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.
Assessing your 2015 Compliance Goals
It is hard to believe that we are half way through the year. Now entering prime vacation season, the office tends to be a little quieter and the work flow slower. This brief reprieve from the office hustle and bustle provides compliance professionals a great opportunity to look back at what has been accomplished thus far this year and prepare for what is to come as we quickly move into the second half of the year. Whether you started the year by conducting a formal risk assessment and prepared a formal remediation and compliance plan, or simply jotted some compliance goals on the office whiteboard, now is the perfect time to check the boxes on the tasks that were completed and see what is left to do. It is also important to ensure the plan you put in place at the beginning of the year still “makes sense” both based on your internal business environment as well as enforcement trends and expectations for the year made known by government agencies such as the DOJ and OIG. Taking advantage of the slower summer to do these things now will prove invaluable so that you can hit the ground running in the fall with a focused and achievable compliance game plan that will allow you to check the boxes all the way down your list.
The sale and use of counterfeit medicines pose a real and potent threat to global health and commerce. Over the past decade, the threat of counterfeit medicines has increased, with incidents of counterfeiting reported in 123 nations. One watchdog group documented 2,193 incidents of pharmaceutical crime in 2013 alone, representing almost a 9 percent increase from 2012. This rise can be attributed largely to the growing online pharmaceutical marketplace that enables counterfeit drugs to permeate households. Counterfeit pharmaceuticals often lack active ingredients, depriving the patient of the medication they need. Even worse, counterfeit drugs have been found to contain poisons such as arsenic, shoe polish, nickel, and leaded road paint. While many counterfeits reach patients through online markets, these falsified medications have also penetrated legal supply chains.
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.
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.
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.
U.S. legislators and enforcement agencies have grown increasingly concerned with physician-owned distributors (PODs) and their relationship with hospitals and other providers. Because physicians may refer patients to hospitals—and use specific products in connection with such referrals—the government asserts that PODs have the potential to unduly influence physician decision making, encourage overutilization of certain products and services, create unfair competition and otherwise increase unnecessary healthcare spending by Federal programs.
U.S. and global regulators heavily scrutinize financial arrangements between healthcare professionals (HCPs) and life sciences companies, including orthopaedic manufacturers and distributors. Recent prosecutions and settlements involving drug and device manufacturers frequently allege that certain payments and other incentives provided to physicians are being improperly made in order to promote their products. Indeed, several prominent medical device companies have been subject to investigations and corporate integrity agreements stemming from alleged improper consulting payment arrangements with physicians.[^1]