The Food and Drug Administration (FDA) announced on Monday that federal regulations on the abortion pill, also known as Mifepristone, will no longer be enforced. The Center for Drug Evaluation and Research (CDER) evaluated the risks and public health consequences of the drug, and the FDA determined that the risks are minimal enough to distribute to women without a medical consultation.
The abortion industry lobbied for the Risk Evaluation and Mitigation Strategy (REMS) mandate for an in-person medical appointment to be lifted, and the FDA is relaxing on account of the pandemic; the drug will now be able to be distributed via mail and telemedicine.
“CDER found that the small number of adverse events reported to FDA during the COVID-19 public health emergency (PHE) provide no indication that any program deviation or noncompliance with the Mifepristone REMS Program contributed to the reported adverse events,” the acting FDA commissioner wrote to the American College of Obstetricians and Gynecologists (ACOG). “In summary, provided the other requirements of the Mifepristone REMS Program are met, and given that the in-person dispensing of mifepristone for medical termination of early pregnancy may present additional COVID-related risks to patients and healthcare personnel because it may involve a clinic visit solely for this purpose, CDER intends to exercise enforcement discretion during the COVID-19 PHE with respect to the in-person dispensing requirement of the Mifepristone REMS Program, including any in-person requirements that may be related to the Patient Agreement Form…”
The FDA’s “out of line” decision drew criticism from Live Action, a prominent pro-life group.
“The abortion pill was created to kill children, has caused a catastrophic death toll, and poses a serious threat to maternal health. Since the FDA first approved this drug, nearly 4 million preborn children have been killed. The FDA itself reports that at least 24 women have died from taking the pill. The FDA has also received over 4,000 reports of adverse events from women experiencing hospitalization, hemorrhage, excruciating abdominal pain, and severe life threatening infections after taking the abortion pill regimen,” the group’s president, Lila Rose, released in a statement. “The FDA is out of line and the American people should respond en masse calling for them to pull the pill.”
Planned Parenthood, the nation's largest abortion provider, praised the FDA's move.
Mifepristone is safe, effective, and has been used by 4+ million people since the FDA approved it more than 20 years ago. Removing medically unnecessary barriers to it is a big win for abortion access & keeps patients, providers, and health center staff safer during the pandemic. https://t.co/ygDB6rxRpw
— Planned Parenthood (@PPFA) April 13, 2021
A victory for reproductive health care and health equity!! Decades-old restrictions on mifepristone are medically unnecessary, and forcing patients to risk their health to obtain time-sensitive health care — during a global pandemic — is unacceptable. https://t.co/42MTtHKvww
— Alexis McGill Johnson (@alexismcgill) April 13, 2021
The FDA’s decision allows for medical consultations for the abortion pill to be sidestepped.
