A dozen states are suing the Food and Drug Administration over what they claim are pointless restrictions on the abortion drug mifepristone.
The Democratic attorneys general of Washington, Oregon, Nevada, Delaware, Arizona, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan, and Rhode Island filed the complaint on Friday in the U.S. District Court for the Eastern District of Washington.
It alleges that federal regulations on mifepristone are “excessively burdensome…despite ample evidence that the drug is safer than Tylenol.” Mifepristone functions by inhibiting a hormone required to maintain pregnancy. It is approved for usage during the first 10 weeks of pregnancy and is administered combined with misoprostol, a drug that induces uterine contractions.
According to the Guttmacher Institute, a research organization that promotes abortion rights and keeps track of federal and state statistics, medication abortions made up 54% of abortions in the United States in 2020. According to the state’s attorney general, pharmaceutical abortions account for roughly 60% of abortions in Washington.
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“The federal government has known for years that mifepristone is safe and effective,” Washington state Attorney General Bob Ferguson said in a statement. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists, and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”
The FDA didn’t immediately reply to a request for comment on the lawsuit. The complaint was filed in the midst of escalating legal disputes over access to abortion in the U.S. after the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which gave states sole discretion over whether abortion is lawful.
With the June 2022 ruling, a patchwork of abortion access has developed throughout the United States. A dozen or so states have passed legislation outlawing almost all abortions, while others have taken action to protect access to abortion through executive orders and state laws. The topic of abortion pills has become a hot button.
To reverse the federal approval of mifepristone, pro-abortion activists sued the FDA and the Department of Health and Human Services last year. Two legal actions against states that prohibited pharmaceutical abortions were filed in January. According to the lawsuits, states cannot impose drug limits that are more stringent than those set by the federal government.
According to the complaint filed on Friday, the FDA approved mifepristone and misoprostol for medication abortions in 2000. The pill has since been used safely more than 5 million times in the U.S.
The federal authorities loosened limits on the medication in 2021, enabling patients to obtain mifepristone without first seeing a hospital or physician. It made improvements in January that made it possible for physical pharmacies to start dispensing the medication.
Yet, the attorneys general contend that the limitations on the prescription and distribution of mifepristone are detrimental and unnecessary. Only 60 of the more over 20,000 medications that the FDA has approved are allegedly subject to the Risk Evaluation & Mitigation Strategies, or REMS, limitations that restrict who may prescribe and dispense the drug.
Additionally, they claim that having to provide proof of a patient’s drug usage results in fewer telemedicine consultations and puts patients in more “danger of violence, harassment, and threats of liability amid the growing criminalization and outlawing of abortion in other states.”
“REMS restrictions are supposed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others,” the attorneys general said in a statement Friday.
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