Comments to FDA on Proposal to Regulate Gene-Edited Animals

ITIF submitted comments to the Food and Drug Administration (FDA) on a proposal to treat gene-edited animals as forbidden until proven safe even in complete absence of any apparent risk. This approach contradicts U.S. regulatory policy in place since 1986, which tasked regulators to prevent or manage "unreasonable risks." Congress gave FDA broad discretion that could be applied to focus on credible risks without burdening and discouraging innovation to no benefit. FDA should re-work the proposal to align it with long-standing policy.