Since 2007, more than 30 bio-pharmaceutical companies have been fined over $13 billion for sales and marketing compliance violations. All of these companies had compliance training programs in place to meet the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers. Yet, these training programs were not sufficient to prevent the violations and fines. Why? They […]
A privately held pharmaceutical company was preparing for the commercial launch of their first prescription drug. The Executive Management team brought their commercial leaders on board just prior to the product being approved by the FDA.
A rapidly growing biotech company was interested in improving organizational efficiency and sales performance. As part of the effort, they conducted a critical review of several departmental functions, looking for opportunities to eliminate unnecessary redundancies. At the same time, the sales team leaders were struggling to align on a coaching model and method to document coaching feedback. The organization wanted to address these challenges before launching their next product.
In the past five years, the Department of Justice (DOJ) has levied almost $22 billion in fines against pharmaceutical companies for compliance violations. In addition to these fines, there are significant costs associated with negative publicity and damaged company reputations. Compliance standards are becoming increasingly rigid with Corporate Integrity Agreements (CIAs) and Risk Evaluation and […]
Given the heightened scrutiny that pharmaceutical companies face in today’s marketplace, all communication is discoverable and could lead to increased regulatory penalties and negative publicity. Companies need to be proactive in providing training and guidance to ensure all interactions with healthcare professionals adhere to compliance requirements. There is ample guidance in place that formalizes the […]
The opioid abuse epidemic in the United States has grown dramatically in recent years. The number of opioid prescriptions in the U.S. increased from 144 million in 2002 to more than 259 million in 20121 . Each day, 44 people in the United States die from an overdose of prescription painkillers 2 . The issue has […]
The primary responsibility of pharmaceutical compliance professionals is to ensure their organizations adhere to government requirements and all company activities align with regulatory policies. An important element of an effective Field Based Monitoring Program includes a reliable plan for compliance reporting. This newsletter will outline five (5) key considerations to enhance reporting of field based […]
Field-based monitoring is generally used by compliance departments to verify and ensure field behavior and activities are compliant with company standards. It is important to note that field-based monitoring can also provide tremendous value when integrated into everyday coaching of the sales field force.
Pharmaceutical sales force leaders currently face a variety of challenges There is ongoing competition from other companies, increased competition from generic drugs, and a changing healthcare environment. There have also been reductions in the number of sales representatives at many pharmaceutical companies and rumors of their eventual replacement by peer to peer selling.