The abortion pill fight (from NYT)
Posted by
prayformojo (aka mayhem)
Mar 8 '23, 04:35
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Becoming mainstream
Since the end of Roe v. Wade last June, access to abortion pills has muted some of the effect of the severe restrictions on abortion that 14 states have imposed. Abortion opponents have responded by trying to reduce access to those pills. The resulting struggle has become the main battle to watch in the post-Roe landscape.
Today’s newsletter examines the latest developments — including a court ruling expected soon — and explains what’s likely to happen next.
How pill access grew
The most effective and safest method of medication abortion requires two drugs. The first, mifepristone, ends the pregnancy. The second, misoprostol, causes cramping and bleeding to empty the uterus, like a miscarriage. In approving this regimen in 2000, the F.D.A. imposed restrictions on mifepristone because of questions then about its safety. Among other rules, patients had to visit a clinic, doctor’s office or hospital to receive the medication.
In 2021, during the pandemic and after President Biden took office, the F.D.A. lifted the in-person requirement. The shift opened a new avenue for telemedicine abortions. In about 30 states, women could legally end their pregnancies at home, with pills prescribed through an online consultation and mailed to them. If they had questions, they could call a private national hotline to talk to medical professionals.
After the Supreme Court overturned Roe last year, demand surged for abortion pills by mail. An international organization, Aid Access, provided prescriptions for the pills from European doctors, often filled in India, to patients in states with bans. Overseas pharmacies, advertising online, also ship abortion pills without a prescription to every state.
These offshore routes to access, which operate in a legal gray area in states with abortion bans, will probably remain open. But they carry potential legal risks for women and it can take a few weeks for the drugs to arrive from overseas, a delay that can create problems since medication abortion is more effective and less likely to cause complications early in pregnancy.
How opponents are fighting back
Opponents of abortion have a bold counterstrategy. They want to block the use of mifepristone not only in states with abortion bans but also nationwide.
In November, anti-abortion organizations and doctors sued in Texas to challenge the F.D.A.’s approval of medication abortion 23 years ago. They argue that mifepristone is unsafe. In fact, research has clearly established the safety and efficacy of the F.D.A.’s approved regimen. Serious complications are possible but rare. So, on the merits, the suit may seem far-fetched.
But the plaintiffs made sure to file suit (a practice some experts call “judge shopping”) in a division of a Federal District Court with one judge, a Trump appointee named Matthew Kacsmaryk who has longstanding views against abortion. If he blocks the F.D.A.’s approval, it would be unprecedented, experts said in an amicus brief.
The drugstore battle
Separate from the Texas case, the national divide over abortion is playing out in pharmacies.
In January, Walgreens, CVS and other companies said they would apply for a newly available certification from the F.D.A. to dispense both drugs in states where abortion remains legal. But 21 Republican attorneys general — including four in states where abortion is still legal — threatened legal action against the pharmacy chains. Walgreens promised not to provide the pills within those states.
The chains see an opportunity for another new market. Their interest signals that medication abortion is becoming mainstream. In large parts of the country, that’s unwelcome.
What’s next
Other lawsuits are trying to protect access to abortion pills. One, filed by states where Democrats are in power, asks a judge to affirm the F.D.A.’s approval of mifepristone and remove the remaining restrictions on the medication. Another, by a U.S. manufacturer of the medication, is challenging state bans on the pill.
For now, mifepristone and misoprostol remain widely and quickly available in states where abortion is legal. And the medications can be obtained through avenues like Aid Access, with a delay, in states where abortion is not legal.
Taken together, the drugs are more than 95 percent effective, research shows. Alternatively, people can take only misoprostol in higher doses, but this method is 88 percent effective, according to a study in the U.S. published last month, and is also more likely to cause side effects like nausea and diarrhea.
A ruling from Judge Kacsmaryk could come any day. If he issues a nationwide injunction to block the provision of mifepristone, his ruling could increase health risks and physical discomfort for women.
“The Texas lawsuit is based on the false claim that mifepristone is unsafe and leads to a high need for physician intervention,” Abigail Aiken, one author of the new study, said. “And yet, if we move to a miso-alone protocol, the need for physician intervention will, if anything, be increased.”
A nationwide injunction would be immediately appealed. It’s also possible that Judge Kacsmaryk can’t actually stop the legal provision of mifepristone, at least in the short term, three law professors argue. Congress set procedures for the F.D.A. to withdraw approval from a drug, and the process takes time to follow. A judge can order a review but shouldn’t have the power to circumvent the rules, the law professors say.
The F.D.A. also has a workaround: When the risk is low, the agency can give manufacturers permission to keep distributing products, like some baby formula, which violate the law in some way.
It’s a strange idea: a federal agency using its discretion to avoid enforcing a court ruling. But it could also be the only way for women in the U.S. to continue accessing the safest and most effective method of medication abortion — as long as a president who supports abortion access is in office.
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