Life Science Compliance Update

April 14, 2017

340B and You: Thoughts on Program Oversight for Pharmaceutical Manufacturers

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The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services primarily to entities that serve low-income populations. The program also is complex and evolving, so compliance challenges will abound for years to come. This article examines those complexities and compliance challenges.

The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services primarily to Disproportionate Share Hospitals (“DSH”), outpatient clinics associated with DSHs, and other entities that serve low-income populations. According to the Government Accountability Office (“GAO”), the program accounts for an estimated 2% of medicines purchased in the United States, approximately $6 billion annually. The 340B Drug Discount Program is a U.S. federal government program created under the Veterans Health Care Act of 1992 (“VHCA”) and administered by the Office of Pharmacy Affairs (OPA) within the Health Resources and Services Administration (“HRSA”). According to the HRSA website:

The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services...

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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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