FDA remove barriers to abortion pills!

The Issue

On June 24 thé Supreme Court ruled to overturn Roe v Wade, effectively leaving millions of women across large swaths of the US with no or very limited access to a safe abortion. 
Abortion medication, a two-drug regimen that consists of misoprostol and mifepristone that allows women to end pregnancies at home safely until 11 weeks, is a cheap and practical alternative, however easy access to this medication is impeded by unnecessary requirements set by the FDA. In December 2021, FDA removed the requirement that mifepristone be dispensed only in certain healthcare settings, however the requirement that only certified healthcare providers who meet certain qualifications are allowed to prescribe, remains. According to the FDA, “healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form”.  These are unnecessary and burdensome requirements that are not justified by the drugs’ safety profile

There is also precedent. Las Libres, an abortion advocacy group in Mexico, has been assisting Mexican women with home abortions since 2000 and based on their 20-plus year experience argue that no medical supervision is needed during the first 12 weeks. 

The evidence that supports that Mifepristone can be safely used without the added restrictions is overwhelming, and now with the end of Roe v. Wade the FDA must weigh the benefit of easing access to an abortion pill that is safe and effective versus women having to secure more violent to themselves and inherently more dangerous means of abortion.  The restrictions governing access to the abortion pill are not based on science but have been influenced by the politics that have deeply divided this country.

In light of current events, it’s time for FDA to remove all these unnecessary restrictions and give  women the freedom to easily access the abortion pill!

 

1,461

The Issue

On June 24 thé Supreme Court ruled to overturn Roe v Wade, effectively leaving millions of women across large swaths of the US with no or very limited access to a safe abortion. 
Abortion medication, a two-drug regimen that consists of misoprostol and mifepristone that allows women to end pregnancies at home safely until 11 weeks, is a cheap and practical alternative, however easy access to this medication is impeded by unnecessary requirements set by the FDA. In December 2021, FDA removed the requirement that mifepristone be dispensed only in certain healthcare settings, however the requirement that only certified healthcare providers who meet certain qualifications are allowed to prescribe, remains. According to the FDA, “healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form”.  These are unnecessary and burdensome requirements that are not justified by the drugs’ safety profile

There is also precedent. Las Libres, an abortion advocacy group in Mexico, has been assisting Mexican women with home abortions since 2000 and based on their 20-plus year experience argue that no medical supervision is needed during the first 12 weeks. 

The evidence that supports that Mifepristone can be safely used without the added restrictions is overwhelming, and now with the end of Roe v. Wade the FDA must weigh the benefit of easing access to an abortion pill that is safe and effective versus women having to secure more violent to themselves and inherently more dangerous means of abortion.  The restrictions governing access to the abortion pill are not based on science but have been influenced by the politics that have deeply divided this country.

In light of current events, it’s time for FDA to remove all these unnecessary restrictions and give  women the freedom to easily access the abortion pill!

 

The Decision Makers

Robert M Califf
Robert M Califf
Commissioner FDA

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Petition created on June 24, 2022