The Department of Justice (DOJ) has appealed a Texas judge’s ruling to withdraw access to the abortion drug mifepristone.
It was announced that the Justice Department would appeal Friday in the hours following U.S. District Court Judge Matthew Kaksmarek, a Trump appointee, on Friday revoking the 2000 Food and Drug Administration (FDA) approval.
The move drew immediate backlash from much of the pharmaceutical industry, with major players like Pfizer and Merch condemning Judge Kacsmaryk’s ruling.
The immediate future of mifepristone now lies in the hands of the Fifth US Court of Appeals. Currently, the property is scheduled to be taken off the market on Friday, but the Court of Appeal may issue an injunction to allow its use for the time being.
This landmark case not only of abortion rights in the United States but also of regulators’ power to oversee medicines is expected to eventually reach the Supreme Court.
Mifepristone, unlike its counterpart Misoprostol, is only approved for abortion healthcare, as well as for some abortions. Approved in 2000. Almost half of all abortions are completed using the two-pill regimen (file photo)
“The Ministry of Justice strongly opposes the decision of the local court… and will appeal the court’s decision and request a stay of pending appeal,” the agency wrote after the ruling on Friday.
Today’s decision overturns the FDA experts’ ruling, made more than two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision.
“The Department is committed to protecting Americans’ access to legal reproductive care.”
Believing that a ruling revoking the FDA’s approval of mifepristone was imminent, several states have already begun stockpiling the drug.
California Gov. Gavin Newsom announced Monday that his office has made plans to secure an emergency stockpile of up to 2 million pills.
Newsom government He saidWe will not give in to extremists who try to outlaw these critical abortion services. Medical abortion is still legal in California.
In Washington, the Department of Corrections has purchased tens of thousands of doses of mifepristone that will soon be authorized for distribution.
“Washington is a pro-choice nation and no Texas judge would order us otherwise,” Gov. Inslee said at a press conference last Tuesday.
Whole Woman Health, an independent provider of medical abortion services in New York City, said Friday: “(N)we follow FDA guidance, not Texas anti-abortion judges who lack any formal medical training.
“Whole Women’s Health will continue to dispense (mifepristone) in our clinics and a pill-by-mail program for the next week as we monitor both decisions.”
Some have also begun stocking up on misoprostol, a stomach ulcer medication used alongside mifepristone in medical abortions.
Although there are no challenges to the drug’s approval, some fear that its arrival may be in the way of chopping up thereafter.
The misoprostol-only regimen is the standard in many parts of the world and even has the full endorsement of the World Health Organization.
But this method is not as effective as a combination of dual medications.
While mifepristone and misoprostol are 100 percent effective in terminating a pregnancy, the latter alone does not always work.
Study published in February Researchers at the University of Texas and Columbia University found that misoprostol alone terminated pregnancies in 88 percent of cases.
Also in the wake of the ruling, more than 300 biotech and pharmaceutical executives signed a letter saying the ruling amounts to “judicial interference” that threatens future approvals of prescription drugs.
Among the signatories signed are Pfizer, BioNTech, Merck and other major players.
Leaders are calling on Judge Kaksmarek to reverse his decision, which has sparked a wave of uncertainty and questions about the legal landscape of abortion access.
They wrote, “We call for a reversal of this decision to ignore the science, and for the appropriate delegation of drug safety and efficacy for all to be returned to the Food and Drug Administration, the agency mandated to do so in the first place.”
It was a rare display of unity from biotech companies large and small in response to the surprising ruling on Friday night.
“We will not give in to extremists who try to outlaw these critical abortion services,” said California Governor Gavin Newsom (pictured). His condition is stockpiling abortion drugs because the fate of mifepristone is still in the balance
They added: “The decision ignores decades of scientific evidence and legal precedent.
“Justice Kacsmarek’s judicial intervention action set a precedent for diminishing the FDA’s power over drug approvals and, in doing so, creates uncertainty for the entire biopharmaceutical industry.”
Since Congress gave the Food and Drug Administration (FDA) blanket jurisdiction to determine whether drugs are safe and effective as part of the Food, Drug, and Cosmetic Act of 1938, courts have typically referred to the agency’s scientific expertise.
But the Texas ruling undermines the FDA’s legitimacy as the arbiter of good medical and scientific regulatory judgment.
Experts fear it could open the door to more political wrangling over drugs deemed largely safe.
They fear the judge’s decision could send a chilling sway through the field of developing medicine, an already risky and expensive endeavor.
The pharmaceutical company directors added: “As an industry, we rely on the FDA’s independence and authority to offer new drugs to patients under a trusted regulatory process for drug evaluation and approval.
Adding regulatory uncertainty to the inherently risky business of discovering and developing new medicines is likely to reduce incentives to invest, putting at risk the innovation that characterizes our industry.
Court challenges like the one staged in Texas could open the door for other parties to challenge FDA approval of other new or existing drugs deemed controversial and caught in the crosshairs of a culture war.
In response to last week’s Texas judge, President Joe Biden He said“If this ruling continues, almost no prescription drug approved by the Food and Drug Administration will be safe from these types of political and ideological attacks.”