How the Abortion Pill Ruling Could Limit the FDA ’ s Authority

When a Texas district judge ruled on Apr. 7 that mifepristone, a drug for inducing abortion, should have its approval suspended—decades after it was granted—the decision didn’t just threaten abortion access. It raised deeper questions about the U.S. Food and Drug Administration (FDA)’s authority and the separation of its regulatory powers from judicial oversight. “The fact that there is judicial second-guessing of the FDA’s expertise is frightening,” says Ilisa Bernstein, interim CEO of the American Pharmacists Association and a former FDA official who worked at the agency for more than three decades. “To know that a judge who has no scientific training or expertise is making these judgments is frightening.” [time-brightcove not-tgx=”true”] What is scaring doctors and drugmakers alike is the possibility that a judge may be able to suspend the FDA’s approval of any drug, no matter how long it’s been on the market or how safe and effective it is. “A very dangerous precedent” The Texas ruling is the first in which a judge’s decision questions the FDA’s authority since the agency was created by Congress in 1906, when it passed the Food and Drugs Act. “This kind of ruling sets a very dangerous precedent for FDA’s authority in terms of other medications that might warrant movement into the marketplace,” Dr. Jane Henney, who was FDA commissioner when mifepristone w...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Drugs healthscienceclimate Source Type: news