The United States Foreign Corrupt Practices Act – Best Practices for Compliance in the Face of Increased Enforcement


Across the globe, investigations by regulators of pharmaceutical and biotech companies continue to grow. Companies need to evolve and adapt to reduce risk when conducting business on a global scale. Among the areas of greatest exposure for pharmaceutical and biotech companies conducting business on a multi-national level is the United States Foreign Corrupt Practices Act (FCPA or the Act), which is comprised of two sets of provisions: 1) anti-bribery provisions; and 2) accounting provisions. The anti-bribery provisions of the FCPA, the subject of this article, prohibit companies from bribing foreign officials to obtain or retain business.
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Is Your Pharmacy Compliant with the FDA’s New Rules on Interstate Shipment of Compounded Drugs?


Interstate distribution of compounded drugs became a focus of the U.S. Food and Drug Administration (FDA) following a recent, highly publicized incident involving the shipment of contaminated medications across state lines. Drug compounding, in general, is preparing a medication that is not commercially available in the strength, concentration, or form needed for a specific patient pursuant to a prescription.  Traditional, non-sterile, drug compounding generally includes medication patients drink, swallow, insert, or apply to skin.  In contrast, non-traditional, sterile, drug compounding typically includes medication intended for injection, infusion, or application to the eyes.
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Vendor Control with Partnerships, Not Checklists


More than ever before, pharmaceutical companies leverage the expertise of software, infrastructure, and service providers as an alternative to building equivalent capabilities in-house. Indeed, outsourcing and partnerships with external service organizations, cloud infrastructure providers, and software vendors have become strategic initiatives in most organizations’ plans.
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It’s Not Fair! Combating Competitors’ Dishonest Marketing Tactics


What do you do when your competitor doesn’t play by the rules?
 
As the “information revolution” flourishes and internet marketing for over-the-counter medical products proliferates, some marketers profit by claiming unapproved therapeutic benefits for products, while manufacturers of approved products with proven benefits suffer. In this dynamic, interactive and free-flowing information environment, new tools are emerging to allow manufacturers to police the content of competitors’ marketing.
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Coupons, Freebies and Perks Complicate Drug Marketing


Some of the best minds in science create groundbreaking drugs that change the lives of millions of patients. New drug targets, genetic connections with medications and a greater understanding of the body’s chemistry have led to the development of more than 4,500 different active pharmaceutical ingredients.   Some of the best intentions run aground, however, when the realities of the marketplace confront the demands of recouping drug development costs. To further complicate matters, the Centers for Medicare & Medicaid Services is requiring this fall for drug makers to disclose their payments to providers under the Sunshine Act.
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Trusted Collaboration


Outsourcing different aspects of the clinical study process is a growing trend; 64 percent of trials are currently outsourced. Of those that don’t currently, 54 percent plan to outsource in the future*. Sponsors outsource to clinical research organizations (CROs) to control operational and infrastructure costs and allow them to concentrate on what they do best – drug development.
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