Hey, FDA? Are you listening? Let’s talk.

February 13, 2020
If you missed the BIO CEO & Investor Conference this week, you can find recaps on our blog. But now, we’re back in Washington, with some insight into what’s going on with animal biotech regulation at FDA as well as some breaking news on the coronavirus, in about 960…

If you missed the BIO CEO & Investor Conference this week, you can find recaps on our blog. But now, we’re back in Washington, with some insight into what’s going on with animal biotech regulation at FDA as well as some breaking news on the coronavirus, in about 960 words, just under 5 minutes.

Hey, FDA? Are you listening? Let's talk.

ICYMI, last week, the Food & Drug Administration (FDA) published commentary in Nature as well as a press release to stand firm in their view that they should continue to have responsibility for assessing and approving animal biotech using a “risk-based approach.” And yesterday in Agri-Pulse we responded to them that while we disagree, it's time to find a workable solution. 

Let’s make one thing clear: We agree with the FDA that pre-market review of animal biotechnology makes sense! We support risk-based pre-market reviews of animals and animal products derived from biotechnology to ensure their safety and to reassure investors, developers, and consumers. 

But we don’t support the status quo. Obviously, the system needs a fix because only one animal biotech food product (AquaBounty salmon) has been approved in 20+ years, while other innovations are mired in an overall regulatory system that remains opaque and cumbersome, needlessly bureaucratic, and vastly disproportionate to actual risk, wrote Dana O’Brien, BIO’s EVP of Food & Agriculture in Agri-Pulse.

So, we say: it's time to fix it. In our role as a consensus builder, BIO has offered several fresh, thoughtful solutions for how to regulate animal biotechnology to the U.S. government, and multiple creative, constructive ideas have been brought forward by stakeholders to improve the unacceptable status quo. And we'll continue to do so by working with the White House, federal agencies and Congress to find a solution. 

But FDA's publications last week demonstrate they may not be listening.

Why it matters: New products in the pipeline, particularly those produced using genome editing, hold tremendous promise for securing the food supply and improving sustainability in the United States and global society at large, but regulatory uncertainty has all but destroyed investment.

Dana's Dialogue: We know the right solution—the one that will enable the United States to meet its innovation goals and position animal biotechnology to help us solve big challenges—is in the mix of the ideas we and others have shared with our nation’s leaders. BIO is at the table. We’ve been at the table and we have presented practical, workable options to move forward. The time for action is now. – Dana O'Brien, BIO's EVP of Food & Agriculture

More Agriculture & Environment News:

The Hill: House Republicans propose carbon capture and sequestration legislation
“The three-pronged plan will focus on carbon capture, clean energy and conservation.”


But are we ready for the next coronavirus?


Cases of the novel coronavirus, now called Covid-19, continue to spike around the world, and although the industry is racing to find a vaccine or cure, experts say we should expect more cases.

The situation: As of this writing, there are nearly 60,000 confirmed cases of the novel coronavirus and more than 1,000 deaths. The Centers for Disease Control and Prevention (CDC) says we should expect more person-to-person transmission in the United States, too.

How can we respond to this outbreak now, and prepare for new viruses in the future? Phyllis Arthur, BIO’s VP of Infectious Disease and Diagnostics Policy, joined Dr. Julie Gerberding, EVP and Chief Patient Officer at BIO member Merck, for a podcast discussion on the coronavirus outbreak. 

Merck is one of many biopharma companies racing to find something to stop it—looking at antivirals and compounds “in the storage room” that might be repurposed against the coronavirus, said Dr. Gerberding, who was director of the CDC during the SARS outbreak. 

What does preparedness look like? “I think of preparedness as a process, not an outcome,” said Dr. Gerberding. “When you look back over the last 20 years or so in the US, we have seen significant advances in certain elements of our preparedness. But each time we get one of these new outbreaks, we get tested in new and different ways.”

Public-private partnership is an important element. “I think it’s really important for the government to build systems that allow them to quickly reach out to industry, have a clear way that companies can say, I’d like to test this molecule and see if it’s effective against the virus,” explained Arthur. “It’s often very hard and very clunky as a process to engage the entire private sector in the response. And you need to have those bridges all built and those systems in place before you’re in the middle of the emergency.” 

And it’s important to finish the job. During outbreaks of SARS, MERS, and Zika, the industry made substantial progress on vaccines and cures, but the work was abandoned when the threat disappeared. But had they finished them, we might be further ahead on research for coronavirus, or whatever else may come along.

Phyllis’ Philosophy: "We should think of this as capability building, capacity building and the going all the way through the process. We have to finish that because every one of those processes and every one of those outbreaks is a learning for the next one. And we go faster and we're better. [T]hat's actually the cornerstone of preparedness and response." – Phyllis Arthur, BIO's VP of Infectious Disease & Diagnostics Policy

Listen to the entire podcast or read the transcript.


More Health Care News: 

Chemical & Engineering News: Biotech firms consider contingency plans as the coronavirus outbreak hits CROs
As the coronavirus threat grows, the industry’s reliance on firms based in China for chemistry services is in the spotlight.

Regulatory Focus: Interview with FDA’s OND Director
“It’s important to realize we’re always dealing with uncertainty, and with rare diseases, where you’re talking about a progressive, severe and ultimately fatal disease, patients and physicians are willing to accept a bit more uncertainty. We have to regulate within that context. How much uncertainty can we accept in the face of patients who are in marked and desperate need of therapies – that’s always a balancing act. We don’t want to give false hope but we want to try to get to an answer and accept some uncertainty,” said Peter Stein, Director of the FDA’s Office of New Drugs.

BIO Beltway Report

President Trump’s Thursday: Meeting with New York Gov. Andrew Cuomo at the White House.

What’s Happening on Capitol Hill: The House and Senate are in session. HHS Secretary Alex Azar will testify on the budget request in front of the Senate Finance Committee.

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