FDA takes a stand on mifepristone

Oct 31, 2022

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By Krista Mahr and Daniel Payne

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Driving the Day

The FDA says prescribing abortion medication to people who aren't pregnant is dangerous. | Allen G. Breed/AP Photo

FDA GOES HEAD TO HEAD WITH ABORTION ADVOCATES — The FDA said health providers prescribing abortion medication to people who aren't pregnant are acting without its authorization, putting the Biden administration at odds with doctors and advocates using the drug to counter states' abortion restrictions, POLITICO's Ben Leonard reports .

Backstory: Some telemedicine providers, including Choix , as well as in-person providers, have begun offering mifepristone, which stops the flow of hormones supporting a fetus in the uterus, before pregnancy as a way to expand access to abortion after the Supreme Court's June decision overturning Roe v. Wade.

Known as "advance provision," advocates say the practice lets patients be prepared in case they need to have an abortion at a later date, and that it's safe and effective.

In December, the FDA allowed doctors to prescribe mifepristone via virtual appointments and mail the drugs to patients. Some abortion advocates, including the American College of Obstetricians and Gynecologists, have called for the FDA to remove all restrictions on the drug.

The FDA disagrees. Abortion medication is regulated more tightly by the FDA than other drugs, restricting how the regimen can be prescribed. An FDA spokesperson told POLITICO that if mifepristone were prescribed before a patient is pregnant, providers couldn't properly oversee care to ensure safety and effectiveness.

Specifically, the agency is concerned that if patients were to take mifepristone weeks or months after getting a prescription filled, a medical professional might not be able to assess whether a pregnancy is intrauterine or ectopic or to date pregnancies properly. The drug is approved up to 70 days of gestation for abortions.

Choix CEO Cindy Adam pushed back against the FDA in a statement to POLITICO, saying that restrictions on medication abortion are unnecessary and the regimen is safe. Choix offers "ongoing, supportive" care throughout the process, she said.

WELCOME TO YOUR HALLOWEEN PULSE — Every year, U.S. emergency rooms see an average of 3,200 Halloween injuries — 55 percent due to pumpkin carving, 25 percent to falls and 20 percent to injuries associated with costumes and pumpkins, among other menaces. Stay safe out there, people, and send those news and tips to kmahr@politico.com and dpayne@politico.com .

TODAY ON OUR PULSE CHECK PODCAST, Megan Wilson talks with Katherine Ellen Foley about the turmoil at the leading industry group for biopharmaceutical companies after the departure of its CEO — just as the Biden administration is set to implement a new law aimed at lowering drug prices. Plus, Chris Hammond, a Covid long-hauler, shares what life has been like for him and why he's not optimistic about additional Covid funding from Congress.

Listen to today's Pulse Check podcast

A message from PhRMA:

The 340B program may be driving up costs for some patients. A new analysis finds average costs per prescription for a patient is more than 150% greater at 340B hospitals than at non-340B hospitals. It's time to fix the 340B program. Learn more.

IN THE STATES

Former President Barack Obama campaigns for Michigan Gov. Gretchen Whitmer during a rally.

Democrats are worried that voters in swing states are less interested in abortion issues. | Carlos Osorio/AP Photo

THE PITCH: PROTECTING ABORTION IS GOOD FOR BUSINESS — With polls showing inflation worries now outrank abortion concerns, Michigan Gov. Gretchen Whitmer is telling voters that electing her — and protecting abortion rights — will help lure employers and workers from neighboring states with anti-abortion laws, POLITICO's Alice Miranda Ollstein reports .

Democrats are increasingly anxious that early outrage over the loss of abortion in more than a dozen states won't push their candidates over the finish line in purple states like Michigan as cost-of-living issues chip away at enthusiasm for their candidates.

In Michigan, Whitmer, along with other Democrats on the ballot, is warning that workers will flee if the state's constitutional amendment to protect abortion rights fails and a long-dormant 1931 anti-abortion law takes effect. They argue it will also make it harder for businesses — particularly those in tech, health care and the service sector — to recruit and retain employees.

Other Democrats around the country are touting a similar message — using the final days of their campaigns to argue abortion and financial concerns are inextricably linked.

FLORIDA MOVES TOWARD BAN OF GENDER-AFFIRMING CARE — A joint committee of the state's medical boards on Friday moved closer toward banning gender-affirming care for transgender kids in Florida, POLITICO's Arek Sarkissian reports .

Members from the Florida Board of Medicine and the state Board of Osteopathic Medicine approved rulemaking language that would ban children from taking hormones or undergoing surgery to treat gender dysphoria.

Both boards are scheduled to meet on Nov. 4, when they'll vote to finalize the rule.

A message from PhRMA:

In Congress

FIRST IN PULSE: BILL TO CREATE NEW HHS OMBUDS — Rep. Nikema Williams (D-Ga.) will introduce a bill today to increase access to reproductive services across the country by creating HHS ombuds for reproductive and sexual health. The ombuds would be charged with monitoring health care misinformation and increasing awareness of abortion resources in the nation. Reps. Sara Jacobs (D-Calif.), Sylvia Garcia (D-Texas), Barbara Lee (D-Calif.) and Veronica Escobar (D-Texas) join Williams in introducing the bill.

"As the assault on abortion rights continues, people are scared and confused as to what resources are available for them," Williams said in a statement. "The HHS Reproductive and Sexual Health Ombuds Act will ensure everyone has timely, accurate information about their abortion rights."

At the Agencies

VAPE MAKER GETS A BREAK — A federal judge on Friday granted electronic cigarette manufacturer Logic a temporary stay on marketing denial orders the FDA issued last week for the menthol-flavored capsules that go into its vapes, POLITICO's Katherine Ellen Foley reports.

That means, for now, Logic's menthol capsules for the Logic Pro and the Logic Power vapes — devices that received marketing authorization in March — can remain on the market.

Backstory: On Wednesday, the FDA ordered Logic's menthol capsules off the market, citing concerns that any menthol-flavored e-cigarettes run the risk of enticing underage users. The agency also noted that Logic failed to demonstrate that menthol-flavored products were better than its existing tobacco-flavored products at helping adult smokers switch to vaping.

Up next: The company has seven days to file a formal appeal, and the FDA has 10 days to respond after that. The temporary stay will remain in place until the court decides on a more permanent one or Logic fails to file a formal appeal.

PENTAGON ABORTION POLICY COMPLICATES NDAA — The Defense Department's new policy to cover travel costs for troops and family members seeking abortions could complicate the final passage of the annual National Defense Authorization Act, POLITICO's Connor O'Brien and Lawrence Ukenye write .

Republicans on Capitol Hill said the administration was politicizing the military by wading into the abortion debate before an election — and siphoning money from top national security needs. Now, some GOP lawmakers want to use the Pentagon policy bill to block the post-Roe v. Wade initiative.

"Taxpayer dollars meant for deterring China and other adversaries should not be squandered on campaign politics," said Rep. Mike Rogers of Alabama, the top Republican on the House Armed Services Committee. "DoD must be blocked from wasting any portion of their budget on this horrendous policy."

What We're Reading

The Los Angeles Times reports on the work being done at a hospice for homeless residents in Salt Lake City.

A devastating cholera outbreak is among the many crises destabilizing Haiti right now, reports The Guardian .

And some tips on how to not lose your mind worrying about your and your family's Halloween candy consumption from The New York Times .

A message from PhRMA:

The 340B program grew, yet again, hitting a whopping $43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growth in care provided to vulnerable patients at 340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole. The program of today is having the opposite effect of what Congress intended when they created 340B. That's a problem. It's time to fix the 340B program. Learn more.