The Drug Safety Enhancement Act, recently introduced by congressional Democrats would give increased funding and regulatory authority to the FDA in order to promote drug safety in light of the recent recalls involving a variety of drugs, but namely tainted Heparin from China. The bill would create a better registry for foregin facilities that manufacture drugs for the US, generate funding for more Good Manufacturing Practice inspections, as well as a number of other measured directed at making drugs safer in the United States.
FDA’s Current Regulatory Ability
Currently there is minimal regulatory authority and ability for the FDA to regulate facilities overseas. This bill would change that, allowing the FDA to deny entry of drugs into the United States that fail to allow inspectors into their facilities, and that fail safety inspections.
The bill would also grant the FDA the authority to issue a mandatory recall of drugs.