Tag Archives: FDA

The OIG Work plan: Potential Implications for Medical Device Manufacturers and Suppliers

By Rosemary Weghorst

The OIG plan for 2015, re-released in May, with updates from the plan that was released in October 2014, demonstrates a pattern of what we have seen in the past, as well as the addition of a few new items. Of note, the OIG will continue its investigative actions focused around their strike force teams (formed in 2007) and the Health Care Fraud Prevention and Enforcement Action Team (HEAT) (started in 2009). The OIG highlighted that their strike force activities from October 1, 2014 to March 21, 2015 have resulted in more than $163 million in fines and charges against 69 individuals or entities. The OIG will also continue to investigate companies that manipulate payment codes and submit false claims, as well as review business arrangements that could violate the Anti-Kickback Statute.

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Regulatory and Compliance Implications of Orphan Drugs

By Edward J. Buthusiem & Gary F. Miller, Jr.

Providing incentives to spur the development of new and novel drugs to combat rare diseases has historically posed a challenge to drug manufacturers, the FDA, the medical community, and—most important—patients afflicted with these diseases. Given the high and ever-increasing costs and challenges of drug development, combined with the relatively small number of patients that would be eligible to receive such treatments—which limits a company’s ability to recoup its R&D investment—pharmaceutical manufacturers have struggled with the economics of rare-disease drug development. The Orphan Drug Act, passed in 1983, was designed to address these concerns by providing incentives for pharmaceutical companies to develop drugs for uses for rare disorders or conditions. While the act was well intended, its application in practice has generated speed bumps as companies try to navigate through the waters of government reimbursement programs applicable to these drugs, as well as an unpredictable and often inconsistent DOJ enforcement pattern.

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