FDA to Unify Agency’s ‘Fragmented’ Safety Surveillance System

The latest action fits with Makary’s promise to overhaul the FDA while speaking to a priority of Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic who has long theorized that the agency’s surveillance misses side effects of inoculations.

Currently, the FDA processes about 6 million reports of possible side effects each year. Any one report can be unreliable, but the agency uses the system to spot trends and identify issues that might require new warnings or even the withdrawal of a product from the market.

The new platform now includes data from four systems that monitored drugs, biologics, cosmetics, color additives, vaccines, animal drugs and animal foods. By the end of May, the agency expects to include databases with reports on medical devices, human food, dietary supplements and tobacco products. The moves will save $120 million over five years, the FDA said.