Margaret Hamburg, one of the longest-serving commissioners in US Food and Drug Administration (FDA) history, plans to announce her resignation tomorrow, FDA officials have confirmed to Regulatory Focus.
Hamburg's final day at the agency will be in late March 2015, Hamburg wrote in an email. She will be succeeded on an acting basis by Stephen Ostroff, FDA's chief scientist since January 2014.
A Long Tenure
Hamburg's resignation brings to an end one of the longest tenures as FDA commissioner of food and drugs in the agency's history. According to data analyzed by Regulatory Focus, Hamburg will be the sixth-longest serving FDA commissioner in history, the longest-serving (and only the second) female commissioner in the agency's history, and the second-longest-serving commissioner of FDA's modern regulatory era.
Assuming Hamburg leaves office on 28 March 2015, she will have served in office for 2,140 days. She was sworn into office on 19 May 2009, and had been the only FDA commissioner to serve under President Barack Obama.
An Agency in Flux
Hamburg's tenure as commissioner has been marked by a number of high-profile changes, struggles and scandals.
She was brought on in the early days of Obama's push for the Patient Protection and Affordable Care Act (PPACA), which established a regulatory pathway for biosimilar products. In 2011, tensions flared between her and Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius after FDA's approval of an over-the-counter birth control product was overturned for reasons that appeared to be more political than scientific.
Hamburg has also overseen massive legislative changes at FDA. The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) created hundreds of new obligations for the agency, and also established several new pathways for approvals, such as the breakthrough therapy designation. The 2013 Drug Quality and Security Actgave the agency broad new powers to ensure the safety of the pharmaceutical supply chain and of compounded pharmaceutical products.
Drug and device approvals also saw marked improvements under Hamburg's tenure, with new drug approvals experiencing perhaps their best year for approvals ever in 2014, and device approvals making slow but steady improvements.
Hamburg also oversaw scandals and problems at FDA during her tenure. FDA was chastised for its lack of oversight of the pharmaceutical compounding industry, for allegedly spying on some members of its medical device review divisions, for its approach to regulating painkillers, and for its regulation of various products and areas.
Hamburg's departure comes at a particularly tricky time for FDA.
Both the House of Representatives and Senate are pursuing new legislation aimed at expediting the processes FDA uses to approve most drugs, and particularly those for patients with rare or life-threatening diseases. The legislation could have a massive effect on the way in which FDA regulates almost every medical product it oversees.
In addition, the agency is preparing to enter into negotiations with the pharmaceutical and medical device industries regarding user fees. Under various pieces of legislation—the Prescription Drug Use Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act and the Biosimilar User Fee Act—FDA collects fees from pharmaceutical and medical device companies to help it hire more staff and review new product applications more quickly. In return for that money, FDA is supposed to adhere to specific timelines for reviewing products.
The negotiations, which notably do not involve Congress, are meant to ensure FDA gets sufficient funding to make improvements, and that industry is assured its funding—which now makes up more than half of all funding at FDA—is actually resulting in more efficient regulatory reviews.
But even more important than what's next is the question of who's next.
Ostroff, who will serve as acting commissioner upon Hamburg's departure, is a relatively little-known regulator outside FDA circles. As of January 2014, he was the chief medical officer of FDA's food science division, the Center for Food Safety and Applied Nutrition (CFSAN), and an advisor to FDA's Office of Foods and Veterinary Medicine.
Given Congress' focus on medical products at the moment, legislators might instead push for someone who is able to focus more on reforming and accelerating medical product approvals at FDA.
In a statement, Rep. Fred Upton, who is leading the House's effort to reform FDA, said he is looking forward to leadership to "ensure we are firmly on the path to cures." Sen. Lamar Alexander, who is leading the FDA reform effort from the Senate side, said he "hopes the president nominates an FDA Commissioner who will work closely with Congress on finding ways to get safe medical treatments, devices and drugs to patients more quickly."
Even Obama might be unlikely to appoint an FDA commissioner who is focused on the regulation of food. As reported by Regulatory Focus last week, Obama has proposed stripping FDA of its authority to regulate food products, which would instead be transferred to a new "Food Safety Administration."
So who might succeed Hamburg? If rampant speculation is any guide, the agency may already have hired its next commissioner. Last month, FDA announced it had hired world-renowned cardiologist Robert Califf to a top role within the agency: deputy commissioner for medical products and tobacco.
Califf has been considered for the role of FDA commissioner on two separate occasions.
In appointing his next choice for FDA commissioner, Obama will also have to grapple with a Republican-controlled House and Senate, both of which might complicate the confirmation process. Hamburg, in contrast, was appointed when both chambers of Congress were overwhelmingly controlled by Democrats.
Read the Reuters report on Hamburg's expected resignation here.
Hamburg's Resignation Letter to FDA Staff
Dear FDA Colleagues:
It has been a privilege to serve as your FDA Commissioner for almost six years. So it is with very mixed emotions that I write today to inform you that I plan to step down as FDA Commissioner at the end of March 2015. As you can imagine, this decision was not easy. My tenure leading this Agency has been the most rewarding of my career, and that is due in no small part to all of you - the dedicated and hard-working people that make up the heart of this Agency. While there is still work ahead (and there always will be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success.
I feel so fortunate to have worked at an organization as remarkable and productive as the FDA. The expertise, dedication and integrity of our people and the unique nature and scope of FDA’s role make this Agency truly special. Every day, FDA employees around the world recommit themselves to the Agency’s work, to quality science, to facilitating innovation, and to the protection of public health. And because of your dedication and your service, we have been able to achieve so many significant milestones over the past years.
From creating a modernized food safety system that will reduce foodborne illness; advancing biomedical innovation by approving novel medical products in cutting-edge areas; and responding aggressively to the need to secure the safety of a globalized food and medical product supply chain, to taking critical steps to reduce the death and disease caused by tobacco, we have accomplished a tremendous amount in the last six years. We can honestly say that our collective efforts have improved the health, safety and quality of life of the American people.
At the heart of all of these accomplishments is a strong commitment to science as the foundation of our regulatory decision-making and of our integrity as an Agency. And while there are far too many significant actions, events, and initiatives to count, there are some highlights of the past years that I particularly want to mention.
In the foods area, we have taken critical actions that will improve the safety of the food Americans consume for years to come. These include science-based standards developed to create a food safety system focused on preventing foodborne illness before it occurs, rather than responding after the fact. We have taken several significant steps to help Americans make more informed and healthful food choices. These include working to reduce trans fats in processed foods; more clearly defining when baked goods, pastas and other foods can be labeled “gluten free;” updating the iconic Nutrition Facts label; and, most recently, finalizing the rules to make calorie information available on chain restaurant menus and vending machines.
We have also made great strides in advancing the safety and effectiveness of medical products. Some of these important steps include new oversight of human drug compounding and provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs. We are continuing to increase the speed and efficiency of medical product reviews. We just had another strong year for novel drug approvals, with most of these drugs being approved on or before their PDUFA goal dates and most being made available to patients in the United States before they were available to patients in Europe and other parts of the world. We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic to help patients with serious or life-threatening diseases. In fact, almost half of the novel new drugs approved in 2014 received expedited review with a combination of breakthrough designation, priority review and/or fast track status. These included drugs for rare types of cancer, hepatitis C, type-2 diabetes and idiopathic pulmonary fibrosis, as well as a number of groundbreaking vaccines. We have also established a regulatory pathway for biosimilar biological products that will create more options for patients.
On the medical device side, the average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval (PMA) device applications that we approve annually has increased since then, after steadily decreasing each year since 2004. We also published the Unique Device Identification (UDI) final rule that is intended to improve the tracking and safety of medical devices. And we proposed a risk-based framework for laboratory developed tests (LDTs) to help ensure patients and providers have access to safe, accurate and reliable tests, while continuing to promote innovation of diagnostic tests to help guide treatment decisions.
We have ushered in the era of personalized medicine across all of our medical product centers. For example, many cancer drugs are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. A growing percentage of our recent approvals have involved targeted therapies, offering many patients more effective response profiles and/or reduced likelihood of side effects.
We made significant progress in implementing both the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. Our tobacco compliance and enforcement program has entered into agreements with numerous state and local authorities to enforce the ban on the sale of tobacco products to children and teens; conducted close to 240,000 inspections; written more than 12,100 warning letters to retailers; proposed the extremely important foundational “deeming” rule; and broken new ground for FDA with the launch of the Agency’s first public education campaigns to prevent and reduce tobacco use among our nation’s youth.
As Commissioner, my goal has been to shape and support an FDA that is well-equipped to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and our new expanding legal authorities. I have worked hard to advocate for FDA and our unique and essential mission, including building new partnerships to support our work. The Agency has received numerous votes of confidence with the bi-partisan enactment of a series of landmark bills extending our authority in the areas of tobacco, food safety and medical products. In addition, we have achieved a dramatic increase in our budget, from some $2.7 billion in FY2009 to almost $4.5 billion in FY2015.
As hard as it is to leave this Agency, I am confident that the leadership team that we have in place will enable FDA to capitalize on, and improve upon, the significant advances we’ve made over the last few years. Many of these leaders have been with the FDA throughout my tenure, and I am proud to say that we’ve recently made some wonderful new additions.
And with respect to the agency’s senior leadership team, I am pleased that Dr. Stephen Ostroff has agreed to serve as Acting Commissioner when I step down. Since joining the Agency in 2013, and most recently serving as FDA’s Chief Scientist, Dr. Ostroff has successfully overseen numerous significant initiatives, while helping to ensure that scientific rigor, excellence and innovation are infused across the Agency. I have every confidence that he will take on this new role with the same energy, dedication and care.
I want to extend my deepest gratitude to each and every one of you for your service and for making FDA an agency that is not only an exciting and rewarding place to work, but also a place of remarkably meaningful achievement and impact on the health and well-being of Americans.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs