FDA Approach On Warning Letters, Drug Approvals Could Change Post-Caroniao

 Industry attorneys suggest FDA warning letters will become more carefully worded and potentially easier to challenge on First Amendment grounds in the wake of the Second Circuit’s decision in the landmark off-label promotion case. FDA’s view of the evidence needed to demonstrate drug efficacy also could evolve. 

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Caronia Webinar - Slides and Audio Available for Download

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Frier Levitt Attorneys at Law Blog post: Federal Appellate Decision Involving Off-Label Drug Marketing Could Expand the Ability of Pharmacies to Market Compound Prescriptions

WEDNESDAY, JANUARY 30, 2013

By Jonathan E. Levitt, Esq. and Jesse C. Dresser, Esq.

Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug.  The decision, United States v. Caronia, could dramatically expand the free-speech rights of pharmaceutical companies and compounding pharmacies alike.  Compound marketers could enjoy greater leeway to share unapproved information.

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