The U.S. Food and Drug Administration is a federal regulator without a key regulatory power: Recall.
That’s why when investigators with the agency confirmed there were high levels of a potentially lethal toxin in toddler teething tablets, there was really nothing they could do other than announce it. The manufacturer of the tablets refused to issue a recall, and the FDA was powerless to force them to do so.
This could soon change. At least, that is the hope of lawmakers supporting the Recall Unsafe Drugs Act. This measure, H.R. 1108, would give the FDA the authority to order mandatory recalls on dangerous drugs and homeopathic products. The measure would revise the current law for the FDA to be allowed to issue mandatory recalls for products it does not directly regulate. The proposed law would also give the agency the power to issue mandatory recalls of pharmaceuticals that have been shown to cause serious health consequences and/or death. Continue reading