Life Science Compliance Update

October 25, 2017

The Expanding Frontier - Commercial Interactions with Patients and Patient Organizations


Over the past two decades, the role that patients play in their health care has dramatically shifted. As a result, there is an increasing need and drive by life science companies to engage with patients (e.g., patient centricity). However, this approach is not without risk as this article will explore.

Over the previous two decades, we have seen a dramatic and transformative change in the role that patients play their health care. Your grandparents, and even your parents, generally were passive players in their care, content to let their “better informed” physicians (“Doctor knows best”) make most of the treatment decisions for them. They confined their roles to making appointments submitting to diagnostic tests, getting prescriptions filled (at a retail pharmacy or via mail order), and contacting their physicians to get renewals and refills thereby ensuring they stayed on treatment. Some, but not all, of this passivity can be attributed to a health insurance scheme that had less “friction” caused by financial-burden decisions. That’s all changed.

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October 23, 2017

Coming Soon to a State or Even City Near You - Part 1 Pricing Transparency


As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The truth of the matter is that the industry is losing ground and leadership within companies cannot begin to sacrifice their compliance and legal departments.

It is a basic principle of physics that nature abhors a vacuum, and thus will move quickly to fill the void. The same is true in the compliance world. Since the implementation of the Open Payments system, the Federal government has done little with the data other than post it. Nor has Congress attempted to address other pharmaceutical related issues like pricing.

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October 20, 2017

The Never-Ending Saga of Off-label Promotion


The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as well as the growing need for data-driven medicine, the agency has been under pressure more than ever to update their regulatory position. This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.

As the Update reported in the August 2017 issue, the U.S. Food and Drug Administration's (“FDA’s”) 23rd Commissioner, Dr. Scott Gottlieb recognizes and indeed publicly acknowledges FDA’s long-standing practice of medicine exception noting that “while the FDA may limit what drug companies may say about their products to the uses that appear on the drug’s official label, physicians may prescribe their drugs for any condition they choose.” He further stated during his confirmation hearings “that doctors are appropriately trained to make medical decisions based on the best interest of their patients.” Consequently, prescribing medicines off label is a common practice, but with life science companies prohibited from sharing information about off-label uses, do physicians get the best available information to make sound clinical decisions?

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