Loeb & Loeb LLP is pleased to announce that partner David G. Mallen will be speaking on a panel at ACI's Second Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs titled, "OTC Enforcement Actions and Private and Public Litigation."
From the program website:
FDA’s NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative which seeks to establish a new paradigm for ‘OTC drugs with conditions of safe use’ will undoubtedly alter existing legal and regulatory protocols and product commercialization in the OTC space. Pharmacist assistance coupled with the use of new technologies and rapid diagnostic testing would in certain instances supplement the current OTC paradigm of self-diagnosis and self-care, thus leading to a multitude of controversies ranging from scope of FDA authority to potential liabilities. Additionally, the granting of OTC status to non-traditional switch candidates such as Oxytrol and the controversy over levonorgestrel also known as Plan B have led to new questions concerning how the NSURE Initiative may also impact the Rx-to- OTC switch mechanism.
To help you make sense of the NSURE Initiative and in furthering the objectives of our inaugural OTC conference, ACI’s Second Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs will help you thoroughly comprehend the continuing evolution of the OTC landscape. By attending this event, you will understand how these latest developments will impact the existing legal and regulatory structures which frame the OTC environment.
12:15 - 1:15 PM - "OTC Enforcement Actions and Private and Public Litigation"
This panel will discuss:
- Recent OTC enforcement actions: case studies and lessons learned
- scope of wrongdoing
- take aways from J&J McNeil
- Exploring trends in private litigation relative to OTC products
- link between private and public OTC suits
- Evaluating the economic cost of enforcement actions: impact on brand and reputation
- Survey of NAD actions relative to OTC claims
- connection to consumer class action suits and government enforcement actions