Good Day BIO: Senate Finance to discuss USMCA today – here's what you need to know

July 27, 2021
It’s a busy day in Washington, with BIO’s Dr. Michelle McMurry-Heath testifying about Mexico’s treatment of agricultural biotech, and BIO’s Phyllis Arthur testifying about lessons learned from COVID-19. Meanwhile, we have details on the “21st Century Cures Act 2.0” and…
BIO

It’s a busy day in Washington, with BIO’s Dr. Michelle McMurry-Heath testifying about Mexico’s treatment of agricultural biotech, and BIO’s Phyllis Arthur testifying about lessons learned from COVID-19. Meanwhile, we have details on the “21st Century Cures Act 2.0” and BIO’s take on how we can best modernize it. (855 words, 4 minutes, 16 seconds)

 

USTR must take action on Mexico’s treatment of ag biotech, says BIO

 
 

The U.S.-Mexico-Canada Agreement (USMCA) was meant to be the gold-standard trade agreement for agricultural biotechnology—but Mexico’s not cooperating. Today, BIO’s Dr. Michelle McMurry-Heath will testify before the Senate Finance Committee and urge USTR to take enforcement action.

To catch you up: Mexico is not adhering to its ag biotech commitments in USMCA. 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.  

More Background: Unpacking Mexico’s economic and environmental paradox   

BIO President and CEO Dr. Michelle McMurry-Heath will testify on the situation today, during a Senate Finance full committee hearing, Implementation and Enforcement of the U.S.-Mexico-Canada Agreement: One Year After Entry into Force (9:30 AM ET). 

“If Mexico does not approve a new corn biotechnology product, U.S. corn farmers are reluctant to plant the product for fear of disrupting trade to Mexico,” Dr. Michelle plans to share in her testimony, which FarmProgress previewed ahead of the hearing

“This means, in effect, that Mexico determines which technology U.S. farmers can use,” she continues. 

BIO strongly urges USTR to begin taking enforcement action on Mexico’s treatment of agriculture biotechnology,” continues the testimony. 

What does BIO recommend? “An enforcement case would at a minimum provide a framework and timeline to resolve the COFEPRIS-related delays in biotechnology approvals and the December 31, 2020, decree. Without a process, BIO and its members fear the Government of Mexico will continue the status quo, and possibly broaden the scope of the decree to additional agricultural products, which would compound the impact on U.S. trade and future innovation.” 

Read BIO’s full testimony.

Read more about what to expect from the hearing in FarmProgress.

 

More Agriculture and Environment News:

The New York Times: Why was Pacific Northwest heat off the charts? Recent research offers clues.
“The study also suggests that the world can expect more off-the-charts heat waves in the future, unless drastic action is taken to curb climate change.” 

 
 
 
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Towards Cures 2.0

 
 

Bipartisan Members of Congress are working to modernize the 21st Century Cures Act. Here’s what’s in the “Cures 2.0” discussion draft, and what BIO says about it.

Passed and signed into law in 2016, the 21st Century Cures Act is “designed to accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently,” as the FDA explains

Now, it’s time to modernize it. On June 22, Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) released a Cures 2.0 discussion draft, which aims to update the legislation with a focus on six key categories: public health and pandemic preparedness, caregiver integration, patient engagement, clinical trial diversity, and modernizing FDA and the Centers for Medicare and Medicaid Services (CMS). 

BIO submitted comprehensive comments—read them here.

Provisions in the draft include:

  • Developing a national testing and vaccine distribution strategy for future pandemics. BIO supports this funding and provides detailed feedback on strengthening immunization information systems and vaccine coverage.
  • Increasing diversity in clinical trials—though BIO recommends a “more rigorous and proactive approach.”
  • Requiring FDA to expand collection and use of Real-World Evidence, or RWE. (BIO has a lot to say about that, too.)
  • Creating an Advanced Research Projects Agency for Health (ARPA-H), to achieve President Biden’s goal of curing cancer. (BIO needs more details.)

The legislation also includes The PASTEUR Act, which would encourage companies to invest in new antibiotics to combat antimicrobial resistance.

 

More Health Care News:

Biopharma Dive: BioNTech, WHO hatch plan to bring mRNA vaccines to Africa
“BioNTech plans to start human testing of its first malaria vaccine candidate by the end of 2022.”

 
 
 
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BIO Start-Up Stadium
 
 

BIO is pleased to announce that Kayothera Inc. is the winner of Start-up Stadium, which took place during BIO Digital in June. The competition brings awareness of innovative biotech start-ups to hundreds of potential investors and partners. 

Kayothera Inc. is developing novel small molecule immunotherapy for incurable cancers. They will receive a one-year membership to BIO and a “fast-track” accelerator application and nomination for the chance to win a $10,000 sequencing grant. 

Congratulation to Kayothera—and all 16 finalists, who are doing innovative work to cure patients, protect our climate, and nourish humanity.

Did you miss BIO Digital? Access select sessions here.

 
 
 
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BIO Beltway Report
BIO Beltway Report
 
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President Biden’s Tuesday: President Biden will visit the Office of the Director of National Intelligence to address the intelligence community’s leadership and workforce. 

What’s Happening on Capitol Hill: At 9:30 AM ET, Senate Finance will hold a hearing on the U.S.-Mexico-Canada Agreement (USMCA), with BIO President and CEO Dr. Michelle McMurry-Heath testifying (see our story above). Then, at 10 AM ET, Phyllis Arthur, BIO’s VP for Infectious Diseases and Emerging Science, will appear before the Senate HELP Committee on lessons learned from COVID-19; we’ll have a recap tomorrow. Meanwhile, the House will begin consideration of a seven-bill FY22 spending package that includes HHS, Agriculture, FDA, and other key agencies, per Roll Call. Noteworthy House hearings include a Small Business Subcommittee hearing on the importance of the clean energy economy and a Science, Space, and Technology Committee markup of multiple bills.

 
 
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