Friday 17 December 2021

FDA loosens restrictions on abortion pills being sent by MAIL to terminate pregnancies of up to ten weeks as the Supreme Court considers rolling back Roe v. Wade

 The federal government on Thursday permanently lifted a restriction on an abortion pill that prevented prescribers from sending it through the mail.

The drug, mifepristone, is the first in a two-drug medication therapy used to terminate pregnancies up to 10 weeks.

Under US regulations on the pill, it must be dispensed in clinics or hospitals by specially-certified providers who must sign an agreement, and obtain the patient's signature to acknowledge the provider informed them about the drug.

The second drug in the regimen, misoprostol, which is taken up to 48 hours after the first, though. has long been obtainable with a prescription at any pharmacy. 

But on Thursday, the Food and Drug Administration means that medication abortion will become more readily available to women who find it burdensome to travel to an abortion clinic, and those who would like to terminate their pregnancies from the comfort of their own home.

It allows patients to have a telemedicine appointment with a provider who can prescribe them the abortion pills, and send them to the patient by mail.

The decision, though, comes as the Supreme Court is set to hear a major case about abortion rights - and could overturn Roe v. Wade. 

The FDA on Thursday lifted a restriction on Mifepristone  that prevented prescribers from sending the drugs through the mail

The FDA on Thursday lifted a restriction on Mifepristone  that prevented prescribers from sending the drugs through the mail

As the Supreme Court prepared to hear arguments challenging the constitutionality of Roe v. Wade, Amelia Bonow, Erin Jorgensen and Alana Edmondson publicly took abortion pills

As the Supreme Court prepared to hear arguments challenging the constitutionality of Roe v. Wade, Amelia Bonow, Erin Jorgensen and Alana Edmondson publicly took abortion pills

Pro-choice activists took abortion pills outside Supreme Court
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Under the current practice, women who live in states that do not allow telemedicine for abortion pills must travel to a state that does - but they may be in any location within the state for the telehealth visit and can receive the pills at any address in the state.

Thursday's decision will not override the regulations in 19 states - mainly in the South and the Midwest - where telemedicine visits for the pills are banned.

'It's really significant,' Mary Ziegler, a law professor at Florida State University, said of the FDA's decision on Thursday.

'Telehealth abortions are much easier for both providers and patients, and even in states that want to do it, there have been limits on how available it is,' she told the New York Times.

Several states have restricted the mailing and prescribing of abortion pills over the past year, with six states banning the mailing of the pills in preparation of the FDA's decision, the Times reports, and seven states passing laws requiring pills be obtained from a provider.

Four others passed laws to set the limit on medication abortion at earlier than 10 weeks gestation, which is when the pills cease to be effective.

Meanwhile, data released last month by the Centers for Disease Control and Prevention shows that medication abortion has become an increasingly popular way to terminate a pregnancy.

The data shows that 42 percent of all abortions and 54 percent of abortions before 10 weeks occurred with medication in 2019.

And in 2020, in states like Indiana, Kansas and Minnesota, medication abortion accounted for the majority of abortions.

The CDC also reported that 79 percent of all abortions occurred before 10 weeks gestation, suggesting more women may choose abortion pills over an in-clinic procedure, according to the Times.


Under previous US regulations on mifepristone (pictured) it must be dispensed in clinics or hospitals by specially-certified providers who must sign an agreement, and obtain the patient's signature to acknowledge the provider informed them about the drug

Under previous US regulations on mifepristone (pictured) it must be dispensed in clinics or hospitals by specially-certified providers who must sign an agreement, and obtain the patient's signature to acknowledge the provider informed them about the drug

Misoprostol, one of the abortion pills, has been readily available at pharmacies throughout the country with a prescription

Misoprostol, one of the abortion pills, has been readily available at pharmacies throughout the country with a prescription

Medical and abortion rights groups have previously urged the federal government to ease restrictions on mifepristone, citing data indicating that it is safe and effective.

And when the coronavirus pandemic began, medical groups filed a lawsuit asking that the in-person dispensing requirement be lifted, claiming that with the pandemic a woman who wants to get the pill could get COVID during an in-person meeting.

A federal judge granted the request, but it was soon overturned after a challenge from the Trump administration.

Then in March, after Joe Biden took office, the medical groups tried once again to get the rule overturned, and in April the FDA decided not to enforce the rule during the pandemic.

Its decision on Thursday has now made that permanent, with the agency saying a scientific review from 2017 supported broadening access, including no longer limiting dispensing to a small number of specialty clinics and doctors' offices.

The prescribers will still need to undergo certification and training, with physicians who prescribe the drug having to certify that they can provide emergency care to deal with potentially adverse side effects, and the dispensing pharmacy will also need to be certified.

The FDA noted in its decision there have been 26 deaths associated with the drug since 2000, though not all of them could be directly linked to the drug due to underlying health conditions.

Common side effects of the drug include cramping, bleeding, nausea, headache and diarrhea. In some cases, the Associated Press reports, bleeding needs to be stopped with a surgical procedure. 

In its decision on Thursday, the FDA said a scientific review from 2017 supported broadening access, including no longer limiting dispensing o a small number of specialty clinics and doctors' offices

In its decision on Thursday, the FDA said a scientific review from 2017 supported broadening access, including no longer limiting dispensing o a small number of specialty clinics and doctors' offices

Anti-abortion groups have now blasted the FDA's decision as 'reckless,' the Hill reports, with Susan B Anthony List State Policy Director Sue Liebel saying it 'puts countless women and unborn children in danger.'

The ACLU, meanwhile, hailed the elimination of the strictest requirements on the drug, but said regulator should have gone further and allow any doctor to prescribe the drug, with more pharmacies dispensing it. 

'The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients,' said Georgeanne Usova, a lawyer with the ACLU. 

'However, it is disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone and these remaining obstacles should also be lifted.' 

Planned Parenthood Federation of America President and CEO Alexis McGill Johnson also called the decision a 'victory for public health and health equity.

'Abortion is time-sensitive, essential health care and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion,' she said in a statement.

'With abortion rights at risk like never before, the FDA's decision is a long overdue step toward expanding people's access to safe medication abortion.'  

The conservative-leaning Supreme Court ruled on December 10 that abortion providers' lawsuit against Texas could proceed but with a limited scope

The conservative-leaning Supreme Court ruled on December 10 that abortion providers' lawsuit against Texas could proceed but with a limited scope

The FDA's decision comes as the Supreme Court returned a case over Texas' six-week abortion ban back to a federal court that twice upheld it, in the latest setback for pro-choice activists. 

In handing it back to the US Court of Appeals for the 5th Circuit, the justices rejected abortion providers and pro-choice advocates' wish to have the case sent to US District Judge Robert Pitman in western Texas, who previously blocked the ban. 

The decision was signed off on by Donald Trump-appointed Justice Neil Gorsuch.

Texas abortion providers also scored a small victory last week when the conservative-majority court ruled that their case against the law can move forward.

However they also allowed the law, which is known as S.B.8 deputizes private citizens to go after women seeking abortions and those who help them, to stay in effect while it's being litigated in a 5-4 vote. 

'Every day S.B. 8 is in effect, it is causing devastation in Texas and surrounding states, forcing countless people to carry pregnancies against their will as they are unable to get the essential health care they need,' the American Civil Liberties Union told DailyMail.com.

'Today's decision by Justice Gorsuch means that the narrow path the Court afforded us is now blocked, and there is no relief on the horizon. Last week's decision was far from a "victory" for providers and Texans, and Justice Gorsuch's order is yet another blow to that effort.' 

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