Every acorn on the ground is just as alive as the three-hundred-year-old oak tree that towers over it.
– Hope Jahren
Providing Practical Compliance From Deeply Rooted Expertise and Experience
Our Focus
Whitelaw Compliance Group focuses on emerging healthcare companies and organizations. We believe that from humble acorns mighty oaks will grow. We also know that every client deserves a high-quality, practical ethics & compliance program that fits the organization’s needs and grows as the company grows. We do this by listening and focusing on each client.
Our Expertise and Experience
With 30 years of working with healthcare companies and having designed, built, and run four different compliance programs, we know from experience what works. We also know how to fit the pieces together to get things done as quickly and efficiently giving us the ability to create innovative, effective compliance, because “out-of-the-box” compliance solutions simply won’t do.
Compliance Blog
How to Sleep Better at Night: Navigating the Dangers of Drug Pricing
Do the complexities and challenges of drug pricing keep you up at night? By applying a few simple principles, you can sleep better at night. To learn more, check out my latest article in the...
Reminder: The Food, Drug, and Cosmetic Act is a Criminal Statute
Because individual prosecutions involving the federal Food, Drug, and Cosmetic Act (“FDCA”) are relatively rare, it is easy to forget that the FDCA is a criminal statute. It also is a strict...
The Numbers Are In – DOJ Releases the Latest FCA Statistics for FY 2023
By Dr. Seth B. Whitelaw and William Sarraille[1] The U.S. Department of Justice (“DOJ”) annually releases False Claims Act (“FCA”) statistics for the previous fiscal year. Given the potential...
A Wide Range of Solutions
With our flexible, efficient, and experienced approach, Whitelaw Compliance Group can provide a wide range of solutions custom-tailored to meet each individual client’s needs and budget, including:
- Compliance vision and risk strategy for the present and future
- Program health checks and CIA readiness assessments
- Board of Director expert services, training, and support
- Interim department staffing
- Policy and SOP development
- Process development and execution
- Helpline creation and management
- Investigation process development and execution
- Staff training and knowledge enhancement
- Regulatory response and remediation
- Serving as an Expert Witness
Company News & Recent Articles
News
MITCHELL HAMLINE SCHOOL OF LAW
This summer for the fourth year, Dr. Whitelaw will be teaching a course on the opioid crisis:
Health Care Law & Opioids: Has the “Man-Made Plague” Changed Anything?
As the fallout from prescription opioids continues, the crisis and its attendant litigation encompass the entire drug supply chain from manufacturers and distributors to pharmacies and prescribers. In addition, it presents students with a unique case study to explore the intersection between public health, regulations, compliance, and the law.
Pharmaceutical Compliance Congress 2023
I am thrilled to announce that I will be joining the speaking faculty at this year’s Pharmaceutical Compliance Congress 2023. I will be leading a session titled, Rethinking and Revolutionizing the Compliance Officer Role and would love for you to join. Please use my code PCCFAV23 to receive 10% off of your registration. Informa Connect
Books & Articles
HCCA Complete Healthcare Compliance Manual: Author of a new chapter entitled The Opioid Crisis and the Risk of Diversion.
HCCA Complete Healthcare Compliance Manual: Primary author of the chapter entitled Healthcare Compliance Programs: From Murky Beginnings to Established Expectation
Opioid Crisis: Whitelaw, S., When Money and Doritos Don’t Suffice – The Crucial Imperative for Integrating Effective Compliance Controls In The Ongoing Opioid Settlements, 5.10 Policy & Medicine Compliance Update, 1 (2019).
Drug Pricing: Whitelaw, Seth; Fiorentino, Nicodemo; and O’Leary, Jennifer (2018) “Drug Pricing—The Next Compliance Waterloo,” Mitchell Hamline Law Review: Vol. 44 : Iss. 4 , Article 2.
Policy & Medicine Articles
2021
Governance & Operations: Ignorance is not Bliss – Why Hope and a “Faith-Based Approach to Compliance are Untenable – Sep. 2021 (co-authored with Manny Tzavlakis
Transparency: Through the Looking Glass – A Patients Perspective on Open Payments Leads to New Transparency Bill – Aug. 2021
Opioid Crisis: Kryptonite for Consultants – Massachusetts Sues Purdue Pharma’s Marketing Consultant – Jun. 2021
2020
Opioid Crisis: Burning Down the House – Lessons from the Insys Therapeutics Saga – Jun. 2020 (co-authored with Robert N. Wilkey, Esq.)
Governance & Operations: Redressing Corporate Misdeeds — Is Holding Individuals Accountable the Answer? – Jan. 2020 (co-authored with Nicodemo Fiorentino, Esq.)
