A step towards modernized animal biotech regulation

December 22, 2020
So much for a slow news week. Yesterday, USDA proposed a rulemaking regarding transferring authority over agricultural animal biotech from FDA to USDA—a welcome step towards a modernized animal biotech regulatory system (and a policy priority for BIO). We also catch…
BIO

So much for a slow news week. Yesterday, USDA proposed a rulemaking regarding transferring authority over agricultural animal biotech from FDA to USDA—a welcome step towards a modernized animal biotech regulatory system (and a policy priority for BIO). We also catch you up on the COVID-19 vaccine news. (737 words, 3 minutes, 41 seconds)

 

A step towards modernized animal biotech regulation

 
 

Yesterday, the U.S. Department of Agriculture (USDA) proposed a rulemaking process on the regulation of agricultural animal biotechnology—a welcome step towards a modernized animal biotech regulatory system and a win for American agriculture.

Currently, the U.S. Food and Drug Administration (FDA) regulates animal biotechnology as “new animal drugs”—but a new regulatory paradigm "for animal biotechnology is required if we expect to fulfill this important mission and fully realize the substantial value that animal biotechnology will bring to society,” BIO’s Dana O’Brien wrote in February.

After all, just two biotech animals for food have been approved in the United States—AquaBounty’s sustainable Atlantic salmon, and recently, genetically engineered pigs that could reduce the potential of meat allergies

Under the new proposal, portions of FDA’s regulatory oversight could transfer to USDA. “USDA will consult with FDA to ensure our reviews benefit from FDA’s expertise, while providing developers with a one-stop-shop for their products at USDA,” explains USDA’s press release.

This would “establish a flexible, forward-looking, risk-proportionate, and science-based regulatory framework that provides a predictable pathway to commercialization and keeps pace with advances in science and technology for certain farm animals (cattle, sheep, goats, swine, horses, mules, or other equines, catfish, and poultry) developed using genetic engineering intended for agricultural purposes,” says USDA

“Whether the plan becomes a reality depends on the priorities of the incoming Biden administration, however,”explains Agri-Pulse. “Any regulatory changes not finalized by the outgoing Trump administration, including this one, can easily be shelved.” (BIO looks forward to continuing work on this issue in the new year.)

Dana’s dialogue: A modern U.S. regulatory system will pave the way for breakthroughs that can help prevent and respond to zoonotic diseases such as COVID-19, improve animal well-being, make our farming and food systems more sustainable, protect our environment, and bolster our resilience to climate change. ­­Dana O’Brien, EVP of BIO’s Food and Agriculture Section

Read our past coverage of the issue:

 
 
 
Twitter
 
LinkedIn
 
Facebook
 
 

Where things stand in the vaccine race

 
 

COVID-19 vaccines are on the way to health care workers and vulnerable patients across the United States—the best holiday gift ever, thanks to biotechnology. Here’s an update on where things stand.

Over the weekend, the FDA authorized Moderna’s COVID-19 vaccine for emergency use—the second to get the authorization following Pfizer-BioNTech the previous week.

Today, Dr. Anthony Fauci and other public health officials will get the Moderna vaccine at NIH, reports POLITICO.

Meanwhile, the European Union, Switzerland, and UK authorized the Pfizer-BioNTech vaccine, too.

Both vaccines are 95% effective—but Moderna offers “particular hope for rural hospitals, which often do not have the ultracold equipment or staffing numbers to handle the Pfizer-BioNTech shipments,” explains The New York Times.

Following health care workers and residents of long-term care facilities, the next group to receive the vaccine (phase 1b) in the United States is expected to be adults 75+ and frontline essential workers, including first responders, teachers, day care workers, postal workers, and people who work in food and grocery stores, agriculture, public transit, manufacturing, and correctional facilities. 

What they’re saying: “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA,” said FDA Commissioner Dr. Stephen M. Hahn.

 

More Health Care News:

Georgia Public Broadcasting: If COVID-19 vaccines bring an end to the pandemic, America has immigrants to thank
“‘We are an intellectual magnet for the best of the best from around the world,’ said Dr. Jeremy Levin, CEO of Ovid Therapeutics and chairman of the Biotechnology Innovation Organization.”

 
 
 
Twitter
 
LinkedIn
 
Facebook
 
 
BIO Beltway Report
BIO Beltway Report
 
Paragraph (sm) - Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus vel facilisis sample link.
 

President Trump’s Tuesday: No public events scheduled. 

President-elect Biden’s Tuesday: ICYMI, Biden got the Pfizer-BioNTech vaccine yesterday. Sen. Majority Leader Mitch McConnell discussed his relationship with Joe Biden and what it means for the president-elect’s nominees

What’s Happening on Capitol Hill: Congress approved the $1.4 trillion spending package and $900 billion coronavirus stimulus last night, narrowly avoiding a pre-Christmas shutdown. POLITICO has details.

 
 
Paragraph (normal) - Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus sample link.
 
Twitter
 
LinkedIn
 
Facebook