Tag Archives: Gary F. Miller

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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Recent Trends in Whistleblower Protection under Dodd–Frank

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

The enactment of the Dodd–Frank Act was intended to provide the SEC with an important weapon in its mission to seek and vigorously prosecute the commission of securities and other types of frauds domestically and overseas. By providing to whistleblowers monetary incentives ranging between 10 percent and 30 percent of fines assessed, the whistleblower program has gained an element of popularity—some would say notoriety—amongst would-be reporters of putative wrongdoing. Recent Federal Court decisions, however, have created significant roadblocks that could blunt the Dodd–Frank juggernaut.

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