Reference no: EM133476656

Question

A partner at a local law firm has contacted you to organize an informational presentation regarding enforcement mechanisms available to the FDA. The firm has recently begun to advise clients in FDA-regulated industries and would like a crash course for all of its attorneys, many of whom have never worked in the area of drug, biologic, and device law.

The partner asks you to provide a summary for the lawyers to review in advance of the presentation. He asks you to identify major statutory enforcement authority under the Food, Drug, and Cosmetic Act (e.g., seizures, injunctions, criminal prosecution), as well as administrative mechanisms available to the FDA (e.g., Warning Letters, inspections and Form 483s, adverse publicity, and recalls). He specifically requests that you make sure to identify what other federal agencies or actors must be involved in the enforcement activities.