On December 17, the U.S. Department of Justice, in an unprecedented application of its statutory authority under section 3730(c)(2)(A) of the False Claims Act, moved to dismiss 11 qui tam complaints pending in district courts...more
12/20/2018
/ Corruption ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Kickbacks ,
Medical Reimbursement ,
Pharmaceutical Industry ,
Qui Tam ,
White Collar Crimes
The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more
1/31/2017
/ Comment Period ,
Draft Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Health Care Providers ,
Healthcare ,
Labeling ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Payor Contracts ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Public Health ,
Required Communications