The FDA Wants to Regulate Edited Animal Genes As Drugs

Noted: “Here is the first thing to know: They are not treating gene-edited animals as drugs,” says Alta Charo, lawyer and bioethicist at the University of Wisconsin Law School. “They are proposing to regulate the altered DNA as a drug.” This refers back to the Food, Drug, and Cosmetic Act, which defines a drug as something that intentionally alters a body’s structure or function. OK, technically, sure. But even the FDA agrees that altered genes aren’t drugs—its new draft regulation needs several exemptions and caveats before it can contort its 1938 law to wrap around 21st century technology.