The Department of Justice (DOJ) has appealed the ruling of a Texas judge to pull access to the abortion medication mifepristone.

It was announced that the DOJ would appeal on Friday in the hours following the decision by US District Judge Matthew Kacsmaryk, a Trump appointee, ruled Friday to undo 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 now lies in the hands of the 5th US Circuit Court of Appeals. Currently, the drug is set to be pulled from the market on Friday, but the appeals court could issue an injunction to allow its use for the time being.

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

Mifepristone, unlike its counterpart misoprostol, is only approved for abortion healthcare, as well as, for some miscarriages. It was approved in 2000. Roughly one-half of abortions are completed using the two-pill system (file photo)

‘The Justice Department strongly disagrees with the decision of the District Court… and will be appealing the court’s decision and seeking a stay pending appeal,’ the agency wrote after the ruling Friday.

‘Today’s decision overturns the FDA’s expert judgment, rendered over 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 Gov Gavin Newsom announced on Monday that his office made plans to secure an emergency stockpile of up to 2 million pills. 

Gov Newsom said: ‘We will not cave to extremists who are trying to outlaw 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 it will soon become authorized to dispense.

Gov Inslee said at a press conference last Tuesday: ‘Washington is a pro-choice state and no Texas judge will order us otherwise.’

And Whole Women’s Health, an independent medication abortion provider in New York City, said Friday: ‘[W]e follow directives from the FDA, and not anti-abortion judges in Texas who lack any formal medical training.

‘Whole Woman’s Health will continue to dispense [mifepristone] in our clinics and our Pills by Mail program for the next week as we monitor both decisions.’

Some have also started to stockpile misoprostol, a stomach 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 next.

A misoprostol-only regimen is 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 dual-drug combo.

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

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

Also following the ruling, over 300 biotech and pharma industry executives signed a letter saying the ruling amounted to ‘judicial interference’ that imperils to future of prescription drug approvals. 

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

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

They wrote: ‘We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place.’

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

California Gov Gavin Newsom (pictured) said: 'We will not cave to extremists who are trying to outlaw these critical abortion services.' His state is stockpiling abortion drugs as the fate of mifepristone remains in the balance

California Gov Gavin Newsom (pictured) said: ‘We will not cave to extremists who are trying to outlaw these critical abortion services.’ His state is stockpiling abortion drugs as the fate of mifepristone remains in the balance

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 FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry.’

Ever 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 to the agency’s scientific expertise. 

But the Texas ruling erodes the legitimacy of the FDA as the arbiter of good medical and scientific regulatory judgement.

Experts fear that it opens the door for more political rifts over medications that have been deemed overwhelmingly safe. 

The judge’s decision, they fear, could send a chilling effect across the field of medicine development, an already risky and expensive endeavor. 

The pharma execs added: ‘As an industry we count on the FDA’s autonomy and authority to bring new medicines 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 medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.’ 

Court challenges such as the one mounted in Texas could open the door for other parties to challenge the FDA’s approval of other new or existing drugs deemed controversial and caught in culture war crosshairs. 

In response to the Texas judge last week, President Joe Biden said: ‘If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.’

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