June 15, 2009
Hamburg: Judge the agency on public health
FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein said in a June 11 New England Journal of Medicine “Perspective” column that the “ultimate measure of FDA's success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.” They wrote that FDA's job is to support people's access to a safe food supply and to safe and effective medical products, and thus to promote health and prevent illness. As a public health agency, they said, FDA should always ask whether delays in approval can be prevented.
Hamburg and Sharfstein acknowledged that for medical products, FDA approval speed has been criticized as being either too fast or too slow, and say that a public health approach recognizes that the potential good of a new medical product or policy must be balanced against the potential harm. Some benefits are not worth the risk, but some risks are worth taking, they said.