On June 1, the U.S. Supreme Court published a unanimous decision in a False Claims Act (FCA) case, United States ex rel. Schutte v. SuperValu, Inc., No. 21-1326. The opinion, authored by Justice Clarence Thomas, was notable...more
With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more
4/23/2020
/ Coronavirus/COVID-19 ,
Drug Compounding ,
Drug Distribution ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Relief Measures ,
Suppliers ,
Supply Chain
Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more
2/26/2020
/ Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Manufacturers ,
Orange Book ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
Prescription Drugs ,
Statutory Violations
In July, The Washington Post published data showing approximately 76 billion oxycodone and hydrocodone pills were purchased and sold in the Unites States from 2006 to 2012. The data came from the Automation of Reports and...more
8/24/2019
/ Attorney-Client Privilege ,
Controlled Substances ,
Criminal Investigations ,
Data Management ,
DEA ,
Department of Justice (DOJ) ,
Drug & Alcohol Abuse ,
Drug Distribution ,
Failure to Comply ,
Government Investigations ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Reputation Management ,
Substance Abuse
On April 23, federal prosecutors announced the first-ever felony charges against a drug distributor — Rochester Drug Co-Operative, Inc. (RDC) — and two of its executives for illegally distributing opioid painkillers....more
5/10/2019
/ Controlled Substances Act ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Felonies ,
Life Sciences ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
White Collar Crimes
On April 3, FDA Commissioner Scott Gottlieb released a statement outlining the agency’s priorities for 2019 with respect to compounding pharmacies and the compounding industry.
...more
On March 25, the U.S. Department of Justice (DOJ) announced that Duke University agreed to settle a False Claims Act qui tam action alleging widespread misconduct in federally funded research. ...more
4/3/2019
/ Department of Justice (DOJ) ,
Environmental Protection Agency (EPA) ,
False Claims Act (FCA) ,
Falsified Documents ,
Federal Funding ,
Grants ,
Medical Research ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
Settlement Agreements ,
Universities ,
Whistleblowers