Feminist Majority Foundation led the campaign to win FDA approval of mifepristone for early medical abortion from 1989 until victory on September 28, 2000. Today some 40% of all early abortions in the United States are performed simply by women taking medication by mouth with no surgical procedure needed. For millions of women who need to or want to end their pregnancy, it has provided a preferred method and is truly a medical advancement.
But the FMF believed then and still believes that the drug can and should be further researched to achieve additional important medical advancements. In the meantime, it should be widely available to treat life-saving medical and mental health conditions now that disproportionately impact women.
Decades of evidence-based, scientific studies indicate that mifepristone, an anti-hormone drug, could be an important treatment for a variety of gynecologic and obstetric conditions. It has been shown to be effective in easing the delivery of at-term babies and is widely used in European countries for this purpose. Moreover, other scientific research has indicated its potential in treating some types of breast, ovarian and uterine tumors as well as psychiatric conditions such as bi-polar disorder, generalized depression and post-partum depression, but because the FDA (for what is believe to be political, not medical safety reasons) severely restricts access to the drug for even doctors and researchers, such research concerning potential usage has been limited.
Doctors cannot even write prescriptions for mifepristone – they have to enter a special agreement with the manufacturer and purchase it for their clinic or hospital only for early medication abortion. Additionally, unlike most drugs, mifepristone is not even able to be used in an “off-label” manner – that is to say, used for conditions other than what the drug was originally approved for by the FDA.
Thankfully, because of its anti-cortisol properties, mifepristone was finally approved by the FDA (in a different dosage) in 2012 as an anti-glucocorticoid for treatment of Cushing’s Syndrome, a rare, but serious, condition most often affecting people in their 20s to 50s and affecting women three times as often as men. A man and a woman who were treated with mifepristone and cured testified in the 1990’s before Congress on how the drug had saved their lives.
Off-label use of medications is common. Look at methotrexate: it’s been on the market for more than 60 years, and was developed as a chemotherapy drug. It’s still used for chemotherapy in a wide variety of cancers, but is also used to treat skin conditions, bowel disorders and auto-immune conditions. It, too, is used as an abortifacient drug, most often to treat ectopic pregnancies, but because its use as a critical treatment in other life-threatening conditions has been established, it can’t be taken away by conservative forces that would like to see any abortifacient restricted or removed from the market
Even though the scientific literature shows that mifepristone could be very helpful for some types of breast cancers, ovarian cancers, uterine fibroids, and other tumors disproportionally impacting women, doctors cannot provide this drug to their patients in an off-label manner- because of the restrictive use the FDA agreed to in order to appease the anti-abortion opponents who threatened its approval. FMF believes that restrictions around accessing mifepristone should be removed so that its full therapeutic value can be thoroughly explored.
FMF understood that even with FDA approval of mifepristone for medical abortion, its severely restricted access would limit its potential to treat patients with life-threatening medical and psychiatric conditions. When no other professional medical organization stepped in to help patients access this novel anti-hormone medication, FMF took the bold step of entering into an arrangement with the Food and Drug Administration to develop a “Mifepristone Compassionate Use program”. For over 15 years, our Compassionate Use program has been the only way for doctors to access this drug for their patients with life-threatening conditions who had exhausted all other forms of traditional treatments. FMF also partnered with the Gynecological Oncology Group, the country’s foremost gynecologic cancer research group (funded by the National Cancer Institute) in conducting a small study on mifepristone for ovarian cancer.
Today, 15 years after its approval for early abortion, FMF remains the sole provider of mifepristone for compassionate use in the United States. Since the Compassionate Use Program began in 1998, nearly 170 patients have received treatment for their various life-threatening conditions. The continuation of this program is integral to the treatment, livelihood, and lives of these patients with various advanced and terminal conditions. Some patients have depended on mifepristone for nearly 20 years, crediting the drug for saving their lives. They have testified to such before the U.S. Congress.
FMF was a critical force in the fight to get mifepristone approved for medical abortion and remains a vital voice in the cry to lift onerous restrictions around mifepristone’s access to doctors, patients and researchers so that its full potential as a novel anti-hormone therapy can finally be explored.