Enforcement and Litigation Conference: FDA Enforcement – More Individuals, More Often
Food and Drug Law Institute Conference
Compliance Services Partner John Brownlee will speak at a Food and Drug Law Institute conference titled, "Enforcement and Litigation Conference: FDA Enforcement – More Individuals, More Often."
Two recent developments in FDA enforcement policy are meaningful for officials at food, drug, medical device and tobacco firms. First, as part of a more aggressive enforcement attitude, FDA officials have announced that they will likely be prosecuting responsible corporate officers for strict liability offenses of the Federal Food, Drug, and Cosmetic Act (FDCA) under the Park doctrine. Second, FDA recently initiated two debarment proceedings against individuals who had been convicted of misdemeanor violations of the FDCA.
In addition to discussing how these developments will translate to FDA enforcement actions, the conference will include:
- An optional "Enforcement Primer," providing the basics of inspections and compliance
- Discussion of when to litigate and when to settle
- A review of major settlements and criminal cases
- Consent decrees
- Provisions in healthcare reform law