The Situation: In September 2024, the U.S. Department of Justice ("DOJ" or "Department") announced updates to its Evaluation of Corporate Compliance Programs guidance covering three primary areas: (1) the risks of artificial...more
10/11/2024
/ Artificial Intelligence ,
Compliance ,
Compliance Management Systems ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Employees ,
Machine Learning ,
New Guidance ,
Risk Assessment ,
Risk Management ,
Safe Harbors ,
Whistleblower Protection Policies
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more
5/15/2024
/ CA Supreme Court ,
Duty of Care ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Gilead Sciences ,
Healthcare ,
HIV ,
Life Sciences ,
Manufacturers ,
Negligence ,
Pharmaceutical Industry ,
Phase II ,
Product Defects ,
Summary Judgment
In light of the DOJ’s most recent guidance on the use of personal devices and third-party messaging applications by corporate personnel, this White Paper addresses issues and challenges that companies are facing in this area...more
10/18/2023
/ CFTC ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Department of Justice (DOJ) ,
Electronic Communications ,
Financial Industry Regulatory Authority (FINRA) ,
Guidance Update ,
Instant Messaging Apps ,
Mobile Devices ,
Policies and Procedures ,
Securities and Exchange Commission (SEC) ,
White Collar Crimes ,
Workplace Communication
Across every industry and every region of the world, corporate compliance programs have increasingly become an integral part of a company's operations and procedures—and the trend shows no signs of slowing. In the first in a...more
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
2/10/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Supply Chain
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
The Situation: The Office of Inspector General ("OIG") recently modified the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand protections to...more
The Situation: The Department of Justice ("DOJ") has updated its "Evaluation of Corporate Compliance Programs" guidance for prosecutors.
The Result: The updates provide additional insights into the factors the DOJ is...more
6/11/2020
/ Anti-Corruption ,
Chief Compliance Officers ,
Compliance ,
Compliance Management Systems ,
Corporate Governance ,
Department of Justice (DOJ) ,
Internal Controls ,
Risk Assessment ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Strategic Planning ,
White Collar Crimes
The Situation: A provision in the False Claims Act ("FCA") had clarified when Anti-Kickback Statute ("AKS") violations can make a claim false, but the provision's rule of per se falsity does not answer when a claim "result[s]...more
2/1/2018
/ Anti-Kickback Statute ,
Appeals ,
Charitable Donations ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Physicians ,
Relators ,
Stark Law ,
Summary Judgment
The Situation: A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements of the False Claims Act.
The Result: Coyne v. Amgen is...more
1/15/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
Health Care Providers ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Prescription Drugs ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more
11/28/2017
/ Acquiescence ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Statements ,
Government Knowledge Defense ,
Material Misstatements ,
Materiality ,
Medicare Part D ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar