A Hawaiian doctor, with the help of the American Civil Liberties Union, has launched a lawsuit against the Food and Drug Administration (FDA) for placing unnecessary restrictions on Mifepristone, also known as Mifeprex, a pill used for medical abortions.
The lawsuit filed in a US District Court against the FDA was announced by the ACLU on Tuesday. The lawsuit concerns the FDA’s restrictions or REMS (Risk Evaluation and Mitigation Strategy) placed on Mifepristone which requires the drug to be dispensed at specific facilities, like a clinic, and not at a regular pharmacy. Dr. Graham Chelius, a plaintiff in the lawsuit, argues that these restrictions prevent his patients who live in rural parts of the Hawaiian island of Kauai from accessing the drug.
According to Chelius, since his practice isn’t able to stock Mifepristone, patients who are seeking a medical abortion are forced to travel to another island to obtain the procedure. This dramatically increases the cost for patients and delays the procedure.
The ACLU is arguing that the purpose of FDA REMS is to “ensure that a drug’s benefits outweigh its risks” but since Mifepristone is proven to be safe and effective, the REMS are entirely unnecessary. The FDA restrictions also put “undue burden” on those seeking a safe and legal abortion, making them unconstitutional.
Mifepristone is an anti-hormone drug that, when used in combination with misoprostol, can be used to terminate pregnancies prior to 10 weeks. The drug can also be used to treat several other gynecological and obstetrical conditions such as endometriosis, breast and ovarian cancers, and fibroid tumors. The FDA approved Mifepristone for early pregnancy termination in 2000. The drug, however, can only be obtained through the manufacturer and dispensed at a doctor’s office or clinic.
Mifepristone has been increasingly used as a private and convenient way for those seeking an abortion to terminate a pregnancy prior to 10 weeks gestation in their own home. The Feminist Majority Foundation has fought for wider availability for several decades and took part in the “Mifepristone Compassionate Use” program to ensure access to Mifepristone for women suffering with any number of debilitating and painful illnesses.
Media Resources: Feminist.org; Feminist Newswire 9/28/15, 3/31/16; Rewire 10/3/17; Mother Jones 10/3/17; Chicago Tribute 10/4/17