DOJ, manufacturer file petitions to review appellate court’s judgement to reinstate abortion pill restrictions

Update:

• The Department of Justice (DOJ) and a distributor of abortion medication mifepristone asked the Supreme Court to review a 5th Circuit decision that threatened to limit access to the drug.
• The decision upheld a Texas federal judge’s order to reinstate mifepristone access restrictions. 
• The DOJ argues that if the 9th Circuit’s affirmation goes into effect, it will cause “damaging consequences” for women seeking lawful abortions and for the health care system at large.  
• Danco Laboratories, which distributes the name-brand version of mifepristone, Mifeprex, also filed a petition to review the decision. 
• The U.S. Food and Drug Administration approved mifepristone in 2000; it is used alongside the drug misoprostol for abortion and miscarriage care.

Supreme Court abortion pill approval overview: 

• Who: The U.S. Supreme Court chose to stay an order by a Texas federal judge to immediately ban access to the abortion pill mifepristone. 
• Why: The decision will pause the order while a case over the legality of the widely used and FDA-approved drug plays out. 
• Where: The Supreme Court decision affects all U.S. citizens. 

(May 10, 2023)

The U.S. Supreme Court chose last month to stay a Texas lower court’s order to ban access to the abortion pill mifepristone while a case debating the legality of the drug plays out.

The Supreme Court’s decision halted a ruling by a Texas federal judge in April that would have immediately prevented individuals from accessing the long-approved and widely used drug, Law360 reports. 

Conservative Supreme Court Justices Samuel Alito and Clarence Thomas both appeared to disagree, according to Law360. Alito dissented, and Thomas indicated he would prefer to deny applications for stay filed by the U.S. Food and Drug Administration (FDA) and Danco Laboratories, which distributes the generic version of mifepristone. 

Mifepristone is available under its generic name or under the brand name Mifeprex, and, when used together with the drug misoprostol, is known as the abortion pill due to its ability to end early pregnancies. 

The FDA approved the drug for use in 2000, but the legality of mifepristone access is now being questioned following the Supreme Court’s June decision to overturn Roe. v. Wade.

5th Circuit decision to keep FDA approval intact would have reinstated pre-2016 restrictions

A 5th Circuit panel ordered to keep the FDA’s approval of mifepristone intact; however, its decision would have reinstated pre-2016 restrictions that prevented access to the abortion pill medication, Law360 reports. 

The restrictions reportedly would have ended access to telehealth abortion care, distribution of mifepristone by mail and approval of the generic version of mifepristone and reinstated a requirement to have three in-person doctor visits prior to getting the drug. 

Pre-2016 restrictions on mifepristone also reduced the drug’s gestational time limit for distribution from 10 weeks to seven weeks, Law360 reports. 

The FDA reportedly argued the 5th Circuit’s stay would have removed mifepristone from the marketplace for months while it relabeled the product. 

Oral arguments in the 5th Circuit are scheduled for May 17, Law360 reports. 

In related abortion pill access news, 12 Democratic attorney generals filed a lawsuit against the FDA in March that demanded the agency drop any and all remaining restrictions on mifepristone. 

Also in March, federal judge in Wyoming also blocked the Life is a Human Right Act, which would have effectively made abortion illegal in the state. 

Do you believe the Supreme Court made the right decision to stay the order? Let us know in the comments! 

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