Despite being one of the nation's most vital watchdogs, compliance and enforcement actions by the U.S. Food and Drug Administration (FDA) have severely declined since the Trump administration took office, according to an investigative report from Charles Piller, a contributing correspondent in the News department at Science. The FDA is the principal federal agency responsible for protecting public health through the supervision and regulation of clinical trials, food safety, product recalls, medications and medical devices, among others. The FDA issues "warning letters," which flag violations and effectively keep dangerous foods, drugs and other products off the market and away from consumers. However, according to Piller's report, agency warning letters have fallen by a third since President Donald Trump took office. There have also been significantly fewer letters during his second year than his first - indicating the overall decline does not simply reflect the slow start of a new administration, says Piller. The insights were revealed through an analysis of enforcement and compliance data from the agency's public records. While the cause of the overall decline in FDA warnings is unclear, Piller notes that agency watchers - including previous FDA insiders - find the trend alarming. A written statement by the FDA did not dispute the findings of the report, suggesting that "less discernable, but equally vital" regulatory and compliance actions are ongoing.
###
Journal
Science