Washington [US], April 8: A federal judge in Texas ruled on the abortion medicine mifepristone on Friday, stating he would suspend the FDA’s two-decade-old approval.
However, the judge postponed his decision for seven days to enable the federal government to file an appeal.
A federal court in Washington state issued its ruling less than two hours later, saying the FDA must maintain access to abortion medications in more than a dozen states with Democratic governors. Since the Supreme Court reversed Roe v. Wade last year, the two verdicts represent the most important abortion-related precedents.
The overturning of Roe vs Wade demonstrates the tangible impacts that it has on patients seeking access to medical procedures. On June 24, 2022, the Supreme Court of the US abolished abortion rights while overturning the constitutional right granted to women in a historical 1973 ruling called Roe vs Wade.
After the Texas judge issued the ruling, the US Food and Drug Administration issued the following statement Friday night saying that the drug is safe and effective for its indicated use.
“The FDA has appealed this decision. FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective for its indicated use – medical termination of early pregnancy,” the statement read.
The approval was based on the best available science and done in accordance with the laws that govern our work. FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that the FDA has determined to be safe and effective for their intended uses, the statement read further.
The decision by the Texas judge on the abortion pill received widespread reactions.
US President Joe Biden declared late on Friday night that his government would challenge the Texas judge’s decision to block the FDA’s approval of an abortion drug.
“My Administration will fight this ruling. The Department of Justice has already filed an appeal and will seek an immediate stay of the decision. But let’s be clear – the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade,” Biden said in a written statement.
The US Food and Drug Administration, for the first time in January this year, cleared a passage for certified pharmacies to dispense abortion pills in the United States.
Previously, only a certified healthcare provider could order, prescribe, and dispense these pills. With the decision, the Pharmacies became certified to dispense the drugs directly to someone who has a prescription from a certified prescriber.
The changes were finalised after the FDA reviewed supplemental applications from Danco Laboratories and GenBioPro, the two companies that manufacture the drug in the United States.
Mifeprex is the brand name for mifepristone, which, when combined with a second drug called Misoprostol, which has a variety of uses including miscarriage management, induces abortions up to 10 weeks into pregnancy in a procedure known as medication abortion.
