12 May 2016 - Although drug regulators aren’t supposed to be concerned with pricing, they’ve been drawn into an acrimonious debate over the cost of medicines.

At the EMA, we often hear conflicting arguments: high and inflexible regulatory standards drive up the cost of pharmaceutical research and development (R&D), thereby increasing drug prices; regulators license products even when the data are insufficient for assessing their value and allow drug makers to overcharge; more generics, biosimilars, and me-too drugs are needed to create a dynamic market that will keep prices down; me-too drugs should be discouraged, since they offer no added benefit to patients and lead to overutilization and higher spending; and regulators shouldn’t allow drugs on the market that no one can afford.

For more details, go to: http://www.nejm.org/doi/full/10.1056/NEJMp1601294?query=TOC