Judith O'Grady on Healthcare

Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context

On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more

5/28/2024 / Accelerated Examination Program , FDA Approval , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Pharmaceutical Industry , Prescription Drugs

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

12/11/2023 / Advertising , Anti-Kickback Statute , Department of Justice (DOJ) , False Claims Act (FCA) , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Marketing , Misleading Statements , Pharmaceutical Industry , Prescription Drugs , Social Media

FDA Issues New Draft Guidance for Unapproved Use Communications

On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

10/26/2023 / Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturers , Medical Devices , Patient Privacy Rights , Pharmaceutical Industry

CMS Publishes Final Rule on Civil Monetary Penalties for Section 111 Reporting

The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more

10/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Civil Monetary Penalty , Final Rules , Healthcare , Healthcare Reform , Medicaid , Medicare , Reporting Requirements

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

11/18/2015 / Healthcare , Medicaid , Medical Devices , Medicare , Section 340B , Work Plans

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

10/26/2015 / Affordable Care Act , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs , Section 340B

Non-Group Health Plan MMSEA Section 111 Reporting Updates

The Centers for Medicare and Medicaid Services (CMS) recently made several announcements regarding Medicare, Medicaid, and SCHIP Extension Act (MMSEA) Section 111 reporting for Non-Group Health Plans (NGHPs). Originally...more

7/28/2015 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Healthcare , Medicaid , Medicare , Reporting Requirements

OIG Work Plan Midyear Update Adds Activities Related to Medicare Part D and Medicaid Rebates

The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more

6/15/2015 / Department of Health and Human Services (HHS) , Healthcare , Medicaid , Medicaid Reimbursements , Medicare , Medicare Part D , OIG , Payor Contracts , Pharmaceutical Industry , Pharmacies , Reporting Requirements

Judith O'Grady

Troutman Pepper

Popular Topics by This Author

Latest Posts › Healthcare