Regulatory Focus™ > News Articles > Report: Track and Trace Provisions Removed from User Fee Bill

Report: Track and Trace Provisions Removed from User Fee Bill

Posted 18 June 2012 | By

Provisions aimed at establishing a system in which drug products would be given unique identifying numbers-a so-called 'track and trace' system-has been removed from a draft user fee bill intended to fund the US Food and Drug Administration, reports Politico.

Negotiators, currently attempting to resolve differences between the House and Senate versions of the user fee bill, have reportedly reached an impasse in their attempt to get track and trace provisions into the final bill and have removed the provisions to move the bill forward.

"Staffers circulated a proposal Friday night for labeling drugs with a unique serial number that could be checked at different points in the supply chain to prevent counterfeit drugs from reaching consumers," explained Politico. "Based on feedback from the trade association stakeholders, FDA and consumer groups, the staffers made a last-ditch effort to fashion an acceptable compromise over the weekend but could not satisfy all involved."

The hang-up reportedly involved the level at which products would be traced: unit level or lot level. Unit level would allow investigators to track the movement of each individual bottle through the supply chain, while lot-level tracking would give all bottles produced in the same lot the same ID number. Negotiators have apparently been hung-up over the cost of the system, which would likely be borne by the pharmaceutical industry in its entirety.

While the proposal could still make it into the final user fee bill draft, track and trace advocates Pew Health Group said they expected the measure to be considered separately after the passage of the user fee bill.

Read more:

Politico - PULSE: 'Track and trace' on ice for now

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