For those who work with livestock, wrangling animals is a tough, but necessary chore. Here in Washington, D.C., bureaucratic power struggles often define another form of wrangling – one that is still tough but totally unnecessary. Washington wrangling elicits skepticism, if not downright anger, from the American people who are seeking solutions to big societal challenges.
That is why our organization, the Biotechnology Innovation Organization (BIO), is working closely with the U.S. government and stakeholders on improving our regulatory system for animal biotechnology – working towards a system that ensures the health and safety of animals, consumers, and the environment while also driving investment.
At the heart of BIO’s mission is a commitment to build consensus and scale around complex policies so that innovation can flourish and truly benefit human life, animal well-being, our food systems, and the planet. 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. The current system simply is not working.
While we appreciate the Food and Drug Administration’s (FDA) efforts to work with individual developers through its “VIP” program, the overall regulatory system remains opaque and cumbersome, needlessly bureaucratic, and vastly disproportionate to actual risk.
In more than two decades, only onebiotechnology food animal has been approved for production and sale in the United States. Other beneficial products are either shelved or have been taken to foreign countries that have more predictable commercial pathways. New products in the pipeline, particularly those produced using genome editing, hold tremendous promise for the United States and global society at large, but regulatory uncertainty has all but destroyed investment.
BIO agrees with the FDA, as recently articulated in Center for Veterinary Medicine Director Steve Solomon’s Nature Biotechnologyeditorial, 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 BIO does not support the status quo, and neither should anyone else.
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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 – to FDA, to the U.S. Department of Agriculture (USDA), to the White House, and to the Congress.
We have shown the government how to keep the FDA in charge of pre-market regulation using a new approach and more risk-appropriate review. Like FDA, USDA also has authority and experience overseeing the health and safety of animals, and we have shown USDA and the White House how FDA and USDA could partner to share regulatory oversight. And we have even shown the White House how the President could move animal biotechnology oversight to USDA – an approach championed by key livestock and scientific stakeholders.
Multiple creative, constructive ideas have been brought forward by many stakeholders to improve the unacceptable status quo. But the FDA publications last week demonstrate that FDA may not be listening.
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.
Now is the time to set aside the bureaucratic wrangling over turf and deliver a meaningful solution to innovators, farmers, and consumers. We call on the President to help us drive results and achieve a favorable outcome on this matter in the next three months. BIO pledges to remain an active and rational partner across the government and with stakeholders as we move to a good American outcome.
Dana O’Brien is the Executive Vice President of Food & Agriculture at Biotechnology Innovation Organization (BIO).