FDA Outlines Plans for Medical Devices with AI
We frequently hear the buzz word “AI” (artificial intelligence), usually coupled with how it’s coming for our jobs and how…
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April 2019
FDA Defends Oversight of Generic Drugs
In response to reports questioning the FDA’s inspections and oversight of generic drugs, FDA Commissioner Scott Gottlieb and…
Oklahoma Medicaid Payment Reform: Success or Bust?
Oklahoma’s experimental Medicaid program is increasingly seen as a warning for the proponents of value-based pharmaceutical…
CMS Turns Focus to Transparency
In mid-February 2019, at the American Medical Association’s National Advocacy Conference, Demetrios Kouzoukas, principal deputy…
SCOTUS Declines to Get Involved in Maryland Drug “Price Gouging” Law
Earlier this year, the Supreme Court of the United States declined to hear a case involving a Maryland law that attempted to…
DOJ Hits Three Companies with FCA Settlements for Co-Pay Assistance…
On April 4, 2019, the Department of Justice announced settlements with three different pharmaceutical companies over allegations…
Duke Agrees to Pay $112.5 Million in False Claims Act Settlement Related to…
Late last month, it was announced that Duke University agreed to settle with the Department of Justice (DOJ) a case involving…
JAMA Article Outlines REMS Failure, Suggests Reforms
In a recent JAMA article, “Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release…
Imported Drugs from Canada? Maybe in Florida
In February 2019, during a news conference at The Villages, Florida Governor Ron DeSantis proposed importing Canadian prescription…
HHS Inspector General Stepping Down Next Month
Daniel Levinson, the inspector general of the United States Department of Health and Human Services (HHS) recently announced that…