Life Science Compliance Update

October 31, 2017

Will Your Whistle Be Heard at Home?

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The distinct split between the Second and Fifth Circuit Courts’ interpretation as to when whistleblower protections are allowed has now summoned the attention of the U.S. Supreme Court. Despite clarifications issued in 2015 by the SEC to shed more clarity on Dodd Frank’s anti-retaliation protection to whistleblowers who reported alleged misconduct either internally to company officials or externally to government regulatory bodies, the U.S. Supreme Court will take the case of Digital Realty Trust v. Somer in the Fall of 2017, and finally render a final verdict for when whistleblower protection becomes enforceable. During the interim, it becomes vital for Compliance Officers to have appropriate policies and procedures in place to guide employees in reporting potential misconduct and/or fraud, and to establish a tone of non-retaliation for such reporting, in order to safeguard the best interests of the public and shareholders of the company.

As a result of the financial crisis during 2007-2010, the Dodd- Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”) was signed into federal law in July 2010 by President Obama to prevent the economic “meltdown” from happening again.

Ostensibly, the legislation was primarily designed to increase overall regulation of the financial industry. However, and perhaps more importantly for compliance professionals, Dodd-Frank also contained a number of enhanced provisions designed to encourage and protect whistleblowers in and outside of the financial industry. These new provisions expanded upon earlier provisions contained in the Sarbanes- Oxley Act of 2002 (“SOX”).

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October 30, 2017

Getting Serious About Fraud - The DOJ Charges 412


With the new administration, there appears to be a renewed commitment to enforcing anti-kickback rules against healthcare providers committing fraud against the government insurance programs. In July 2017, the Department of Justice and Department of Health and Human Services announced the largest-ever fraud takedown in the health care arena. This article outlines the announcement, and what it may mean for the future of health care.

It has long been a topic of discussion among life science compliance professionals that when it comes to anti-kickback enforcement, the government favors prosecuting manufacturers and healthcare institutions over individual providers. The speculation was that those two categories were favored because of their deep pockets. However, that old rubric just may have changed.

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October 27, 2017

UPDATE: Round 2 with Ohio’s Drug Sample Verification Requirements


In the September issue of the Life Science Compliance Update, the authors discussed the new Ohio drug distribution verification requirements that impact non-controlled prescription drug sampling. This article provides an update with new information from the Ohio State Board of Pharmacy, as well as a one-page “cheat sheet” of those requirements.

The following synopsis provides an update to the article, Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain. In addition, this update provides new data, a one-page “cheat sheet” for non-controlled prescription drug sample distribution into and within the state that also includes the supporting references and an example of a sample/complimentary request form. Finally, this update is limited to a discussion on the non-controlled verification requirements for samples and complimentary supplies only.

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