FDA Seeks New Powers for Safer Eyedrops Amid Recalls

The agency requests the ability to mandate drug recalls and require pre-shipment inspections, following recalls linked to unsanitary conditions at foreign manufacturing plants.

The Food and Drug Administration (FDA) is seeking new powers from Congress, including the ability to mandate drug recalls and require eyedrop manufacturers to undergo inspections before shipping products to the U.S.
FDA foreign inspections were down 79% from 2019 in 2022, with inspections increasing this year but still far below pre-pandemic levels.
An October recall of two dozen eyedrop brands was triggered by unsanitary conditions found at a Mumbai plant that supplied products to major U.S. retailers. This was the first time FDA staff had visited the site.
The FDA is asking for the power to require manufacturers of eyedrops and other sterile products to give at least six months notice before shipping products from a new factory, allowing time for inspections.
The FDA currently lacks the authority to force recalls of drugs and must ask companies to voluntarily take action. The agency has recently asked Congress for mandatory recall authority over drugs.