August 26, 2019

Lawmakers Join Effort

Lawmakers to FDA: Base animal product approval on actual health risk

On July 26, more lawmakers joined the effort to support a “revised regulatory approach for animal biotechnology.” In a letter to Acting FDA Commissioner Norman “Ned” Sharpless, the bipartisan group of 23 Members of Congress urged the agency to revise their current position that DNA from “intentionally altered” food animals and their offspring be reviewed as an “animal drug.”

“In recent years advances in animal genetics have provided significant breakthroughs that can help to address some of society's most difficult challenges,” the lawmakers write. “While we think a robust conversation should be had on the best way to provide transparency to consumers and users on the nature of these animals, that discussion will be moot if our nation’s regulatory system prevents these animals from coming to market.”

These lawmakers join animal scientists and agricultural producers who have called on the FDA to base product approval on the scientific evidence of product safety, not a blanket approval process designed for measuring drug risk.

Experts have shown that dietary DNA poses no health risk, whether it comes from conventional breeding, genetic engineering, or gene editing. The process of reviewing gene-edited DNA as a drug would subject new products to an approval process that can take decades and cost millions. At the moment, DNA from gene-edited plants is subject to no such review, and many have argued that animal products should be treated the same.

The current FDA regulations also hold back research toward stopping animal health threats like African swine fever, the lawmakers write. These regulations also put American farmers at a competitive disadvantage in the global market, where many countries are moving forward with products from gene-edited animals.

“U.S.-based companies are already turning to foreign markets for development and marketing of animal innovations. We encourage you to work with other relevant agencies and stakeholders to develop a revised regulatory approach for animal biotechnology that is science and risk-based, provides a viable pathway to market, and ensures the safety of these products for humans, animals, and our environment,” the lawmakers write. “Suggesting that U.S.-raised animals contain a ‘drug’ invites foreign competitors to impose non tariff trade barriers on U.S. goods.”

The full letter has been posted by Politico, though it is behind a paywall: https://subscriber.politicopro.com/f/?id=0000016c-3b53-d88f-a9ec-3fdfcf620001