2 new studies show the FDA is rushing more drugs to market based on shoddy evidence – Updated by Julia Belluz on September 24, 2015, 5:39 p.m. ET


There was a time when the Food and Drug Administration was so sluggish and conservative in approving new drugs that people who desperately needed access to medicines would die waiting.

But by the early 1990s, Congress had created four programs to expedite the development and approval process for new pharmaceuticals (the breakthrough drug designation, priority review, fast track and accelerated approval). 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.

fda jb

(Javier Zarracina)

 

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http://www.vox.com/2015/9/24/9387987/fda-expedited-drug-approvals