Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more
1/6/2023
/ Consolidated Appropriations Act (CAA) ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCEI ,
Information Sharing ,
Joe Biden ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry
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
The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more
2/5/2019
/ Amended Rules ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors