By Henry Miller, M.S., M.D. and John Cohrssen

Over the weekend, the FDA issued an emergency-use authorization for Johnson & Johnson’s Covid-19 vaccine, clearing the path to market for the third coronavirus vaccine. The FDA had previously approved the Pfizer-BioNTech and Moderna Covid vaccines in record time—mere weeks after their makers submitted results of the clinical studies demonstrating safety and efficacy. When the FDA wants to, it can get desperately needed products expeditiously to those who need them.

But for some other innovations, and even entire product classes, the FDA slows or obstructs approval, sometimes by imposing nearly insuperable regulatory burdens. For example, animals modified by traditional breeding receive no special government oversight, while those engineered with molecular techniques are subjected to onerous requirements and long delays. Modifying animals by either traditional breeding or genetic engineering (GE) can improve the nutritional characteristics of food; prevent animal disease; reduce greenhouse-gas emissions; speed growth, which reduces costs and environmental impacts; and even create products valuable for the treatment of human diseases.

The 1986 Coordinated Framework for the Regulation of Biotechnology (CF) provided a blueprint for federal agencies’ oversight of genetic engineering that was prepared by the White House Office of Science and Technology Policy (OSTP). However, it soon became evident that the agencies’ regulatory scope was flawed, so reforms were added in the 1992 follow-on OSTP “Scope Document” to create more narrowly targeted, risk-based oversight. Neither the CF nor the Scope Document detailed the requirements for genetically engineered animals because they were thought to be years away from commercialization; nor was it contemplated that the FDA would seek to regulate them at all. However, when the FDA responded to an inquiry in 1994 about the possible regulation of “AquAdvantage,” a faster-growing GE Atlantic salmon, it decided that the use of GE techniques would trigger regulatory oversight and, thus, that agency oversight thereafter would include all GE animals. Regulators issued an Investigational New Animal Drug authorization for the AquAdvantage salmon. This began the current policy, published as an FDA Guidance Document in 2008, with a draft update in 2017, to include all GE animals. The FDA’s policy relies on a law specifically designed to authorize the marketing of animal drugs—a very different regulatory purpose and paradigm.

This approach has been largely unworkable and has obstructed promising R&D advances for GE animals. For example, the FDA took an inexplicable 21 years to grant marketing approval for the AquAdvantage salmon, which consumes 25 percent less feed and reaches maturity 40 percent faster than other salmon, with no detectable difference in the fish’s appearance, size, taste, or nutritional value. Moreover, the environmental impacts are negligible because the fish are all sterile females and farmed inland in a closed system. After the two-decades-long regulatory process, the FDA finally concluded what should have been obvious long before from the scientific evidence: that no health or environmental risks or food-quality concerns existed.

Or consider the Oxitec GE mosquito, designed to control the mosquitoes that transmit Zika virus, yellow fever, dengue fever, and chikungunya. The GE male mosquitoes contain a genetic defect lethal to themselves shortly after release and to their offspring, resulting in a marked reduction in the mosquito population. The FDA took five years to approve a single small-scale field test of the Oxitec mosquitoes—an approval that came only after mounting pressure from the growing Zika threat and the consequent need for mosquito control. In August 2016, the agency finally approved a field trial at one site in the Florida Keys, a trial that has yet to begin and which has now been transferred to the Environmental Protection Agency, the agency charged with the regulation of insecticides. The FDA relinquished its jurisdiction after our op-ed in the Wall Street Journal pointing out that the new animal-drug requirement of “safe and effective” was a logical impossibility for a mosquito engineered to, in effect, commit suicide.

The “GalSafe” GE line of pigs eliminates a specific sugar in pigs’ cells that can cause severe allergic reactions in humans who consume pork. The FDA took an inexplicable 10 years to approve it for human consumption and for the eventual development of health-related products, each of which will be required to go through another, separate regulatory process.

Only a few GE animals have been formally approved via the new animal-drug pathway, though a sizeable number are in the marketplace, including various GE laboratory animals and the popular ornamental GloFish. The FDA granted de facto approval to those others by using its “enforcement discretion” to exempt them from extensive review. The agency simply does not have the resources to review every GE animal, which points up the arbitrary and capricious nature of its processes.

A recent article by University of California professor Alison Van Eenennaam explores the substantial costs of delaying the introduction of GE animals. For the AquAdvantage salmon, she estimates the costs at more than $25 billion. Bovine mastitis is estimated to cost the global dairy industry from $19.7 billion to $32 billion annually for the treatment and loss of animals, so a transition to resistant animals would be a huge benefit to the industry and to consumers. The researchers estimate that the cost of a five-year regulatory delay would run to billions of dollars.

The FDA fails to consider that a continuum exists in animal breeding, including techniques such as cloning and interspecies hybrids (such as the beefalo, a cow-bison cross) which are not subject to pre-marketing approval. Instead, the FDA relies on its own arbitrary determinations of which GE animals should be subject to onerous regulation as a “new animal drug” or should be exempted from regulation entirely. The FDA should adopt a regulatory regime that takes into consideration economic costs and benefits (rather than just “safety” and “effectiveness”) in the evaluation of new breeding technologies. But this cannot be done using a new-animal-drug regulatory regime, which is designed for a totally different purpose.

Memorandum of Understanding (MOU) between the Department of Agriculture (USDA) and the Department of Health and Human Services (on behalf of the FDA) announced on January 19 should markedly improve the situation. It outlines “responsibilities concerning the regulation of certain animals developed using genetic engineering that are intended for agricultural purposes (such as human food, fiber, and labor).” The essence of it is summarized here:

The MOU also allows for the transition of portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA. USDA would continue to coordinate closely with FDA to fulfill oversight responsibilities and provide the appropriate regulatory environment, ensuring the safety of products derived from new technologies and fostering innovation at the same time. As always, FDA would continue its review of intentional genomic alterations intended for any purpose other than agricultural use…

The MOU offers a more rational regulatory approach that would address the problems that Van Eenennaam and others have raised, taking into consideration the economic costs and benefits of the regulatory burden on the development of GE animals. This approach will prevent the U.S. from losing a promising industry to its competitors while also benefiting American consumers.

John J. Cohrssen is an attorney who served in senior positions for White House agencies, including the office of Vice President Dan Quayle. Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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