Amy Fowler, R.A.C., J.D. founded Pathmaker Law to address the complex and evolving regulatory demands placed on medical device and pharmaceutical companies.
The mission of the firm is to support FDA-regulated industries in accomplishing their business goals in a compliant fashion. She is not afraid to push back when FDA is being unreasonable or inflexible.
Amy started the firm after working in industry and in private practice for 25 years, first as a regulatory affairs officer and later as an attorney. Prior to founding Pathmaker, Amy worked in roles at 3M, Ecolab, and in private practice. In her time as a lawyer, Amy has counseled hundreds of clients on regulatory matters.
With her experience in industry and in private practice, Amy knows your struggle and how difficult it can be to navigate the complexities of FDA’s regulatory minefield.
Besides helping clients getting their drugs and devices to market, Amy teaches the “Legal Basis of Regulatory Affairs” course at St. Cloud State University. Amy is also a counsel member of MSBA, FDD and a former chair.
Main practice areas include:
- Food, Drug and Cosmetic Act
- Anti-Kickback Statute
- False Claims Act
- Physician Payments Sunshine Act
- State reporting and compliance laws
- HIPAA
- Foreign Corrupt Practices Act
- Stark Law
- Federal Trade Commission Act
- Public Health Service Act
- PhRMA, AdvaMed, and ACCME codes
Representative matters include:
- Leading the compliance function via day-to-day counsel to business leaders and managers
- Serving on promotional review (Medical, Legal, Regulatory) teams
- Serving on Scientific and Medical Review Committee (SMRC) Teams
- Training staff on various compliance and regulatory topics
- Performing compliance audits and investigations
- Designing and implementing compliance programs and policies
- Responding to regulators and competitors
- Resolving government enforcement actions
- Performing regulatory assessments
- Making FDA submissions
- Quality System Management services and remediation
Helping clients achieve their business goals in an efficient and compliant fashion.
To be recognized as a preeminent provider of best-in-class legal counsel and regulatory services for pharmaceutical and medical technology companies.
Integrity, reliability, collaboration, pragmatism, and dynamism. We believe in and follow the highest level of professionalism and ethical standards; maintain a healthy culture; and give back to the communities in which we serve.