U.S. regulators lift in-person restrictions on abortion pills
The U.S. Food and Drug Administration on Thursday permanently relaxed some restrictions on abortion drugs, including long-term requirements for taking the drugs in person.
Officials said a scientific review supports expanding access and allowing more pharmacies (including mail order services) to distribute medicines.
But prescriptions will still be limited to doctors who have completed special certifications. In addition, the agency stated that dispensing pharmacies must be registered with the FDA.
The decision is the latest shift in the polarizing legal battle over medical abortion, a shift that only intensified in the devastation of the COVID-19 pandemic. This will certainly cause legal challenges and more restrictions in Republican-led states.
Earlier this year, due to the pandemic, the FDA stopped implementing face-to-face spending requirements. According to Thursday’s decision, the agency will permanently cancel the rule, which has long been opposed by medical associations including the American Medical Association. The rule says these restrictions have no obvious benefit to patients.
The FDA’s latest scientific review stems from a 2017 lawsuit by the American Civil Liberties Union that argued that the agency’s restrictions hindered or delayed health care, especially for people in low-income and rural communities.
FDA officials said on Thursday that doctors who prescribe the drug mifepristone must prove that they can provide emergency care to deal with its potential side effects, including excessive bleeding.
This change still means that more doctors will be able to prescribe this drug, and most Americans will be able to fill out orders at thousands of pharmacies, including through online and mail-order services.
The effect will vary from state to state. More than a dozen Republican-led states have passed measures restricting access to these pills, including a ban on mail delivery.
Considering that leaders of the anti-abortion movement generally stated that they do not approve of criminalizing the actions of women seeking abortions, and that mail delivery may be an elusive target for prosecutors, so mail order about pills is increasingly used. Will bring difficulties to the anti-abortion movement.
The latest policy change occurred as advocates on both sides of the abortion debate waited to see whether the conservative Supreme Court would weaken or even overturn the decision of Roe v. Wade, which guarantees abortion rights across the country.
Roe’s death may prompt at least 20 Republican-controlled states to implement comprehensive bans, and 15 Democratic-controlled states may reiterate their support for abortion access. More complicated are the politically divided states in which the fight over abortion laws can be fierce.
Medical abortion has been used in the United States since 2000, when the FDA first approved mifepristone to terminate pregnancy for up to 10 weeks. Taken with a hormone blocker called misoprostol, it constitutes the so-called abortion pill.
Approximately 40% of abortions in the United States are now done with medication rather than surgery, and this choice becomes even more critical during the COVID-19 pandemic.
At the time of approval, the FDA imposed restrictions on the way the drug is distributed, including prohibiting sales in regular pharmacies, and requiring all doctors who provide the drug to be specially certified. Women also need to sign a form stating that they understand the potential risks of the drug.
In the early stages of the outbreak, the FDA abandoned its in-person requirements for almost all drugs, but retained the requirements for mifepristone.
This triggered a lawsuit from the American College of Obstetricians and Gynecologists, which successfully overturned the federal court’s restrictions. The Trump administration subsequently appealed to the Supreme Court, which reinstated this request in January.
In April, when the FDA stated that it would not enforce dispensing restrictions under the current public health emergency, this became meaningless—at least temporarily.
“The FDA’s decision will bring great comfort to countless abortion and miscarriage patients,” said ACLU’s attorney Georgeanne Usova. “However, it is disappointing that the FDA has failed to abolish all medically unnecessary restrictions on mifepristone, and these remaining obstacles should also be removed.”