Washington, DC—Mark S. DeFrancesco, MD, MBA, President of the American Congress of Obstetricians and Gynecologists (ACOG), today released the following statement regarding the updated Food and Drug Administration (FDA) oversight of mifepristone:
"Access to reproductive services, including abortion care, is essential for women's health. Medication abortion, performed through a combination of mifepristone and misoprostol, has provided a safe, effective option for induced abortion that has benefitted millions of women. In fact, 15 years of use of mifepristone for induced abortion has not just proven it to be safe and effective, but have also supported an evidence-based regimen that improves care and the personal experience for women who find that it is the right choice for them.
"ACOG is pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices, and includes many of the recommendations that ACOG had presented to the agency. Extending approved use of mifepristone through 70 days of gestation is proven to be safe and effective, and will give women more time to make the decision that is right for them.
"The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion. And by allowing more qualified health care providers to prescribe and administer mifepristone, and removing the in-person follow-up appointment, the updated label will also make medication abortion accessible to more women, including previously underserved and rural women.
"We do believe that there is more work to do in updating the mifepristone label to reflect the current evidence. For example, ACOG believes that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary for mifepristone, given its history of safe use. The REMS requirement is inconsistent with requirements for other drugs with similar or greater risks, especially in light of the significant benefit that mifepristone provides to patients.
"For example, while the agency notes rare cases of fatal infections, it is important to note that no specific connection exists between medication abortion and these infections, which can also occur with other obstetric and gynecologic processes and procedures. The mortality rate associated with medication abortion continues to be lower than the mortality rate associated with childbirth.
"As physicians dedicated to safe, accessible health care for women, we are pleased with the FDA's updated label. We know that medication abortion has been subject to legislative attacks in various states across the country, including mandated regimens that do not reflect the current scientific evidence. We hope that these states take the FDA label into account, making safe, effective medication abortion available in a way that is medically appropriate and putting health care decisions back in the hands of patients and their trusted health care providers."
The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of approximately 58,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org