Mifepristone ruling is an 'assault on science'

Friday’s mifepristone ruling in Texas is an assault on the FDA’s approval process, says BIO—here’s what happened. Plus, Mexico is seemingly doubling down on the biotech corn ban as the possibility of a formal dispute looms. (497 words, 2 minutes, 29 seconds)

Texas mifepristone ruling is ‘an assault on science’

On Friday, a judge in Texas ordered a hold on federal approval of mifepristone, which was approved by the U.S. Food and Drug Administration (FDA) in 2000—here’s what BIO says about it.

Why it matters: “The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines,” says BIO’s interim CEO, Rachel King. “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.”

The big picture: The persistent undermining of the FDA—whether targeting the Accelerated Approval process, the Centers for Medicare and Medicaid Services’ coverage decision regarding a groundbreaking Alzheimer’s treatment, or this ruling in Texas—puts patients at risk, is a blatant negation of good science, and threatens the innovative American system that has paved the way in medical innovation, explains Bio.News.

What’s next: BIO hopes the Texas ruling is overturned, says King, “so that patients and drug developers can rely on the rigorous FDA approval process as the scientific and trusted standard for drug approvals.”

Read more at Bio.News. 

Watch BIO’s John Murphy explain what happened and BIO’s take:

Mexico doubles down on anti-science corn ban

After the U.S. Trade Representative formally requested technical consultations on Mexico’s biotech corn ban under the U.S.-Mexico-Canada Agreement (USMCA), Mexico has seemingly doubled down on its anti-science stance.

The latest news: Mexico’s Commission for Biosafety of Genetically Modified Organisms held a two-hour webinar doubling down on the decision, reports Agri-Pulse.

What they said (or didn’t say): While the speakers “went into great depth about desires to protect the biodiversity of Mexico’s plants and animals and the proliferation of genetically modified DNA in seeds being used by Mexican farmers, they did little to make the case that there is a health risk to Mexican consumers,” explains Agri-Pulse.

But we need to take a science-based approach, as BIO, the Biden administration, and many Members of Congress have said in recent months.

The next steps: The U.S. requested technical consultations but has not formally entered into a dispute with Mexico; Friday was the first day the U.S. could do so.

BIO’s take: “BIO remains hopeful for a successful, science-based outcome to the technical consultations. Otherwise, the U.S. should begin the formal dispute resolution process without delay,” said BIO’s VP of International Affairs, Nancy Travis.

President Biden’s Monday: Hosting the White House Easter Egg Roll.

What’s Happening on Capitol Hill: Recess continues.