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Judge reverses FDA approval of abortion drug after 23 years

by Universalwellnesssystems

A federal judge in Texas ruled on Friday to stop the use of the abortion drug mifepristone, approved by regulators 23 years ago and now one of the most popular abortion methods in the country. .

US District Judge Matthew Kacsmaryk has ruled to suspend FDA approval of mifepristone. The verdict has him on hold for seven days, so the federal government may appeal.

Attorney General Merrick Garland said the Justice Department strongly disagreed with the decision and would appeal.

“Today’s decision reverses FDA’s expert judgments made more than 20 years ago that mifepristone is safe and effective. The division continues to defend the FDA’s decision,” said Garland. said in a statement.

Kacsmaryk, Trump’s appointee, held a hearing on the issue in Amarillo, Texas, on March 15, and conservative plaintiffs in the case said the Food and Drug Administration was wrong to approve mifepristone. claimed to be.

Meanwhile, a Washington state judge on Friday issued an injunction to stay a duel in a separate case regarding mifepristone’s FDA approval status. granting the preliminary injunction sought by the plaintiffs, composed of the Attorneys General of the United States, preventing the FDA from “changing the status and rights relating to the availability of mifepristone.”

GenBioPro, the maker of generic mifepristone, said it was confident in the drug’s legality in response to Kacsmaryk’s ruling.

“The court order does not change decades of science and evidence regarding the safety and efficacy of mifepristone,” said Evan Masingill, CEO of GenBioPro.

Mascingill added that GenBioPro is considering Rice’s order, but “is pleased that he recognizes the importance of maintaining the status quo related to the availability of mifepristone.”

As of 2020, nearly half of all abortions in the United States were medical abortions, according to data collected by the Centers for Disease Control and Prevention. Such methods usually rely on mifepristone in her two-drug regimen along with misoprostol.

Erik Baptist, senior attorney for Alliance Defending Freedom, the group that filed the Texas lawsuit, said the judge would have to check the FDA after the hearing in March. Most doctors disagree.

“The FDA did not have the authority to approve these drugs and remove important safeguards,” Baptist said.

A government attorney representing the FDA said at the hearing that the government had reviewed extensive data and found no such safety concerns.

Justice Department attorney Julie Strauss Harris said that “the public interest would be dramatically harmed” by taking the side of the plaintiffs, and Baptiste told the judge, “Relief must be complete and national.” must.

Outside, pro-abortion supporters were outspoken. “There are many reasons why this court should dismiss [the lawsuit] It’s out of control,” said Carrie Flaxman, senior director of public policy litigation and law at the Planned Parenthood Federation of America.

ABC News has reached out to the FDA for comment.

If the conservative Fifth Circuit Court of Appeals upholds the Texas decision and the two federal orders remain in conflict, the issue will likely go to the Supreme Court.

Alexis McGill Johnson, president and CEO of the Planned Parenthood Federation of America, said in a statement to ABC News that the judge’s decision in Texas “could threaten the FDA’s role in the country’s public health system. It has far-reaching and unprecedented consequences, far beyond abortion, if it is allowed.”

The decision “is outrage and exposes the weaponization of the judicial system to further restrict abortion nationwide. However, we want to be clear that access to mifepristone is safe for now.” the statement said. “But we are all outraged that one judge can unilaterally dismiss medical evidence and reverse the FDA’s approval of a drug that has been used safely and effectively for more than 20 years. should.”

The American College of Obstetricians and Gynecologists condemned Texas’ decision in a statement Friday, calling it “a grave legal deviation from America’s established regulatory system.”

“The decision itself deliberately ignored decades of evidence-based scientific data and used clinically relevant language about mifepristone, an important drug used in the management of both abortions and miscarriages. It betrays the prejudices and prejudices that influenced that rhetoric it avoids,” said Dr. Iffath Abbasi Hoskins. The organization’s president and its CEO, Dr. Maureen Phipps, said in a joint statement.

Meanwhile, Alliance Defending Freedom said Friday’s decision in the lawsuit “is an important victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls.” rice field.

Vice President Kamala Harris gave the first reaction from the Biden administration to the Texas ruling, setting a “dangerous precedent,” telling reporters Friday night as she prepared to depart Nashville, Tennessee. Said to set

She and President Joe Biden “will stand for women in America and do everything we can to empower women to make decisions about their own health and reproductive health,” Harris said. . “It’s up to them to decide, not their government.”

ABC News’ Justin Gomez and Meredith Deliso contributed to this report.

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