Track And Trace: Substandard System Is Not Better Than Nothing, FDA Says
CDER Director Janet Woodcock says an industry coalition’s proposal would not meet FDA’s drug tracking needs and is not worth the cost of implementing, even though industry says FDA’s preference is cost-prohibitive.
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Though not required by law, process offers “a little bit of a brand protection.”
Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.
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.