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June 2018 Issue Free Article
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By Gwendolyn Ball
Tags: OIG report
June 2018 Issue Summary
As we noted last month, despite the political climate in Washington, life science compliance shows no signs of slowing down. Here at the Update the writers and editorial staff have been busy shifting through all the developments.
For June, we start out examining MCKESSON’S latest compliance challenge involving allegations of REPACKAGING the overfill from SINGLE-USE VIALS to improve margins but violate the FALSE CLAIMS ACT. Later on, we take a look at the defeat of Maryland’s pharmaceutical price gouging law for violating the Commerce Clause.
Potomac River Partners takes another look at the OIG-HCCA guidance but from a SMALLER COMPANY’S perspective, and we follow that up with OIG’s thoughts around the TOP MANAGEMENT CHALLENGES facing HHS.
In the area of recurring themes, we take a look at OPDP’s lack of OFF-LABEL activities in 2018 and examine the continuing debate over regulating COMPOUNDING PHARMACIES from the perspective of trying to MEASURE the “PROBLEM.”
Carolyn Greene, Esq.
Tags: False claims act
Carla-Marie Ulerie, Eric Davis, and Jon Wilkenfeld
Tags: OIG guidance
Nicodemo (Nico) Fiorentino, Esq.
Tags: Drug pricing, Transparency
Kaitlin Fallon Wildoner, Esq. and Seth B. Whitelaw, J.D., LL.M, S.J.D.
Tags: Off-label, OPDP
Tags: Compounding, Pharmacy