As I see it
By getting back to basics, the FDA's new leadership says its first priority is to restore public confidence in an agency whose public esteem has never been lower.
Commissioner Margaret Hamburg put it just that way in her first major speech to a regulatory audience in September. Addressing an enthusiastic Regulatory Affairs Professionals Society annual meeting, she lamented her agency's current standing in public esteem as revealed in a summer Gallup Poll: “I'm sorry to have to report to you that FDA ranked second to last. Perhaps even more disturbing, we ranked below the IRS! So here is my first priority as commissioner: to step above the IRS and most importantly to rebuild public trust and confidence in an agency that's critically important to the health and wellbeing of all Americans.”
Hamburg's task would seem daunting. Three months earlier, a more probing Harris Interactive/HealthDay poll found that 47% of those asked said FDA does a poor job monitoring the safety and effectiveness of prescription drugs.
It hasn't always been this way—in 1990, a Roper poll found FDA second only to the National Park Service in public esteem. Other polls routinely show they also have a palpable contempt for the competence of government in everything it tries to do.
Nevertheless, efforts to restore the FDA to its former luster will have their goodwill, especially when it involves improving public safety the old-fashioned way: through beefed-up surveillance and enforcement, and scientific, efficient admission of significant new health products to the market. Both of these things Hamburg and her principal deputy commissioner have committed themselves to do.Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)