Mifepristone and Mexico's corn ban

We interrupt your mid-August doldrums with big news: a federal appeals court rules to restrict access to mifepristone, and USTR is expected to take action today on Mexico’s corn ban. (579 words, 2 minutes, 53 seconds)

Appeals court rules to restrict access to mifepristone

While the court ruled mifepristone should remain legal, it also ruled to limit access, reversing science-based decisions by the Food and Drug Administration (FDA).

Catch up: In April, a federal judge in Texas ordered a hold on the 20-year-old FDA approval of mifepristone. The U.S. Court of Appeals for the Fifth Circuit quickly ruled to block the hold. The Supreme Court subsequently ruled the drug would remain available during the appeals process, sending it back to the appeals court.

This week: The appeals court ruled yesterday that mifepristone should remain legal, but with restrictions. Specifically, the court ruled to reverse FDA’s 2016 changes allowing prescriptions by midwives and via telemedicine, as well as allowing the drug to be sent to patients by mail.

Why it matters: As an April amicus brief signed by BIO explains, a court questioning scientific decisions made by the FDA creates uncertainty for patients and investors, undermines appropriate use of safety data, and unnecessarily complicates the regulatory process.

The impact: All FDA decisions on mifepristone remain in place during the appeals process, under the Supreme Court ruling. However, if upheld, yesterday’s ruling “would mean that patients would have to make three visits to a doctor to get mifepristone and could not receive it in the mail,” explains The New York Times.

What’s next: The U.S. Justice Department, representing the FDA, will appeal the ruling before the Supreme Court. The Supreme Court will decide in the coming months whether to let the appeals court decision stand or rule on the case.

BIO’s view: The April 7 ruling to undo FDA decisions “has consequences that extend well beyond the single drug, and stokes regulatory uncertainty in an industry responsible for bringing life-saving and life-enhancing therapies to vulnerable patient populations,” said BIO President and CEO Rachel King.

Reports: USTR expected to escalate Mexico corn dispute today

The U.S. will announce a decision today to escalate its dispute with Mexico over a planned ban on biotech corn, Bloomberg reports—here’s what we know.

What’s happening: The U.S. Trade Representative will request the formation of a dispute resolution panel under the U.S.-Mexico-Canada Agreement (USMCA), says Bloomberg, citing “people familiar with the matter.” USTR declined official comment.

What could happen next: A panel of trade experts would decide whether Mexico’s ban on biotech corn violates the USMCA. Its findings would be binding, and a ruling favoring the U.S. could result in tariffs on Mexican goods.

How did we get here? In 2020, Mexico announced a plan to phase out imports of biotech corn. USTR took formal steps to address the ban and requested dispute settlement consultations in June. Now, 75 days after that request (yesterday), USTR can call for the panel.

Why it matters: Mexico annually imports more than 17 million tons of U.S. corn, most of which is biotech corn. The ban would significantly impact the economies of both countries and threaten Mexico’s food security, Bio.News reported.

BIO’s view: Mexico must “return to the science-based trading system and obligations to which both our countries committed” in the USMCA, Nancy Travis, BIO VP for International Affairs previously said. The ban would hurt U.S. farmers and “have a devastating impact on the agricultural innovation needed to achieve our climate goals and ensure we can meet the world’s growing demand for food.”

President Biden’s Thursday: Visiting Scranton, PA, to pay respects privately to former Pennsylvania First Lady Ellen Casey before a public viewing, per the Times Leader.

What’s Happening on Capitol Hill: The House and Senate are in recess through Labor Day.