On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more
10/1/2020
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Preamble ,
Proposed Rules ,
Repeal ,
Totality of Circumstances Test
On April 30, the Criminal Division of the Department of Justice released an update to the Fraud Section’s February 2017 guidance document titled “Evaluation of Corporate Compliance Programs.” ...more
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
5/13/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Free Speech ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Regulatory Oversight ,
Statutory Authority ,
Television Commercials ,
Trump Administration
The pharmacy benefit manager (PBM) industry recently has come under significant scrutiny by the Trump administration....more
2/8/2019
/ Advertising ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Claims Act (FCA) ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Safe Harbors ,
Trump Administration