March 23, 2023

Though the anti-abortion movement notched a historic victory in the overturning of Roe v. Wade, it now faces a landscape where the medications collectively known as “the abortion pill” are increasingly accessible. 

Partially, that’s thanks to the Biden administration lifting some of the restrictions on mifepristone, the first medication in the combo, a policy move that supporters of abortion access have clamored for for years. This week, marking Roe’s would-be 50-year anniversary, President Joe Biden signed a memorandum pledging to continue to protect and expand access to the drug, reminding readers that the Food and Drug Administration (FDA) will continue to allow mifepristone to be prescribed via telehealth and delivered through the mail, and to be dispensed at certified pharmacies. 

Since its approval by the FDA, mifepristone has been subject to unusually intensive regulation. It became, and still is, subject to Risk Evaluation and Mitigation Strategies (REMS), a program meant to control the distribution and use of drugs with significant safety concerns. Drugs under REMS include fentanyl and other opioids. 

Major medical organizations have long called for mifepristone’s inclusion in REMS to be lifted entirely, arguing that the restrictions are much more political than they are grounded in science. Misoprostol, the second drug usually prescribed to induce an abortion, is primarily used to treat ulcers and thus is much less stigmatized. 

The use of medical versus surgical abortions has been climbing for years, with the CDC reporting a 154 percent increase from 2011 to 2020. It’s easy to understand why: the FDA has approved the pills’ use for up to 10 weeks into a pregnancy, including much of the first trimester when, as of 2020, 93 percent of abortions occur. It’s less invasive than the surgical process, and often cheaper. Now that patients can pick up the medication at certain pharmacies or get them mailed, they can take the pills in the comfort of their own home. 

And skirting state bans has become drastically easier too. Some mobile clinics set up shop in an abortion-friendly state right across the border from one where abortion is illegal. Other operations involve mail forwarding from an abortion-safe state to a hostile one. Online resources instruct patients on how to get the pills. 

The anti-abortion movement has noticed. The White House enumerated the ways in which mifepristone has come under heightened threat since Dobbs. 

“Some State officials have announced that they will impose restrictions to limit access to this evidence-based, safe, and effective medication,” it said in a statement this week. “In a letter to the FDA, for example, 22 State Attorneys General threatened to enforce State laws that purport to interfere with access to mifepristone.”  

“In Florida, the Governor recently said that major pharmacy chains in the State will not offer mifepristone,” it continued. “Florida health officials issued guidance discouraging pharmacies from dispensing mifepristone, claiming that State law limits where abortion medication can be provided to hospitals, clinics, or physician offices.” 

Lawsuits

And already, major lawsuits over the drug’s accessibility have begun, putting the FDA at the center of the litigation. 

This week, GenBioPro Inc., the maker of generic mifepristone, sued West Virginia for its anti-abortion scheme, arguing that federal law preempts the state’s bans. 

“West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime,” the company said in its Wednesday lawsuit. 

It argues that West Virginia is violating both the Supremacy and Commerce Clauses of the Constitution. 

“The Supreme Court’s decision in Dobbs did not displace Congress’s and FDA’s roles in protecting the public health by deciding whether drugs are safe and effective, determining which precautions — if any — are necessary to ensure a drug’s safe use, and ensuring safe and effective drugs are available to the public,” it added.

An FDA spokesperson told TPM that the agency wouldn’t comment on “possible, pending or ongoing litigation.” 

Earlier this month, the Biden administration responded to another major suit over mifepristone, where anti-abortion medical organizations are suing the FDA and other administration officials to overturn the agency’s 20-plus year authorization of the drug. 

The groups’ lawsuit is riddled with baseless anti-abortion smears, including that the abortion drugs have potentially “life-threatening effects” on patients. 

They also contend that, in contrast, “pregnancy rarely leads to complications that threaten the life of the mother or the child,” which is simply false — mifepristone is 18 times safer than childbirth, according to the draft paper “Abortion Pills” released by a trio of leading scholars on the topic this week.

The administration responded earlier this month that the group both lacks standing, and has run afoul of the statute of limitations to challenge the authorization. 

“Plaintiffs are attempting to challenge agency action long after the limitations period has expired and raising claims they did not exhaust with FDA,” it said in its response. 

The administration added that much of the groups’ argument is founded on speculation about possible harms. 

“That omission is particularly telling given the more than two decades that mifepristone has been in use,” the administration said. “If Plaintiffs’ injuries had an evidentiary basis, then Plaintiffs would be able to marshal allegations grounded in fact rather than conjecture.”

Still, the lawsuit could succeed. The medical groups “judge shopped” to lodge their complaint in the court of an anti-abortion judge in Texas, which is governed by the notoriously right-wing Fifth Circuit Court of Appeals. If the groups are successful, it could stop the distribution of mifepristone nationwide. 

The accessibility of mifepristone and misoprostol, especially now that patients don’t need to travel to clinics to pick up the former, is one of, if not the, defining differences of the abortion landscape pre- to post-Roe. The anti-abortion movement will continue to target this method both through legislation and litigation, and may successfully shut down the legal distribution of mifepristone with an assist from right-wing judges. But they’ll find it impossible to stem the flow of the pills altogether.   

“Just how revolutionary abortion pills are cannot be understated,” the trio of professors wrote. “Separating abortion from in-person care has created new avenues to safe abortion, even in states that ban it. And this form of abortion will likely be highly resilient; as one method to obtain pills becomes limited or is shut down, another will open.”

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