But fast forward to the early 1990s. By then, Congress had created four programs to expedite the development and approval process for new pharmaceuticals. These pathways were intended to push innovative new drugs — drugs to treat rare, serious, or life-threatening diseases — through the FDA more quickly.
Since these medicines were sorely needed, the idea was that rushing them through, often on the basis of more limited and preliminary clinical trials data, would help patients languishing with unmet medical needs.
Today, the FDA is now considered the fastest regulatory agency in the world. But there’s some concern that these expedited pathways are being used by drug companies to speed through medicines that aren’t actually helping patients with unmet medical needs — and that often aren’t any improvement over what’s already on the market.