Anti-abortion group that helped overturn Roe v Wade sues FDA to revoke approval of abortion drug

A right-wing group that has supported anti-abortion litigation across the US, including the landmark Supreme Court case that overturned Roe v Wade, is suing the Food and Drug Administration to reverse its approval of a commonly used abortion drug.

Mifepristone is used in medication abortion, a procedure that accounts for a majority of abortions in the US. It is also commonly used to treat miscarriages. Mifepristone and misoprostol are the only drugs recommended by the American College of Obstetricians and Gynecologists to treat an early pregnancy loss.

Alliance Defending Freedom filed a lawsuit in Amarillo, Texas on 18 November against the FDA and US Health and Human Services Department on behalf of four anti-abortion groups and four doctors.

The suit claims that the FDA does not have authority to approve the drug, which the groups claim is “dangerous”.

Mifepristone was approved for use by the FDA in most cases up to 10 weeks of pregnancy in 2000. Multiple studies have determined they are overwhelmingly safe and effective, used in roughly 54 per cent of all abortions. A vast majority of abortions occur within the first nine weeks. In 2019, nearly 93 per cent of all abortions were performed before the 13th week.

Last year, the FDA permanently lifted the in-person requirement for medication abortion prescriptions, allowing patients to access the drugs via telehealth appointments and online pharmacies so patients can take the drugs at home.

But within the last year, anti-abortion state legislators filed more than 100 bills to restrict the availability and distribution or abortion drugs, or sought to ban them altogether.

In a statement to The Independent, Alliance for Defending Freedom’s senior counsel Julie Marie Blake claimed that FDA-approved abortion drugs pose “serious and life-threatening complications” to patients, despite evidence from major medical groups showing otherwise. Medication abortions requiring hospitalisation for any reason typically occur within less than one half of 1 per cent of patients.

The conservative Christian legal advocacy group claims that the FDA has “never had the authority” to approve the drug, which senior counsel Erik Baptist claims has “always stood on shaky legal and moral ground.”

“On behalf of the national health care organizations and physicians we represent, we ask the court to hold the FDA accountable for its reckless, unlawful behavior,” he said in a statement.

The Alliance Defending Freedom is among powerful anti-abortion groups that have worked with state legislatures to advance anti-abortion laws in an effort to draw legal challenges they would appeal up to the Supreme Court.

At an anti-abortion Evangelicals For Life Conference in Washington DC in 2018, the group and other campaigns hailed a new legal strategy within state legislatures: advancing unconstitutional anti-abortion laws that would attract lawsuits from abortion rihts groups arguing that they defy Roe v Wade and Planned Parenthood v Casey protections.

Mississippi’s Gestational Age Act, drafted by the Alliance Defending Freedom, force abortion rights groups into a legal battle that would eventually land at the Supreme Court as Dobbs v Jackson Women’s Health Organization.

In June, with a new conservative supermajority on the court – the product of a parallel campaign among anti-abortion groups to seat judicial appointments who could overturn Roe – the nation’s high court revoked a constitutional right to abortion.

President Joe Biden’s administration and abortion rights advocates have denounced the latest suit.

“For decades, women in this country have had access to FDA-approved medication abortion as a safe and effective option,” according to a statement from HHS. “Denying women access to any essential care they need is downright dangerous and extreme.”

In the wake of the Dobbs decision, the administration has directed federal agencies to “identify” ways to protect access to mifepristone.

Senators Elizabeth Warren, Bernie Sanders, Mazie Hirono, Kirsten Gillibrand, Angus King and Chris Van Hollen have urged the FDA to eliminate barriers to abortion drugs, which are currently regulated under a “medically unnecessary in-person dispensing requirement” provision.

“As states implement new restrictions, it is more important than ever that you take immediate steps to expand access to medication abortion,” they wrote in a letter to commissioner Robert Cardiff on 18 November.

Democratic Senator Tina Smith also introduced the Protecting Access to Medication Abortion Act, which would codify FDA guidelines to ensure patients can access drugs by telehealth appointments and mail-order pharmacies.

Mutual aid organisations and international aid groups have also mobilised to connect patients with abortion drugs through the mail in an attempt to circumvent state laws criminalising US-based providers.