Life Science Compliance Update

February 27, 2017

FDA’s Meeting on Promotion - Can We Glimpse the Future?

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In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.

It is no secret that ever since the Coronia case, the United States Food and Drug Administration (“FDA”) has been working on a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved/cleared medical products. These are products that are approved to be marketed for a particular use, but physicians and healthcare professionals have discovered other uses for the product that the FDA has not approved (e.g., unapproved use). The question dogging the FDA is whether a manufacturer may legally discuss the unapproved use with healthcare professionals beyond merely responding to a question if the information being imparted is both truthful and not misleading.

Read the full article in the February 2017 issue of Life Science Compliance Update

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February 24, 2017

Are the Safe Harbors Still Safe? - OIG Issues Final Rule

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The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.

On December 7, 2016, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule, revising safe harbors under the Anti-Kickback Statute (“AKS”). At the same time, the OIG revised the definition of “remuneration” under the Civil Monetary Penalty (“CMP”) rules regarding beneficiary inducements. As has always been the case, the safe harbor revisions will prevent certain initiatives of doctors, hospitals, and pharmacies from being treated as fraudulent kickbacks by Medicare and Medicaid. The final rule took effect January 6, 2017.

Read the full article in the February 2017 issue of Life Science Compliance Update

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February 22, 2017

Valeant and Philidor Controversy Comes to a Head

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Valeant Pharmaceuticals, Inc. has had quite the year - they have been under scrutiny since October 2015. However, in November 2016, one former Valeant executive and one former Philidor executive, were arrested and charged with criminal complaints. This article outlines those complaints, and the actions the individuals allegedly took to be criminally charged. 

It all started back in October 2015, when a short seller alleged that there was something inappropriate with the relationship between Valeant Pharmaceuticals and its closely linked specialty pharmacy, Philidor. Members of Wall Street – among others – thought that Valeant’s CEO Michael Pearson had a new plan: to create a drug company that focuses on distribution, and let someone else do the research. While controversial, the plan seemed to work for some time, as Valeant’s stock rose to an all-time high of $260.00 per share. What a difference a year makes. Now Valeant stock is trading around $14.00 per share.

Read the full article in the February 2017 issue of Life Science Compliance Update

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