Life Science Compliance Update



June 2018: Life Science Compliance Update

Written by , Posted in June 2018 LSC Update, This Month in Compliance

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Looking Back – Reviewing OIG’S Report On The Top Management & Performance Challenges For HHS
By Gwendolyn Ball
Greg Demske’s recent keynote address at Mitchell Hamline’s Health Law Institute Symposium and the OIG’s report on the top management challenges facing HHS published in 2017 provide a remarkably consistent picture of the OIG’s focus and direction. As this article highlights there are no magic bullets to address those challenges.

June 2018 Issue Summary

June 2018 LSCU Cover

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.”


Everything Old is New Again – McKesson Accused of Skimming Cancer Meds in FCA Suit
Carolyn Greene, Esq.
In response to concerns about the provenance of cancer drugs its providers received from McKesson, Omni has filed an FCA suit alleging that McKesson engaged in a scheme to increase profits illegally on cancer drugs. Specifically, Omni asserts that McKesson harvested and pooled overfill from single-use vials of cancer medications. McKesson then re-packaged these cancer drugs into pre-filled syringes. By collecting the overfill, Omni alleges that McKesson increased the number of doses of the cancer medications. This practice led to adulteration of the drugs themselves, as well as the submission of fraudulent claims to various government agencies for reimbursement on these extra doses of drugs created from the overfill. This case is yet another example of the re-occurring themes of overfill harvesting and “playing the spread” in conjunction with submission of fraudulent claims to the federal government for pharmaceutical reimbursement.


Finding The Golden Nuggets – OIG-HCCA Recommendations For Smaller Life Science Companies
Carla-Marie Ulerie, Eric Davis, and Jon Wilkenfeld
Recently the OIG and the HCCA published a resource guide with recommendations for determining if a compliance program is effective. Since small to mid-sized pharma and medical device companies typically operate with limited compliance staff and financial resources, we identified recommendations that were relatively easy or low cost to implement but were rarely adopted. Based on our review we have determined the “golden nuggets” from that guide.


Maryland Loses Rx Price Gouging Law But Not The Debate
Nicodemo (Nico) Fiorentino, Esq.
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Recently the United States Court of Appeals for the Fourth Circuit overturned Maryland’s law prohibiting price gouging for essential off–patent or generic drugs. This article highlights Maryland’s first-in-the-nation prescription drug price gouging legislation, key points to the commerce clause, and the impact the court’s ruling has on similarly proposed legislation throughout the country.


Where In The World Is OPDP? Where In The World Is OPDP?
Kaitlin Fallon Wildoner, Esq. and Seth B. Whitelaw, J.D., LL.M, S.J.D.
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OPDP enforcement activities have sharply declined over the past several years. That trend continues in 2018 as OPDP has only issued one letter involving opioids and a conference booth. This article looks at the trend, reviews the most recent letter and tries to determine what this means for compliance and regulatory professionals.


Solving The Problems With Drug Compounding – Sparse Data And An Inconsistent Regulatory Framework Muddy The Waters
Carolyn Greene
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At least partly in response to the 2012 fungal meningitis outbreak, Congress passed the DQSA to increase federal regulatory authority over compound pharmacies. Many states also joined in the increased FDA regulatory oversight, strengthening their quality requirements. Data on compound drug quality is limited, but the data that does exist depicts an industry with a substantial number of quality and safety problems, potentially endangering the health of millions of Americans. The compound pharmacy industry isn’t helping matters – instead, they insist that compound drugs are safe. Since the passage of the DQSA, significant improvements have been made in the quality and safety of compound drugs, but much work remains.

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