USTR takes action on Mexico's biotech corn ban

USTR takes action on Mexico’s planned ban on biotech corn, and the FDA grants Priority Review to a breakthrough Alzheimer’s drug. (657 words, 3 minutes, 17 seconds)

U.S. takes step toward legal resolution of Mexico’s biotech corn ban

The U.S. Trade Representative (USTR) yesterday requested technical consultations on Mexico’s biotech corn ban under the U.S.-Mexico-Canada-Agreement (USMCA)—something that BIO has been urging for months to avert a food security crisis in Mexico and a big hit to the U.S.' No. 1 export market for corn.

What just happened? In a letter to Mexico’s Economy Secretary Raquel Buenrostro, USTR said it is exercising its rights under UMSCA’s Article 9.19 to initiate technical consultations with a partner country regarding a matter “that may adversely affect its trade.”

How did we get here? Mexico has planned to phase out imports of biotech corn by next year. Demanding a “science-based approach,” USTR sent a formal request for an explanation on Jan. 30. Mexico sent a Feb. 14 reply, “which will help inform technical consultations,” USTR said. Mexico's reply and a revised decree created "more questions than answers," said BIO, which called for technical consultations to begin "to provide a framework and timeline to resolve this issue"

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 welcomed USTR’s action: “It’s time to send a strong message to the government of Mexico and return to the science-based trading system and obligations to which both our countries committed,” said Nancy Travis, BIO’s VP for International Affairs. 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.”

What’s next: Article 9.19.3 of the USMCA says there should be a meeting within 30 days of the formal request with the aim of resolving the dispute within 180 days. USTR is awaiting a response from Mexico’s officials.

More Agriculture and Environment News:

BIO: Statement on USDA Report on Competition & Innovation in Seeds & Other Ag Inputs
“The Biotechnology Innovation Organization appreciates that USDA and the Biden Administration are aiming to increase access to modern, innovative seeds. We are reviewing USDA’s report, ‘More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs,’ to identify potential concerns about weakening intellectual property protections for biotech companies.”

The Hill: White House weighs mass poultry vaccination amid bird flu outbreak
“The Biden administration is considering the use of vaccines in poultry as one option to address a bird flu epidemic that has killed millions of chickens and contributed to high egg prices.”

Alzheimer’s drug granted Priority Review for traditional approval

After receiving Accelerated Approval in January, the breakthrough drug LEQEMBI could receive traditional Food and Drug Administration (FDA) approval later this year.

ICYMI: LEQEMBI (lecanemab-irmb) received FDA Accelerated Approval on Jan. 6 based on the secondary endpoint of reducing brain plaque. It’s one of two new Alzheimer’s drugs in 20 years.

The latest news: FDA granted LEQEMBI a Priority Review for traditional approval because it achieved the primary endpoint of reducing memory decline in a clinical trial, with an action date of July 6, according to manufacturers (and BIO members) Eisai and Biogen. The FDA plans to hold an Advisory Committee to discuss the application on a date TBA.

Why it matters: This could be the first new Alzheimer’s treatment covered by insurance. The Centers for Medicare and Medicaid Services (CMS) confirmed they would continue to severely limit coverage for monoclonal antibodies targeting Alzheimer’s, like LEQEMBI, without traditional FDA approval.

Only FDA approves drugs—and FDA Accelerated Approval speeds patient access to needed breakthroughs. But by limiting coverage of drugs if they only have Accelerated Approval, CMS restricts patient access, in what The Wall Street Journal calls “Medicare rationing.”

What’s next: With traditional approval, more patients can access LEQEMBI—but “the rest of the market is left without any guidance from CMS as to when it will usurp the FDA’s scientific determinations,” causing “a demonstrably chilling impact on future innovations,” according to BIO’s Chief Policy Officer John Murphy.

President Biden’s Tuesday: No official events scheduled.

What’s Happening on Capitol Hill: Tomorrow will be the first part of a House Judiciary subcommittee hearing on IP and strategic competition with China. House Ways and Means Committee members yesterday praised the decision by USTR to take action against Mexico’s proposed biotech corn ban (see story above).