Public debate in the 1990s over drugs’ clinical toxicity has given way to concerns about their financial toxicity. 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 European Medicines Agency (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.
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