Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement

The situation also is a perfect example of FDA doing what it says it does – paying more attention to the thinking behind advisory committee votes than the votes and vote totals themselves.

a wooded block with "yes" and a wooden block with "no". Finger points to "no" block.
When FDA disagrees with its advisory committees its more likely to result in a negative outcome for sponsors. • Source: Shutterstock

The US Food and Drug Administration has drawn a lot of negative attention in recent years for approving drugs like Alzheimer’s treatment Aduhelm over the objection of its outside advisers. But this type of controversial decision by FDA is fairly rare.

FDA and its advisory panels usually agree and when they don’t, the agency is more likely to take more conservative actions than its committees

More from Complete Response Letters

More from Product Reviews