Good Day BIO: How to "remodel" the regulatory framework for GE animals

Gene editing of agricultural animals could help us solve climate change, hunger, and disease pandemics. (No big deal, right?) But to get there, we need “a remodeling of the federal regulatory landscape,” says a new report by the American Association of Veterinary Medical Colleges (AAVMC) and the Association of Public and Land-grant Universities (APLU).

Animals modified or developed through genetic engineering are regulated as “new animal drugs,” overseen by the U.S. Food and Drug Administration (FDA). 

This framework “is based on processes established for transgenic technologies which do not align well with the state-of-the-art gene editing technologies,” says the AAVMC/APLU Gene Editing in Agriculture Task Force Report. “In addition, the processes are viewed by many developers of genetic engineering applications in livestock as ambiguous, glacial in pace, and cost-prohibitive.” 

BIO has long expressed concern over this approach, which deters R&D and stigmatizes these animals and their progeny, reducing the likelihood such animals will be grown by producers or accepted by consumers, as we explained in recent comments to USDA.

“Thus, a remodeling of the federal regulatory landscape is needed for the U.S. to sustain its place as a global leader and innovator in the animal agriculture sector and keep pace with the exponentially expanding global human population,” the AAVMC/APLU report continues. “A coordinated assessment and approval process between the USDA and FDA is essential to establish a framework that is streamlined, cost-effective, and ensures safe food, with the decision-making process anchored on logic and fact.”

The report suggests four things that need to occur:

1. “Update the existing FDA regulatory framework…and develop a coordinated, streamlined, fact-based, and cost-effective assessment and approval process between the USDA and FDA to ensure safe food.”
2. “Develop an evidence and logic-based decision-making protocol for gene editing applications,” regulated separately from GMOs.
3. “Develop streamlined assessment and approval processes” to categorize GE applications by type of change, method, impact on the animal, and potential for negative impact on the environment.
4. “Develop a regulatory channel for approval of gene-edited agricultural animals with genomic structures that could have arisen in nature as safe for human consumption.” 

What’s next? As we reported, the Trump administration proposed transferring parts of FDA’s oversight to USDA. The Biden administration reopened the comment period, and BIO submitted comments in February. 

The AAVMC/APLU Gene Editing in Agriculture Task Force Report was based on 18 months of research by experts including Dr. Clint Nesbitt, BIO’s Senior Director of Science and Regulatory Affairs for Food & Agriculture.

While progress has been made on integrating diversity, equity, and inclusion in biotech companies, significant work remains, found BIO’s recent survey on the topic. What exactly can companies do—right now—to have an impact? We compiled three practical and concrete ideas.

1. Create pipelines of talent from underserved communities.

Biogen set metrics including increasing the number of managers from minority populations by 30%, Biogen CEO Michel Vounatsos explained during BIO Digital 2021. 

But while it helps to “put the bar somewhere,” we need to address the root cause, specifically the talent pipeline, he noted.

“We need to work proactively...with community colleges and more diverse universities" and consciously work on the pipeline "in a sustainable manner.”

2. Reach down, reach up.

 “You have two hands in a corporate ladder—one to pull up and one to pull somebody else up behind you,” said Todd Sears, Founder of Out Leadership, during a BIO Digital 2021 session on growing LGBTQ leadership in biotech. (BIO is the first advocacy association member of Out Leadership.) 

Ideas: Establish and champion Employee Resource Groups (ERGs), and implement sponsorship programs with an emphasis on empowering underrepresented employees.

3. Collect data and learn from it.

Experts agree on the need to collect data on employees and track improvements and work to be done. 

“Data matters,” said Juliet Choi, President and CEO of the Asian & Pacific Islander American Health Forum. Data can not only demonstrate representation, but also ensure the visibility of these communities.

From 2019 to 2020, 1 in 5 companies decreased representation of employees of color at the executive level by at least 5%, according to BIO’s new report. In addition, just 13% increased executives of color by at least 5%. This shows why collecting and analyzing data can help your company understand progress made and work to be done.

Why it matters: “You will have a better, stronger company which makes better decisions if you have diversity,” said Dr. Ted Love, President and CEO of Global Blood Therapeutics (GBT). 

More reading: BIO’s second-annual report on DEI in biotech, Measuring Diversity in the Biotech Industry: Advancing Equity and Inclusion, was published in June 2021 in partnership with Coqual. Read the full report here.

President Biden’s Tuesday: Heading to Philadelphia, where he’ll give remarks on voting rights at 2:50 PM ET.

What’s Happening on Capitol Hill: We’re keeping an eye on a Senate Judiciary Committee hearing, A Prescription for Change: Cracking Down on Anticompetitive Conduct in Prescription Drug Markets (2:30 PM ET).