Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
9/9/2021
/ Criminal Investigations ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Falsified Documents ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Product Defects ,
Qui Tam ,
Whistleblowers
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
8/18/2021
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fifth Amendment ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Product Labels ,
Safe Harbors
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
7/15/2020
/ Coronavirus/COVID-19 ,
Domestic Corporations ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rating System ,
Re-Opening Guidelines ,
Risk Assessment ,
Safety Inspections ,
Tobacco Regulations
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
1/24/2020
/ Anti-Kickback Statute ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Costs ,
Imports ,
Innovation ,
Legislative Agendas ,
Life Sciences ,
Medical Devices ,
Medicare Part D ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Proposed Legislation ,
Settlement Agreements ,
State Legislatures ,
Trump Administration
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
12/2/2019
/ Anti-Kickback Statute ,
Big Data ,
CDRH ,
Charitable Organizations ,
Co-payments ,
Data Privacy ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Disgorgement ,
Drug Pricing ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Lanham Act ,
Life Sciences ,
Medical Devices ,
NAD ,
Off-Label Promotion ,
OIG ,
OPDP ,
Pharmaceutical Industry ,
Physician Compensation Arrangements ,
Pleading Standards ,
POM Wonderful v Coca Cola ,
REMS ,
RICO ,
Risk Assessment ,
Risk Management ,
SCOTUS ,
Tobacco