Costly Track-and-Trace Provision Dropped from Pending FDA Bill


"Pharmaceutical companies have gotten more aggressive in pushing for a national framework to avoid the costs of complying with individual state tracking laws. Industry groups said they would continue working toward a federal track-and-trace system."

Associated Press, Matthew Perrone

A bill designed to beef up the safety of the nation's prescription drug supply is poised to pass Congress, but without a tracking system that public health advocates say is critical to weeding out counterfeit pharmaceuticals.

House and Senate lawmakers agreed late Monday on compromise legislation that helps supplement the U.S. Food and Drug Administration's budget. The two chambers previously passed separate versions of the bill, which also increases safety inspections and penalties against drug counterfeiters.

Lawmakers dropped a Senate provision that would have created a national network for tracking drug shipments and preventing counterfeit and stolen drugs from entering the U.S. supply chain. Pharmaceutical companies and regulators have argued over the cost and scope of the network for over a decade, though industry observers hoped this year's must-pass FDA bill might provide a vehicle for a compromise.

Key lawmakers said Tuesday they were unable to bridge disagreements over the so-called track-and-trace system. . .View Full Article

Get Our Streetwise Reports Newsletter Free

A valid email address is required to subscribe