Life Science Compliance Update

June 23, 2017

Chicago’s Attempt to Regulate Drug Reps - A Real Public Health Initiative or Simple Revenue Generator?


Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

The origins of the Chicago ordinance date back to October 2016. The city faced with increasing crime and overdose rates tied to illegal drugs needed to do something. As a result, Mayor Rahm Emmanuel announced new initiatives to combat heroin addiction in Cook County based on recommendations developed by a Task Force. Part of those initiatives was increasing the regulation of pharmaceutical representatives working within Chicago.

It is interesting to note that nowhere in the recommendations of the Task Force was there a call for licensing pharmaceutical representatives. However, the Mayor in his press releases stated that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction. The Illinois Attorney General echoed this sentiment. “I support the City’s efforts to license pharmaceutical sales representatives to curb the abusive overprescribing of opioid painkillers that feed our country’s heroin epidemic,” said Illinois Attorney General Lisa Madigan. “My office has investigated misconduct of pharmaceutical sales representatives and recently filed a lawsuit against the maker of a powerful opioid for directing its sales reps to promote prescriptions for inappropriate uses that can be addictive and deadly.”

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June 21, 2017

Europe Moves to the Next Level in Protecting Personal Data - The GDPR & Research


As cross-border business and technology advances, the European Union’s need to address data privacy protection continually rises. The General Data Protection Regulation will soon be enforceable and undoubtedly will have impact on how pharmaceutical and medical device companies conduct clinical trials and research studies. This article reviews key updates for companies to consider for their clinical trials and research functions as the May 25, 2018 enforcement date approaches.

After four years of discussion, the European Parliament adopted the European Union (“EU”) General Data Protection Regulation (“GDPR”) in April 2016. With an enforcement date starting May 25, 2018, the GDPR will replace the current Directive implemented in 1995 and will be applicable to Member States. As an EU-wide regulation, the GDPR introduces a single set of rules to allow for consistent data protection standards and enforcement.

While the GDPR preserves the core principles of the Directive, it also introduces clearer and broader definitions, increased data subject rights, and significant penalties for non-compliance (i.e., up to 4% of annual worldwide turnover or €20 million, whichever is higher). Considering that life science companies handle a large amount of personal information such as customer data, patient details, and marketing intelligence, the GDPR introduces significant new compliance obligations.

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June 20, 2017

The Battle Over Patient Assistance Programs Heats Up


Patient assistance programs have been in the spotlight for the past few years as the drug pricing controversy comes to a head. This article outlines some of the recent subpoenas, with focus on the most recent subpoena to make the news, that of Pfizer. 

For decades now, connecting with the patient has been the holy grail of pharmaceutical marketing. Even though drugs traditionally are marketed by influencing the learned intermediary (the doctor), companies have long struggled to reach patients. This need to reach patients is particularly the case now as patient power and sophistication have increased. However, pharmaceutical marketers have yet to find an efficient way to get to the ultimate user (the patient) without running afoul of government restrictions. First, it was direct-to-consumer advertising, and then it was patient advocacy groups, now it is patient assistance programs (“PAPs”).

Despite the various ways companies have attempted to influence patients, government regulators continually and consistently have expressed concern over these direct patient connections. Their skepticism tends to center around whether manufacturers are leveraging their marketing muscle to drive up product utilization, and ultimately, healthcare costs paid for by U.S. taxpayers.

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