Academic Medical Centers and FDA – Working Together for the Future

By: Robert M. Califf, M.D.

FDA and the nation’s academic medical centers (AMCs) have a rich history together. Many of us at FDA trained and worked at AMCs, and many of us will go back to AMCs when we leave FDA. AMCs are where much of the basic science of medicine is advanced, and where the fundamental concepts for many of the tools to test for and treat illnesses are initially developed. Increasing numbers of AMCs have regulatory science programs, FDA has memoranda of understanding with numerous AMCs, and we are pleased to host a number of fellows from AMCs annually. All of these intersections advance our shared goals of protecting and promoting public health while also helping to speed innovation. Together, we push the boundaries of the known and possible, and ensure that in doing so the health and safety of patients is the primary concern.

Robert CaliffMany of these intersections have been coincidental or ad hoc – people reaching out to each other as needed and as helpful.  To better understand our interactions, and to find ways to make those interactions more deliberate and strategic, I spent part of this fall on a college tour of sorts, visiting eight states across three time zones. I spent time at some of the nation’s leading AMCs which are increasingly becoming integrated economic and medical systems that play a key role in the development of solutions to health care challenges for the American public, and are therefore an essential partner for FDA.

During my meetings with professors, students, researchers, administrators, and academic partners, I saw many different ways in which people were engaged in remarkable science, policy analyses and discussions to advance the human condition. From university undergraduates to experienced researchers and clinicians, the men and women with whom I met share a commitment to ameliorating and curing disease for individual patients and promoting public health. Several themes and common challenges emerged from our discussions and laid the foundation for a positive course of action.

AMCs have evolved from “ivory tower” teaching hospitals with associated basic research labs to multi-billion dollar enterprises that own an array of entities in a common corporate structure. These entities, usually not for profit, include the traditional teaching hospitals and labs, as well as community hospitals, large and small physician practice groups, hospice, long-term care, extended living and social services organizations. In addition, AMCs are spinning off biotech startups and working directly with private corporations, state and federal partners, and entrepreneurs.

These AMCs are often part of larger complexes that cross state lines and international borders and they have the increasing ability to take on unprecedented health care. In the past they could claim to be separated from the responsibilities of health care delivery, population health and the success of the medical products industry as a key part of our economy. Now they are large employers, economic engines and the critical elements of strategies to develop new ideas and technologies for the future and they are accountable for the healthcare for most Americans.

An increasing proportion of large healthcare delivery systems include a medical school and other healthcare professions schools. And in many states major universities are partners or owners of such systems. This concentration of economic and intellectual talent, combined with the entrepreneurial spirit and stated mission of innovation, demand our attention and strategic thought.

Consider the Texas Medical Center (TMC) in Houston. With eight million patient interactions a year, TMC is the eighth largest business district in the United States; they deliver more than 25,000 babies a year and have $3 billion in construction projects underway. I met with researchers and academic leaders at TMC, and was introduced to a group of young entrepreneurs working in a medical tech incubator housed in what was once a Nabisco cookie factory, a facility funded by a mix of public, private, and corporate donors.

One area of focus everywhere I went is how to collect, manage, and use the unprecedented amount of data now accessible on the human genome, human behavior, how much people earn and spend, the environmental conditions, and other subjects. With information such as this at the societal and individual level, clinicians and health system leaders will ultimately be able to chart precise treatments for each person and evidence driven policies for populations. To be useful, we expect these data to accurately measure what they claim to measure and to be connected to the medical condition to which they claim to be connected.

And as much as possible, these datasets must be accessible and shared. To succeed, researchers at Southern Illinois University need to be able to combine their observations with data in Morgantown, Birmingham, New York, and Des Moines. The best minds must be brought to bear on the best data, no matter where those people happen to live or where the data happens to be stored. It can be tempting to wall-off data, protecting it as one does a garden. But just as the “walled garden” was a failed model for the internet in the 1990s, the walled garden is a failed model for the data needed for precision medicine to succeed.

FDA can be an important partner in this effort. Scientists, whether at FDA, in academic institutions across the nation, or in private industry, share the goal to protect and promote public health. Together we can ensure that researchers, patients, and health care providers can trust the data and ensure that as many people as possible have access to it. It is also true that even those of us with the best motivations are human. We make mistakes, get sloppy, and occasionally let things slide. That’s where FDA can play such an important role, by helping to maintain and hold everyone to a high standard while driving innovation forward.

In addition to raising the bar, standards can help products stand out in an increasingly crowded marketplace. In Cambridge, for example, I met a young innovator who said he was having trouble attracting venture capital to fund his idea in part because potential investors saw an unregulated marketplace into which competitors whose products sounded similar but with no proven positive effect, could begin marketing immediately and undercut him. Requiring FDA approval essentially freezes out fly-by-night companies more interested in quick profits than developing and disseminating technologies with evidence for benefits to individuals and populations.

Make no mistake, FDA has room to improve. During my trip I heard directly, without equivocation, how FDA could do a better job.  As someone who spent most of my career at an academic medical center, I understand those concerns up close and personal, and I also know that there is room for improvement on both sides.

That means I also know firsthand the challenges, and opportunities, presented by both AMCs and this important scientific regulatory agency. After my tour, I am more convinced than ever that FDA and the academic medical center enterprise need each other, must continue to communicate and engage with each other, and, where appropriate, must collaborate to advance their shared missions.

This is not a short-term project. This engagement must continue long after I leave FDA.

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

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