Limited track-and-trace moves forward in U.S.

The U.S. House of Representatives has advanced one step closer to delaying the tracking of individual drug units. A House bill passed today would direct the FDA to create national standards for monitoring drug distribution but would prevent the FDA from even considering tracking on the unit level until 2017.

Republicans are touting the bill, which would require links in the distribution chain to provide notification to regulators about products unsuitable for distribution. In light of last year's fungal meningitis outbreak, the bill would also dictate an FDA-established licensing program for third-party logistics providers to ensure greater patient safety.

The bill would also stall a track-and-trace program that would prove costly for shippers and distributors--and override a California law requiring unit tracking by 2015. The bill is at odds with another bill from the Democrat-controlled Senate that increases regulatory controls and introduces unit tracking much sooner, which the FDA has asked for. California Democrat Henry Waxman criticized the House bill, saying it "falls far short" of adequately protecting the prescription drug supply chain, as quoted by Bloomberg.

It was disagreements like these that eventually ceased negotiations last fall, but the advancing California law implementation has spurred pharmaceutical and drug-distribution industry groups to call for congressional action. But while the House bill could delay track-and-trace practices in the U.S. for now, other countries are on their way to increasing that kind of regulatory oversight. Nations like China are looking to impose systems that can help regulators prevent counterfeiting, which is responsible for deaths at home and abroad every year, and international organizations have emphasized the responsibility of individual countries given the global nature of manufacturing and trade.

- get the story from Bloomberg

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