- In her final speech as FDA commissioner after six years of service, Margaret Hamburg responded to critics pushing for a faster approval process.
- Her comments were partially directed towards proponents of the 21st Century Cures Initiative, specifically the provision calling for approval of breakthrough therapies based on preliminary clinical data.
- Commissioner Hamburg emphatically made the point that the FDA approved the most new drugs in 20 years in 2014.
Stakeholders who want more regulatory reform to allow for faster approval processes argue that timing is of the essence for very sick patients awaiting an innovative treatment option that may be bogged down in the FDA review process. But on the flip side, as Commissioner Hamburg argued in her speech to the National Press Club, innovation is useless if the therapy does not work.
The primary point of contention here is the Breakthrough Therapy designation, which is currently given when early data demonstrates that a product may confer substantial improvement over an existing therapy. However, reformers want to have regulators approve medications based on preliminary evidence alone and conduct longer trials post-approval.
Although it's not clear exactly how this difference will be reconciled, it is apparent that over the years, the FDA has become more efficient at reviewing and approving innovative therapies.