The Fight Against Bribery in Pharma: What You Need to Know Now

Over the past several years, the pharmaceutical industry has become subject to heightened attention in the face of the U.S. government’s prosecution against global bribery and corruption. Under the Foreign Corruption Practices Act (FCPA), U.S. authorities have investigated and subsequently charged some of the largest multinational pharmaceutical companies with international bribery violations, including Pfizer, Eli Lilly and Johnson & Johnson, to name a few. Recently, the SEC announced an FCPA enforcement action against Bristol-Myers Squibb regarding its joint venture (JV) in China. The JV made cash payments and provided other benefits to health care providers at state-owned and state-controlled hospitals in exchange for prescription sales. Pursuant to a cease and desist order and settlement, the company agreed to pay $14 million in fines and penalties.
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FCPA and the Pharmaceutical Industry: A Uniquely High-Risk Environment

The corruption risks for companies and individuals engaged in business outside the United States have received a tremendous amount of attention in the last ten years. The pharmaceutical industry is uniquely positioned to be exposed to such risks and potential FCPA enforcement actions. This risk and exposure is, in large part, due to the industry’s regular contact with healthcare professionals and customers considered to be “foreign government officials” under the FCPA. This article explores some of the common interactions between pharmaceutical manufacturers and foreign government officials as well as the increasing involvement of third parties to market and sell pharmaceutical products.
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A New “Quality System” Training Approach for Sales Reps Creates a “One-Stop” Resource for Achieving Commercialization Compliantly

The concept of a “Quality System” has been around for quite some time. However, what’s new is its application to compliance within the marketing sector of the pharmaceutical industry. Do sales representatives always know what to do or say when facing sensitive situations? Are they aware of the new or revised laws and regulations?
Imagine a compliance program that ensures sales representatives know what to do or say with clarity when facing sensitive situations. One in which reps understand the way new or revised laws and regulations or [promotional] violation letters directly impact their interactions with HCPs. And where compliance support for tricky situations is accessible 24/7.
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Automated Compounding Reduces Hospital Costs and Pharmacy Errors

Recent news of a $200 million fund to compensate victims of the bankrupt New England Compounding Center (NECC) is an extreme example of how expensive manual compounding errors can be. Contaminated compounds produced by NECC were linked to a 2012 meningitis outbreak that killed 64 people in 20 states and sickened more than 750.
But compounding errors don’t have to result in multi-state disease outbreaks to be costly. In fact, a single compounding error can cost a hospital tens of thousands of dollars (or more) if it causes an adverse patient reaction. Research has found automated compounding technology, such as the RIVA system, can help reduce costs by eliminating errors. Automation also reduces the cost-per-dose of medication. A closer look at costs reveals some compelling facts.
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One Basis for Determining “Intended Use” of Drugs and Devices Could Go Up in Smoke

The concept of “intended use” is a fundamental underpinning of the U.S. Food and Drug Administration’s (FDA) regulation of medical products. The agency applies “intended use” to determine whether a particular product is subject to FDA regulation, as well as whether a product manufacturer may have overstepped its approved intended use(s) of a product through its marketing activities, thus driving decisions about potential enforcement. Given the central role that the concept of intended use plays in medical product regulation, FDA’s proposed changes to its intended use regulations offer a rare opportunity for industry to seek further clarity from FDA about its interpretation of the intended use regulations, and perhaps offer specific proposals for other revisions to these regulations.
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The Birth of phactMI™ – Pharma Collaboration for Transparent Medical Information

There’s a new Consortium of drug companies called phactMI™ that you should know about. PhactMI™ stands for the Pharma Collaboration for Transparent Medical Information. Medical Information (MI) departments from 19 manufacturers have raised their hands in collaboration to address the continuously growing need among healthcare professionals (HCPs) for more convenient access to transparent medical information. The focus is to help inform HCP decision-making around patient care. The Consortium’s name delivers on the mission according to the Consortium founders. Manufacturers have more facts about their own drugs because they are the source of clinical research and development with access to all the relevant data.
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