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# What of FDA’s Gold Standard After Kacsmaryk?
- URL: https://www.fdaweb.com/what-of-fdas-gold-standard-after-kacsmaryk/
- Published: 2023-04-10T12:00:00.000Z
- Updated: 2026-09-14T18:24:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154169

Texas federal judge **Matthew J. Kacsmaryk**’s unprecedented late-Friday decision against the 23-year-old approval of mifepristone (Mifeprex) ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5154168&cate=&stid=%241%24cw0.%2FF5.%248GmDaaWekzUsTXVdxrV4R.&ref=fdaweb.com)) has provoked many reactions from across the spectrum that worry about FDA’s globally respected approval gold standard and the court’s ideological stance that is trumping science. Once the Texas ruling was handed down, FDA through the Justice Department immediately appealed the decision. “FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective for its indicated use – medical termination of early pregnancy,” the agency said. “The approval was based on the best available science and done in accordance with the laws that govern our work.”

The White House also wasted no time in reacting, releasing a Biden Administration [statement](https://www.whitehouse.gov/briefing-room/statements-releases/2023/04/07/statement-from-president-joe-biden-on-decision-in-alliance-for-hippocratic-medicine-v-fda/?ref=fdaweb.com) saying the “court in this case has substituted its judgment for FDA, the expert agency that approves drugs. 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… But let’s be clear – the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring *Roe versus Wade*.”

Echoing similar frustration with the decision, HHS secretary **Xavier Becerra** told CNN on Sunday that he was worried about the precedent this could set in challenging other FDA approvals, and how it could hurt drug industry research and development when the FDA approval process is “turned upside down… I mean, come on, if a judge decides to substitute his preference, his personal opinion, for that of scientists and medical professionals, what drug isn’t subject to some kind of legal challenge?

Mifeprex maker Danco Laboratories said it strongly disagrees with Kacsmaryk’s preliminary injunction. The company’s lead counsel in the case, Hogan Lovells’ **Jessica Ellsworth**, had this to say: “The court's ruling rewrites the facts and the law to tell its preferred narrative — which is a storyline that conflicts with established legal principles and with Mifeprex's well-established safety profile. Danco is appealing this ruling and feels strongly that the rule of law should prevail in this case, which would result in a reversal of this ruling. Danco will continue to take all steps available in this litigation to protect the availability and accessibility of Mifeprex.”

Biotechnology Innovation Organization said the decision was an “assault on science… For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations. This decision has ramifications that extend well beyond this case, setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies.”

Meanwhile, Pharmaceutical Research and Manufacturers of America (PhRMA) continued as an outside observer and worried about FDA’s standing as offering the gold standard for drug approvals. “While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines,” the group said.

Dozens of drug company CEOs have also signed an [open letter](https://urlisolation.com/browser?clickId=46778ED5-610B-4FF3-A088-D7647BE64E53&traceToken=1681159254%3Bpfizer%5Fhosted%3Bhttps%3A%2Fdocsend.com%2Fview%2F2ahvmwy8&url=https%3A%2F%2Fdocsend.com%2Fview%2F2ahvmwy8djzxax3g&ref=fdaweb.com) supporting FDA and calling judge Kacsmaryk’s order an act of “judicial interference.” They said that as an industry, “we count on the FDA’s autonomy and authority to bring new medicines to patient under a reliable regulatory process for drug evaluation and approval… While the drug development, approval, and monitoring process is not perfect, the agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.”

On Capitol Hill, Representative **Anna G. Eshoo** (D-CA) said the ruling was another assault on women’s reproductive freedoms. “Following FDA approval in 2000, mifepristone has proven to be safe and effective and is used in 53% of abortions nationwide,” she noted. “Science should not be overruled by politics, and an extremist judge with a history of anti-abortion views should not be undermining evidence-based regulatory processes.

Energy and Commerce Committee ranking member **Frank Pallone**, Jr. (D-NJ) said the decision is not “grounded in science or the law. It is intended to further Republicans’ extreme political agenda to eliminate access to abortion nationwide. A single right-wing judge should not be able to abolish decades of peer-reviewed scientific evidence on the safety of a medication. This decision creates a dangerous precedent that attempts to undermine FDA’s drug approval process and furthers Republican efforts to dictate their ideological views to our nation’s public health agencies.”

And while many Republicans remained silent, Representative **Nancy Mace** (R-SC) offered this reflection: “This is an issue that Republicans have been largely on the wrong side of. We have over the last nine months not shown compassion towards women. And this is one of those issues that I’ve tried to lead on as someone who’s pro-life and just have some common sense. In the state of South Carolina just a few weeks ago, we had some folks in the state legislature that essentially wanted to execute women who had abortions. So we’ve got some extreme views on this issue, but 90% of America is somewhere in the middle and I think that 90% would be okay with listening to the FDA rather than a judge who used an old law that was determined unconstitutional by the Supreme Court.”

While appeals are underway, the Texas decision is also conflicted by aWashingtonfederal judge’s [order](https://int.nyt.com/data/documenttools/court-decision-keeping-mifepristone-available/1d2b761e9ab275f7/full.pdf?ref=fdaweb.com) one hour later to prevent the agency from scaling back access to the drug in 17 Democrat-leaning states that brought the lawsuit. Because this order conflicts with the Texas ruling, it almost assures an expedited Supreme Court review.