Last week, FDA and Amarin Corporation reached a negotiated settlement of a legal case concerning off-label promotion for use of a drug for an unapproved indication. The negotiation established parameters for how Amarin and the FDA will operationalize the Court’s finding that the FDA cannot stop a company from providing truthful and non-misleading information about unapproved new indications of a drug. What the Court decision and the negotiated settlement mean for the future of off-label new use promotion beyond Amarin will become clear over time. What this case prompts for me is perhaps the bigger question – and that is, how should FDA and life science companies consider the larger set of data issues that sit at the heart of our healthcare system’s transition from volume to value?

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Recognizing the value of patient insights in drug development, FDA has made great efforts to integrate patient perspectives into its benefit risk framework for a number of disease areas through the Patient-Focused Drug Development (PFDD) program, an initiative of the Prescription Drug User Fee Act (PDUFA) V of 2012. One of the common points patients shared at the PFDD workshops held over the past two years is the feeling that their “chief complaints” or needs are not being factored into drug development plans, including measures of a drug’s benefit in clinical trials. To get an inside read on why this may be occurring and what can be done to correct it, we spoke with representatives from the Obesity Action Coalition, the IBD Support Foundation, and the Arthritis Foundation, all of whom are actively engaged in giving a voice to patients in their communities and improving access to optimal care. They shared their perspectives on how the role of patients has evolved in the past decade and what can be done in the future to better factor patients’ feedback into drug development and access planning.

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Europe clearly has its own distinct set of issues: a highly variable healthcare and payer system across countries, and now a massive influx of refugees, increasing pressure on already stressed healthcare resources. While there are differences, there are increasing similarities between Europe and the United States in terms of concern and criticism of drug prices. In side conversations at the Forum, European officials mused that the U.S. was finally asking the questions being asked in Europe for years. What is society willing to pay, or can afford to pay, when it comes to medicines?

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Prescription drug pricing has become a very hot topic in the last year. To have a better and more productive policy debate about drug pricing, we need to have a better understanding of how the market landscape—and the market risks—have shifted for the branded biopharmaceutical business in recent years. What follows is a brief analysis of changes in the U.S. health care marketplace and how they may affect drug launch prices.

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ASCO 2015 may be remembered as the year when the high cost of drugs got nearly as much attention as the major scientific breakthroughs in deadly cancers. Indeed, looking back at the presentations and conversations at this year’s oncology conference, what was clear was the growing tension between the breathtaking progress of scientific advancements in cancer therapies – even a potential cure – and what has been dubbed the “financial toxicity” of these treatments. That refers to the high cost of many innovative products.

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Today’s biopharma industry faces more in-market risks than ever before. These include payment reforms such as bundled payments and limited global health care budgets. The industry must also manage greater provider financial risk for outcomes and resource use, as well as payer consolidation and new insurance designs that shift more costs to patients. And this is just the tip of the iceberg. In this environment, the stakes are high. Identifying and communicating the value proposition of innovative products is nothing less than critical.

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