An auction of items that belonged to the late, great Betty White is about to be underway, and you could be the proud owner of her VHS tape collection or even her bedroom door.
In health care, the Biden administration is pushing back on Sen. Lindsey Graham’s (R-S.C) proposal for a national abortion ban, with one White House staffer warning it would lead to “crisis.”
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Officials warn against national abortion ban
A top White House official warned in a memo issued Thursday that Sen. Lindsey Graham’s (R-S.C.) proposal for a national abortion ban would lead to a “nationwide health care crisis” and transform reproductive medicine.
Jennifer Klein, director of the Gender Policy Council at the White House, wrote in a memo obtained by The Hill that Graham’s legislation would endanger pregnant women and have catastrophic consequences for the health care system
“If passed and enacted, this bill would create a nationwide health crisis, imperiling the health and lives of women in all 50 states. It would transform the practice of medicine, opening the door to doctors being thrown in jail if they fulfill their duty of care to patients according to their best medical judgment,” Klein wrote in the memo.
Klein cited a study from The New England Journal of Medicine that looked at a Texas law imposing an abortion ban after six weeks of pregnancy that went into effect in September 2021. The study found that many providers do not provide information to patients about abortion in cases where the health of the mother or the fetus is in danger out of fear of legal and professional consequences.
“Providers have sent home patients whose health is in jeopardy, unable to provide care under the law, and only provided appropriate treatment once they returned with signs of a life threatening condition like sepsis. Finally, the study notes that some providers are planning to leave Texas entirely,” Klein wrote.
Graham earlier this month introduced his proposed 15-week national abortion ban, saying he was motivated to act following attempts by Democrats to enshrine abortion protections into federal law.
Read more here.
FDA user fee reauthorization added to bill
Sen. Richard Burr (R-N.C.) on Thursday said the five-year reauthorization of the Food and Drug Administration’s (FDA) user fee program will be included in the stopgap spending bill meant to prevent a government shutdown.
A senior GOP committee aide confirmed to The Hill that the measure is included in the stopgap spending bill, adding that conversations on FDA user fees are still “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 the FDA’s authority to collect user fees.
The House passed an FDA user fee package in June with added provisions such as diversifying clinical trial participation. Burr later introduced a “clean” user fee package in the Senate that left out what he referred to as “harmful additions.”
An aide for Sen. Patty Murray (D-Wash.), chair of the Senate HELP committee, said, “Senator Murray has reached a deal on a practically clean reauthorization that ensures Congressional inaction won’t force FDA to send out pink slips along with some additional policies.”
“Even after we have addressed this immediate challenge before the looming deadline she believes we can’t, and she won’t, stop pushing for the kind of reforms families need to see from the drug industry and this critical agency,” said the aide.
Potential consequences: Congress must pass a funding bill by Oct. 1 to avoid a government shutdown. While Congress has missed the deadline to reauthorize the FDA user fees in the past, the head of the FDA warned this year that if reauthorization isn’t passed then the agency will have to carry out furloughs.
Read more here.
JUDGE PUTS INDIANA’S ABORTION BAN ON HOLD
An Indiana judge put the state’s abortion ban on hold on Thursday, one week after it went into effect.
Monroe Circuit Court Judge Kelsey Hanlon granted abortion providers a preliminary injunction, blocking enforcement of the ban. Indiana’s abortion ban, which went into effect on Sept. 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 putting the law on hold pending litigation that there is “a reasonable likelihood that this significant restriction of personal autonomy offends the liberty guarantees of the Indiana Constitution.”
Indiana Gov. Eric Holcomb (R) signed the abortion ban into law on Aug. 5, making Indiana the first state to pass restrictions on abortion access since the Supreme Court overturned Roe v. Wade in June.
Several Indiana abortion providers filed suit on Aug. 30, claiming the law violates the Indiana Constitution.
Read more here.
PFIZER AGREES TO SUPPLY MILLIONS OF GLOBAL PAXLOVID COURSES
Pfizer announced on Thursday it has reached an agreement to supply up to six million courses of its COVID-19 antiviral Paxlovid to the Global Fund to get treatment to low and middle-income countries.
This supply agreement was made as part of 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 grant support to low- and middle-income countries to purchase COVID-19 tests, treatments, personal protective equipment and critical elements of health systems strengthening,” Pfizer said.
“PAXLOVID treatment courses will be available for procurement through
this mechanism, subject to local regulatory approval or authorization, by the 132 grant-eligible countries determined by Global Fund based on income classification and disease burden.”
Access to coronavirus therapeutics like Paxlovid, which must be administered within five days of symptom-onset, has been limited for poorer countries. Some efforts to provide access to these treatments to poorer countries have been made since they were authorized..
Earlier this month, Pfizer donated 100,000 courses of Paxlovid to the Covid Treatment Quick Start Consortium, a newer organization created with the goal of helping countries set up test-and-treat programS.
Read more here.
FDA blames formula crisis on outdated systems, training
An internal Food and Drug Administration (FDA) report examining what went wrong with the federal government’s response to the infant formula shortage earlier this year found 15 areas where the FDA could have better managed the crisis.
The report from Steven Solomon, director of the FDA’s Center for Veterinary Medicine, recommended the agency update emergency response systems, increase staff training and modernize information technology, among other changes.
What can be improved:
The FDA report says agents who inspect infant formula plants need more training and investigators who are part of the foods division of the federal agency are understaffed.
Solomon also found fault with the FDA’s communication and coordination efforts on managing the crisis, citing “inadequate processes and lack of clarity” on handling whistleblower complaints and outdated information systems where reports and product complaints are submitted.
Solomon said many of the findings he has outlined, along with the recommendations to fix them, are already being addressed.
“This is one of our most important obligations,” Solomon wrote. “As public health servants, our commitment to protecting the nation’s food supply should be never-ending.”
The infant formula shortage drew national headlines earlier this year as families scrambled to get the product before the shortage eased in the summer.
Read more here.
WHAT WE’RE READING
Why Omicron Might Stick Around (The New York Times) NIH launches the next stage of its ‘human genome project’ for the brain (Stat) On National Physician Suicide Awareness Day, doctors raise the alarm on physician deaths (ABC News)
STATE BY STATE
Opponents of California’s Abortion Rights Measure Mislead on Expense to Taxpayers (Kaiser Health News) Rhode Island approves health insurance rate increases (The Boston Globe) Former lawmaker blasts Tennessee’s effort to find millions of dollars erroneously paid out in health claims (WTVF)
THE HILL OP-EDS
Secure the food supply chain before the next disaster strikes The five bold actions needed from the White House food summit
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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