Dr. David Collier
I attended the BIO conference in Chicago last week. On Wednesday afternoon I was in the audience for a panel discussion entitled “Advances in Regulatory Science.” The keynote speaker on the panel was Margaret Hamburg, the new Commissioner of the FDA, appointed in 2009 by President Obama.
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Dr. Hamburg gave a speech that covered the paths her career has taken and how those paths have interacted with the evolution of “regulatory science” at the FDA. She spent some time talking about her early years in the practice of medicine, at a time when AIDS appeared as a deadly medical mystery. AIDS led to major changes at the FDA as patients who were dying from the disease clamored for access to therapies that were in development. What was the point of preventing them from getting these drugs, they argued, if they were going to be dead anyway by the time the drugs were approved? This political pressure led to the FDA’s Fast Track and Accelerated Approval processes, under which urgently needed drugs can be approved faster, based on slimmer evidence of safety and efficacy, in exchange for completing clinical studies after they are on the market. Dr. Hamburg showcased this as an example of how the FDA has evolved to meet the real needs of patients.
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