The Biden administration urged the Supreme Court to maintain widespread access to a drug commonly used in medical abortions and warned that restricting the necessary medication would “inflict profound harm on women, the medical system, the agency, and the public.”
US solicitor general Elizabeth Prelogar and counsels for the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) filed a joint brief on Tuesday in defence of mifepristone – the drug that a group of conservative doctors and associates are challenging.
In their brief, the federal agencies said that challengers’, known as the Alliance for Hippocratic Medicine, are incorrect in claiming that the FDA’s approval of mifepristone in 2000 was flawed and that later decisions to make the drug more accessible were a safety risk.
“Study after study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are exceedingly rare,” the Biden administration said in its brief.
The government said that numerous studies and real-life observations were conducted from the time of the drug’s approval in 2000 to 2016, when the FDA determined the medication could be safely taken up to 10 weeks gestation and did not require more than one in-person visit for patients. The agency also lowered the dosing regimen in 2016 after finding it was as effective.
Despite this, the Alliance for Hippocratic Medicine says the medication is dangerous, and the FDA did not conduct enough studies to determine its safety.
“To the government’s knowledge, this case marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgement about the conditions required to assure that drug’s safe use,” the government’s brief said.
The government says that Alliance for Hippocratic Medicine’s argument is largely driven by their religious and moral beliefs that abortion is wrong rather than based on fact.
Alliance for Hippocratic Medicine is backed by the ultra-conservative group Alliance Defending Freedom (ADF) which aims to expand Christian values, restrict LGBT+ rights and outlaw abortion. ADF previously represented plaintiffs in Masterpiece Cakeshop v Colorado Civil Rights Commission which limited the rights of same-sex couples. They also provided model legislation, which was used to help overturn Roe v Wade in Dobbs v Jackson.
More than half of the abortions conducted in the US use medication.
Mifepristone and misoprostol are part of a two-drug combination known as the “abortion pill” which allows individuals to conduct an abortion outside of a medical setting, in the privacy of their homes.
“For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma,” the Biden administration said in their brief.
The cases challenging accessibility to mifepristone are FDA v Alliance for Hippocratic Medicine and Danco Laboratories v Alliance for Hippocratic Medicine. Oral arguments in the consolidated cases have not been set yet.
A decision in the cases will likely arrive in or before June of this year.