Navigated through key government investigations
"After engaging with Mary, my team always had practical answers to our issues that we were able to implement. She has an unparalleled ability to grasp our business goals, understand the legal ramifications, and teach us how to operate successfully to minimize the risk."
Susan Sybert, Former Executive Director, Payor Marketing, Amgen
Challenge
I entered industry to counsel regional facilities following the clinical laboratory settlements of the late nineties. In the 25 years that have followed, government investigation has become routine. I’ve witnessed them all, counseling clients on how to operate in ambiguity, and helping litigation teams to appreciate the nuances of the business activities under scrutiny.
Solutions
Results
Average Wholesale Price (AWP):
As the government was investigating spread cases, sales staff still had to go out there every day. Customers asked questions and our reps needed answers. My role included:
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Counseling clients on thorny discussions
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Working with the litigation team on strategy
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Handling a congressional investigation
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Helping our corporate communications team with crisis management and press inquiries
Off Label Promotion: While our compliance program was still new, the government launched an investigation into the company’s promotional activities. Despite the usual practice of avoiding change while under scrutiny, we carried on, looking for weaknesses, making improvements and developing new policies to address the risks we identified.
As the company moved toward settlement, the government was satisfied the company had implemented an effective compliance program. My team’s work, and perseverance in the face of these challenges, had a demonstrable impact on the outcome.
Patient Assistance Programs (PAP): I helped compliance and business leaders navigate activities during this industry-wide probe. Following settlement, the company leveraged my risk assessment expertise to develop a program that would meet the new US requirements, while allowing our broader global program to proceed as planned.