Three Pharma Companies Sue HHS, Judge Rules in Their Favor
In June 2019, several drug manufacturers filed a lawsuit against the United States Department of Health and Human Services (HHS)…
Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Monthly Archives
July 2019
SCOTUS Rules Judge Should Decide Merck Labeling Case
Right before their term ended, the Supreme Court of the United States issued a ruling in Merck Sharp & Dohme Corp. v. Albrecht…
New FDA Draft Guidance on Opioid Benefit-Risk Assessment Includes…
Recently, the US Food and Drug Administration (“FDA”) published a new draft guidance entitled Opioid Analgesic Drugs:…
Insys $225 Million Settlement and Corporate Integrity Agreement
Last month, buried in all the other Insys news, was the news that Insys Therapeutics agreed to pay $225 million and plead guilty…
Idaho Prescription Monitoring Program Monthly Manufacturer Reports for…
The State of Idaho recently sent out a letter to drug distributors, reminding companies of the law that went into effect on April…
Update: Econometrica and Open Payments Oversight
You may recall back in October 2018 when we wrote a short article on the contract the Centers for Medicare and Medicaid Services…
Senators Grassley and Wyden Expand Their Opioid Investigation to Tax-Exempt…
In 2012 Senators Grassley and Baucus sent letters to the American Pain Society and other pain-related organizations including the…
Study Shows that Patients’ Out-of-Pocket Costs for Neurology Drugs Have…
The journal Neurology recently published an article by lead author Brian Callaghan, MD at the University of Michigan, reporting…
FDA Issues Advertising Warning Letter to Vivus
The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second untitled letter of the year to California drugmaker Vivus…
HHS OIG Report: Using Health IT for Care Coordination
Recently, the Office of the Inspector General published a report, “Using Health IT for Care Coordination: Insights From Six…