Inside D.C.

Pay attention to the White House, biotech

There’s a quiet albeit high-level “review” of how the federal government regulates biotechnology going forward, an effort not getting a lot of media attention, but an effort that will dictate the future of this home-grown technology, particularly as it’s used in agriculture both in the U.S. and overseas.

President Obama recently ordered the White House Office of Science & Technology Policy (OSTP), in coordination with USDA, EPA and FDA, to revisit the so-called federal “Coordinated Framework” on biotechnology regulation.  It’s not clear what the purpose of this revisit is given the Obama Administration, while saying all the right things about fostering technology and the use of the “best available science,” has done little to do either of those things.

USDA regulates plant biotechnology under the Plant Protection Act; FDA oversees animal biotechnology using the Center for Veterinary Medicine’s (CVM) new animal drug approval (NDA) process – only the genetic “construct” is approved, not the whole animal. This bifurcation exists because the Bush Administration couldn’t get its arms around single agency oversight, nor overcome agency competition for program dollars and authority.  EPA is in the mix to handle the environmental impact of plants with new and differently functions than their conventional cousins.

A public meeting last week illustrates the battle lines already drawn.  Industry sees the review as how to make a good system better; anti-biotechnology forces see the White House effort as kicking open the door to reregulate all forms of biotechnology in the strictest way possible.

For instance, at a public meeting last week in Maryland, the National Grain & Feed Assn. (NGFA) urged the administration to keep the needs of export markets in mind when reinventing biotechnology approvals.  Meanwhile, consumer groups and those which apparently exist only to sue the federal government told the White House the regulatory review should focus on setting new, far stricter rules for biotech approvals.  Other biotechnology supporters urged the administration to make biotech oversight “truly risk-based,” and “restore the balance between oversight and product safety.”

“This review must address the challenge of achieving regulatory coherence and compliance in the global market,” said NGFA, reminding regulators of the hurdles faced by grain exporters trying to move into major new markets, including China, and these hurdles have cost exporters millions in lost sales.

However, Consumers Union (CU) said the federal biotechnology review and approval systems is broken, using laws “that were never designed to address biotechnology, trying to put square plugs into round holes,” a not-so-subtle jab at FDA’s use of its drug authority.  The law-suit happy Center for Food Safety (CFS) said new rules need to take into account novel forms of genetic engineering, such as gene editing and RNA interference technologies, as products using these techniques are not routinely regulated.

My guess this Administration has neither the inclination nor the time to take on yet another controversial issue, particularly one as complex and mind-numbing to the public as biotech.  This makes the review more window dressing that priority.  However, the White House doesn’t even have to whip out the executive order pad to start changing how high and how many hurdles must be overcome by companies and universities when it comes to getting the latest biotech discovery to market.

The great policy divide on biotechnology is obvious. Given this Administration’s priority on “legacy” issues, it behooves those in the U.S. who benefit from biotechnology – as well as those for whom the technology holds great promise – to engage now, convincing the President he wants to be remembered as the president who did more to feed the world than his predecessors.

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