Margaret Hamburg Ends Six-Year Run As FDA Commissioner
ROBERT SIEGEL, HOST:
The agency that Margaret Hamburg has been running for the past six years likes to say that it oversees 20 cents of every dollar of consumer spending. She is leaving the post of commissioner of the Food and Drug Administration. We spoke on this program when she first came to Washington from New York City when she'd been commissioner of health. That was back in 2009. Doctor Hamburg, since we spoke at the beginning of your time at FDA, we thought we'd have an exit interview. Is that OK?
MARGARET HAMBURG: That's great. Yes - sort of bookends to the experience.
SIEGEL: There you are. Back in 2009, we talked about tobacco, and I didn't ask you then about electronic cigarettes 'cause I don't think I knew about them. The Centers for Disease Control now says that between 2010 and 2013 the use of e-cigarettes doubled among American adults. Was the FDA too slow out of the gate on e-cigarettes?
HAMBURG: We actually tried to take an action to regulate e- cigarettes shortly after I became commissioner. We wanted to regulate them as drugs alluded by a device, but we lost that effort in court, and we were told to regulate them using our new authorities in the Tobacco Prevention and Control Act. And we are in the midst of trying to extend our authority over tobacco products to include e-cigarettes and also other tobacco products - gels and lozenges, hookahs.
SIEGEL: But it sounds that - in the case of e-cigarettes, say - that the agency has been outraced by the market in this case - that you're playing catch-up with them.
HAMBURG: Certainly, e-cigarettes are becoming increasingly prevalent in the marketplace. I think it's also important, though, to recognize that there's a lot still to be known about e-cigarettes. We don't know, for example, whether e-cigarettes are a gateway to other significant tobacco use or whether they can be a meaningful tobacco cessation tool.
SIEGEL: I want to ask you about the criticism that the group Public Citizen makes of the relationship between the FDA and the drug companies. They say that the partnership - a partnership that you've praised when it's been efficient - just is not the proper relationship between the regulators and the regulated. Is there need for reforming that relationship?
HAMBURG: In terms of the ability to deliver on the promise of science and the opportunities for new medical product development today, FDA must be a partner with the research community, academia and industry and must make every effort to streamline and modernize our regulatory review systems at the same time that we adhere to established standards for safety and efficacy. I'm very proud of what we've been...
SIEGEL: You're talking about a balance. You're talking about a balance here...
HAMBURG: A balance.
SIEGEL: ...Which is making sure that unsafe drugs don't reach the market, but also you're saying drugs should reach people in need of those drugs as quickly as possible.
HAMBURG: That's right. We joke at the FDA that there are only two speeds of approval - too fast and too slow. And people's assessment of is it too fast or is it too slow, I think, depends on the particular circumstance and their particular needs.
SIEGEL: Doctor Hamburg, do you assume that one of your successors at FDA as commissioner in the near future will have responsibility for regulating recreational marijuana?
HAMBURG: Well, of course we've seen an explosion of marijuana for medical purposes and recreational purposes across the United States. Our role in terms of oversight of various kinds of drugs, including botanical drugs, really has to do with assessing the product in terms of treatment of a specific medical condition or need.
SIEGEL: Still med - you're still speaking of medical marijuana. You don't think the FDA should be ready for some new responsibility comparable to its tobacco authority. Should that be working its way through Congress now?
HAMBURG: You know, I have not heard discussion of that, but one thing I've learned in my role as FDA commissioner is to be prepared for the unexpected. Certainly, many of the kinds of products that we're regulating now were products that I had never dreamed of before either during my medical training or even when I took on the mantle of FDA commissioner.
SIEGEL: Apart from e-cigarettes, which we talked about, what's an example of something you found yourself surprisingly in charge of regulating in Washington?
HAMBURG: Well, for example, it never occurred to me that we would be regulating replacement body parts created by 3-D printers.
SIEGEL: Yeah, it was hard to see that one coming a few years ago I guess.
HAMBURG: (Laughter) No, but it's making a difference. It's really quite dramatic, quite remarkable. You talk about personalized medicine - this is, you know, one new aspect of personalized medicine.
SIEGEL: Doctor Hamburg, thank you very much for talking with us today.
HAMBURG: Thank you.
SIEGEL: That's Margaret Hamburg who, after six years, is leaving the position of commissioner of the Food and Drug Administration.
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