Senate Democrats urge FDA to ease access to abortion pills

A group of Senate Democrats are calling on the Biden administration to make it easier for patients to have access to medication abortion in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

The lawmakers, led by Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), want the Food and Drug Administration to lift certain restrictions on how patients can obtain mifeprestone, as well as add a new indication to make it clear the drug can be safely used to help reduce complications from a miscarriage.

“For over two decades, women have been safely and effectively using medication abortion –
Mifepristone and misoprostol – to terminate a pregnancy. But the Supreme Court’s reckless
decision to overturn Roe v. Wade now endangers millions of women in this country who are
facing restrictions to lifesaving care and rights,” the lawmakers wrote in a letter to FDA Commissioner Robert Califf.

The letter is also signed by Sens. Mazie Hirono (D-Hawaii), Kirsten Gillibrand (D-N.Y.), Angus King (I-Maine), Chris Van Hollen (D-Md.), Ed Markey (D-Mass.), Ron Wyden, (D-Ore.) and Brian Schatz (D-Hawaii).

With Republicans in control of the House starting next year and with a maximum majority of only 51 seats in the Senate, Democrats likely won’t be able to take action on protecting abortion unless it’s through executive authority.

Following the reversal of Roe, many states passed laws that severely restrict or outright ban medication abortion.

Attorney General Merrick Garland in June indicated the Justice Department will take action against states that ban abortion pills, though it’s unclear if the federal government has that power.

In 2000, the FDA approved mifepristone for medication abortion. The drug is used in combination with a second pill, misoprostol, during the first 10 weeks of pregnancy. In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S.

The combination of mifepristone and misoprostol can also significantly improve the
management of early pregnancy loss and result in fewer complications.

But that combination is not explicitly indicated for miscarriage management, and patients in states that have restricted access to abortion have reported being denied the medications to treat their miscarriages, as pharmacists said they feared prosecution for dispensing the drugs.

In addition, the FDA’s own restrictions on the drug can be a barrier for patients, something the lawmakers asked the agency to reassess.

Mifepristone is regulated under a Risk Evaluation and Mitigation Strategy (REMS), a safety program the agency required for certain drugs to ensure that their benefits outweigh their risks. The mifepristone REMS requires pharmacies that dispense the drug to be certified and mandates that patients sign an agreement acknowledging the drug’s risks.

The FDA temporarily lifted a requirement that mifepristone be dispensed in person at a clinic or hospital because of the COVID-19 pandemic, and the Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.

But the changes have still not been finalized. In the letter to Califf, the Democrats asked FDA not only to make the changes final, but to remove any “medically unnecessary” restrictions like
patient consent forms.

“As states implement new restrictions, it is more important than ever that you take immediate steps to expand access to medication abortion. We encourage and support your efforts to protect access to abortion and reproductive rights across the nation,” the Democrats wrote.

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