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New lawsuits challenging restrictions to abortion pills will set precedent

The FDA has preemptive rule in the constitution. Can they authorize distribution of medical abortion pills in states that ban abortion? 
By admin
Feb 6, 2023, 11:48 AM

New lawsuits filed in late January are challenging restrictions to abortion access in two states, continuing the ongoing battles over abortion following the repeal of Roe v. Wade.  

The suits, brought on by an OB-GYN in North Carolina and a generic abortion pill manufacturer GenBioPro in West Virginia allege that the restrictions are unconstitutional as they go beyond what was approved by the FDA.   

A medical abortion, as opposed to surgical abortion, is a noninvasive procedure that involves taking two prescription pills, mifepristone and misoprostol. Mifepristone is taken first and blocks the hormone progesterone which is needed to sustain a pregnancy. Misoprostol, also prescribed to treat stomach ulcers, is taken 24 to 48 hours later and causes the uterus to dispel pregnancy tissue.  

The FDA approved the use of mifepristone to terminate pregnancy in 2000, though it had been approved and used in other countries 22 years prior. With its approval came many regulations, including the requirement that patients take mifepristone in-person at a designated clinic.  

In late December, the FDA lifted certain restrictions to permanently allow pharmacies to dispense abortion pills to patients, after temporarily lifting these restrictions during the COVID-19 pandemic. The FDA will now also allow mail order pharmacies to ship the pill, and telehealth providers to prescribe it.  

Since then both CVS and Walgreens have started the certification process to be able to distribute the pill.  

States versus federal preemption

GenBioPro CEO Evan Masingill called the move, “a step in the right direction,” but noted that it won’t make abortion pills easier to access in states with high abortion restrictions.  

Some states are implementing even stronger anti-abortion measures to prevent the new FDA decisions from improving access in their state.  

The Florida Agency for Healthcare Administration sent a warning to healthcare providers reminding them, “The Agency issues this alert to remind providers that they must continue to comply with Florida laws that govern the performance of abortions,” reported the Union-Bulletin.  

The email also stated that violation of the abortion laws would result in a criminal penalty.  

Last Wednesday, twenty Republican state attorneys general sent a letter to CVS and Walgreens to tell them that distributing abortion pills through the mail is “both unsafe and illegal.”  

The letter refers to the Comstock Act of 1873, which prohibits anyone from sending or receiving a drug that will “be used or applied for producing abortion.” 

In early January, the Department of Justice (DOJ) published a legal opinion at the request of USPS and concluded that the mailing of mifepristone or misoprostol does not violate the Comstock Act, “where the sender lacks the intent that the recipient of the drugs will use them unlawfully.”  

The debate over whether or not FDA regulation supersede state restrictions is the major question in both the North Carolina and West Virginia lawsuits, and has been an ongoing point of contention between pro-choice and pro-life advocates,  

Law professor Carl Tobias thinks these suits have a good chance in court, based on the argument of preemption.  

“We have a federal republic and, basically, preemption involves the notion that the federal government is supreme when it acts in certain areas and in certain ways. The FDA is one of the most important agencies for establishing this idea, because of the complexity of its regulatory process and the product it regulates,” Tobias tells STAT.  

“They’re [states] sovereign within their sphere and you want them to have flexibility and the ability to react to all kinds of situations. But I don’t think these cases raise states’ rights issues. There’s this doctrine called the supremacy clause that comes out of the Constitution that says the FDA and other federal agencies have to be able to preempt state law,” he continued.  

Greer Donley, law professor at University of Pittsburgh told Bloomberg News that if the courts in West Virginia determine that the state’s abortion ban “is partially preempted because it essentially banning an FDA-approved drug, that could have very important implications for the whole country.  

The precedent would be “essentially creating somewhat of an exception to every state’s abortion ban to say the state has to permit the distribution, sale, and use of medication abortion,” she said. 

These specific cases might establish a federal authority on abortion, but currently access to abortion across state lines remains drastically different.  

A Texas conservative group filed a motion to halt mifepristone’s sale and distribution based on the argument that the FDA incorrectly categorized pregnancy as an illness.  

NYC Mayor Eric Adams recently announced the city will provide free abortion pills in their public health clinics, “We are going to build a city that is here for all women and girls.”  

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