Temple Law School has launched the Temple Law Center for Compliance and Ethics, designed to prepare professionals and students to better understand and respond to the legal, regulatory, and ethical issues facing today’s corporate compliance professionals. Edward Buthusiem chairs the Law School’s Advisory Board for the center.
In today’s life sciences industry, mergers and acquisitions are becoming ever more prevalent as a means to ensure that strategic, operational, and financial goals are met, and that customers and patients have the products they need. The planning and execution of a partnership is often vetted thoroughly in terms of complementary product lines, financial goals, strategy for market presence, and access for those who need it.
So your Board of Directors and senior management just handed you the keys to a brand-new, shiny compliance program. It conforms to the seven elements of the OIG Guidance for implementing an effective compliance plan. You’ve been designated as the chief compliance officer with single-point accountability for managing the day-to-day operations of the compliance program (No. 1). You’ve approved written policies and procedures for implementing your compliance program (No. 2). You’ve developed and trained all relevant personnel on your compliance program (No. 3). You’ve implemented a hotline for employees to anonymously report putative compliance violations (No. 4). You’ve developed a comprehensive auditing and monitoring program, in partnership with Internal Audit and the company’s external auditors (No. 5). You’ve created a program to investigate and take corrective actions to remediate credible allegations (No. 6). And finally, you’ve demonstrated a track record of taking disciplinary action against transgressors (No. 7).
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.
Mistakes are common. We all make them. According to my teenage kids, I make mistakes every single day! Some mistakes are benign; no one gets hurt. But some mistakes are costly and can lead to potentially catastrophic results. Whereas some individuals may have the luxury of making the same mistake twice, for many a single mistake may cause irreparable harm. Nowhere is this more evident than in the compliance field.