USFDA appeals ruling against abortion pill

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The decision by the Texas judge on the abortion pill received widespread reactions…reports Asian Lite News

The United States Food and Drug Administration (FDA) has filed an appeal on Friday against a recent federal judge’s ruling that overturned the approval of a safe and effective abortion pill.

In response to the judge’s decision, the FDA issued a statement defending their approval of the medication, stating that “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 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.

If the judge’s ruling is allowed to stand, it would revoke the FDA’s approval of mifepristone, a drug that has been widely used for over two decades to terminate unwanted pregnancies. The FDA’s appeal was filed in Texas and signed by lawyers representing the agency, as per court documents.

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, Al Jazeera reported.

ALSO READ: Texas judge suspends approval of abortion pill

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