed bill will also direct formula manufacturers to develop risk management plans for the supply of their products and increase the FDA’s inspection authority.
The bill was introduced by Sens. Bob Casey (D-Pa.), Sherrod Brown (D-Ohio), Elizabeth Warren (D-Mass.), Tammy Duckworth (D-Ill.) and Kirsten Gillibrand (D-N.Y.).
In a statement, Casey said that Congress has the “responsibility” to tackle this issue, adding that they must do everything to ensure that parents have formulas on the shelves.
“I am introducing the Protect Infants from Formula Shortages Act to avoid another massive disruption in availability of life-saving and life-sustaining formula and other products,” Casey said.
CDC INVESTIGATING CASES OF UNEXPLAINED HEPATITIS IN CHILDREN
The Centers for Disease Control and Prevention (CDC) is now looking into 180 cases of pediatric hepatitis that were reported over the past seven months, 71 more cases than what was being reported earlier this month.
In a statement, the CDC stressed that while this may appear to be a large increase in cases, most of them are “retrospective,” with the agency looking at patients as far back as October 2021. Not all the cases that have been detected are recent, and the agency noted that some may end up not even being related to the current investigation.
“Additionally, there have been no reported deaths since February 2022, and the proportion of patients requiring liver transplants has gone down from 15 percent to 9 percent since May 5,” the CDC said.
Since the beginning of the CDC’s investigation into the unexplained pediatric hepatitis cases, a possible link to adenovirus has been speculated due to the high rate in which it has been found in the affected patients.
In its update, the CDC said adenovirus has been found in almost half of the children with unexplained hepatitis and said it “continues to be a strong lead” as a potential cause.
The agency added that childhood hepatitis continues to be a rare condition. However, parents should still be aware of the potential symptoms. These include vomiting, dark urine and light stools. One of the most notable symptoms of hepatitis is jaundice, which is a yellowing of the skin.
CDC advisors recommend boosters for kids 5-11
A panel of independent advisors to the Centers for Disease Control and Prevention on Thursday recommended booster shots of the Pfizer-BioNTech vaccine for children ages 5-11.
This recommendation comes just two days after the Food and Drug Administration (FDA) expanded the authorization of Pfizer’s COVID-19 booster shot for children in that age group.
CDC Director Rochelle Walensky is likely to sign off on the recommendation later today. Children who received their first dose at least five months ago will then be eligible.
Throughout the five-hour meeting that the ACIP held on Thursday, health officials continually cited data that found booster doses in children within this age range were safe and effective at reducing hospitalizations and deaths.
While pediatric hospitalizations increased to record numbers during the omicron surge, parents have proved hesitant to vaccinate their kids.
According to the most recent data from the CDC, about 36 percent of children in the U.S. aged 5-11 are partially vaccinated and nearly 29 percent are fully vaccinated.
WHAT WE’RE READING
- 17 suspected monkeypox cases seen in Montreal, as European tally increases (Stat)
- In rural, low-income parts of the country, how do you find baby formula when there is nowhere to look? (The 19th)
- U.S. CDC says COVID vaccine-related myocarditis much lower for children than teens (Reuters)
STATE BY STATE
- This rural, red southern county was a vaccine success story. Not anymore (Kaiser Health News)
- Pro-Trump counties continue to suffer far higher COVID death tolls (NPR)
- Here’s how abortion clinics are preparing for Roe to fall (Associated Press)
That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you tomorrow.
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