Post-Approval or Commercialization Issues
We assist our clients with the legal issues surrounding all post-approval and commercialization issues, including:
-
Post-market duty-to-warn issues.
-
FDA preemption issues.
-
Advertising and marketing agreements.
-
Chain of distribution agreements.
-
Phase IV studies for secondary indications for drugs.
-
Compliance with reporting requirements.
-
Development of regulatory compliance programs and related training for employees and sales force.
-
Compliance investigations.
-
Pricing issues including those related to Average Manufacturing Price (AMP) and Average Sales Price (ASP).
-
State formulary issues.
-
Export and import issues related to either the product or intellectual property.
-
Adverse event and reporting requirements and development of crisis plans based on Homeland Security guidance.
-
Anti-counterfeiting investigation and enforcement, including programs to detect, intercept and seize counterfeit products throughout the world.
-
Issues involving parallel imports and reimported products globally.
Post-Approval or Commercialization Representative Matters
-
Develop and provide ongoing training to the marketing and sales teams of clients.
-
Conduct internal audits of marketing and sales techniques including, obtaining secondary indications, marketing “on-label,” investigate internal reports of misconduct, develop compliance policies related to marketing, sales and investigations.
-
Represent clients on state formulary board issues related to bioequivalent listings.
- Represent clients on issues related to early generic market entry.