Good Day BIO: Senate talks ag biotech and pandemic preparedness

Senators on both sides of the aisle agreed yesterday that agricultural biotech has huge potential to help us solve the climate crisis—but we need to get to the bottom of why Mexico is blocking approval of this technology.

ICYMI: BIO President and CEO Dr. Michelle McMurry-Heath testified before the Senate Finance Committee yesterday about the U.S.-Mexico-Canada Agreement (USMCA) and Mexico’s treatment of ag biotech—read our preview. 

To catch you up: Mexico’s food and drug regulator has not approved a new biotech trait since May 2018, and in December, Mexico's president issued a decree stating the intention to phase out biotech corn for human consumption by 2024 and refrain from future biotech approvals.   

“This means, in effect, that Mexico determines which technology U.S. farmers can use,” said Dr. Michelle in her testimony.

Is there scientific reasoning for the delay? asked Ranking Member Mike Crapo (R-ID). “As a former regulator, I can assure you there is not,” said Dr. Michelle. Mexico’s behavior is “very unusual…incredibly disturbing.” 

“Because Mexico is such an important trade partner for us in our agricultural products, it hampers our innovators from developing new technology not just for use in Mexico, but for use at home and use around the world,” she continued. It’s also affecting other industries: Mexico has not approved a new biopharmaceutical product since 2019, either.

What steps should USTR take? Sen. Chuck Grassley (R-IA) asked. Dr. Michelle said the administration must open an enforcement case, which would give us “at minimum a framework and timeline” to resolve the delays and decree. 

On another note: Sen. Robert Menendez (D-NY) asked about BIO’s interactions with the administration on the proposed TRIPS waiver. While the proposal is “well-intentioned,” she said, it won’t get more vaccines to people who need them—but BIO’s SHARE program might. 

Although we’re still battling COVID-19, we must start thinking about preparing for the next pandemic—and the biotech sector has an important role to play, bipartisan Senators agreed yesterday.

ICYMI: Phyllis Arthur, BIO’s VP of Infectious Diseases and Emerging Science, testified yesterday before the Senate Health, Education, Labor, and Pensions (HELP) Committee during a hearing on lessons learned from the COVID-19 pandemic.

We must strengthen our national preparedness through coordinated leadership, expanded partnership with industry, and better public health infrastructure,Phyllis said in her testimony. 

“The U.S. Government, through the Biomedical Advanced Research and Development Authority (BARDA), the Project BioShield Special Reserve Fund (SRF), and the Strategic National Stockpile (SNS), must invest in and procure the necessary medical countermeasures to be ready for the next pandemic and other biological threats,” she said. 

Public-private partnership programs have been key to developing COVID vaccines, therapeutics, and diagnostics—but funding has “remained largely stagnant over the past decade,” she continued. BIO calls for budget increases for BARDA, SNS, and other pandemic projects. 

“I believe that had it not been for our ability to partner with the private sector, we might not be sitting here today” having a conversation in person, said Sen. Tim Scott (R-SC) around 1:40:00. “The greatest economic engine—the greatest engine of innovation our nation has seen in health care—doesn’t come from the government. It comes from the private sector.”  

“What was really strong about Operation Warp Speed was the collaboration and the skills that were deployed by industry—with the help and advice of government, but really, the U.S. Government relied on” decades of industry experience, Phyllis responded.

“I’ve been in the vaccine business 25 years," she continued. "I’m still marveling that we made these extremely important, efficacious, and safe vaccines in a year, and deployed them in six months.”

More Health Care News:

The New York Times: Scientists finish the human genome at last
“The complete genome uncovered more than 100 new genes that are probably functional, and many new variants that may be linked to diseases.”

President Biden’s Wednesday: Biden is expected to announce a vaccination (or regular testing) mandate for all federal workers, CNN reported. Meanwhile, he’s traveling to Allentown, PA, to visit the Mack Lehigh Valley Operations Manufacturing Facility, where he will speak at 2:00 PM ET about American manufacturing.

What’s Happening on Capitol Hill: We’re watching a couple hearings today, including a House Energy & Commerce Committee hearing on several bills to modernize the Federal Trade Commission (FTC) and consumer protection (10:30 AM ET), and a Senate Judiciary Committee hearing on America’s food supply chain (2:30 PM ET).