The industry is headed toward some form of track-and-trace in the U.S., but what shape it will take and whether it will get to the unit level is the question on everyone's mind. A bill advancing in the U.S. Senate would make that happen sooner than later, but the U.S. House has pushed through a proposal that would put off that level of drug monitoring for more than a decade.
The House bill passed today would direct the FDA to create national standards for monitoring drug distribution but would prevent the agency 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 and dictate an FDA-established licensing program for third-party logistics providers, Bloomberg reports.
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. That bill is at odds with the 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. The House bill could delay track-and-trace practices in the U.S. for now, but 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. International organizations also have emphasized the responsibility of individual countries given the global nature of manufacturing and trade.
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