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FDA Chief Counsel, DOJ Promise Off-Label Enforcement Based On Risk, Patient Harm

March 13, 2018
FDA Chief Counsel Becky Wood’s recent remarks that FDA is taking a “risk-based approach” toward warning letters, focusing on “significant public health risks, rather than overly technical or insignificant violations,” left one industry attorney pleased, pharma critics frustrated and some policy watchers waiting for more details before predicting how the Trump FDA will deal with off-label promotion. Wood’s remarks came just days after a deputy assistant attorney general also underscored that the Department of Justice will go after off-label cases...