Thursday, January 30, 2014

Policy and Medicine Blog--Pharmaceutical and Device Healthcare Fraud: Enforcement Perspectives for 2014

CBI's Pharmaceutical Compliance Congress started off both mornings of their two day conference with a matter sure to get industry members' attention: enforcement. A variety of government attorneys offered a glimpse into their approach to healthcare fraud, and shared insights into what they consider to be best practices regarding compliance. Carmen Ortiz, U.S. Attorney for the District of Massachusetts, began by highlighting the high priority areas of 2014. The "enforcement panel" of five government attorneys followed, splitting their time between healthcare fraud on the one hand, and the importance of robust compliance programs on the other. On Wednesday, Assistant Attorney General, Stuart Delery, spoke regarding civil enforcement and non-monetary penalties the Department of Justice (DOJ) has utilized See more here

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MUST READ Interview with Jane Axelrad, CDER's associate director for policy---FDA News FDA to Partner with States on Compounding Oversight

Jane Axelrad, CDER’s associate director for policy, spoke with Drug Daily Bulletin to discuss the FDA’s strategy for regulating compounding pharmacies following the recent passage of the Drug Quality and Security Act.

FDAnews: What is the greatest challenge the FDA faces as it sets out to regulate the compounding industry with its new authorities?
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