After Dr. Robert Califf stepped down from his position as commissioner of the U.S. Food and Drug Administration earlier this year, President Donald Trump announced his new pick to head the agency—Dr. Scott Gottlieb. Gottlieb, a conservative, worked as a senior adviser to Dr. Mark McClellan when McClellan was FDA commissioner from 2002 to 2004. The Chronicle spoke with McClellan, now director of the new Duke-Margolis Center for Health Policy, about Gottlieb's nomination and his thoughts on rising drug prices and health care reform.
The Chronicle: What do you think of Scott Gottlieb's nomination by President Trump to be FDA commissioner?
Mark McClellan: I think he’s a very good nomination. He was actually a senior adviser for me when I was commissioner, and he subsequently served as deputy commissioner.
The main thing is that Scott has a lot of experience in government through his previous time at the FDA where he worked very effectively with the staff of the agency and with outside stakeholders on trying to develop better approaches to regulatory issues. He’s also scientifically and clinically knowledgeable—he still practices medicine. He has been involved in a range of applied projects on getting better treatments to patients. He’s also got a unique patient perspective as a cancer survivor. And finally, he knows how to get things done in a policy environment, working with not just people in Washington, but industry, patient groups and all kinds of stakeholders on important public health initiatives. He’s very well-qualified for the position, and he is very dedicated to finding better ways to protect and improve the health of the public, all of which are great prerequisites for FDA commissioner.
TC: It’s been reported that those in the health care field and pharmaceutical industry are "breathing a sigh of relief" at Trump picking Gottlieb. Why do you think that is?
MM: Well, I don’t know about a sigh of relief, but I think he’s just very well qualified. I think that hopefully will make for a smooth confirmation process.
This is a really important time for the agency. Congress just passed strong bipartisan legislation that touches on many issues relating to 21st Century Cures and improving FDA processes and the scientific development process more generally. It was [one of the last bills] that President Obama signed, and it would benefit from a new commissioner implementing it.
TC: What do you think are the biggest challenges facing the FDA in the coming years?
MM: One is the rising expectations and rising opportunities reflected in recent and upcoming legislation. In contrast to some other issues in health policy, this is an area where there has been a lot of bipartisanship, as reflected 21st Century Cures legislation and in the agreement coming together behind the upcoming FDA user fee legislation.
The FDA is a really challenging place, it’s an agency that has an influence over a quarter of the nation’s economy and most products that consumers use to influence their health. The agency has only limited resources to use to support all of that. Its budget may seem large, but given the scope of its responsibilities, it has much smaller resources today than the Department of Agriculture has to oversee its part of food safety. So a big challenge is getting the most impact with limited resources. It’s not just about writing regulations, it’s increasingly about interactions with industry, with patient groups and with other stakeholders to help make complex scientific processes related to the development of new drugs or new types of food products work as well as possible. The science related to the FDA is changing faster than ever, not just in biomedical technology, but also in food and nutritional products, alternatives to high risk tobacco products—all of this is the FDA’s jurisdiction.
The work the FDA does is so important, and people have different views of how to weigh these priorities and different ways of interpreting some of the scientific evidence. There is always controversy in the decisions the FDA makes. I always found it a great place to work, not just because of the really interesting science or the very high level of importance of the decisions being made, but also because no matter what you did, you knew you were going to be criticized. That was actually pretty freeing to enable you to focus on what really matters most for the health of the public.
TC: You, along with other former FDA commissioners, recently authored an open letter warning Congress of the risks of allowing commercial drug importation. Is there consensus among the scientific and medical communities that drug importation is dangerous for consumers?
MM: There’s certainly consensus from all of us who have spent time at the FDA, who have seen the science and have seen what comes in from outside of the carefully regulated approaches. When it comes to drugs that can have life saving impacts but can also cause serious unintended harm, it’s very important to have a strong regulatory process in place. All of us who signed that letter are very concerned about the high rising costs of prescription drugs in the U.S., and we absolutely support effective science-based steps to address that, as mentioned in the letter.
Not only we, from a scientific standpoint or regulatory standpoint, but also experts on drug pricing like the Congressional Budget Office have concluded that this approach is not going to lead to significant savings for consumers and will run the risk of exposing people to significant new adverse effects from drugs that are not what they report to be. There’s several reasons we have concluded this. One is that unlike clothes or watches, it’s very hard for consumers to tell whether a product that claims to be a legitimate one, really is.
The way we ensure that now in our drug regulation safety system is by having a closed system, meaning there’s a mechanism in place for tracking and ensuring the legitimacy of a drug at every step of the process—from manufacturing to distribution to dispensing to patients—that process involves regulation of the manufacturers of drugs. If the FDA does not have the authority to do that kind of regulation, which it wouldn’t for drugs that are being sent from places other than the manufacturers, there isn’t any easy way to ensure safety. It is conceivable that a big regulatory system could be put in place to create something like this closed, confident approach that we have now for drugs. But everyone who’s looked at it thinks it would be very costly, and none of the legislative proposals have any real appropriations—and I’m talking hundreds of millions of dollars the FDA would need to create that infrastructure. And even then, the problem is that there’s just not much supply of these drugs.
TC: The failure of the GOP health care bill has been big news recently. Do you have any thoughts on what direction health care reform might be headed in, or what direction it needs to be headed in?
MM: It is getting harder and harder to reach an agreement on how to provide coverage for needed medical treatments in the U.S., in large part because health care costs keep getting higher and higher. I just co-chaired a major set of reports released by the National Academy of Medicine on vital directions for health and health care that laid out a very large number of specific directions. They could not only help bring health care costs down—in ways that have evidence behind them but also considerable bipartisan support—but also could help take more direct steps to improve the health of the population and avoid medical costs and complications.
As important as health care is, the main things that determine the health of the public, leading to higher spending on complications, are things like behavioral choices, environmental exposures and social environments in which people are living. There are some very innovative programs getting at the root cause of health problems—whether it’s substance abuse problems or lack of access to good nutrition, for example—which do take time to have effects, but are increasingly showing evidence that they can improve outcomes and avoid health care costs. For example, programs for low-income Medicaid beneficiaries who have children with asthma—instead of paying for emergency room visits, they're getting at the root cause by helping a family with [the asthmatic child] make modifications at the home to reduce allergens.
It requires rethinking the way we approach health care. There is a whole set of direct recommendations that could get bipartisan support and make it easier to bring down the cost of care and improve access.
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