Danco Laboratories, a manufacturer of the abortion pill mifepristone, told the Supreme Court on Tuesday that restricting use of the medication would cause “tremendous harm” to women.
the high court in September alongside the US Department of Justice to reverse a Fifth Circuit decision that would limit mifepristone’s use to conditions that existed before the FDA loosened some of its regulations in 2016 and 2021. Those changes have allowed the drug to be distributed by mail, lowered the requirement for in-person clinical visits, and extended how late into pregnancy a patient may take the drug from seven weeks to 10.
Pictured: Front view of the Supreme Court building/iStock, SeanPavonePhoto
The U.S. Supreme Court on Wednesday agreed to hear the legal case regarding the abortion pill mifepristone and how it is currently delivered and distributed. According to several media reports, the high court will hear arguments in the coming months and will likely reach a decision in the summer during the 2024 U.S. presidential election.
The Supreme Court’s decision on Wednesday to hear the case follows an appeal by the Biden administration in response to an August 2023 ruling by a U.S. federal appeals court, which put restrictions on the broad access to mifepristone. At the time, the court found no need to take mifepristone—made by Danco Laboratories—off the market, but disallowed telemedicine prescriptions and its distribution via mail.
White House Press Secretary Karine Jean Pierre in a statement said that the Biden administration welcomes the Supreme Court’s decision to review a lower court’s verdict on mifepristone, which not only “threatens to undermine the FDA’s scientific, independent judgement” but also “reimpose outdated restrictions on access to safe and effective medical abortion.”
Pierre added that President Joe Biden and Vice President Kamala Harris “remain firmly committed to defending women’s ability to access reproductive care.”
The recent legal tussle over mifepristone runs back to November 2022, when the Alliance for Hippocratic Medicine—along with other pro-life organizations—filed a lawsuit against the FDA, claiming that the agency “never studied the safety of the drugs under the labeled conditions of use” and that mifepristone’s approval was influenced by politics.
In April 2023, Texas federal judge Matthew Kacsmaryk ruled in favor of the Alliance for Hippocratic Medicine and issued a preliminary injunction, blocking the sales of mifepristone. A few days later, the 5th Circuit Court of Appeals partly blocked Kacsmaryk’s ruling.
Soon after, the Supreme Court granted the FDA’s application for a stay, which effectively allowed mifepristone to remain on the market while the case has yet to be resolved.
The case was sent back to the 5th Circuit Court of Appeals, where Attorney General Sarah Harrington argued in front of a three-judge panel that Kacsmaryk’s decision undermined the FDA’s scientific expertise. The appellate justices took issue with this line of reasoning and raised doubts about whether the FDA had done its due diligence before expanding access to mifepristone.
Lawrence Gostin, a professor at the Georgetown University Law Center, on Wednesday wrote in an X posting that “in one fell swoop” the Supreme Court next year “will decide access to the most common abortion method and the functioning of the FDA,” adding that “reproductive freedom is at stake as well as the scientific judgments of health agencies.”
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at firstname.lastname@example.org or email@example.com.
NEW YORK, Dec. 13, 2023 /PRNewswire/ -- We at Danco are gratified that the Supreme Court has granted Danco's and the United States' requests to review the Fifth Circuit's August decision invalidating changes that FDA approved to the conditions of use for Mifeprex® in 2016 and in 2021. That decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges. Danco continues to be at the forefront of this fight and is working closely with the reproductive rights community and pharmaceutical industry to support the changes made by FDA.
Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use. Because the Supreme Court's stay will remain in place until that Court issues a decision, Mifeprex® will continue to be available under the current FDA-approved conditions, which include use in pregnancy up to 10 weeks gestation, with prescribing after in-person or telehealth examination and dispensing by certified healthcare professionals, brick-and-mortar pharmacies, or mail-order pharmacies.
The FDA actions at issue were well supported by extensive safety and effectiveness data from clinical trials and decades worth of real-world experience in millions of patients. The changes in 2016 and 2021—approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits.
Mifeprex® is the most commonly used medication for termination of early pregnancy. Over 5 million women have used Mifeprex® in the United States since its approval in 2000. Mifeprex® is ~97% effective in terminating early pregnancy; approximately 3% of women will require surgical intervention for ongoing pregnancy, heavy bleeding, incomplete expulsion, or other reasons such as patient request.
MIFEPREX: Important Safety Information
WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use. No causal relationship between the use of MIFEPREX and misoprostol and these events has been established.
Atypical Presentation of Infection. Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination. A high index of suspicion is needed to rule out serious infection and sepsis.
Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed.
MIFEPREX is only available through a restricted program called the Mifepristone REMS Program.
Before prescribing MIFEPREX, inform the patient about these risks. Ensure the patient knows whom to call and what to do if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise for more than 24 hours after taking misoprostol.
Administration of MIFEPREX and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:
Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
Chronic adrenal failure (risk of acute renal insufficiency)
Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
Inherited porphyrias (risk of worsening or of precipitation of attacks)
Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device ("IUD") in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used.
Warnings and Precautions
Infection and Sepsis
As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of MIFEPREX. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.
Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfusions. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.
Mifepristone REMS Program
MIFEPREX is available only through a restricted program under a REMS called the Mifepristone REMS Program, because of the risks of serious complications. Notable requirements of the Mifepristone REMS Program include the following:
Prescribers must be certified with the program by completing the Prescriber Agreement Form.
Patients must sign a Patient Agreement Form.
MIFEPREX must only be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers.
MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.
Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.
The use of MIFEPREX is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.
Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.
This is the Important Safety Information. For more information, please see the Full Prescribing Information, including
BOXED WARNING and Medication Guide, available at
SOURCE Danco Laboratories