An auction of items that belonged to the late, great Betty White is coming up and you could be the proud owner of her VHS collection or even her bedroom door.
On the health front, the Biden administration is pushing back on Sen. Lindsey Graham’s (RS.C) proposal for a national abortion ban, with a White House staffer warning it would create a “crisis.”
Welcome to overnight health care, where we follow the latest developments in policies and news affecting your health. For The Hill we are Nathaniel Weixel and Joseph Choi. Someone forwarded this newsletter to you? Subscribe here.
Officials warn of national abortion ban
A senior White House official warned in a memo released Thursday that Sen. Lindsey Graham (RS.C.)’s proposal for a national abortion ban would create a “nationwide public health crisis” and transform reproductive medicine.
Jennifer Klein, director of the White House Gender Policy Council, wrote in a memo obtained by The Hill that Graham’s legislation would endanger pregnant women and have disastrous consequences for the health care system
“If this law were passed and enacted, it would create a nationwide public health crisis that would endanger the health and lives of women in all 50 states. It would transform medical practice and open the door for physicians to be thrown in prison for using their best medical judgment in fulfilling their duty of care to patients,” Klein wrote in the memo.
Klein cited a study from the New England Journal of Medicine that looked at a Texas law banning abortion after six weeks of pregnancy, which went into effect in September 2021. The study found that many providers do not inform patients about abortion in cases where the health of the mother or fetus is at risk for fear of legal and professional ramifications.
“Carers have sent home patients whose health is at risk, who by law cannot afford care, and only provided appropriate treatment after they have returned with signs of a life-threatening condition such as sepsis. Finally, the study notes that some providers are planning to exit Texas entirely,” Klein wrote.
Graham unveiled his proposed 15-week national abortion ban earlier this month and said he was motivated to act on Democrat attempts to enshrine abortion protections in federal law.
Read more here.
Added FDA user fee reauthorization to invoice
Sen. Richard Burr (RN.C.) said Thursday that the five-year reauthorization of the Food and Drug Administration’s (FDA) user fee program will be included in the emergency spending bill designed to prevent a government shutdown.
A senior adviser to the GOP committee confirmed to The Hill that the measure is included in the stopgap bill, adding that talks on FDA user fees are “ongoing.”
FDA user fees are collected from drug and medical device companies to fund and expedite the agency’s review of products. Every five years, Congress must vote to reauthorize FDA’s authority to collect user fees.
The House of Representatives passed an FDA royalty package in June with additional provisions such as diversification of clinical trial participation. Burr later introduced a “clean” royalty package in the Senate that left out what he called “harmful additions.”
An aide to Senator Patty Murray (D-Wash.), Chair of the Senate HELP Committee, said, “Senator Murray has reached agreement on a virtually clean reauthorization that ensures congressional inaction will not force the FDA to do so to send along a pink note with some additional guidelines.”
“Even after we have addressed this immediate challenge ahead of the upcoming deadline, she believes we cannot and will not stop pushing for the kind of reforms that families need to see from the pharmaceutical industry and this critical agency,” the adviser said .
Possible consequences: Congress must pass a funding bill by Oct. 1 to avoid government shutdown. While Congress has missed the deadline to reauthorize FDA user fees in the past, this year the head of the FDA warned that the agency will have to take a vacation if the reauthorization doesn’t pass.
Read more here.
JUDGE ISSUES INDIANA’S ABORTION BAN
An Indiana judge put the state’s abortion ban on hold Thursday, a week after it went into effect.
Monroe District Court Judge Kelsey Hanlon granted abortion providers an injunction and blocked enforcement of the ban. Indiana’s abortion ban, which went into effect September 15, criminalized the procedure except in the case of rape, incest, or to protect the life of the mother.
constitutionality: Hanlon noted in Thursday’s decision to stay the law pending litigation that “there is a reasonable likelihood that this significant limitation of personal autonomy violates the liberty guarantees of the Indiana Constitution.”
Indiana Gov. Eric Holcomb (R) signed the abortion ban into law Aug. 5, making Indiana the first state to pass restrictions on access to abortion since the Supreme Court ruled Roe v. Wade lifted in June.
Several Indiana abortion providers filed suit on Aug. 30, claiming the law violates the Indiana Constitution.
Read more here.
PFIZER AGREES TO DELIVERY MILLIONS OF WORLDWIDE PAXLOVID COURSES
Pfizer announced Thursday that it has reached an agreement to supply up to six million courses of its COVID-19 antiviral Paxlovid to the Global Fund to treat low- and middle-income countries.
This supply agreement was made under the Global Fund’s COVID19 Response Mechanism (C19RM), Pfizer said in a statement provided to The Hill.
“The C19RM has been the primary channel for providing grants to low- and middle-income countries to purchase COVID-19 testing, treatment, personal protective equipment and critical items to strengthen health systems,” Pfizer said.
“PAXLOVID treatment courses will be available via
This mechanism will be subject to local regulatory approval or approval by the 132 eligible countries determined by the Global Fund based on income classification and burden of disease.”
Access to coronavirus therapeutics such as Paxlovid, which must be administered within five days of symptom onset, is restricted for poorer countries. Since their approval, some efforts have been made to make these treatments accessible to poorer countries.
Earlier this month, Pfizer donated 100,000 Paxlovid courses to the Covid Treatment Quick Start Consortium, a newer organization formed with the goal of helping countries build test-and-treat programs.
Read more here.
The FDA blames outdated systems and training for the formula crisis
An internal Food and Drug Administration (FDA) report examining what went wrong in the federal government’s response to the infant formula shortage earlier this year found 15 areas where the FDA could have handled the crisis better.
The report, by Steven Solomon, director of the FDA’s Center for Veterinary Medicine, recommended that the agency update emergency response systems, improve staff training, and modernize information technology, among other things.
What can be improved:
The FDA report says agents who inspect infant formula facilities need more training and investigators who are part of the federal agency’s food division are understaffed.
Solomon also criticized FDA’s communication and coordination efforts to manage the crisis, citing “inadequate processes and a lack of clarity” in handling whistleblower complaints and outdated information systems where reports and product complaints are filed.
Solomon said many of the findings he outlined are already being addressed, along with recommendations for resolving them.
“This is one of our most important commitments,” Solomon wrote. “As public health workers, our commitment to protecting the country’s food supply should never end.”
Baby formula shortages made national headlines earlier this year as families scramble to get the product before the summer shortages eased.
Read more here.
WHAT WE READ
Why Omicron might stay around (The New York Times)
NIH Launches Next Stage of Brain “Human Genome Project” (Stat)
On National Physician Suicide Awareness Day, doctors sound the alarm over physician deaths (ABC News)
STATE BY STATE
Opponents of California’s abortion rights measure mislead taxpayers (Kaiser Health News)
Rhode Island approves increases in health insurance rates (The Boston Globe)
Former lawmaker slams Tennessee efforts to find millions of dollars wrongly paid out on health claims (WTVF)
THE HILLS OP EDS
That’s it for today, thanks for reading. Visit The Hill’s Health Care page for the latest news and reports. See you tomorrow.
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