Today the Washington Post has an article – "FDA Commissioner Faces Formidable To Do List" that outlines the many challenges that Dr. Margaret Hamburg and Dr. Joshua Sharfstein face as they get settled into their new jobs. This includes the usual suspects that have been well documented and bemoaned these past eight years – politics trumping science (Plan B fiasco), enormous food recalls (frankly not the fault of the agency), whistle blowing employees, and the growth of interaction brought on by the global economy without a corresponding change in agency approaches and resources. All vexing and huge problems.
In the article, Dr. Hamburg is quoted and echos themes she laid out in the joint editorial she and Dr. Sharfstein published in the New England Journal of Medicine last week. The two made an excellent decision to lay out their vision for returning the agency to its roots – to being a public health agency. They state – "The ultimate measures of the FDA's success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or the number of drugs approved." That is an excellent summation that says – we're here for the mission of the agency.
How will they do that? Again in broad brushstrokes they talk about their own strategic directions for change which include FDA's collaboration with other federal agencies such as the CDC, NIH and others to bring in additional information that will help FDA improve (one hopes this will include FTC which has a much better handle on the advertising and Internet issues than does FDA).
Are these the people who can do that? When she was the NYC health commissioner, Dr. Hamburg not only faced a similar situation – where a predecessor had been at the center of controversial storms, an agency that faced budget shortfalls and where both credibility and image were compromised, but she also championed and won reforms against political tides – bringing order to the Riker's Island Hospital Ward (where I once saw a doctor smoking) and accomplishing the task of making others see the public health wisdom of needle exchange to help control an out-of-control AIDS epidemic. She has both strategic vision and the ability to execute and reform.
The dynamic duo close their editorial with the sentiment that the agency must communicate frequently about its efforts and its plans to be credible. Nothing could be truer. So far, in the speeches docket on the FDA Web site, there are no speeches listed by either of them. One looks forward to that changing so that the broad brushstrokes outlined in the excellent editorial begin to appear as more of a Suerat pointillist painting, where we can see how each point begins to fill in and create a new picture of the FDA.
Drs. Hamburg and Sharfstein are good medicine – they are just what the doctor ordered.
We hope that now all want to be involved in the medical system is improved, but not because they think the medical system is very much less come to trust that these events will reduce the cost and benefit millions of people throughout the country, and they say that things in findrxonline improved from 60% in recent weeks, hopefully this is the case ..
There is a nice video of Hamburg on the FDA website http://www.accessdata.fda.gov/videos/oc/hamburg-welcome-508.wmv