OTC Drug Recalls: Prudent Steps to Prepare your Company for When it all Goes Sideways
Todd H. Halpern
Assistant General Counsel
Sedgwick Brand Protection Solutions
Wiley Rein LLP
- Analyzing practical, real-life examples of OTC drug recalls, e.g. ,hand sanitizer contamination, packaging and labeling concerns
- What were the nature of these recalls?
- What corrective actions were taken?
- What are the lessons learned?
- Deciphering Implications of emergency use authorizations during COVID
- Developing an action plan for small to large scale recalls
- Tracking products when there is a middle market of distribution e.g. hotels and airlines
- How to handle adverse events
- Evaluating the risks and benefits of cooperating with FDA in the course of a recall
- Voluntary recalls versus mandatory recalls
- What are the consequences of not instituting a recall?
- FDA seizure and injunction power
- Devising best practices for formulating effective recall execution strategies
- Assessing the impact of divergent post-marketing reporting requirements for OTC drugs
- Exploring the interaction between recalls and corrective and preventive action
- Developing Strategies for introducing a product back to market