The federal health authorities approved on Thursday another generic version of the Mifepristona abortive pill, a regulatory formality that quickly caused the rejection of groups that are against abortion and politicians aligned with the president’s government, Donald Trump.
The medication manufacturer avoids solutions announced on its Internet site that the Food and Medicines Administration (FDA) approved its low -cost version of the pill, whose use is authorized to interrupt pregnancies in the first 10 weeks.
Students for Life Action, a group that opposes abortion, issued a statement on Thursday in which it described approval as “a stain in Trump’s presidency and a new sign that the deep state (Deep State) In the FDA it must disappear. ”
Republican senator Josh Hawley also criticized the measure and published on the social network X: “I have lost confidence in FDA leadership.”
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Criticisms occur at a time when Trump’s main health officials, including the Secretary of Health, Robert F. Kennedy Jr., face increasing pressure from the opponents of abortion to revalue the use of the minifepristone, which was approved 25 years ago and that FDA scientists have repeatedly considered as safe and effective.
The FDA approved the original version of the Mifepristona in 2000 and gradually facilitated its access. That included the approval of the first generic pill in 2019, which is produced by the Genbiopro drug manufacturer.
During the government of President Joe Biden, the FDA allowed in 2021 the prescription on the Internet and the mail delivery of the medicine, which greatly facilitated access. Oppositors to abortion have fought against change since then.
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The approval of generic medicines It is usually a routine process in the FDAwith the approval of multiple versions once the original medicine patent expires. In most cases, generic medication manufacturers only need to demonstrate that their medicine coincides with the ingredients and the formula developed by the original manufacturer.
In general, the FDA approves these types of applications within a period not exceeding 10 months. But documents on the FDA website show that Evita Solutions submitted her application to market the mini -Christone four years ago.
The company did not respond at the moment at requests for comments.
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Evita affirms in its portal that “All people should have access to (…) a safe abortionaffordable, high quality, effective and compassionate ”.
The approval of a generic second is unlikely to affect access to the pill, which is generally taken with another medicine, misoprostol. The combination represents approximately two thirds of all abortions in the United States. Mifepristona dilates the cervix and blocks the progesterone hormone, while misoprostol causes the uterus to contract.
Access to Mifepristona is restricted in much of the country due to state laws that prohibit abortion or have restrictions on the use of medication. These laws are subject to a series of demands that currently advance by the legal system.
The restrictions on the use of the pill They do not have support From most of the main medical societies, including the American Medical Association.
