Health Care — US Postal Service cleared to deliver abortion pills

by Nathaniel Weixel and Joseph Choi - 01/04/23 7:09 PM ET

Chaos continued in the House today after Kevin McCarthy (R-Calif.) failed to get enough votes on a sixth straight ballot for Speaker. We are heading into day three of the 118th Congress without a Speaker.

In health news, the Biden administration is taking steps to expand access to abortion pills in states that haven’t outlawed the procedure.

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter?

Postal Service given OK to deliver abortion drugs

The U.S. Postal Service is legally allowed to deliver prescription abortion drugs even in states that have curtailed access to abortion, the Justice Department said.

A legal opinion from the agency’s Office of Legal Counsel (OLC) found that mailing mifepristone or misoprostol does not violate the Comstock Act, a nearly 150-year-old law originally written to stop anything that could “corrupt” morals from being sent in the mail, if the sender does not know if the drugs will be used illegally.

Abortion pills are rapidly becoming the next major flashpoint in the abortion battle.

Federal law does not prohibit the use of mifepristone and misoprostol, and the Food and Drug Administration has found them to be safe and effective for terminating early pregnancy.

“There are manifold ways in which recipients in every state may use these drugs, including to produce an abortion, without violating state law,” OLC chief Christopher Schroeder wrote in the opinion.
“Therefore, the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.”

There has been a growing effort to circumvent the laws by mailing the drugs, often from overseas, directly to people seeking them.

Republican-led states have been moving to limit or even completely ban access to the drugs, and advocates have been concerned the Supreme Court’s decision overturning Roe v. Wade will embolden even more states to crack down.

Read more here.

FDA to expand availability of abortion pills

A rule change from the Food and Drug Administration (FDA) will allow U.S. retail pharmacies to offer abortion pills directly to patients with a prescription in states where abortion is legal.

The move happened without much fanfare, but it was a step that abortion advocates had been clamoring for. The agency first announced it was seeking to change the prescribing safety protocols last year.

Mifepristone is regulated under a Risk Evaluation and Mitigation Strategy (REMS), a safety program the agency required for certain drugs to ensure that their benefits outweigh their risks.
The medication is used with another drug, misoprostol, to terminate pregnancies, and the FDA has said the drugs are safe and effective for use in the first 10 weeks of pregnancy.

The FDA started the reevaluation process by temporarily lifting a requirement that mifepristone be dispensed in person at a clinic or hospital because of the COVID-19 pandemic. The Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.

But those changes were never finalized under the regulatory process, until now.
Now, pharmacies that are certified in the FDA’s REMS program can now dispense mifepristone directly to patients in stores and by mail. But it’s unclear how many pharmacies will choose to do so.

Medication abortion is becoming increasingly common. In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S., according to the Guttmacher Institute, a pro-abortion research group.

Attorney General Merrick Garland in June indicated the Justice Department will take action against states that ban abortion pills, though it’s unclear if the federal government has that power.

Read more here.

WHITE HOUSE WARNS AGAINST PANIC AS SUBVARIANT SPREADS

White House health officials are cautioning against a rush to panic over the XBB.1.5 omicron subvariant, which has rapidly grown to account for 40 percent of U.S. COVID-19 cases, with officials stating it is not yet known if this version is more dangerous.

White House COVID-19 response coordinator Ashish Jha posted a lengthy Twitter thread on Thursday addressing concerns over the sudden rise of XBB.1.5. He acknowledged that the subvariant going from 4 percent of cases to 40 percent in a matter of weeks was a “stunning increase.”

Jha said XBB.1.5 is likely more immune-evasive than other omicron subvariants and could likely be more contagious as well but said it is not yet known if it is more dangerous than previous mutations.
“If you had an infection before July or your last vaccine was before bivalent update in September, your protection against an XBB.1.5 infection is probably not that great,” Jha said.

COVID-19 antivirals such as Paxlovid and Molnupiravir, however, should still work in treating infections, Jha said. Paxlovid, a combination of two antiviral medications, functions by blocking an enzyme the SARS-CoV-2 virus needs to replicate.

Food and Drug Administration Commissioner Robert Califf said on Thursday, “It is highly likely that the current bivalent vaccines provide some protection against XBB, especially in the prevention of serious illness and death.”

Read more here.

TOP WHO OFFICIAL SAYS CHINA UNDERCOUNTING COVID DEATHS

A top World Health Organization (WHO) official on Wednesday said China is underreporting deaths from COVID-19 and called for more transparency about the scope of the country’s outbreak.

“We believe the current numbers being published from China underrepresent the true impact of the disease in terms of hospital admissions, in terms of ICU admissions, and particularly in terms of death,” said Mike Ryan, head of the WHO’s health emergencies program.
“We still do not have complete data,” Ryan said. “We do not discourage doctors and nurses reporting these deaths or these cases.”

Ryan said China is using too narrow a definition of death attributable to COVID-19. According to WHO guidelines, COVID-19 should be listed if the disease “caused, or is assumed to have caused, or contributed to death.”

The WHO official added that even though there don’t appear to be any new variants circulating in the country, poor surveillance and poor vaccine coverage will lead to missed cases and more deaths.

Read more here.

Experts urge action against winter COVID surge

Much of the U.S. is in the throes of a winter COVID-19 surge with cases poised to eclipse last year’s summer peak, driven by new variants, waning immunity and holiday gatherings.

Last week, the U.S. surpassed 100 million total cases since the start of the pandemic, according to data from the Centers for Disease Control and Prevention. The actual totals are likely much higher because of infected people who never got tested or those who tested positive at home and never reported the result.

But public health experts are expressing frustration that instead of focusing on mitigation measures including masking and improved ventilation, U.S. officials have turned their attention toward China.

Beginning Thursday, all incoming travelers from China, including Hong Kong and Macau, will need to present negative COVID-19 tests before entering the United States regardless of vaccination status.

Key quote: “We should probably look at ourselves first. Any country ought to be testing people from the United States,” said Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Osterholm pointed to the “atrocious” levels of booster shot uptake and the rapid rise of the XBB variant, particularly in the Northeast.

Administration officials argue China has virtually stopped reporting any outbreak data, and officials said they are concerned about potential new variants circulating without their knowledge.
But infectious disease experts said new variants are much more likely to arise domestically than to come from China. The virus mutates to escape immunity, whether from prior infection or from vaccination. The U.S. currently has much higher levels of both compared to China.

Read more here.

WHAT WE’RE READING

Covid misinformation spikes in wake of Damar Hamlin’s on-field collapse (Washington Post)
Public health agencies try to restore trust as they fight misinformation (Kaiser Health News)
Providers say Medicare Advantage hinders new methadone benefit (Roll Call)

STATE BY STATE

UF med school professors slam Florida surgeon general over COVID vaccine research (Miami Herald)
Gov. Newsom declares state of emergency as Northern California braces for another storm (Los Angeles Times)
Indiana proposal to restructure public health faces uphill battle (The Indianapolis Star)

OP-EDS IN THE HILL

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.

Tags Ashish Jha Kevin McCarthy