Good Day BIO: Yes, we're still talking about Mexico

It’s a new year…and yes, we’re still talking about Mexico’s treatment of biotech. Senate Finance Committee leadership sent a letter to USTR to urge them to take action. Meanwhile, we keep hearing some misconceptions about the role of NIH grants in developing new drugs, so we fact-check it. (593 words, 2 minutes, 57 seconds)

It’s a new year—and we still need to address Mexico’s treatment of biotech

That’s what the Senate Finance Committee leadership said in a letter to U.S. Trade Rep. Ambassador Katherine Tai yesterday.

The background: In defiance of the U.S.-Mexico-Canada Agreement (USMCA), Mexico has failed to maintain a science-based regulatory system for agricultural biotechnology and, as a result, has not approved a new biotech product in three years. Moreover, the government continues to make troubling statements regarding imports of corn produced with biotechnology—“explicitly stating that imports will be prohibited by 2024 and future approvals will be denied and existing approvals will be revoked,” BIO explained in testimony last year. 

USMCA has “potential to deliver tangible benefits to America’s workers, farmers, and businesses,”said Senate Finance Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID)—but not without “full implementation and enforcement of the Agreement as written.” 

USTR has addressed some labor violations but needs to do more—especially on biotech: “Mexico has failed to properly consider or approve applications for innovative U.S. biotech products. The Mexican government’s only decision, in fact, was to issue a rejection that lacked the appropriate science-based justification.”

The ask: USTR must “continue to diligently monitor Canada and Mexico's compliance with the Agreement and ensure that every chapter of the Agreement is fully enforced,” they conclude. 

BIO has led the charge on this issue, calling for USTR "to begin taking enforcement action on Mexico's treatment of agriculture biotechnology," this summer when BIO's Dr. Michelle McMurry-Heath testified before the Senate Finance Committee.

So, what now? Deputy U.S. Trade Rep. Jayme White met virtually yesterday with Mexico’s Under Secretary for International Trade Luz María de la Mora, where Ambassador White “highlighted science- and risk-based regulatory approaches in agriculture, and the approval of agricultural biotechnology products that can help farmers meet sustainable production goals,” per a USTR readout.

Ambassador White's statement echoes BIO's guidance to USTR that in order "to position agriculture as a solution to domestic and global climate and sustainability challenges, the United States must continue to address acute and systematic trade barriers to innovative biotechnology tools in export markets." We’ll be keeping an eye on this. 

Read: Unpacking Mexico’s economic and environmental paradox

Fact Check: NIH vs. private sector investment in biomedical innovation

A recent study by Vital Transformation tracked more than 20,000 patents linked to an NIH grant over 20 years, identifying those associated with clinical trials and approved medicines, and quantifying the public and private investments made for those investigational and approved medicines. 

The key finding: 23,230 NIH grants in the year 2000 were linked by NIH supported patents to 41 investigational drugs, only 18 of which gained FDA approval by 2020. 

None of these medicines reached approval without significant private investment. Total private investment for those 18 approved medicines exceeded NIH funding by orders of magnitude: $44.2 billion in private investment (98.5%) compared to $670 million in NIH (1.5%). As industry’s share of total investment increased, so did the likelihood of approval.

This is not meant to be critical of NIH—which is a valued partner in basic research.

But: It’s clear that the biopharmaceutical industry has a critically important role to undertake the clinical research required to advance that basic science research into safe and effective treatments available to patients. 

So, the next time you hear someone argue that new drugs were “funded by taxpayers,” you know the truth about who really took them over the finish line to get them to patients. 

Read and share the infographic.

President Biden’s Thursday: At 10:30 AM ET, he will speak about the government’s COVID-19 response, joined by the Secretary of Defense and the FEMA Administrator. This afternoon, he’ll meet with Senate Democrats to discuss voting-rights legislation. 

What’s Happening on Capitol Hill: After a few delays, the Senate HELP Committee will vote on the nomination of Dr. Robert Califf for FDA Commissioner.