Some bureaucrats in the Trump administration seem not to have gotten the memo about deregulation being good for innovation, the economy, and public health. Far from deregulating, FDA Commissioner Dr. Scott Gottlieb has doubled down on his agency's failed policy toward an entire sector of biotechnology — the production of genetically engineered animals.
In May, he publicly embraced the Obama administration's proposed expansion of the agency's ill-conceived 2009 policy for the regulation of such animals to include the use of the most innovative, precise and predictable gene editing techniques such as CRISPR-Cas9. The FDA then scheduled but postponed (apparently because of pushback on Gottlieb's policy from within the government) a public webinar that "will focus primarily on the current scientific evidence, promising uses of this technology in animals, and the potential risks."
It will also, the FDA said, "provide information to all interested stakeholders about CVM's flexible, risk-based approach to the regulation of intentional genomic alterations in animals."
The trouble is, FDA has never had a logical, risk-based approach to genetically engineered animals, so we can expect the webcast to be another example of double-speak and obfuscation.
Genetically modified animals have the potential to benefit consumers and the environment with faster growing and more environmentally friendly food animals that could produce less-toxic waste, and with other traits attractive to consumers.
Modern genetic engineering techniques offer a more efficient and cost-effective way to improve the characteristics of animals when compared to traditional trial and error breeding, which is less able to effect predictable, stable and desired traits.
Is DNA A Drug?
In a 2009 guidance document, FDA announced that the tiny snippet of introduced DNA used in the molecular genetic engineering of an animal would be considered a "new animal drug," and therefore require the animal to be reviewed as such under the Federal Food, Drug, and Cosmetic (FD&C) Act — even if it was intended to be used neither as food nor as a source of a drug.
The Act requires that new animal drugs be both safe and effective before they can be approved for marketing. Therefore, the animal must undergo onerous government review and approval by the FDA's Center for Veterinary Medicine, the same as veterinary drugs such as an antibiotic or pain reliever. However, FDA had never before evaluated, for example, a new variety of pig with novel traits introduced by traditional breeding.
The legal basis for the 2009 guidance is dubious. There is no hint anywhere in the FD&C Act that animals could be, in effect, regulated as a drug. Nor is such an interpretation necessary for the safe consumption of genetically engineered animals.
Thus, FDA's 2009 guidance and its proposed expansion are based on regulatory opportunism rather than scientific or regulatory principles. In fact, for millennia farm animals and others have undergone continual genetic modification, mostly by laborious and imprecise trial-and-error breeding.
For example, the dozens of varieties of cattle raised today are all derived from the now-extinct auroch, which was used both for food and as a beast of burden from ancient times until the 17th century. A relatively recent (20th century) new food animal, the "beefalo," a cow–bison (buffalo) hybrid, combines the superior hardiness, foraging ability, calving ease, and low-fat meat of the bison with the fertility, milking ability, and convenient handling of the cow.
None of these innovations has been intensively evaluated by regulators. And not only have all these imprecise genetic modifications not been associated with significant risks but they have markedly increased ranchers' productivity and societies' food security.
In seeking to regulate the newest, state-of-the-art techniques, Gottlieb warned stakeholders against challenging his demand that human gene therapy and genetically engineered animals be regulated similarly because both involve the same technologies:
"(G)roups should be mindful that if they lobby for an exception when it comes to gene editing on the animal drug side of our house, it will inevitably undermine our regulation of these same technologies when it comes to human drugs ... And if we create these dubious distinctions [between human gene therapy and animal genetic engineering], there's a big risk that we erode confidence in these promising technologies before they have the opportunity to have their full impact on public health."
That rationale is a non-sequitur, like saying that FDA would be obligated to regulate a red food-color additive in the same way as the same dye used on a food box label because the "technology" is the same.
Instead of the 2009 guidance and Gottlieb's just-announced plan for even more burdensome regulation of genetically engineered animals, FDA could adopt the more appropriate and less burdensome approach to food taken by another FDA component, the Center for Food Safety and Nutrition.
For certain products — "food additives," such as preservatives, antioxidants, coloring agents and emulsifiers used to preserve or add flavor, color, or texture to food — the FDA requires premarket clearance.
Otherwise, the law places the burden of ensuring the safety of foods and food ingredients on those who produce them by prohibiting the adulteration (contamination) or misbranding (mislabeling) of food — but it does not require the evaluation or inspection of all food before its sale in shops, supermarkets, or restaurants.
Rather, FDA oversight relies on market surveillance or post-marketing regulation, and the agency takes action only when there is a problem. For all animals the Department of Agriculture and states impose animal safety and health requirements.
On this issue Gottlieb should take note of the analysis of his "senior science and regulatory advisor," Randall Lutter, who while the FDA deputy commissioner in 2009 supported the "new animal drug" guidance, but in June of last year described it — as well as the substance of Gottlieb's proposed expansion of its scope — as a failed policy: "FDA's proposed guidance for genome edited animals lacks a cogent scientific basis, is inconsistent with FDA's policies regarding genome edited plants, and is unlikely to advance FDA's mission to protect and promote public health."
In a June 6 blog posting, Gottlieb described FDA's approach this way: "for genetically engineered animals, FDA evaluates not only the safety of food or drug products derived from that animal, but also the effect of the genetic alteration on the health of the animal."
Actually, the FDA doesn't. The reality is that after claiming regulatory jurisdiction over all genetically modified animals, FDA invoked "enforcement discretion" and chose not to evaluate the vast majority of them, including lab animals, mostly rodents, created with recombinant DNA technology, which were sometimes designed to be less than healthy for research purposes; the novelty pet GloFish®; and the new varieties that have resulted from conventional breeding.
Also contrary to Gottlieb's assertions, FDA has stumbled badly under its "new animal drug" policy since it was announced a decade ago. The agency took 20-plus years to review a faster-growing salmon and stalled for five years on the application for a single field trial of self-destructing, non-biting, pesticidal mosquitoes (jurisdiction over which FDA eventually had to punt to the EPA).
The FDA appears to be doubling down, ensuring that new, even more stultifying regulation of genetically engineered animals will keep the entire sector moribund. Talk about "erosion of confidence" in regulators. We fully expect the now-postponed webcast to offer more of the same.
- Cohrssen is an attorney who has served in a number of government posts in the executive and legislative branches of the federal government, including as counsel for the House Energy and Commerce Committee.
- Miller, a physician and molecular biologist, was the founding director of the FDA's Office of Biotechnology. He is the author of "To America's Health: A Proposal to Reform the Food and Drug Administration."