As it has since 1995, the Healthcare Compliance Packaging Council (Bon Air, VA), a trade group of unit-dose packaging developers and manufacturers, selects a Package of the Year and two runners-up from among products that entered commercial distribution in the […]
Read MoreThe FDAA Act of 2007 empowered the FDA to require Risk Evaluation and Mitigation Strategies (REMS) for new and existing pharmaceutical products. After the first programs were introduced in 2008, REMS have now become an established part of the pharmaceutical […]
Read MoreThe fast-changing nature of the Internet continually opens new opportunities for communicating with consumers and physicians. It also brings new regulatory challenges, as the FDA struggles to keep up—and pharmaceutical companies try to take advantage of technology without falling foul […]
Read More“Fair market value” is a legal term that tries to define the appropriateness of payments when there are conflicting or at least multiple justifications for those payments. FMV turns up in many business transactions, but specifically in payments occurring where […]
Read MoreOver the last few years, the power of managed care plans to influence physicians and patients has grown significantly. Through the use of prescribing restrictions, such as step programs and prior authorization, as well as tiered formulary plans with varying […]
Read MoreThe 2010 Survey of Health Care Consumers, conducted by the Deloitte Center for Health Solutions, is Deloitte’s third annual study of consumers’ attitudes, behaviors and unmet needs. Deloitte’s survey measured consumers’ views and actions across a wide range of issues […]
Read MoreEvery other pharma sales and marketing event I attend highlights the changing dynamics of the pharma sales profession. The layoffs that have been coursing through the industry (see p. 1) are one very obvious change. The “key account” dynamic—where industry […]
Read MoreThe thinning out of pharma sales forces is a well-recognized industry trend. Less well known is the growth in contract sales, partially a direct result of that winnowing. According to IMS Health, contract sales organizations (CSOs) are in the process […]
Read MoreBy all accounts, biopharma executives have a complex 2010 agenda, requiring that they work tirelessly to: Reconsider their basic business models while driving efficiencies in their in-line assets, with 75% of mature markets being undifferentiated (see box) by 2015 Improve […]
Read MoreOff-label prescribing has made a splash in the news in recent months. A September 2009 settlement of a lawsuit against pharmaceutical giant Pfizer is once again bringing attention to the practice of off-label prescribing and marketing of pharmaceuticals. The settlement […]
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