I recently had the pleasure of attending the Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference in Washington, DC. There were several interesting topics in a variety of sessions:
- The “Enforcement Basics” session included discussions surrounding 11 potential situations involving the FDA and how to handle them.
- The session on “cGMP Enforcement Issues” included discussion on handling various situations before, during, and after an FDA inspection. There were also questions and discussion regarding recent FDA guidance on investigators taking photos during an investigation, how to respond to warning letters, and how and when to communicate with the FDA.
- I personally found the “Interagency Enforcement Action: An Inside Look” session quite interesting as the panelists discussed how the FTC, DOJ, CPSC, FDA Office of the General Counsel, and FDA Import Operations work together in various capacities and where one jurisdiction ends and another begins. They also discussed their most recent collaborations regarding football helmets, homeopathic substances, HCG diet products, health apps, labelling and advertising on the internet, and decorative contact lenses.
- The session on “Criminal and Civil Enforcement: Domestic and International Developments” had mini presentations by the four panelists. The most interesting to me was Eugene Thirolf’s talk entitled “Too Hard to Jail” where he described the expense and difficulties in trying complicated cases where the companies are diffuse and top executives are well-insulated.
- Two of the panelists of the “Clinical Trial Data Integrity” session discussed the top 483 observations and data falsification and fabrication. The third panelist discussed the Site Specific Research Organization (SSRO) model and how it provides data integrity by overlaying GMP principles at the investigative site. (Disclaimer: I work with the third panelist, Dr. Anton Usala, at CTMG as part of the SSRO model.)
I enjoyed my time at the conference and hope to attend the FDLI Annual Conference in April.
