DOJ appeals order that could make ban abortion pill FRIDAY

The Department of Justice (DOJ) has appealed a Texas judge’s ruling to revoke access to the abortion drug mifepristone.

It was announced that the DOJ would appeal Friday in the hours following the decision of U.S. District Judge Matthew Kacsmaryk, a Trump appointee, who ruled Friday to overturn the 2000 Food and Drug Administration (FDA) approval.

The move was met with immediate backlash from much of the pharmaceutical industry, with major players such as Pfizer and Merch condemning Judge Kacsmaryk’s ruling.

The immediate future of mifepristone is now in the hands of the 5th US Circuit Court of Appeals. Currently, the drug is withdrawn from the market on Friday, but the appeals court could issue an order to allow its use for the time being.

This groundbreaking case for not only abortion rights in the US, but also for the power of regulators to oversee drugs, is expected to eventually make it to the Supreme Court.

“The Justice Department strongly disagrees with the court’s decision … and will appeal the court’s decision and request a stay pending appeal,” the agency wrote Friday after the ruling.

“Today’s decision reverses the FDA’s expert judgment, 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 to invalidate mifepristone’s FDA approval was imminent, several states have already begun stockpiling the drug.

California Governor Gavin Newsom announced Monday that his office has made plans to secure an emergency supply of up to 2 million pills.

Government Newsom saidWe will not give in to extremists who try to ban these critical abortion services. Medication abortion remains legal in California.”

In Washington, the Department of Corrections has bought up tens of thousands of doses of mifepristone that will soon be dispensed.

Gov. Inslee said at a news conference Tuesday, “Washington is a pro-choice state and no judge in Texas will order us otherwise.”

And Whole Women’s Health, an independent provider of medication-abortion services in New York City, said Friday: “[W]We follow FDA guidelines and not Texas anti-abortion judges who have no formal medical training.

Whole Woman’s Health continues to provide [mifepristone] in our clinics and our Pills by Mail program for the week ahead as we monitor both decisions.”

Some have also started on misoprostol, an anti-ulcer drug used alongside mifepristone in medication abortions.

While there are no challenges to the drug’s approval, some fear its access could be on the chopping block.

A misoprostol-only regimen is standard practice in many parts of the world and is even fully endorsed by the World Health Organization.

But this method is not as effective as a combination of two drugs.

Although mifepristone and misoprostol are 100 percent effective in terminating a pregnancy, the latter alone does not always work.

A study published in February researchers at the University of Texas and Columbia University found that misoprostol alone terminated pregnancies in only 88 percent of cases.

Also following the ruling, more than 300 biotech and pharmaceutical industry executives signed a letter saying the ruling amounted to “judicial interference” jeopardizing the future approval of prescription drugs.

Signatories included those from Pfizer, BioNTech, Merck and other major players.

The leaders are calling on Judge Kacsmaryk to reverse his decision, which has sparked a wave of uncertainty and questions about the legal landscape of access to abortion.

They wrote: “We call for the reversal of this decision to disregard science, and the appropriate return of the mandate for the safety and efficacy of drugs for all to the FDA, the agency entrusted with this in the first place. ‘

It was a rare show of unity from large and small biotech companies in response to Friday night’s surprise ruling.

They added: “The decision ignores decades of scientific evidence and legal precedent.

“Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing the FDA’s authority over drug approvals, thereby creating uncertainty for the entire biopharmaceutical industry.”

Since Congress gave the FDA overarching jurisdiction to determine whether drugs are safe and effective as part of the Food, Drug, and Cosmetic Act of 1938, courts have typically deferred the agency’s scientific expertise.

But the Texas ruling undermines the FDA’s legitimacy as an arbiter of good medical and scientific regulatory judgment.

Experts fear it opens the door to more political division over drugs considered overwhelmingly safe.

They fear the judge’s decision could have a chilling effect on drug development, an already risky and expensive endeavor.

The pharma execs added, “As an industry, we count on the autonomy and authority of the FDA to bring new drugs to patients under a reliable regulatory process for drug evaluation and approval.

“Adding regulatory uncertainty to the already inherently risky work of discovering and developing new drugs is likely to reduce incentives for investment, jeopardizing the innovation that characterizes our industry.”

Court challenges, such as the one in Texas, could open the door for other parties to challenge FDA approval for other new or existing drugs that are considered controversial and caught in the crosshairs of the culture war.

In response to Texas Judge last week, President Joe Biden said: ‘If this ruling were to hold, there will be virtually no prescription, approved by the FDA, that is immune from this kind of political, ideological attack.’