HEALTH INFORMATION: Abbott, FDA Approves Formula Factory Restart

Abbott Laboratories reached a deal with federal authorities that would allow it to start manufacturing baby formula again at a ailing Michigan plant, a move that could help ease a supply shortage that has rocked many parents.

Under the terms of the agreement, which was filed Monday by the Justice Department in a Michigan federal court, Abbott must take steps mandated by the Food and Drug Administration to ensure it can safely manufacture formulas. The agreement still requires court approval, the FDA said Monday. Among other things, Abbott must meet FDA food standards if it decides to resume production, the agency said.

This facility has been closed since February after four children who were fed formula made there contracted Cronobacter bacteria and two died. No other cases of infants sickened by formula have been reported since then, the Centers for Disease Control and Prevention said. Abbott said its products were not to blame for the illnesses and deaths.

The closure helped make an already existing baby food shortage far worse, and the crisis has deepened in recent weeks as stocks in stores have been depleted by panic buying. State and federal law enforcement officials say they are also on the lookout for price gouging. In addition to the agreement with Abbott, the FDA on Monday set standards for importing formulas made by foreign companies. Read more from Anna Edney.

  • The shortage is forcing more parents to look around an even more expensive alternative: breast milk from donor banks. Requests for donor milk have increased 20% since the shortage began, said Lindsay Groff, director of the Human Milk Banking Association of North America. That follows a record year of distribution: HMBANA member banks donated 9.2 million ounces to families and hospitals of babies in need in 2021, a 22% increase from 2020, Groff said. Ella Ceron has more.
  • Continue reading: Addressing the Infant Formula Shortage: Explaining FDA’s Powers

Also on the radar of the legislature

Hearings on Tuesday:

  • The Senate Appropriations Subcommittee on Labor, HHS and Education will hold a hearing Tuesday on the National Institutes of Health’s fiscal 2023 budget proposal. Acting NIH director Lawrence Tabak and director of the National Institute of Allergy and Infectious Diseases Anthony Fauci are among those scheduled to testify.
  • The House Science, Space and Technology Committee on Tuesday planned to surcharge legislation, including HR 7180, authorizing the National Science Foundation to award grants to support research into disruption of regular cognitive processes related to Covid-19.
  • The Military Construction and Veterans Affairs Budget Appropriations Subcommittee will hold a hearing Tuesday on modernizing electronic medical records at the Department of Veterans Affairs.
  • The House Oversight Coronavirus Crisis Subcommittee holds a hearing on Tuesday on the impact of the Covid pandemic on the low-wage female workforce in the country.
  • BGOV calendar: See the full list of Tuesday’s hearings.

Bills for the passage: The house plans to vote Tuesday on measures related to health care for military veterans under suspension of rules – which will require a two-thirds majority – including:

  • HR 7500, which would authorize large medical facility projects for the Department of Veterans Affairs. The bill would authorize $3.4 billion to restore or build 12 medical facilities in VA in fiscal 2022. The House Veterans’ Affairs Committee did not consider the bill. For more information, see Christina Banoub’s BGOV Bill Summary.
  • HR 5754, which would require the VA’s Office of Patient Advocacy, would need to create an online system for veterans to file and track complaints about VA health care services. The House Veterans Affairs Committee approved the bill by ballot on April 6. For more information, see Christina Banoub’s Summary of the BGOV Bill.

CBO reviews deficit impact of lower Medicare age: Lowering the age for joining Medicare to 60 would increase the federal deficit by $155 billion between 2026 and 2031 and bring 7.3 million new people into the public program, according to an analysis by the CBO. Analysis by the Congressional Budget Office outlined the effect of more people joining Medicare on Medicaid and employer plans, showing that 150,000 people would retire early because they would no longer need a job for coverage, reports Alex Ruoff. Read it here.

The coronavirus pandemic

The US extends the public health emergency again: The US government will extend the Covid-19 public health emergency beyond mid-July, continuing pandemic-era policies as the nearly 2 1/2-year outbreak drags on. The Department of Health and Human Services has repeatedly renewed the public health emergency since its inception in January 2020. The declaration allows the federal government to issue emergency drug and vaccine approvals and has enabled millions to receive Medicaid coverage.

National health organizations, including the American Hospital Association, the American Medical Association and the American Academy of Pediatrics, have campaigned for the public health emergency to be extended. Last week, they wrote to Secretary Xavier Becerra, urging the Biden administration to maintain the state of emergency “until it is clear that the global pandemic has receded and the capabilities approved by the PHE are no longer needed.”

The Biden administration is expanding the statement as it simultaneously urges lawmakers to approve additional billions to fight the pandemic. Meanwhile, Republicans have encouraged the White House to reverse the statement made about the Public Health Service Act. When the state of emergency ends, the US will lose certain powers and likely roll back many programs that pharmaceutical companies, telemedicine providers and insurers have relied on. Riley Griffin has more.

Vaccination protection better than records show: Widespread methods used to count Covid hospitalizations in the US can make vaccines appear less effective than they actually are, according to a group of Boston-based researchers. The researchers argue their work raises questions about how the US should approach future booster shot campaigns and how the country measures the severity of Covid. This may also affect bonus payments for hospitals caring for Covid patients. Drew Armstrong has more.

China spat may spoil deal for vaccine IP waiver: A looming trade dispute between the US and China could derail nearly two years of efforts to relax intellectual property rules for manufacturing Covid vaccines and further challenge the World Trade Organization’s reputation as a negotiating forum. Biden’s top trade official in Geneva said any WTO deal related to Covid vaccines must specifically exclude China from benefiting from the deal. Read more from Bryce Baschuk.

More headlines:

What else should you know today?

Conflicting Laws in the Northwest Reveal Post-Roe Chaos: The stark divisions and murky legalities of how states handle abortion rights are perhaps most intense in the US Northwest. Less than two months before a leaked Supreme Court document announced the imminent death of Roe v. Wade signaled, the governors of Washington and Idaho signed diametrically opposed abortion laws. Now Washington’s clinics are bracing for a flood of Idahoans seeking help. Read more from Dina Bass and Mat Day.

  • George P. Bush, who is eyeing the GOP nomination for Texas Attorney General, said he would support more efforts to limit abortion if elected, including rules penalizing companies that pay for employees to travel to other states for such procedures. Bush said lawmakers should ban companies that offer such benefits from doing business with the state. He also vowed to crack down on the shipping of abortion pills to Texans. Shelly Hagan has more.

FDA will be “deeply involved in ARPA-H”: The FDA’s ability to advance biomedical discoveries from Biden’s new research center will depend on an efficient partnership and will likely intensify an ongoing debate about expedited approvals, the agency’s deputy said. Janet Woodcock’s comments on Monday provided some of the first glimpses of how the FDA views and is getting off the ground in its role as the Advanced Research Projects Agency for Health (ARPA-H). Read more from Jeannie Baumann.

Employers pay hospitals double Medicare rates: Employers and health insurers were paying hospitals more than double what Medicare would have paid in 2020, according to a RAND report Tuesday. Prices paid by employers and private insurers to hospitals for inpatient and outpatient services in 2020 averaged 224% of what Medicare would have paid, RAND said in its fourth report, which compared private insurance payments to healthcare providers with Medicare tariffs were compared. Sara Hansard has more.

LGBTQ couples IVF hopes depend on fertility definition: The Biden administration is considering a requirement that some health insurance plans cover fertility treatment for policyholders regardless of their sexual orientation or gender identity. The White House could use an upcoming Obamacare update to tackle the definition of infertility, which is often used by insurers to determine eligibility for in vitro fertilization, which some LGBTQ people find impossible to meet is. Shira Stein has more.

Spike from substance abuse hampered labor recovery: According to a recent paper released by the Federal Reserve Bank of Atlanta, a rise in substance abuse during the Covid-19 pandemic has hampered the recovery in America’s job market. Increased substance abuse accounted for 9% to 26% of the decline in labor force participation among workers aged 25 to 54 — the so-called prime age — between February 2020 and June 2021, the study authors said. Read more from Alex Tanzi.

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Supported by Alex Ruf

To contact the reporter on this story: Brandon Lee in Washington [email protected]

To contact the editors responsible for this story: Giuseppe Macri at the [email protected]; Michaela Ross at the [email protected]

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