A leading pro-life Congressman is celebrating a judge’s ruling late Friday that blocks the abortion pill nationwide.
Rep. Chris Smith, a New Jersey Republican, today said: “Pro-life Americans have always been deeply invested in protecting the most vulnerable members of our society. While the FDA has enabled the abortion industry to prey on women and girls during their most vulnerable moments of need, today’s decision finally puts the health of women first—protecting them from the known and unknown risks of chemical abortion.”
Smith said, “the FDA’s egregiously flawed and unlawful approval process has endangered—and continues to put at serious risk—pregnant adolescents by unlawfully waiving the pediatric study requirement. Under the Pediatric Research Equity Act (PREA), assessments of new drugs must include studies showing the safety and efficacy of a drug for pediatric use, as well as the proper dosing and administration for adolescent patients. The FDA absolutely failed to do this.”
Smith, who chairs the Congressional Pro-Life Caucus said: “The FDA has blatantly ignored warnings of life-threatening complications associated with mifepristone and misoprostol—the drug regimen used in chemical abortions. Also, the FDA’s actions unlawfully permit chemical abortion drugs to be prescribed via telemedicine and distributed through the USPS and private carriers.
“Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas in his 67-page opinion stayed FDA approval of the abortion pill, to take effect in seven days pending appeal.
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“Judge Kacsmaryk wrote that FDA’s actions are likely to cause ‘irreparable injury’ and cited Plaintiffs concerns about the ‘many intense side effects’ and ‘significant complications requiring medical attention’ resulting from the FDA’s actions noting, ‘Many women also experience intense psychological trauma and post-traumatic stress from excessive bleeding and from seeing the remains of their aborted children… .’
“In his decision, Judge Kacsmaryk asked, ‘Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right?’
The Judge wrote in response, “Simply put, FDA stonewalled judicial review—until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” 21 C.F.R. § 10.30(e)(2)). But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. See ECF Nos. 1-14, 1-28, 1-36, 1-44 (“2002 Petition,” “2019 Petition,” respectively). Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.”