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Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, March 15, 2023.
Moises Avila | AFP | Getty Images
A federal judge in Texas on Friday suspended the Food and Drug Administration’s approval of the abortion drug mifepristone, but delayed the ruling’s entry into force by a week, giving the Biden administration time to appeal.
Mifepristone was approved by the FDA over 20 years ago. The long-awaited ruling comes nearly a year after the U.S. Supreme Court overturned his constitutional right to abortion that had been in effect since the early 1970s.
Judge Matthew Kaksmalik of the Northern District of Texas, USA, held an important hearing in Amarillo a few weeks ago. The U.S. Food and Drug Administration, abortion drug maker Danko Laboratories, and anti-abortion group Alliance Defending Freedom each made their case in court.
The alliance represents a coalition of anti-abortion physicians called the Hippocratic Medical Alliance, which sued the FDA in November over the approval of mifepristone. This approval dates back over 20 years, starting in 2000.
The group alleged that the FDA abused its authority by approving mifepristone through an accelerated new drug process to help patients with serious or life-threatening illnesses.
In response, the FDA called the lawsuit “unusual and unprecedented.” The agency’s attorneys were unable to find any past instances of courts reconsidering the FDA’s decision to approve a drug.
The agency also said mifepristone is not approved under the accelerated route.It took more than four years from initial application to approval.
On March 14, 2022, a box of mifepristone, a drug used to induce medical abortions, was prepared for a patient at the Planned Parenthood Health Center in Birmingham, Alabama.
Evelyn Hochstein | Reuters
The FDA has approved mifepristone as a safe and effective way to terminate early pregnancies based on extensive scientific evidence, writes FDA attorneys. Decades of experience with thousands of women confirm that drug therapy is the safest option compared to surgical abortion or childbirth for many patients, the lawyers argued.
The FDA warned that withdrawing mifepristone from the U.S. market would put women’s health at risk without access to pills to safely terminate pregnancies. Weaker powers and regulatory uncertainty in the market will hamper drug development, government lawyers say.
“If long-standing FDA drug approvals were easily withheld, even decades after they were issued, pharmaceutical companies would be forced to buy drugs that Americans rely on to treat a range of health conditions. We will no longer be able to confidently rely on FDA-approved decisions to develop our infrastructure,” wrote an attorney for the Biden administration.
Mifepristone has been at the center of a legal battle over access to abortion since a conservative majority overturned Roe v. Wade in the Supreme Court last June.Mifepristone, used in combination with another drug called misoprostol, is the most common method for aborting pregnancies in the United States, accounting for about half of all abortions.
Mifepristone has been subject to FDA restrictions since it was approved in 2000 to monitor the safety and efficacy of pills. These restrictions have been the subject of criticism and lawsuits from medical groups such as the American College of Obstetricians and Gynecologists and, more recently, Democratic-led state attorneys general.
The FDA has gradually eased restrictions on mifepristone over the years as more evidence became available. The FDA has scrapped previous rules requiring in-person visits with medical professionals to allow pills to be mailed. The FDA recently allowed licensed retail pharmacies to dispense mifepristone if the patient has a prescription from an approved healthcare provider under the FDA’s oversight program.
Misoprostol, a drug used with mifepristone, is recommended by the World Health Organization as the sole method for abortion. However, the FDA has not approved misoprostol as a stand-alone abortion drug.
The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative to early abortion when mifepristone is not available, but it is not as effective as two-drug regimens, according to the organization.
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