Senate Democrats call on FDA to ease access to abortion pill

"The reckless decision to overturn Roe v. Wade puts millions of women in this country at risk," states a letter sent to the FDA.

Published by

Verónica Silveri Pazos

27 de noviembre, 2022

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A group of Democratic senators called on the Biden Administration to make it easier for women to access medication abortion, following the Supreme Court's decision to overturn Roe vs. Wade.

Led by Sen. Elizabeth Warren and Bernie Sanders, lawmakers are asking the Food and Drug Administration (FDA) to lift some restrictions on obtaining mifepristone, as well as add a new indication to make it clear that the drug can be used safely to help reduce complications from a miscarriage.

In a letter to FDA Commissioner Robert Califf, the lawmakers wrote:

For more than two decades, women have safely and effectively used pharmacologic abortion -mifepristone and misoprostol- to terminate a pregnancy (...) But the Supreme Court's unwise decision to overturn Roe v. Wade now endangers millions of women in this country who face restrictions on life-saving care and rights.

11/22/18 Letter to FDA Re Medication Abortion by Voz Media on Scribd

With Republicans in control of the House starting next year and with a maximum majority of only 51 seats in the Senate, Democrats will likely be unable to take action to protect abortion unless it is through executive authority. However, Attorney General Merrick Garland indicated that the Department of Justice will take action against states that ban abortion pills.

Not for miscarriages

In 2000, the FDA approved mifepristone as an abortion drug. The drug is used in combination with a second pill, misoprostol, during the first 10 weeks of gestation. The combination of the two can improve the management of early pregnancy loss and lead to fewer complications. However, these drugs are not indicated for the treatment of miscarriages.

Patients in states where abortion rights have been restricted have reported being denied this medication, as pharmacists fear prosecution for dispensing the drugs. But it is the FDA's own restrictions that do not permit sale. According to an article in The Hill:

"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 REMS for mifepristone requires pharmacies dispensing the drug to be certified and requires patients to sign an agreement acknowledging the drug's risks."

Democratic lawmakers called on the agency to reevaluate and move quickly to remove the restrictions:

In December 2021, the FDA conducted a scientific review of mifepristone and announced that it would modify the existing REMS for mifepristone, including the elimination of the medically unnecessary in-person dispensing requirement (...) This amendment would expand access to medical abortion. by allowing patients to access mifepristone at retail pharmacies.

However, the FDA is still processing the changes and has not yet finalized them (...) It is crucial that you act as soon as possible to allow patients access to Mifepristone via certified mail delivery and at retail pharmacies (...) Until the updated REMS is finalized, we ask the FDA to continue its policy of exercising enforcement discretion to protect access to medical abortion.