Monday, April 10, 2023

Two abortion pill rulings. One uncertain future.

Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Apr 10, 2023 View in browser
 
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By Daniel Payne and Krista Mahr

Driving the Day

Abortion-rights activists setup an abortion pills educational booth as they protest outside the Supreme Court.

Judges in two states issued conflicting rulings on abortion pills last week. | Jose Luis Magana/ AP Photo

BITTER PILLS — With less than a week before a Friday court ruling — which could effectively ban the sale of abortion pills in the U.S. — goes into effect, the Biden administration hopes an appeal will not only stop the ban but also maintain the FDA’s larger approval process.

HHS Secretary Xavier Becerra said Sunday on CNN’s “State of the Union” that last week's ruling in Texas that the FDA approval of the abortion drug mifepristone is unlawful would not only limit access to abortion pills but also affect the entire drug regulatory process, POLITICO’s Shayna Greene reports.

“First and foremost, when you turn upside down the entire FDA approval process, you’re not talking about just mifepristone,” he said. “You’re talking about every kind of drug. You’re talking about our vaccines, you’re talking about insulin, you’re talking about the new Alzheimer’s drugs that may come on.”

The response came after the Biden administration faced tough court rulings on its abortion pill policy not only in Texas but also in Washington state, which both decided against the FDA’s regulations.

But the judgments were contradictory, leading to a host of questions about what can be enforced in the near term — and whether the arguments will eventually end up in the Supreme Court.

Texas’ restrictive ruling: U.S. District Court Judge Matthew Kacsmaryk sided with anti-abortion medical groups that challenged the drug’s federal regulation, POLITICO’s Alice Miranda Ollstein reports.

Kacsmaryk ruled the FDA’s initial approval in 2000 and more recent FDA decisions allowing the pills to be prescribed via telemedicine, delivered by mail and dispensed at retail pharmacies are unlawful.

The crux of the case is whether the FDA properly scrutinized mifepristone as a safe and effective drug more than two decades ago.

Meanwhile, in Washington: A federal judge issued a conflicting order Friday night that blocks the FDA from rolling back access to the pills in the dozen blue states that brought the lawsuit, another rebuttal of the Biden administration’s policy on the drugs — this one saying the FDA is overly restrictive.

The ruling from U.S. District Court Judge Thomas O. Rice, an appointee of former President Barack Obama, clashes with Kacsmaryk’s in that it orders the FDA to maintain the status quo, raising the likelihood that the issue could go before the Supreme Court.

The administration is expected to appeal the Washington state ruling.

Both cases going to their respective circuit courts could set the stage for the Supreme Court to ultimately decide.

WELCOME TO MONDAY PULSE. Need to catch up on what a weekend full of news means for abortion pills? POLITICO’s Dan Goldberg answers your burning questions on the history that led up to the ruling and what comes next.

We have some questions for you, too: What’s the big news no one’s reported yet? Let us know at dpayne@politico.com and kmahr@politico.com.

TODAY ON OUR PULSE CHECK PODCAST, host Katherine Ellen Foley talks with Ruth Reader about a new survey finding that teenage girls think their social media use is out of control —a view that aligns in many ways with those of lawmakers in Congress and the states.

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Abortion

Sen. Ron Wyden is pictured walking.

Democratic Sen. Ron Wyden of Oregon and other lawmakers want the White House to "ignore" the Texas abortion pill ruling. | AP Photo

DEMS’ RULING RESPONSE — Some Democrats offered another idea for the Biden administration’s response to the Texas abortion pill ruling: Act as if nothing happened, Alice reports.

“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Sen. Ron Wyden (D-Ore.) said Friday, arguing the ruling would be “devastating” if followed.

Wyden’s call was backed up by other Democrats, like Rep. Alexandria Ocasio-Cortez (D-N.Y.), who called the ruling “deeply partisan” and unfounded.

But administration officials think it would be “premature” and “pretty risky” to take the step Wyden is calling for, because it’s possible a higher court would reverse the decision by Kacsmayrk, according to a person advising the White House on legal strategy.

 

GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat.

 
 
Public Health

COVID LITIGATORS CONVENE — People taking the government and health care systems to court over Covid-19 came together to discuss strategy recently, hinting at the next battleground of the pandemic: the courts.

Krista reports from Atlanta that the 275 people who registered for the Covid Litigation Conference, organized by the Mendenhall Law Group, swapped ideas — and shared inspiration — for the coming battles over Covid mandates from governments and employers and malpractice suits against medical professionals.

Much like the post-9/11 lawsuits that sickened first responders filed against the government, cases challenging mask and testing mandates, vaccine requirements, quarantine measures and medical malpractice make up a growing — and lucrative — area of U.S. civil law.

“We got 30, 40, 50 calls a day,” Ralph Lorigo, whose law practice sued hospitals in 40 states that refused to give Covid patients ivermectin, a drug the NIH recommends against using, told Krista. “We saved lives — and we also made money.”

IN THE STATES

FLORIDA MEDICAID CHIEF TO TESTIFY — A Tallahassee federal court judge has ordered Florida’s top Medicaid regulator to testify in a lawsuit challenging a ban on covering the costs of transgender surgeries and hormone therapy for beneficiaries, POLITICO’s Arek Sarkissian reports.

Secretary Jason Weida, secretary for the Florida Agency for Health Care Administration, should be questioned in deposition about whether the agency’s public rulemaking process to create the ban was a just charade in support of a predetermined result, according to the order from Judge Robert Hinkle.

The rules adopted by the agency in August block the state’s Medicaid program from covering the costs of puberty blockers, hormone therapy and surgeries to treat gender dysphoria, which is the feeling of discomfort or distress some transgender people experience when their bodies don’t align with their gender.

HOUSE TAKES UP TRANSGENDER SPORTS BILL — The House Rules Committee could take up the GOP’s bill that would restrict transgender students from playing on women’s sports teams when lawmakers return to Washington in two weeks, POLITICO’s Bianca Quilantan reports.

House Rules Chair Tom Cole (R-Okla.) announced on Thursday that his committee might convene the week of April 17 to consider Rep. Greg Steube’s (R-Fla.) Protection of Women and Girls in Sports Act of 2023.

The measure would prohibit transgender women from playing on sports teams consistent with their gender identity and amend Title IX, which prohibits sex-based discrimination in education, to define sex as based solely on a person’s reproductive biology and genetics at birth. But transgender students would be able to practice with athletic programs designated for women or girls “so long as no female is deprived of a roster spot on a team or sport.”

The bill, which faced fierce pushback from Democrats, cleared the House Education and Workforce Committee in a vote along party lines following a markup in March that took roughly 16 hours.

IOWA VS. VICTIM ADVOCATES — The Iowa Attorney General’s Office has paused its practice of paying for emergency contraception — and in rare cases, abortions — for victims of sexual assault, a move that drew criticism from some victim advocates.

Federal regulations and state law require Iowa to pay many expenses for sexual assault victims who seek medical help, such as the costs of forensic exams and treatment for sexually transmitted infections. Under the previous attorney general, Democrat Tom Miller, Iowa’s victim compensation fund also paid for Plan B, the so-called morning-after pill, as well as other treatments to prevent pregnancy.

WHAT ELSE WE'RE READING

The AP reports that China is lashing out at the WHO and defending the country’s virus research.

The Wall Street Journal reports on virtual reality therapy.

The New York Times remembers Colin McCord, the surgeon who championed an indoor smoking ban in New York City.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
 

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