Updated House Track-And-Trace Draft Bill Would Require Unit-level Tracking – Or Would It?
This article was originally published in The Pink Sheet Daily
Authors of draft legislation slated for May 8 subcommittee markup add requirement for FDA rules on an interoperable electronic tracking system at the package level, but without a date for final rules and a 14-year wait for proposed regs.
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House discussion draft of track-and-trace legislation draws fire from Democrats during April 25 hearings for failing to require a unit-level tracking system, but Energy and Commerce Committee Chairman plans markup of a bill in May and predicts a final measure will reach President Obama’s desk by the August recess.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.