The FDA: Faster, but not necessarily better. And that could threaten the agency's brand
Faster FDA drug approvals may reflect less rigorous evidentiary standards, a new analysis suggests.
In 1962, the regulatory scrutiny of medicines by the FDA intensified in reaction to thalidomide, an anti-nausea drug that gained notoriety after its link to severe skeletal birth defects. Since then, a flood of incentives has made the US system of getting drugs approved easier and the agency seemingly more flexible. Regulatory incentives — such as fast-track and breakthrough therapy status, orphan drug designations as well as accelerated and conditional approvals — have diminished review times and encouraged the use of surrogate endpoints. And while the industry has encouraged it, some researchers see a downside.
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