On October 6, 2010, The New England Journal of Medicine published a well written “perspective” on FDA Commissioner Dr. Margaret Hamburg’s efforts to “revive the FDA.” Her principal deputy commissioner, Dr. Joshua Sharfstein, echoed the same sentiment: “I keep a list of things I wish were moving faster and a list of things moving at just the right speed, and these nothing on the second list.” (emphasis added). Dr. Hamburg is just completing her first year as commissioner at the FDA. We can only hope she remains and stays steadfast to the goals and objectives she has set out to achieve.
Since the NEJM is a subscription journal, I’m not sure if you will be able to access the full article, but I certainly hope you can.
Of significance for those of us who deal with FDA’s actions on virtually a daily basis, Commissioner Hamburg’s first quoted comment is of particular interest: ““You feel it differently at the FDA — how long it takes to move things through the system.” Welcome to bureaucracy at its finest, Commissioner.
What Commissioner Hamburg has done, however, deserves a lot of credit – at least in my non-politically based opinion.
Her objectives are listed by the NEJM article as being making “the FDA more nimble and proactive, restoring its credibility and refocusing staff on its public health mission, persuading Congress to boost funding for its expanding portfolio of responsibilities [and] sharpening its ability to deal with new science and globalization.” A very healthy list in all senses of the word.
Here is a list of just some of the actions taken and projects underway:
- major recalls of over-the-counter pediatric medications
- major recalls of salmonella-contaminated eggs
- engaging in major debates over direct-to-consumer genetic testing
- addressing safety concerns over the “blockbuster” diabetes drug, rosiglitzone
- implementation of a 2009 law making the FDA responsible for tobacco regulation
- making food-package labeling more evidence based
- launching initiatives to “clarify and standardize” processes for evaluation drugs and medical devices
- making more information public
As far as dealing with the issue of bureaucratic lethargy, Hamburg, Sharfstein and other key people at the FDA have created a new process known as “risk control review.” Under this program, field inspectors, who had previously been required to simply file reports that would eventually wend their way through the bureaucratic maze, when they detect “urgent health threats,” can now initiate direct meetings with key agency personnel to discuss taking emergency action. As a result of another initiative, an agency food-safety registry, in the first seven months of Hamburg’s leadership, more than 100 food-safety reports were submitted.
For those familiar with how the FDA worked, it is common knowledge that regulators of drugs and medical devices have been under pressure to approve them quickly. In response to criticisms of this so-called approval process, Dr. Hamburg and her staff have created an internal task force to review the way such decisions are being made at the Center for Drug Evaluation and Research (CDER). This approval process, called the 510(k) clearance process, was first met with outright dissent. After a “scathing internal FDA review” identified some of the major problems with the former way of doing business, officials at CDER adopted some of the recommended reforms – hopefully leading to “a clearer, fairer decision-making process.” Another IOM panel report is due next year; it is anticipated that further reforms in such process will be recommended.
Dr. Hamburg’s mantra has been – “follow the science.” Her response to the questions from her people at FDA in terms of what they can do about concerns of immediate public health safety is reported as being – “What do you think the right thing to do is from a public health perspective?” Seems like the Commissioner is a good listener and a pro-active responder.
Needless to say, Dr. Hamburg’s activities could well fill pages of text. She faces issues relating to globalization (ensuring products made overseas and entering our marketplace are safe), funding for her agency (a never-ending task seeking dollars for her projects and people in a seemingly pitiful federal budget), improvement of post-marketing safety studies, implementing and overseeing a data-mining system used to analyze electronic safety records (Harvard Pilgrim Health Care’s Sentinel System) to improve numerous aspects of patient safety, and forging key partnerships with private industry and academia scientists to “get it right” – to name just some of the projects for which her agency is responsible.
All one can say – thank goodness the Doctor is in the house! We wish her continued strength, patience, perseverance and success.