A pair of conflicting Holy Week federal rulings concerning the “mifepristone” pill have brought the larger issue of abortion back into focus this Easter.
Rep. Chris Smith (R, NJ-04) came down firmly in favor of the Texas court decision of U.S. District Judge Matthew Kacsmaryk whose 67-page opinion would delay approval of the controversial medial abortion drug.
“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,” said Smith. “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.”
“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 USPS and private carriers,” Smith added.
In his opinion, Judge Kacsmaryk rhetorically wondered “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?”
Answering his own question, the Trump appointee continued:
“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.”
Meanwhile, almost simultaneously on Good Friday, U.S. District Judge Thomas O. Rice of Washington issued a contrary order directing the FDA to NOT reverse course and restrict the drug in 17 states in addition to D.C. (each of which is suing to expand access).
“In response to today’s ruling on mifepristone, I want to reiterate our administration’s commitment to ensuring every New Jerseyan’s right to reproductive freedom,” New Jersey Governor Phil Murphy tweeted after the Texas ruling came down. “We will continue to fight any attempt to restrict access to reproductive health care.”
The Biden Administration has seven days to appeal the Texas ruling, and the reality of competing federal court opinions almost guarantees an eventual trip to the U.S. Supreme Court.
