Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.

May

2018

May 2018: Life Science Compliance Update

Written by , Posted in Home page, May 2018 LSC Update, This Month in Compliance

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It’s Not Just Money – Theranos & SEC Come to Terms
By Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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On March 14, 2018, the SEC charged Theranos and two of its executives in Silicon Valley with raising more than $700 million from investors through a fraud in which they exaggerated or made false statements about the company’s technology, business, and financial performance. Even though Theranos was a private company, the SEC settlement stands as a cautionary tale to those life science companies seeking financing.

May 2018 Issue Summary

May 2018 LSCU Cover

This definitely is not a slow compliance year and here at the Update, we’ve been busy sifting through all the activities. This month we are featuring an EXCLUSIVE – coverage of GREG DEMSKE’S recent talk at Mitchell Hamline’s Health Law Institute Symposium. We have heard many OIG PRESENTATIONS over the years, but this one was decidedly different.

Carrying on with enforcement, Nicodemo Fiorentino has examined the recent Federal INDICTMENT of five, prominent NEW YORK PHYSICIANS and found the CONNECTION between the ALLEGATIONS and what was reported in OPEN PAYMENTS. We also have taken a look at the recent THERANOS settlement and the SEC noting that even PRIVATE COMPANIES with no marketed products need to be careful with their PUBLIC STATEMENTS.

Shifting gears to the FDA, we have two articles covering the new guidance on HEALTH INFORMATION collected by MEDICAL DEVICES and the new DRAFT GUIDANCE for COMPOUNDING PHARMACIES.

Finally, we finish up with an UPDATE on ALLERGAN’S apparently discredited strategy of using NATIVE AMERICAN TRIBES to expand patent protection.


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Not Your Average OIG Presentation – Greg Demske Defines A “Successful” OIG Based On Fairness, Communication, And Compliance At The Mitchell Hamline Symposium
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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Recently Greg Demske, Chief Counsel for the Department of Health and Human Services Office of Inspector General provided the keynote address at Mitchell Hamline’s Health Law Institute Symposium, “Hot Topics in Healthcare Compliance.” His speech was noteworthy not because he announced new policies, but rather for its focus and key messages of fairness, communication and compliance.

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Open Payments & Kickbacks: Are Indicted Physicians on Your Company’s Payroll?
Nicodemo Fiorentino, Esq.
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This article uses Open Payments data from the government’s publicly available database to provide a different way of reading the U.S. Government’s recent unsealing of a criminal indictment. The indictment alleges five (5) New York licensed physicians violated, among other laws, the Federal Anti-Kickback Statute for their participation in accepting speaker program fees and other payments in return for prescribing a fentanyl product indicated for the management of breakthrough pain in cancer patients. Additionally, the Government provides evidence that the pharmaceutical company lacked the ability to ensure compliance with U.S. fraud and abuse laws. Compliance and legal departments will want to carefully review the indictment and watch the case closely. It may turn out to be a test case for the Centers for Medicare & Medicaid Services to finally enforce the Physician Payments Sunshine Act and implementing regulations.

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The Intersection Between Patients, Health Information And Devices – New FDA Guidance Attempts To Prevent A Traffic Accident
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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The rapid of expansion of connected medical devices producing patient-specific health information is the focus of a new FDA guidance document. This article explores the requirements in the guidance and what impact it might have on medical device manufacturers.

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The Wheels of Time Grind Slowly – FDA Issues Draft Guidance For Compound Pharmacy Outsourcing Facilities
Carolyn Greene
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In response to concerns about the safety of compounded drugs, particularly those produced in bulk, Congress passed the DQSA which amended the FFDCA to create a new category of compound pharmacies referred to as “outsourcing facilities.” Outsourcing facilities are subject to heightened FDA regulatory authority compared to traditional compound pharmacies. The FDA has just issued a Draft Guidance outlining some of the new regulations relevant to outsourcing facilities. These regulations limit the drugs that outsourcing facilities may produce in bulk quantities.

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Update – Allergan’s Patent Transfer To Native Americans Lacks Merit
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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In an effort to preclude competitors including generic drug companies from entering the market, many pharmaceutical companies, most notably Allergan PLC (“Allergan”) with its dry-eye medication Restasis has sought to enter into patent transfers with Native American Tribes, taking advantage of sovereign Indian Nation status to thwart off intellectual property challenges and create additional barriers to market entry. In October 2017, a U.S. Federal Court dismissed Allergan’s lawsuit seeking to enforce its Native-American patent partnership, taking issue with Allergan’s seeking to stifle competition by way of seeking refuge by way of Native American sovereign immunity. Seeking further legal relief from the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office (“USPTO”), Allergan’s latest efforts to invoke sovereign immunity as the basis to limit generic drug competition has similarly failed.

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