Life Science Compliance Update

March 28, 2017

A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure

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In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.

In the final days of the Obama Administration, the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) issued over a dozen draft and final guidance documents. It appears the CDRH was anticipating that this might be its last chance to issue formal guidance to the industry before the Trump Administration imposed its much talked about regulatory slowdown. CDRH’s new guidance documents address a broad range of topics including: investigational device exemptions, cybersecurity, combination products, postmarket surveillance, and medical product communication.

 

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March 22, 2017

Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?

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Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the second in the two-part series.

Although adapting to changes in regulatory environment and technology has always been a necessary skill of successful life science compliance officers, few would argue that there has been a more challenging and uncertain environment faced by these professionals as 2017 begins. From rapidly changing communications technology to the uncertain future of the Affordable Care Act, to the unpredictable nature of a Donald J. Trump presidency, several factors will impact the life sciences industry in 2017 and beyond, and sound strategies will be necessary to mitigate the risk to companies in the industry. The following discussion specifically highlights how social media platforms and cyber security pose a significant risk.

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March 20, 2017

Accountability: The shifting landscape of compliance responsibilities

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The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.

Now that we are two months into the new year, this is a good time to reflect and examine the effectiveness of healthcare compliance programs. The measure of what “effective” means has changed dramatically in recent years. When the PhRMA Code on Interactions With Health Care Professionals (“Code”) was published in 2002, and for many years after, effectiveness was essentially defined by a company’s compliance department as adhering to the OIG’s Seven Elements of an Effective Compliance Program, as well as providing review and approval of individual activities or transactions. It was essentially the compliance department’s responsibility to “police” the organization and prevent them from making poor decisions. Today’s measure of effectiveness still hinges on decision-making, but the accountability is more squarely placed on the shoulders of the decision makers.

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