Margaret Hamburg’s Remarks at FDA Track Launch

Margaret A. Hamburg, M.D. is the Commissioner of Food and Drugs. Here are her remarks at FDA Track Launch.

Remarks as Delivered of Margaret A. Hamburg, MD., Commissioner of Food and Drugs at the FDA Track Launch on August 31, 2010

Good afternoon—thank you, Dr. Sharfstein, for that introduction and thank you all for being here today to recognize and celebrate this important new chapter of transparency and accountability at FDA…a milestone that reflects this administration’s efforts to prioritize openness in the federal government. This really was Dr. Sharfstein’s vision and commitment.

Long before I arrived at the FDA, I heard concerns about the FDA being a “black box” where decision making takes place in dark rooms, behind closed doors, away from scrutiny, and out of the public eye. But at the same time, these decisions affect many Americans in very fundamental ways, through drugs, vaccines, medical devices, food, cosmetics, sunscreen—products that people depend on every day and that matter to their health, well-being and safety. This is an extraordinary agency with an extraordinary mission to promote and protect the health of the people.

My goal as Commissioner—and the goal of everyone here today—has been to revitalize this agency into the productive, creative, science-driven public health agency that it is—an agency that holds itself accountable first and foremost to the American people. And that is precisely what FDA-Track will allow us to do.

As you know, FDA-Track launched on April 7th of this year as one of three flagship programs of HHS’s Open Government initiative. Today, we open this room on our beautiful White Oak campus so that we have a physical location in which to facilitate the dialogue and exchange the ideas that are key to the development and implementation of the initiative.

After all, it encompasses the entire agency, touching everyone from frontline inspectors to administrative support staff to center directors, and everyone holds a stake in its success.

FDA-Track was designed to hold our agency’s employees more accountable and to make our work more transparent by giving staff at all levels a new way to measure effectiveness in meeting goals to protect the public health…and, in turn, by giving the public a new way to judge how well we’re doing our jobs through the FDA-Track website.

The initiative will monitor more than 110 FDA program offices through data assessing key performance measures and projects. This data will then be presented to senior leadership every quarter, giving myself and Dr. Sharfstein unprecedented opportunities not only to examine and discuss the issues that come up each quarter but to have a new forum through which to hear what is really on the minds of FDA employees…something that, as you can imagine, is logistically difficult to do.

Of course, there is still more we can do, and the agency’s senior leaders are already working on steps to improve the program and ensure its sustainability—including, to name only a few, aligning FDA-Track measures to those required by the Government Performance and Results Act of 1993, enhancing the data management and reporting software, and improving measures based on public input and experience so they are more closely tied to the public health mission of the agency.

In short, we are all working hard to make FDA-Track a model for open government at the federal level. And I hope that if we maintain a laser-like focus on the fundamental principles of FDA Track—aptly spelled out in its name as Transparency, Results, Accountability, Credibility and Knowledge-sharing—we can, and we will, set a new gold standard.

But this is about more than just the FDA.

This is about our entire government. FDA-Track is just one of the open government initiatives being rolled out in departments and agencies across the federal government. These efforts are a cornerstone of what the Obama administration stands for, and we are proud to play our part.

And—above all—this is about the American people. We will use FDA-Track to monitor and track issues like food safety, our role in healthcare reform and medical countermeasures—issues that are priorities not just for our agency, but also for HHS, for the administration, and for the public. And we will hold ourselves accountable by soliciting feedback and making sure that they are easily accessible on the website, so that the public understands the actions we are taking and, more fundamentally, the role we play in moving key issues forward. This is a tangible way to demonstrate the true range of our responsibilities and the extent of our impact as an agency on the everyday life of the American people.

That is a big, and incredibly important change for the FDA—and one that has been a long time coming.

So let me close by extending a special thank you to the people who have worked so hard to make this program a reality. First, to our partners at OMB and HHS as well as to the Alliance for a Stronger FDA for your support and collaboration as we propel our agency forward into the 21st century. And last but not least, to our team here at FDA—to those of you up on stage now and to the dozens who have worked tirelessly to shape this initiative. Your work is critical to the strength and vitality of the FDA, and I thank you for your time, your commitment, and your ideas.

We have come a long way, and I look forward to the possibilities we can achieve if we continue to work together.

Thank you.