Key takeaways from the Ag & Environment Summit

A busy week comes to an end with a recap of what policymakers and regulators said at yesterday’s  Agriculture & Environment Summit, plus more news you might have missed. (795 words, 3 minutes, 58 seconds)

What happened at the BIO Agriculture & Environment Summit

BIO’s inaugural Agriculture & Environment Summit brought together regulators and bipartisan policymakers who emphasized the promise of innovation to address key challenges such as climate change. Several speakers underscored the necessity of rules-based trade to foster American biotech innovation and leadership, stressing the importance of intellectual property protection and science-based trade policies and agreements.

Rep. Deborah Ross (D-NC), whose district includes NC State University and much of Research Triangle Park, highlighted the need to invest in biotech, particularly climate-smart technology.

The key takeaway: “In North Carolina, our communities and farmers are too familiar with the devastating impacts of climate change,” she said. “Agriculture and environmental biotechnology can help us produce climate-resistant crops that are better able to survive extreme weather and help our food security. Investment and innovation in these technologies is essential.”

The regulators: Madison Le, Director of the Biopesticides & Pollution Prevention Division at the Environmental Protection Agency, Bernadette Juarez, Deputy Administrator for Biotechnology at USDA, and Dr. Kristi Muldoon Jacobs, Acting Director of the Office of Food Additive Safety at the FDA, focused on their coordinated efforts and regulatory priorities to address climate challenges and the need to feed a growing population.

The key takeaway: Biotechnology regulators are working together to keep pace with scientific innovations in agricultural and environmental biotechnology and emphasize the importance of stakeholders engaging with regulatory agencies early and often.

Ambassador Doug McKalip, Chief Agricultural Negotiator at the Office of the U.S. Trade Representative, emphasized the pivotal role of American agriculture in global innovation and the necessity of trade policies that support market access and sustainability.

The key takeaway: Innovations from BIO members will “drive solutions going forward,” he said. “Our products will outcompete anybody on consistency and quality”—IF trade policy advances fair market access and innovation.

Rep. Adrian Smith (R-NE) said America leads the world in biotech innovation—and we need rules-based trade and IP protections to ensure we don’t “cede that spot.”

The key takeaway: “Rules-based trade is the best way to level the playing field,” he said, referencing the biotech corn dispute resolution underway with Mexico under the U.S.-Mexico-Canada Agreement (USMCA). We can’t give Mexico a ‘pass,’ because that will be ‘problematic to all rules-based trade.’ (FWIW, McKalip was optimistic about the Mexico outcome.)

Alexis Taylor, Under Secretary for Trade and Agricultural Affairs at USDA, highlighted the “great story to tell” about American agricultural innovation, and four key priorities of the administration for its global engagement: enforcing trade agreements, eliminating technical barriers to trade, ensuring international policies are science-based and transparent, and diversifying markets."

The key takeaway: “The U.S. has an opportunity to drive what that means and create new market opportunities, and hopefully, new revenue streams for our agricultural community as a leader in this space.”

Read the full recap in Bio.News.

A few health headlines...

While we were focused on the BIO fly-in and Agriculture and Environment Summit, here are a few things you may have missed from the health side.

Proposed EU pharma legislation would reduce investment and patient access, finds a new study from Vital Transformation. Reduced exclusivity for new drugs in the European Union would decrease biotech EU biotech investment and harm patient access. Clawbacks play a key role—and the rate of clawbacks in Europe is growing, creating unpredictable costs for drug makers and uncertainty for investors.

BIO’s take: “This report shows that the proposed revisions to the General Pharmaceutical Legislation will not only negatively impact patient access in the short term, but will potentially harm the biotech pipeline affecting long-term access to these life-saving medicines,” says Nancy Travis, BIO’s VP of International Affairs.

“Drive-by analysis of accelerated approval is intellectual malpractice,”writes BioCentury’s Steve Usdin. “Academic opponents of accelerated approval have cranked out another misleading paper, this time creating the false impression that about half of the cancer drugs granted accelerated approval turn out to be useless,” he writes. “You wouldn’t know it from reading the JAMA paper or the stories that were written about it, but there is a world of difference between the finding that an overall survival benefit wasn’t demonstrated in confirmatory trials and concluding that a drug doesn’t confer clinical benefit.”

“Patient advocates shred Becerra’s copay accumulator comments during House hearing,” reports Fierce Healthcare. “[A]n exchange with Rep. Buddy Carter, R-Ga., over copay accumulators more than 90 minutes into Becerra’s third day of testimony drew some of the toughest criticism yet from patient advocacy groups, leaving some to question where his loyalties lie and others wondering if he’s simply uninformed on the issue.”

Congratulations, Michele Oshman! On April 18, the National Psoriasis Foundation (NPF) recognized Michele Oshman, BIO’s VP for External Affairs, as one of three outstanding leaders at the 2024 D.C. Soirée & Play. The awardees “have each touched countless lives,” said NPF President and CEO Leah M. Howard.

President Biden’s Friday: Addressing the International Brotherhood of Electrical Workers Construction and Maintenance Conference. 

What’s Happening on Capitol Hill: No hearings today.