For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more
9/21/2016
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Classification ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Manufacturers ,
MDRP ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Rebates
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
7/6/2016
/ Antitrust Litigation ,
Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Injunctive Relief ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Price Transparency ,
Proposed Legislation ,
REMS ,
Research and Development ,
Senate Judiciary Committee