What to Read: FDA Commissioner Hamburg on the Agency's Role

What to Read: FDA Commissioner Hamburg on the Agency's Role

08.01.11 | By Kate Connors

Monday's Wall Street Journal features an op-ed (subscription) by Margaret Hamburg, the commissioner of the Food and Drug Administration, who discusses the difficult balance that the agency strives to achieve between protecting the public health through regulation and promoting innovation and access.
"Despite common criticisms that our agency impedes innovation by being slow and bureaucratic, we actually play a proactive role in promoting innovation by ushering new products through the approval process and to market - while making sure they meet the standards of safety and effectiveness that have served the American people well," she writes.
She highlights misconceptions about the American regulatory review system in comparison with the European counterpart by showing higher approval numbers in America. For example, she points out that all 23 cancer drugs approved by both the FDA and the European Medicines Agency from October 2003 to December 2010 were marketed first in the U.S.
America's biopharmaceutical research companies similarly strive to find the balance between safety and access. As we come closer to reauthorization of the Prescription Drug User Fee Act, I'm sure we'll discuss the issue further.
Until then, today's column by Commissioner Hamburg is a reminder that although the FDA is an oversight body that strictly regulates the work that we do, it also shares our commitment to innovation.
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