Value Frameworks: Are They the Way of the Future?
Pharmaceutical companies have long been dealing with negative press about the supposed “rise of prescription drug costs.” Now,…
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AseraCare – Even Courts Seek Second Medical Opinions
In the AseraCare case, the United States Department of Justice (DOJ) sought to show that AseraCare submitted false claims. Relying…
Mylan CEO Under Fire at House Hearing
Two weeks ago, in the midst of the hubbub surrounding Mylan and its EpiPen, Jason Chaffetz and Elijah Cummings, Chairman and…
Kaiser Family Foundation Releases Report on Medicare Part D Trends
Late last week, the Kaiser Family Foundation (KFF) released a new report, “Medicare Part D in 2016 and Trends over Time.” The…
FDA Offers Update to Orange Book Website
In August 2016, the Food and Drug Administration (FDA) launched an updated web-based version of its “Orange Book,” the publication…
As If the DOJ Weren’t Enough – Shareholders Are Increasingly Quick to Sue…
Recent plaintiff wins in lawsuits against life sciences companies seeking to recover lost shareholder value resulting from…
PDUFA IV: Full Steam Ahead?
On July 15, 2016, the Food and Drug Administration (FDA) released a forty-six page document outlining how the FDA will use the…
Legislation Introduced to Modify Hospital Quality Star Ratings Release
We have previously covered another of CMS’ transparency initiatives—its hospital star ratings—and some of the concerns industry…
On a Collision Course – FDA Clinical Investigator Disclosure and Open…
FDA’s requirements for clinical investigator d closure and the Open Payments requirements are at odds in many ways. This article…
New Rule and Guidance Issued on Clinical Trials
Clinical trials are one of the most visible components of the biomedical research field, in part due to the way they directly…