[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR 2011
_______________________________________________________________________
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
________
SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG
ADMINISTRATION, AND RELATED AGENCIES
ROSA L. DeLAURO, Connecticut, Chairwoman
SAM FARR, California JACK KINGSTON, Georgia
ALLEN BOYD, Florida TOM LATHAM, Iowa
SANFORD D. BISHOP, Jr., Georgia JO ANN EMERSON, Missouri
LINCOLN DAVIS, Tennessee RODNEY ALEXANDER, Louisiana
MARCY KAPTUR, Ohio
CHET EDWARDS, Texas
MAURICE D. HINCHEY, New York
NOTE: Under Committee Rules, Mr. Obey, as Chairman of the Full
Committee, and Mr. Lewis, as Ranking Minority Member of the Full
Committee, are authorized to sit as Members of all Subcommittees.
Martha Foley, Leslie Barrack, Alexander Gillen, and Matt Smith,
Staff Assistants
________
PART 4
Page
Global Food Security............................................. 1
Farm and Foreign Agricultural Services........................... 49
Food and Drug Administration..................................... 153
Drug Safety...................................................... 267
________
Printed for the use of the Committee on Appropriations
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR 2011
_______________________________________________________________________
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
________
SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG
ADMINISTRATION, AND RELATED AGENCIES
ROSA L. DeLAURO, Connecticut, Chairwoman
SAM FARR, California JACK KINGSTON, Georgia
ALLEN BOYD, Florida TOM LATHAM, Iowa
SANFORD D. BISHOP, Jr., Georgia JO ANN EMERSON, Missouri
LINCOLN DAVIS, Tennessee RODNEY ALEXANDER, Louisiana
MARCY KAPTUR, Ohio
CHET EDWARDS, Texas
MAURICE D. HINCHEY, New York
NOTE: Under Committee Rules, Mr. Obey, as Chairman of the Full
Committee, and Mr. Lewis, as Ranking Minority Member of the Full
Committee, are authorized to sit as Members of all Subcommittees.
Martha Foley, Leslie Barrack, Alexander Gillen, and Matt Smith,
Staff Assistants
________
PART 4
Page
Global Food Security............................................. 1
Farm and Foreign Agricultural Services........................... 49
Food and Drug Administration..................................... 153
Drug Safety...................................................... 267
________
Printed for the use of the Committee on Appropriations
U.S. GOVERNMENT PRINTING OFFICE
57-781 WASHINGTON : 2010
COMMITTEE ON APPROPRIATIONS
DAVID R. OBEY, Wisconsin, Chairman
NORMAN D. DICKS, Washington JERRY LEWIS, California
ALAN B. MOLLOHAN, West Virginia C. W. BILL YOUNG, Florida
MARCY KAPTUR, Ohio HAROLD ROGERS, Kentucky
PETER J. VISCLOSKY, Indiana FRANK R. WOLF, Virginia
NITA M. LOWEY, New York JACK KINGSTON, Georgia
JOSE E. SERRANO, New York RODNEY P. FRELINGHUYSEN, New
ROSA L. DeLAURO, Connecticut Jersey
JAMES P. MORAN, Virginia TODD TIAHRT, Kansas
JOHN W. OLVER, Massachusetts ZACH WAMP, Tennessee
ED PASTOR, Arizona TOM LATHAM, Iowa
DAVID E. PRICE, North Carolina ROBERT B. ADERHOLT, Alabama
CHET EDWARDS, Texas JO ANN EMERSON, Missouri
PATRICK J. KENNEDY, Rhode Island KAY GRANGER, Texas
MAURICE D. HINCHEY, New York MICHAEL K. SIMPSON, Idaho
LUCILLE ROYBAL-ALLARD, California JOHN ABNEY CULBERSON, Texas
SAM FARR, California MARK STEVEN KIRK, Illinois
JESSE L. JACKSON, Jr., Illinois ANDER CRENSHAW, Florida
CAROLYN C. KILPATRICK, Michigan DENNIS R. REHBERG, Montana
ALLEN BOYD, Florida JOHN R. CARTER, Texas
CHAKA FATTAH, Pennsylvania RODNEY ALEXANDER, Louisiana
STEVEN R. ROTHMAN, New Jersey KEN CALVERT, California
SANFORD D. BISHOP, Jr., Georgia JO BONNER, Alabama
MARION BERRY, Arkansas STEVEN C. LaTOURETTE, Ohio
BARBARA LEE, California TOM COLE, Oklahoma
ADAM SCHIFF, California
MICHAEL HONDA, California
BETTY McCOLLUM, Minnesota
STEVE ISRAEL, New York
TIM RYAN, Ohio
C.A. ``DUTCH'' RUPPERSBERGER, Maryland
BEN CHANDLER, Kentucky
DEBBIE WASSERMAN SCHULTZ, Florida
CIRO RODRIGUEZ, Texas
LINCOLN DAVIS, Tennessee
JOHN T. SALAZAR, Colorado
PATRICK J. MURPHY, Pennsylvania
Beverly Pheto, Clerk and Staff Director
(ii)
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR 2011
----------
Thursday, March 11, 2010.
GLOBAL FOOD SECURITY
WITNESS
THOMAS MELITO, DIRECTOR, GAO; INTERNATIONAL AFFAIRS AND TRADE
Ms. DeLauro Opening Remarks
Ms. DeLauro. The hearing will come to order. First of all,
our apologies to you, but we just concluded voting on the floor
of the House and got here as quickly as we could. So I
appreciate your forbearance--to our guests, and also to our
guests who are here for the hearing.
What we want to do is to, first, to welcome you and to say
thank you for coming here, Thomas Melito, director of the
General Accounting Office's international affairs and trade
team. Mr. Melito is here to present the report, which I had
requested, and that GAO is releasing today at this hearing, on
our government's current approach to international food aid and
food security. So, again, we thank you for being here.
The funding of international food aid is another of the
fundamental responsibilities of this subcommittee. I am very
proud of the fact that, together, Democrats and Republicans
have both worked to increase funding for the Food for Peace
program, P.L. 480, by 38 percent in last year's appropriations
bill. And, thanks to Republican champions of food aid like
Representative Jo Ann Emerson, we also more than doubled
funding for the McGovern-Dole program, including funding for
pilot programs and fortified food that will improve nutrition
for the recipients of this aid.
So, I am proud of what we have accomplished in this arena
so far. Nonetheless, because of higher food prices and global
economic uncertainty, the number of undernourished people has
increased by over 150 million over the past 2 years. And now,
for the first time ever, over a billion souls on our planet go
hungry or are ill-fed. Every six seconds a child in this world
dies because of hunger or hunger-related causes.
If that statistic were not, in and of itself, horrible
enough, that's just the hunger side of the ledger. We also know
that malnutrition causes all kinds of lingering problems for
the underfed. Research shows that children's mental and
physical development are stunted by inadequate nutrition, that
women are more likely to suffer from conditions like obstetric
fistulas, and that people's immune systems across the board are
all adversely affected by malnourishment.
I believe, and I know many here agree, that the continued
existence of such famine in our day and age is a moral outrage.
We have the resources and the ability to confront this kind of
suffering in our world, and it behooves us to act when and
where we can put a stop to it.
You know, even if you do not share the sense of moral
obligation, however, global hunger is a national security
issue. We know for a fact that hunger, gnawing, unyielding,
forces people into desperate acts and dangerous pacts. Famine
and starvation create the conditions for militant extremism
around the world, the very extremism that we fight right now in
Iraq and in Afghanistan.
Simply put, international food aid is not only an important
aspect of our diplomacy, it's a crucial aspect of our current
efforts to combat global terror. We fight hunger, and we
undercut the recruiting base of those who would threaten us. As
a former national security advisor, Sandy Berger wrote in the
Los Angeles Times last year, ``Ensuring that no child goes to
school hungry is the single greatest investment we can make in
building prosperous, healthy, and stable societies.''
This is one reason why I am concerned about the flat
funding levels in the USDA's proposed budget for the P.L. 480
Title II program and the McGovern-Dole program. Now, when the
world needs our help and is looking to us for moral leadership,
now is not the time to forsake our commitment to funding food
aid. After all, it is no hyperbole to say that helping to feed
the world in this manner also helps to keep our troops safe.
Of course, we must make sure that our food aid is
distributed effectively and efficiently, and that the money we
are spending on these programs is getting to the people who
desperately need it, as the single comprehensive food safety
agency.
Based on the report that we have, it seems that we may face
a predicament in our current approach to global food security.
We now have 10 agencies that have jurisdiction over our
international food commitments. And again, perhaps this is an
arena where some streamlining and consolidation of our global
food security apparatus would benefit everyone involved, not
the least all of the hungry that we are trying to help.
Let me just indicate to you that this is not a new concept
for me, in trying to get to one single agency that has to deal
with food safety. There are 15 at the moment. In my view, there
are 14 too many. So we seem to have a number of agencies that
are engaged in this effort, as well.
In any case, I look forward to hearing what the GAO report
has ascertained about our current multi-faceted food security
strategy, and I hope and I expect that today's testimony will
help to illuminate the path ahead, as we consider these issues
on the subcommittee.
So, thank you once again for joining with us today, Mr.
Melito, and let me now recognize my colleague, Congressman
Kingston, for any opening remarks that he may have.
Mr. Kingston Opening Remarks
Mr. Kingston. Thank you, Madam Chair, and thank you for
having this hearing. I know that this is a great passion for
all three of us that are here--in fact, the whole committee and
most Members of Congress. Yet, at the same time, my perspective
might be a little bit different than my two colleagues up here,
from a number of points of view that I want to just talk about
briefly.
Number one, very important, do you know what the deficit
was last month? $223 billion. One month's deficit. One month.
The deficit projection for this year is $1.6 trillion, about 37
percent of our entire budget.
Now, I just heard a Republican colleague of mine, Bob
English, say--and I'm not sure if this is accurate; I'm going
to check it out --he said, ``Basically, we have enough money
that comes in to pay for Medicare, Social Security, and most of
the entitlement programs. Everything else that the Federal
Government spends money on is actually borrowed money or
printed money. It's deficit spending.'' Sobering thought.
The Republican conference just voted to not do any earmarks
this year, just sort of as a show. And now we all, as
appropriators, think that the Administration actually does need
our input on their budget, and so that's not necessarily a
position of everybody's here, because if you do not earmark the
budget or change it, you're essentially agreeing with the
executive branch, which the legislative branch would not want
to do. But I think there is the theme that the budget issue is
huge. And for too long we have chosen to ignore it, both
parties.
A second concern of mine is that--and I think you're
addressing this, it's just the lack of comprehensive data on
the funding on what are we doing. You know, it's amazing that
every generation thinks they've discovered something new, food
aid being one of them, as if we weren't in many of these
countries for decades already.
I was recently in Ethiopia. And one of the food aid--we
went to a food aid program, which I enjoy doing immensely when
I go to other countries. I want to see the plate in the child's
hand. Sometimes that's hard to do, by the way. The
international communities resist you going out and doing site
inspections. But I don't stop until I see the plate in the
kid's hand. And one of the workers said to me, ``You know, this
might be''--and the kind of, I'd say, self-dramatization of
many aid workers--``This child might only have this plate of
food today.'' I talked to a local who said, ``That's not true
at all.''
Case in point. I lived in Ethiopia in the 1950s. The
population was around 12 million to 13 million people. Today
it's 80 million people. Now, they have had all kinds of
problems with their government, as you may know, all kinds of
problems with droughts, and so forth. Yet, somehow, they are
getting food, because their population has gone up so much. It
could not have done--it could not have happened.
International aid--and food aid included in that--in Africa
has been just churning for years. Very few bright spots in it.
You get a country like Botswana, that's making a lot of
progress, but we don't allow U.S. developmental aid. And so
here is a country that, if you will, has kind of graduated from
the primary care stage, needs technical assistance, but because
they're prosperous they don't get it any more. And to me,
that's an inconsistency.
Switching back to Ethiopia, what's interesting, as we were
going outside of Addis Ababa to visit this village and this
school that had a program, we actually had some down time in
which we saw another school. And I said, ``Well, let's stop at
this school.'' Both schools, concrete or dirt floor. No
electricity, no insulation. The kids all sharing a desk, kind
of a plank table--you've seen those before. But one school gets
the aid, the other one doesn't. Don't know why. I mean, we can
say, ``Well, it's lack of resources,'' but what was the
decision that chose one over the other? Where was the decision-
making in that?
Another concern of mine is how much of this is skimmed off
by corrupt governments? In Zimbabwe, the aid is led by the host
country. Is that a great idea, with the Mugabe Government?
Probably not.
Another issue which I think is very important--and I
actually think food aid is ahead of most aid on this--is using
the host country resources. You know, we want to employ as many
people on the ground as possible for the manufacturing and for
the distribution. And I think food aid actually is moving in
that direction, more than some of the other aid. But that's
something that we need to address.
And so, I am very interested in this, very committed to it,
and very curious about it. But, you know, people who are on the
ground who would give food aid an A plus, I don't know what
their grade scale is. I think absolute A plus for compassion,
absolutely A plus for purity in heart and idealism. But in
terms of delivery, in terms of long-term results, in terms of
helping impoverished countries so that they don't need aid,
it's a C minus, at the best.
So, I am looking forward to your testimony, looking forward
to a relationship, and working with you in the long term.
Ms. DeLauro. Thank you very much, Mr. Kingston. Mr. Melito,
you are now free to engage in testimony, and the full report of
your testimony will be on the record. And you are free to
summarize or to characterize your remarks. Thank you.
Mr. Melito Opening Statement
Mr. Melito. Thank you. Madam Chairwoman and members of the
subcommittee, thank you for the opportunity to discuss our work
on U.S. agencies' progress toward the development of a
government-wide strategy to address global food security.
Global hunger continues to worsen, despite the world
leaders' 1996 pledge, reaffirmed in the year 2000 and again in
2009, to halve hunger by 2015. The Food and Agriculture
Organization recently reported that more than one billion
people were undernourished, worldwide. In 2009, major donor
countries pledged about $22 billion for agriculture and food
security in developing countries, of which the U.S. share is at
least $3.5 billion.
Since assuming office, the President and the Secretary of
State have each stated that improving global food security is a
priority of this Administration. Consistent with the
recommendation in our 2008 review of food and security, U.S.
agencies have launched an effort to develop a government-wide
strategy to combat global hunger.
My statement is based on our report released today on
government-wide efforts to address global food insecurity. I
will focus on two topics: first, the types and funding of U.S.
global food security programs; and second, progress in
developing an integrated U.S. government-wide strategy, and its
potential vulnerabilities.
Regarding the first topic, we found that the U.S.
Government supports a wide variety of programs and activities
for global food security, but it lacks comprehensive data on
funding. As a result, it is difficult to determine the full
extent of such programs and activities, and to estimate
precisely the total amount of funding that the U.S. Government,
as a whole, allocates to global food security.
In response to GAO's data collection instrument, seven
agencies reported funding for global food security in fiscal
year 2008. USAID and USDA reported the broadest array of
programs and activities, while USAID, MCC, and Treasury
reported the highest levels of funding.
The seven agencies together directed at least $5 billion in
fiscal year 2008 to global food security, with food aid
accounting for about half of that funding. However, the actual
total is likely greater for two reasons.
First, the agencies lack a commonly accepted operational
definition of global food security programs and activities.
Such a definition would enable U.S. agencies to apply at the
program level for planning and budgeting purposes.
Second, some agencies' management systems are inadequate
for tracking food security funding data comprehensively and
consistently. Most notably, USAID and State fail to include a
very large amount of food aid funding in a database they both
use to track foreign assistance.
Regarding our second topic, the Administration is making
progress toward finalizing a government-wide strategy, but its
efforts are vulnerable to data weaknesses and risks associated
with the strategy's host country-led approach. The
Administration has established inter-agency coordination
mechanisms at headquarters. In addition, it is finalizing an
implementation document and a results framework, both of which
are expected to be released shortly.
However, the lack of comprehensive data on funding levels
may deprive decision-makers of information on available
resources and a firm baseline against which to plan.
Furthermore, the host country-led approach, although promising,
has three key vulnerabilities.
First, the weak capacity of host governments can limit
their ability to sustain donor-funded efforts. For example, the
multilateral development banks reported relatively low
sustainability of agriculture-related projects in the past.
Second, a shortage of expertise in agriculture and food
security at U.S. agencies could constrain efforts to help
strengthen host government capacity. In 2008, 3 former USAID
administrators reported that the agency had only 6 engineers
and 16 agricultural experts at that time.
And, third, policy differences between the United States
and host governments may complicate efforts to align our
assistance with their strategies. For example, Malawi's
strategy of providing subsidized agricultural inputs to farmers
runs counter to the U.S. approach of encouraging the
development of agricultural markets, and linking farmers to
those markets.
In the report issued today, we recommend that the Secretary
of State work with other agencies to develop an operational
definition of food security, establish a methodology for
consistently reporting comprehensive data, and periodically
inventory food security-related programs. We also recommend
that the Agency specify measures to mitigate the risks
associated with the host country-led approach. The agencies
concurred with our recommendations.
Madam Chairwoman, this concludes my statement. I would be
pleased to respond to any questions that you or other members
of the subcommittee may have. Thank you.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeLauro. Thank you very much for your testimony. Let me
just start right in.
I am troubled by the discrepancy that you found in the data
that USAID reported for Title II of P.L. 480, which, as you
know, is one of the most popular and most effective
international food aid programs. You report that the Foreign
Assistance Coordination and Tracking System, the database
that's used by both the State Department and USAID, included a
number that was over $1 billion short of the actual 2008
appropriation of $2.1 billion--a significant discrepancy.
Mr. Melito. Yes.
Ms. DeLauro. Troubling, also, that USAID was unaware of the
mistake until you brought it to their attention.
Your report also suggests the database was not immediately
corrected after the mistake was discovered.
Equally troubling is your conclusion that USDA has no
established mechanism for reporting data on food security
programs, and that several different conflicting estimates were
provided to you after several inquiries.
Why do you think USAID and USDA had so much difficulty in
reporting accurate data? What effect is this likely to have on
the food aid programs at these agencies? How do USDA and USAID
compare with the other agencies that you reviewed?
Mr. Melito. Thank you. The situation with USAID was that
they had a fairly--actually, they had a very accurate number
for the initial appropriation. Where it broke down was on the
supplemental. They included a couple of supplemental items, but
they didn't include the very large Title II supplemental item,
which was very large and, obviously, very clear to us, when we
compared it to the IFAR and other documents, including the
budget.
We did bring that to their attention, and they did tell us,
``Yes, you used a larger number.'' Where there seems to be some
discrepancy----
Ms. DeLauro. Was there any reason why they didn't include
it?
Mr. Melito. They didn't seem to have a good process for
updating----
Ms. DeLauro. I got it, okay, okay.
Mr. Melito [continuing]. After the budget was supplemented.
Ms. DeLauro. Okay.
Mr. Melito. Where we're a little confused is in their
agency comment letter. They have--they're not seeming to
indicate that that's a problem. Although, informally with us,
they agree it was a problem. And they ultimately included the
number in the official number that we have here. So we're still
in dialogue with them----
Ms. DeLauro. Okay.
Mr. Melito [continuing]. About exactly what processes they
will have in place, and thus, our recommendation.
Regarding USDA, I would say that the issue was stovepiped
within the organization, that there really was no good way of
cutting across different parts of USDA to see across--for
something which touches a number of different programs. Also, I
don't think they initially assigned it to someone at a high
enough level for them to actually help us with this.
That all said, I think ultimately we have a pretty good
USDA number. But it took a lot of work with us to work with
them.
We consider all of this to be a problem, though, because
this strategy is an attempt to be a whole-of-government
approach. And they're going to be needing--or they're going to
say they need resources. And we think you can't really give a
good number on what resources you need unless you know what
resources you already have. So, this is an attempt by GAO--
we're working with the agencies to create as good a baseline as
possible.
That said, we know in our report this is an understatement.
There are a number of categories--there is over $800 million of
USAID funding which overlaps with other programs, such as
health and such, that we know there is a food security
component, but we couldn't tease it out. If they had a better
definition, AID ultimately could tease it out----
Ms. DeLauro. Well, that's what--we will get to those
questions.
Mr. Melito. Right, yes.
Ms. DeLauro. But I--just quickly, USDA, USAID, a comparison
to other agencies that you reviewed, or are these the two major
pieces that----
Mr. Melito. Those are the two largest discrepancies. State
Department, we had a lot of problems early on with State
Department, separate from the issue with the supplemental.
Their initial number didn't include their contribution to the
Food and Agriculture Organization, their initial----
Ms. DeLauro. Oh, okay.
Mr. Melito [continuing]. Which is $100 million a year.
Ms. DeLauro. Sure, sure, sure.
Mr. Melito. And we sat down with them and ultimately----
Ms. DeLauro. And said, ``You've got to''----
Mr. Melito. Yes, then----
Ms. DeLauro. That fits. That fits. Okay.
Mr. Melito. We thought we had pretty good numbers with MCC.
The other large player was Treasury.
Ms. DeLauro. Yes.
Mr. Melito. There, the numbers were fine. The question was
the methodology. How do you attribute our contributions to a
multilateral organization? And I think we came up with a
mutually agreeable methodology between GAO and Treasury on how
we're scoring that.
Ms. DeLauro. I think your point is well taken. I have one
more question in regard to that before--I know my time is going
to be up.
But it would appear to me that what we're talking about
is--rather than substance--is process here, in terms of getting
to figuring out how much there is, what a definition is, and
what gets allocated. It is really the process and not, if you
will again, the substance of the commitment to doing that, or
to getting the food----
Mr. Melito. That's exactly right. That's a separate
consideration.
Ms. DeLauro. That's a separate consideration.
Mr. Melito. Yes.
Ms. DeLauro. Just quickly, have you seen specific
improvements with either agency since your initial review? And
what is your current assessment of--your assessment of the
current capabilities of USDA and USAID to collect and to report
data for food security programs?
What specific steps should each agency take to correct the
problems?
Mr. Melito. I would say our story is the current story,
because we were making adjustments based on dialogue with them
through the end of February.
Ms. DeLauro. Got you.
Mr. Melito. So--but I--they concurred with our
recommendations.
Ms. DeLauro. Okay, okay.
Mr. Melito. So I think they do agree they can do better.
And I think we've given them a path to that.
Ms. DeLauro. Okay. Okay, and you've laid out--the specifics
are laid out in your recommendations?
Mr. Melito. Yes.
Ms. DeLauro. My time has expired. Thank you very much. Mr.
Kingston?
Mr. Kingston. Mr. Melito, if I am kind of listening to you
correct, you're the--kind of the bean counter of the operation,
the cold-hearted accountant guy, right? Do you think they're
going to listen to you? Do you think Congress or the agencies
will?
Mr. Melito. Well, I can only go by what they currently
said, which is they do agree they need something, a good
comprehensive number, for planning purposes.
They have yet to come out with their official strategy. And
that official strategy should start having some budget numbers,
going forward. That will be, I think, the first test. And that
should be in the next couple of months, whether or not they
actually will act on GAO's recommendation.
Mr. Kingston. You know one of the things that's interesting
to me? I deal a lot with USDA employees. And I think they're,
on the whole, a very, very good group of people, very
dedicated. And the ones that are international are among the
sharpest people I've ever met. And you know, you just--it's
incredible, how smart some of these people are.
In the planning, are they ever included in the strategy, in
terms of, ``Okay, what do you need to get out of there in five
years?''
Mr. Melito. For this particular assignment, we looked at
the State Department effort right now to create a government-
wide strategy. USDA is an important part of the strategy.
Mr. Kingston. But are the people in the field given input?
Mr. Melito. You highlight an important issue. We were very
careful in the report to talk about this as a headquarters
effort. We were silent on what this will mean on the field,
because we don't know yet.
In the past, these kind of efforts have broken down when
you've gone from headquarters to field. We hope and don't know
that's true, but that will be one of the important
implementation steps, which GAO would like us to look at, six
months or a year from now.
Mr. Kingston. You know, people who spend their lives in
third-world countries who could make more back home and live
more comfortably back home and be with their families back
home, they're pretty dedicated people. They're very interested
in what they're doing, not just passionately, but they have an
understanding and a sense of, ``I want to get something done.''
And I think we're remiss in not listening to them, and drawing
them into the process more.
A problem we have politically is--we're looking at
international aid, including food aid--is the State Department
vote rating system. Are you familiar with that?
Mr. Melito. Just very little----
Mr. Kingston. Well, I'm not an expert on it. But as I
understand it, maybe 20 or 30 years ago, Congress mandated that
the State Department rates UN voting, and there is a sample of
13 different votes which the State Department deems important.
And then they publish once a year to Congress how these
countries have--how every country that's in the UN votes, in
terms with us. Israel, Great Britain are, you know, in the 70s,
the 90s. South Korea is in the 70s.
But then, it just falls. And so many of the countries that
we give aid to have very, very low rating systems. So when our
constituents are looking at international aid, foreign aid,
which generally isn't the most popular thing on the budget, and
they look at that, then they say, ``Look, look at all the money
we're giving to people who vote with us 10 or 15 percent of the
time.''
Now, that's an outrage, and I like to bring it up when I'm
on these international meetings. But the truth of the matter
is, if it was voting--if I was doing the voting, or with my
colleagues to my right and left, philosophically and spatially,
they would not have 100 percent, either. Because the votes are
all about the Middle East, Israel, Cuba boycott, and the death
penalty. I mean they're just, frankly, stupid votes. And yet,
that's what our constituents are going to use as a gauge to if
a country is an ally or not.
What we, I think, need to do is look at the broader
context. Take a country like Nigeria, which is very helpful, in
terms of, you know, looking at Abdulmutallab, The Underwear
Bomber, you know, the investigation of him trying to tap down
local dustups in that area of Africa, they are a good ally of
us, but they don't vote with us in the UN, necessarily.
So, we need to, I think, change that voting sample to give
a truer picture. Because it is really detrimental, if you are
trying to give food aid to people. And, you know, it's so easy
for us to grandstand. And somebody like Ms. Emerson, who has
dedicated so much of her life to it, we're pulling out the rug
from under the efforts.
And I'm talking to you only because you go in these
circles, and you can talk to people. But it's something that we
should say, ``You know what? It's probably proper for us to
look at UN voting, but not these votes.'' And it's also not
proper to end it at voting, because if they're sending people
to Afghanistan, or they're helping with local skirmishes in
their part of the world, we need to give them some credit for
that beyond it, so that Members of Congress can go back to
their folks and say, ``Look, these people are allies, they're
helpful.'' You know, there is a case for it.
So, I know I'm out of time, and we will look forward to
more questions.
Ms. DeLauro. Ms. Emerson.
Ms. Emerson. Thanks, Madam Chairwoman. Dr. Melito, thanks
for being here.
Mr. Melito. Sure.
Ms. Emerson. And thanks for doing this study, which is
quite interesting. And I am hopeful it will be quite helpful.
I do want to concur with my chairwoman about the need to
streamline things. It would just be so much simpler just to
have one place where everything was done. And that way you
could monitor it, we would know how much money we were
spending, we could perhaps figure out if we were doing any good
a lot easier than we are now.
I also want to say I share your view that we shouldn't
expect any easy solutions here, and we're dealing with a long-
term sustained effort that is going to be necessary, I think,
by every single person, every single government agency, every
country involved in trying to ensure that we can feed those
people who otherwise are unable to do so for themselves.
But let me ask you, just--you know, one of the things that
is concerning--and I think this plays off of what Jack was
saying--we really somehow, if you want to look at it from the
military perspective, we've got to be able to show that there
is a strong and vested coalition of nations in the fight
against global hunger, and not just us.
But--so while you raise the concerns that we lack data
across agencies, did you look at any opportunities to improve
data across nations, or efforts to improve international
coordination of aid efforts?
Mr. Melito. We wholeheartedly agree that this coordination
and integration effort has to be much larger than the U.S. That
said, this U.S. Government effort was much more difficult than
my team and I ever anticipated it was going to be.
Ms. Emerson. I think if you probably did that for every
single piece of the government you would probably say the same
thing.
Mr. Melito. It took almost a year. And it was really
difficult to get the agencies engaged. And once they engaged,
it became very difficult to get them to coordinate and align,
and what not. But there probably needs to be a similar
international exercise, which I think would help. But I guess
one battle at a time.
Ms. Emerson. Yes, precisely.
Mr. Melito. Yes.
Ms. Emerson. No, it is interesting, though. Hopefully, by
having engaged all of the agencies, somehow you made them start
thinking about perhaps we ought to keep better track, or try to
at least have some cost-benefit analysis done for the work that
they're doing.
I also understand your concern about a country-led
approach. And, you know, obviously it would go without saying
that the American taxpayer does expect competent and honest
governments and NGOs with whom to partner.
But you know, I was reading the discussion that you wrote
about in Malawi. And it's just interesting, because I happen to
know the nephew of the president of Malawi, and I know that
they're trying to do some different things there. Obviously,
their approach to adding value, if you will, to the producers'
labor--actually creating subsidies, which is a bad word--I
think that that is helpful.
But there is obviously some pushback by some of our
government agencies about the way that they are helping their
farmers, and therefore we should take a step back. I would be
interested just--and your thoughts a little bit more about
that.
And, I don't know, I don't know how to fix this, or try
to----
Mr. Melito. Right.
Ms. Emerson [continuing]. Go on the path to make us be
efficient and streamlined, and be able to help more people. If
we could just somehow better direct resources.
Mr. Melito. Malawi was a carefully chosen example. Because,
if you look at it, you can see that they both have somewhat of
a credible argument to make. Malawi is a pretty good performer,
and they're actually meeting the pledge that--they've already
provided more than 10 percent of their budget towards
agriculture. But the U.S. has a long-running reason for wanting
to mark markets.
So, we chose that example because the host country-led
approach is going to create conflict and difficulty for
agencies a number of ways. And this one would be one where,
basically, two different philosophies, which may have
justification, are going to clash.
I mean, we could chose examples where one side looks--The
policy is not correct.
Ms. Emerson. Right.
Mr. Melito. This one, it's debatable policy. So I don't
think, actually, I can tell you how the U.S. Government is
going to approach this. We just want them to basically begin
thinking about this. They're going to be confronting it a lot,
probably, as they deploy lots of money right now, and think
about basically reinvigorating U.S. food security approaches.
Ms. Emerson. Yes, it's going to be--it is going to be
interesting----
Mr. Melito. Yes.
Ms. Emerson [continuing]. Once this whole strategy is
finalized, I guess, is the best way of putting it. But it is,
in my opinion--I mean there are great challenges. But, then
again, there is also an understanding--at least I can
understand, given that I come from an ag district--that you
want to help your farmers be able to create some sustainable
lifestyle.
So, my time is up. I will wait and ask another question.
Thanks. Thanks, Dr. Melito.
Ms. DeLauro. Dr. Melito, let me try to get to the issue of
the definition of global food security.
Mr. Melito. Sure.
Ms. DeLauro. And that--one of your findings in the report
suggested a cause of incomplete funding is the lack of a
commonly accepted government-wide definition of global food
security.
And you further posit that, without that understanding or
that definition, many agencies will submit inaccurate funding
data by defining the term too broadly or too narrowly.
What you did was you used a working definition of global
food security, based on your prior work with and in
consultation with agencies. You included programs, as I
understand it, containing elements such as food aid, nutrition,
agriculture development, rural development, safety nets, policy
reform, market intelligence and monitoring, and future
challenges to food security. This strikes me as a broad
definition. Why did you include, for instance, elements such as
rural development?
My further question is here--is how do we get to an
acceptable global food security definition, if that is
fundamental to our being able to calculate what it is that we
are--you know, what is it we're doing, and what kind of
resources we have, and how we can monitor those resources? Why
rural development, first.
Mr. Melito. Well, it's a broad category, but it's not
everything in rural development. But the infrastructure of
rural areas, most especially the roads, has been pointed out in
many studies as an enormous impediment to being able to
effectively take advantage of surpluses.
So, if you actually do the good work of increasing yields
and surpluses, but you can't then bring it to the market, then
your efforts are going to fail.
Similarly, the issues of microcredit in the rural areas is
something which--it's often very difficult for the farmers to
take advantage of new technologies without some kind of credit
system.
So, those are two areas. But it's not all the elements of
rural development, but those are two vital areas which are
directly linked to ag security.
You mentioned that our definition is broad. It's broad
because this is an interactive process. You mentioned correctly
that we had--in a previous report, our 2008 report----
Ms. DeLauro. Right.
Mr. Melito [continuing]. We also had nine different focus
groups with experts and with practitioners in the field----
Ms. DeLauro. Okay.
Mr. Melito [continuing]. So we refined what we had in the--
for our report, based on that. But then--that became the basis
for our data collection instrument with the 10 agencies. Then
we basically went back and forth with the agencies.
So, some of that will get added--got added--because the
agencies made a compelling case that we should also add this
category. So the broadness was also a product of the dialogue
that we had with the agencies.
But we also pushed back in places where we thought that
was--``Your link to food security is way too indirect.'' We're
not saying these aren't important things, but basic education
spending is just--you know, obviously, it's a vital development
goal, but it's not directly related to food security.
Ms. DeLauro. So help me. So that would include, if you're
looking at transportation--and I understand that--so then it is
the amount of resources that we provide that help to build
roads, deal with reconstruction efforts, and--
Mr. Melito. Road building is probably the single biggest
expense there, for that category, although there are other--
some subcategories, as well. But yes, it's ways of trying to
improve the marketing of ag products through rural
infrastructure. And this is done by a number of U.S. agencies,
as well as the World Bank and others will also work in that
area.
Ms. DeLauro. Now, I'm not--I'm just----
Mr. Melito. Yes.
Ms. DeLauro. You then multiply the various, you know,
sources of funding, if you will, in terms of these--you know,
these efforts, which is--I mean, look, the delivery system is
important to this.
I need to think about that, in terms of, you know, how do
you then do get to this definition of what it is. And if you
make it so broad, are we ever going to get to a conclusion,
whereas we're delivering a food product and--because that--
these are categorized as international food aid.
And to go back to what my colleague was saying, it's food
aid. And if we're dealing with all these other pieces in a
number of ways, it gives you a false view of what we are
providing to a country in direct food aid, so that you run the
risk of constituencies who say, you know, ``What are you doing
here,'' and it's not just the food aid that you're doing, but
you've got all these other pieces that are linked to it.
I will be very honest with you. There are a whole lot of
folks in the U.S. who are not terribly concerned about us
building roads and reconstructing, you know, countries and
communities, et cetera. They--I would--I believe I'm standing
on 100 percent solid ground when I say giving food to people
who are hungry and who are starving, you bet. You bet they're
there. But--and so you begin to mix up a process here.
I need to think about it, because I understand what you're
saying, but I----
Mr. Melito. Let me just say this is the kind of thing we're
struggling with. But we are differentiating in our work, and it
is also being differentiated in the strategy, between
humanitarian assistance and development assistance.
Ms. DeLauro. That's right.
Mr. Melito. So, the humanitarian assistance is the direct
intervention on the part of the U.S. and other donors to
mitigate a serious immediate food crisis. The development
purpose is to try to get ahead of the crises, to try to improve
their own----
Ms. DeLauro. I understand that.
Mr. Melito. Yes.
Ms. DeLauro. But we have two pieces here. One is the
humanitarian, the other is the developmental. And, quite
frankly, developmental funding has dropped substantially.
Mr. Melito. You're telling me.
Ms. DeLauro. Substantially, worldwide. And we now just
respond to emergencies. So we don't have a balance.
Now, that's where--but you look at another--you look at
other portions of our budget, and the USDA budget, which we
have jurisdiction over, where you can look at developmental
efforts to deal with productivity. You've got the foreign
operations subcommittee, which deals with that effort, as well.
But by commingling them in some way here, it may be some false
impressions about what's happening with the humanitarian side
of food aid.
I will leave it at--my time is well over.
Mr. Melito. Okay.
Ms. DeLauro. Mr. Kingston.
Mr. Kingston. I think the chairwoman has really touched
something very important to all of us. Because, in my
experiences going to Rwanda, people are collecting water. Every
house has a banana plant and a water vat, and--for the rainy
season. You go to a place like Senegal, where I went in Dakar,
they don't have it.
And so, that's a developmental issue. You say, ``Okay, come
on now. Look, guys, you've got to collect your water.'' And
that is basic. But the chair is correct. You start getting into
things where our constituents back home are saying, ``Well,
you're building water--you're building dams and ponds and
irrigation over there? Hmm, we don't have it in our own farms
back home.'' And so that is really a challenge.
And here is a frustration that I have, as well. I would
like to know, by your rating system, what works and what
doesn't. I notice that you did have water here checked off by a
number of the groups that are involved in it, which is a good
thing, because you have to have water, and you have to be a
good water steward.
But I was in Afghanistan this weekend. And what the--and
Pakistan. What the Pakistanis and the Afghan folks say is,
``Look. We are trying to close the gap between military victory
and civilian stability,'' civilians coming in and taking over.
The biggest cash crop in Afghanistan is poppies, $100
million a year. And it would be so great if we could say,
``Hey, you know what worked in some country somewhere is that
USDA program or the USAID program that we can--we're going to
take that and we're going to put it in Afghanistan right now,''
because that's the key to winning the war.
Secretary Vilsack was here two weeks ago, and requested
that we go from 14 to 64 USDA employees in Afghanistan. We're
all going to support that.
I had a briefing while I was over there, which I haven't
had a chance to tell you about. It was a really good briefing.
And, again, very sharp people on the ground over there.
But what I would love to know is, you know, if we could
have something that we knew would work, because----
Mr. Melito. Right.
Mr. Kingston [continuing]. To get them away from poppies,
it is one of the most--it just doesn't seem like it could be so
complicated, but it is real complicated. But you can't
substitute something with nothing. You have to have a program
that will really help these folks. And with all of our foreign
aid around the world all these years, you would think there
would be five or six surefire programs that could be helpful.
Mr. Melito. Unfortunately, in the area of ag development
and food security, the success rates are generally lower than
other development projects. And, for that reason, assistance--
development assistance to this area actually dried up heavily.
It reached its peak in the mid-1980s, and then it steadily fell
until it was a very low part of development assistance by the
mid-part of the last decade.
Ms. DeLauro. Mr. Kingston, would you mind if I asked----
Mr. Kingston. Sure, sure.
Ms. DeLauro [continuing]. Why the food assistance is in a--
--
Mr. Melito. It's multifaceted, why there is a problem. But
World Bank did an excellent study in 2008, where it looked
backwards and did its own mea culpa. And I don't think they
gave a real satisfying reason. I think everyone is appealing
right now to an evaluation, as we really need to really
understand better what's working.
But the point, though, was by--in the process of pulling
out of investing in ag sectors, hunger got worse. And the
instance of emergencies got more frequent.
Ms. DeLauro. That's right.
Mr. Melito. So, there is no easy answer here. So we are
faced with a very difficult development option. But if we
don't, we know that hunger is going to get worse. So----
Mr. Kingston. Well, you know, getting back to my point on
the budget--and I really think we're sitting on the cusp of a
big taxpayer backlash, and foreign aid is going to be out
there.
And so, the question is, which NGOs are the most effective?
Mr. Melito. I don't have that----
Mr. Kingston. But could we ask you to give us an
evaluation? Which ones are really out there, and which ones
aren't?
Rosa, this was interesting. Several years ago I was in
Tajikistan with Chairman Kolbe, when I served on the foreign
operations committee. And many of the women--excuse me, it was
Uzbekistan--but many of the women run the village, because the
men go to Russia to work. I think the population is five
million, and one million people go to Russia, looking for work.
And so, we went into this house, and it's, you know, a one-
room, two-room kind of house, and they don't have beds, they
all sit up on things, a table, and then it's a bed at night.
And we sat with the village mayor, if you will, and about five
or six women, poor as they could be, beautifully dressed, nice
as they could be, serving us some kind of a native food.
And so, here we were, richest nation in the world facing
the poorest nation in the world, ambassador-to-ambassador, if
you will. And we asked them, ``What can we help you with? What
do you need?''
And they talked amongst themselves for a few minutes, and
then the mayor came back to us and she said, ``Our village
really needs three more cows.''
And now, we never heard of Heifer International, but I
was--we actually came back, passed the hat, and bought them
three or four cows, you know. But it was the only way to get
there. And I was just thinking, this is just so--there has got
to be a better way to fill the micro and the macro big picture.
Mr. Melito. I think the focus--the new focus on global food
security is a good thing. We need to, though, learn lessons of
the past, and learn what is and is not working. You're asking
me excellent questions about who is more productive, who is
doing it better. I actually don't think that data exists yet,
and I think it's vital that we make sure that we do collect it.
Mr. Kingston. I'm wondering if we could ask you to collect
it. And I don't know the--but because it would just be so
helpful. I know there are so many good-hearted groups in
America who want to do things and can't get overseas. And if we
could say, ``Look, here are some really good ones. Now, these
ones talk a good game, they've got great advertising, they've
got movie stars. But these are the ones on the ground that know
what's going on.''
Ms. DeLauro. Ms. Emerson.
Ms. Emerson. Actually, playing off that, it would be really
nice to know precisely how many NGOs there are in the food
security, and then the developmental side.
I actually have a friend who is working--has been working
on this project kind of on the side of the World Food Program,
US-based, to try to do a surveillance, I mean seriously, to put
together the list and figure out who is doing what where.
But it seems to me that if there is any way that that
information could be collected, and instead of having a lot of
overlap, that we're actually leveraging and maximizing our
opportunities, you know, with who specializes here and who
specializes there, and then we do this, and somebody else
does--I mean, to me, that seems like the most logical, common-
sense way to do it. I realize that, in reality, that doesn't
exist.
But it would be helpful, because we don't have infinite----
Mr. Melito. Right.
Ms. Emerson [continuing]. Resources, that we take advantage
of every opportunity.
Mr. Melito. I have done some work on AID's data systems,
and I don't think they are equipped to easily give this answer
to themselves or to anyone else. They are supposed to improve
their data systems. I mean this is getting into the contracting
databases----
Ms. Emerson. Right.
Mr. Melito [continuing]. How you can actually aggregate up.
There is a lot of weaknesses in the contracting databases. They
have--it's recognized by--they've got this new system called
GLAAS, which they have been working on, which aspires to reach
a level where you can do this. But I think they're quite a ways
away from implementing that.
Ms. Emerson. Well, it's just worrisome. Based on what you
say, it's really hard to know what--the right hand doesn't know
what the left hand is doing.
I mean, you know, in a--how do I want to say this nicely?
It doesn't matter. It's just--it seems to me that if we could
get our arms around this, we could certainly reach more people
and better utilize the resources that we have right now.
Mr. Melito. Right.
Ms. Emerson. And, you know, I think it's important, because
you know, I love the--I have, up in my office, you know, the
wheat bags and the rice bags with the red, white, and blue, and
the USA, whether it went to Cuba or whether it's gone, you
know, to Africa or sub-Saharan Africa, wherever. And that's
been a lot of--there has been a lot of goodwill given to us for
that.
I wonder if--you know, is anybody paying attention to this
whole goodwill that we are doing? I mean, are we--how do we
fix--how do we create, you know, this global strategy and still
allow us to get some credit for it? I mean the taxpayers are
going to continue to demand more and more----
Mr. Melito. Right. Whether or not the U.S. is getting
sufficient credit for its effort, the U.S. is, by far, the most
generous country when it comes to providing food assistance.
And we have been the most generous for 50 years.
Ms. Emerson. Right.
Mr. Melito. We provide, at varying points, half of the
amount of assistance of the world. And everyone else is the
other half. So we have got a lot to be proud of. We have taken
a vital leadership role. This has been a bipartisan commitment
to food assistance.
Ms. Emerson. Absolutely.
Mr. Melito. So I don't know if the State Department or AID,
or whoever is doing--in terms of advertising that, but there is
a good story to tell.
Ms. Emerson. Yes, and I mean, you know, it is--I mean,
hunger, we know, is--knows no politics. So----
Mr. Kingston. And if the gentlewoman will yield?
Ms. Emerson. Sure.
Mr. Kingston. I think, in a lot of instances, the people
like us. Their governments might not, but people-to-people, the
relationships, I think we do get goodwill.
Ms. Emerson. Right.
Mr. Kingston. It might not be reflected in the government.
Ms. Emerson. Thanks, Dr. Melito.
Mr. Melito. Sure.
Ms. DeLauro. Dr. Melito, there was--I think an interesting
point in your report is that, according to FAO, from 1990 to
2004, 2006, there was actually a decline in the percent of
undernourished people in key areas. Sub-Saharan Africa down
from 34 percent to 30 percent, South Asia down from 25 percent
to 23 percent, Haiti down from 63 percent to 58 percent.
You do note, however, during this period the number of
undernourished people increased. I presume this was because of
population growth.
Mr. Melito. Right.
Ms. DeLauro. Still, I would just say this. It was
encouraging that some progress was made. Can you speak to what
worked during those years in reducing the proportion of
undernourished persons?
Also, you have a number of observers who believe that the
worldwide economic decline in the last two years or so,
accompanied by steep increases in food prices, could undo
progress that has been made. And do you share that view? What
worked in those years?
Mr. Melito. Well, I would be very hesitant to say anything
``worked.'' It gets into a couple of problems that we have
discussed--we only allude to it in this report, we discuss it
more fully in our 2008 report--and that comes down to how
they're measuring the prevalence of hunger, and also problems
with FAO's own methodology. But it just comes down to how
they're measuring.
The 1996 original pledge was an absolute number.
Ms. DeLauro. Right.
Mr. Melito. They wanted to reduce hunger----
Ms. DeLauro. By 2015.
Mr. Melito. In terms of the number of people. The pledge
thing got changed in the year 2000--well, they never actually
rescinded the other pledge, so they're side-by-side. But the
2000 pledge became a proportion pledge.
So, the progress, for the most part, especially when you
look at the poorest countries, in Africa and in Haiti, it's due
to population growth. So you're having the denominator growing
faster than the numerator is growing. The numerator is growing,
which is the number of hungry people.
Ms. DeLauro. Right.
Mr. Melito. The places where there has been success has
been Asia, and it's mostly China and India. There you have
absolute numbers of people going down, as well as, you know,
the proportion. But in terms of Africa, the absolute numbers of
hungry people have steadily risen over this period of time.
So, what you were looking at there was the proportion of
hungry people went down. But that's mostly driven by population
growth.
Ms. DeLauro. But still, you know, what allowed for that to
happen?
Mr. Melito. Right.
Ms. DeLauro. I mean, I understand what you're saying.
Mr. Melito. Right.
Ms. DeLauro. You know, I believe we're all here on the
first goal, which is to end hunger. But something happened that
allowed for a decrease here.
Mr. Melito. I would not characterize this as any success,
though. I mean, yes, population growing is actually a sign that
there are some good things going on.
Ms. DeLauro. Right.
Mr. Melito. I mean let's not understate that. But that is
not--those numbers are not being used as an indicator of
success.
Ms. DeLauro. Okay.
Mr. Melito. And even in----
Ms. DeLauro. By you, or by FAO?
Mr. Melito. By FAO. We're not the arbiters of this, okay?
Ms. DeLauro. No, I understand, right.
Mr. Melito. So, yes.
Ms. DeLauro. Okay. A shortage of expertise at agencies----
Mr. Melito. Yes.
Ms. DeLauro [continuing]. Which you also make reference to,
USAID, you note in-house expertise in agriculture has declined
over the years. Efforts need to be made to add foreign service
officers with technical expertise in agriculture.
You talk about USDA with oversight of food aid programs and
recipient countries. FAS regional office is engaged in that
effort. It is a little troubling, with regard to FAS, because
they don't maintain nearly 100 offices around the world with
their efforts.
What specific effects has this shortage of expertise had on
programs? Let's just start there.
And with respect to FAS, is one of the problems the fact
that overseas FAS staff has focused too much on trade and not
on food assistance?
And is there a clearly differentiated role between USAID
agriculture staff abroad and FAS agriculture staff abroad, or
are we duplicating the same work?
So, three questions.
Mr. Melito. Those are three good questions.
Ms. DeLauro. Specific effects of the----
Mr. Melito. Right.
Ms. DeLauro [continuing]. Shortage of expertise.
Mr. Melito. In our 2007 food aid report, where we raised
concerns about the efficiency and effectiveness of food aid, we
demonstrated that both the AID and USDA had almost no monitors.
So that's getting even away from providing technical
assistance. They didn't have any of the expertise of people to
actually know that the food was going to the right people in
the right amounts, and that it was having the impact they were
looking for.
We are, in this report, highlighting that if you are
actually going to pursue actively this host government
approach, you have to recognize that these governments have
very weak technical capacities on their own.
So, you are putting in their hands the responsibility of
running what is, in many ways, a technical exercise without
them having the technical expertise. We have a responsibility,
in that case, to assist them. And if we have--we don't have
technical experts in the field, that's going to be very, very
difficult to do.
Ms. DeLauro. And we don't, in terms of your view.
Mr. Melito. And we don't----
Ms. DeLauro. We don't have the experts in this area. I
mean, I understand----
Mr. Melito. Right.
Ms. DeLauro [continuing]. About monitors. But your view is
that we don't have----
Mr. Melito. Right. So I'm going with two different things,
but they both impact the way these programs work.
Ms. DeLauro. Okay.
Mr. Melito. AID--you know, you had that star quote from the
former AID director in 2008. They have done a lot of hiring in
2009.
Ms. DeLauro. Yes.
Mr. Melito. But--so they're recognizing and they're acting.
They are nowhere near where they want to be, but they are
acting on it.
FAS has traditionally been very interested in market
promotion.
Ms. DeLauro. Trade.
Mr. Melito. Trade. And they won't deny that. But market
promotion and development assistance are two very different
things.
Now, they are talking about invigorating and adding to
development assistance, and they're talking about bringing
somebody to Ethiopia for the first time, and that makes sense.
Ethiopia is one of the largest recipients of USDA resources.
This is--needs to be seen. They are making a verbal commitment;
we would like to see it actually be deployed.
Ms. DeLauro. Well, so FAS has spent most of its time and
its resources with regard to market promotion, is that correct?
Mr. Melito. There aren't that many USDA people in the
field, to begin with.
Ms. DeLauro. No, I understand.
Mr. Melito. Very small numbers----
Ms. DeLauro. I am just trying to get it, because----
Mr. Melito. We're getting this from--my team goes to Africa
regularly on this, and they meet with the USDA representatives.
And they come back with stories about, basically, the person
has done very little on the development side, because his
portfolio is active on the marketing side.
Ms. DeLauro. Right.
Mr. Melito. Yes.
Ms. DeLauro. That's what I'm trying to get at. The
portfolio is on the market promotion side----
Mr. Melito. Yes, yes.
Ms. DeLauro [continuing]. And not on the food assistance
side, or the development side.
Mr. Melito. Right, yes.
Ms. DeLauro. Now, and you just mentioned that your
understanding is that they are going to try to move in this
area. I must tell you--and we will go back and check--their
budget doesn't reflect what you are talking about. But we will
get to asking----
Mr. Melito. That's an important point. That's an important
point.
Ms. DeLauro. We will go back to ask that question.
Mr. Melito. Yes.
Ms. DeLauro. Again, then are we looking at--USAID and FAS
and that staff that's on the ground, are we doing different
work or are we doing the--duplicating efforts between these two
agencies?
Mr. Melito. Well, we start with the premise that, up until
now, very little has been happening.
Ms. DeLauro. I'm there. But----
Mr. Melito. But moving----
Ms. DeLauro. But whatever little is happening----
Mr. Melito. Right, right.
Ms. DeLauro [continuing]. Tell me about it.
Mr. Melito. I think, moving forward----
Ms. DeLauro. Yes.
Mr. Melito [continuing]. If we actually--and this is--I
want to say ``if,'' I want to put two underlines on the word
``if.''
Ms. DeLauro. Right, right.
Mr. Melito. If they actually successfully start
coordinating at the head, they are going to confront the
challenge of coordinating at the field level. They are going to
have to confront that.
We look for opportunities of leveraging. Do they need to
have the same people in the same places? They probably do not.
I guess this is going to be something that has to happen
over time, as they recognize that maybe they have shortage of
resources, they can deploy them in ways which may take
advantage of opportunities, and they may not need to be in the
same place.
Ms. DeLauro. I understand the limitations. I understand
that. As of this moment, today, now, with regard to on the
ground, are we more duplicating functions or are we dealing
with separate functions here and now at the present moment?
Mr. Melito. We are talking about very few people. I think
there has been----
Ms. DeLauro. Of the two people there, are both of them
doing the same thing or two different things?
Mr. Melito. They are doing two different things, but the
USDA person for the most part is doing market promotion.
Ms. DeLauro. The USDA person is doing market promotion.
Thank you. My time has long expired.
Mr. Kingston.
Mr. Kingston. The questions just keep coming. I hope you
brought dinner. [Laughter.]
The 1949 foreign aid original concept was spreading some
goodwill around the world in the Cold War context. That was
number one. Number two, development of underdeveloped countries
who needed help with science and investments to overcome
poverty.
Number three was dealing with our surplus for our own
farmers because of our great new production technique, and then
number four was the leg of developing markets.
It would appear to me that the answer to the Chairwoman's
questions should really be at the USDA in Washington, D.C.
where somebody says okay, any given country, tell us where we
are in these four areas.
It is shocking to me that you are saying there is not
really an answer. I am not picking on you. I am not picking on
anybody.
Here is where my question is, can you tell me ten success
stories? What do we have, 168 countries around the world that
we have given aid? What are some of the hey, this is where we
made a difference?
Mr. Melito. My team has traveled extensively to Africa.
They went to Bangladesh. They went to Haiti. They came back
with a number of success stories, but they are success stories
at a very localized level.
We at GAO are looking at systems. We are looking at
processes. We know that yes, this particular version of the
program seems to be doing well here, but we also see weaknesses
there. Then we comment on the overall working of the program.
Mr. Kingston. You are saying maybe in a given region of a
country, you had success?
Mr. Melito. Yes. A particular orphanage, a particular
school district.
Mr. Kingston. That success would be measured by?
Mr. Melito. It's tricky. We have concerns with how they do
monitoring and evaluations. Then it really comes down to more
ad hoc.
Mr. Kingston. Switching lanes for a minute, one of the
things about micro credit, and I traveled to Africa twice with
the Banking Finance Committee, and one of the things I have
learned is micro credit, when everybody says let's get a 94
percent pay back record, one reason is they keep lending money
to people, so it is not that.
If it was that good of an investment, the private sector
would be there.
A lot of it, you have to keep asking and asking questions
to really find out, and that is why when you say we have had
success in an orphanage, the add on question is tell me about
it, are these people out being productive and doing great
things.
Mr. Melito. We hesitate to declare any of the projects we
look at as going well in GAO. We witness things which are not
working well. We hesitate to call that a ``failure.'' Again,
those are just data points to what we were trying to get at a
larger level.
Our biggest concerns in terms of effectiveness is there is
not really a good way for USAID and USDA right now to tell you
how their programs are working. They do not collect data well.
They do not do a good job of monitoring and evaluation.
Ms. DeLauro. We do not have a definition of what this issue
is, and we do not have a structure that allows us to----
Mr. Kingston. I think some of the finest people that I have
met in Government are involved in this program.
I want to ask you this. You just said half of the world
food aid comes from America. I have heard that statistic. In
reading your testimony, you said $22.7 billion with America
doing $3.5 billion, which is not half.
What is that?
Mr. Melito. That is a commitment for new money for food
security. We are counting food aid as well as part of the
budget. We are very hesitant to comment on that $22 billion
number and the $3.5 billion number because we have not quite
seen exactly how the details are going to work on that.
There is always the risk there is double and triple
counting going on.
Mr. Kingston. Japan is number two?
Mr. Melito. For food aid, I believe so. EU as a whole is
number two.
Mr. Kingston. It might be good if you could rattle off
that, because one of the things that really shocked me is in
the Middle East with all the oil rich countries, they do not
seem to do much, or if they do it, it is all spent locally.
Mr. Melito. The Middle East countries have a large role in
IFAD, but I agree, they are not one of the major players in
food aid. They are not.
Mr. Kingston. People flying around in gold plated jets, it
is kind of interesting you do not see much coming from them.
Why did not the Administration get OMB to conduct the
cross-cut rather than GAO?
Mr. Melito. They did not get GAO. GAO got requested by the
Chairwoman, and we did the exercise.
OMB, fortunately, after they really recognized what we were
doing, saw that they themselves could do something like this.
They could make this call.
I do not know why they have not yet been asked. We made a
point of putting in our report that they say they can do this.
I think that is an important part of how the Administration
moves forward.
Mr. Kingston. Would it be helpful for us to insist or write
a letter? It seems to me that you are actually doing something
that they do normally.
Mr. Melito. We recognize that what we did there was
probably something which was a little non-standard, but it
could have been very easy for us to write a report to say the
data was bad, and we really wanted to understand why the data
was bad and to understand how to make the data better.
It now needs to be the Administration's exercise moving
forward and OMB is clearly a vital player, and congressional
support and pressure is probably a good idea.
Mr. Kingston. I think Secretary Vilsack would be on the
same sheet, too.
Ms. DeLauro. Let me talk a little bit about food quality
control and nutrition. In your 2007 report, you concluded that
``U.S. agencies were not coordinating adequately to respond to
food quality and delivery problems.''
You said that ``Various agencies involved different
tracking systems and were not able to effectively monitor and
resolve problems that occurred. In some cases, agency country
offices were unclear about their role in tracking food
quality.''
You concluded that ``USAID and USDA had no central process
for updating food aid products, specifications or nutritional
standards.''
You recommended that ``USAID and USDA establish a
coordinated system for tracking and resolving food quality
complaints and develop an inter-agency mechanism to update food
aid specifications and products.''
In your September 2009 report, you concluded ``The agencies
have implemented'' your 2007 recommendations on food quality
control and nutrition.
Can you just walk us through the improvements that USDA and
USAID made in nutrition and food quality since your 2007 report
and what effect are the improvements likely to have on the
delivery of food aid?
Mr. Melito. In the case of both recommendations, we wanted
them to establish processes. Processes have been established. I
will not go beyond that and say now that means it is working.
We do have a request that we have just gotten recently
where we are being asked to look at both the changes on the
nutrition side and the changes on the food quality side. We
were going to be launching that as soon as this study ended.
We have reasons to believe in the case of nutritional
quality, they are working with Tufts University and NGO,
SUSTAIN. They have some ongoing studies going on.
The great frustration we had in 2007, and I am still not
yet convinced this particular thing is overcome, so that is why
our new job is going to be important, even when the science is
clear and even when the interest and desire is there, there
seems to be bureaucratic inertia to actually get it rolled out.
This is a relatively inexpensive way of greatly improving
the effectiveness of U.S. food aid. It will not cost a lot of
money and can have actually a dramatic impact on nutrition.
I think our next study is going to be vital.
Ms. DeLauro. What would be the timing on that next study?
Mr. Melito. Probably early next year. We have to work with
the agencies. We have to go and look in the field for what they
say they are doing. That is usually the hardest part, the field
work.
Ms. DeLauro. The Chicago Council, can I talk about them for
a second here? The Chicago Council on Global Affairs, they have
been a major contributor on key global policy issues.
I asked them a while ago, and it was not in relationship to
this hearing, to get me a memo that raised some of the possible
areas for our work on this subcommittee and what we could do in
these areas under our jurisdiction. We like to stretch our
jurisdiction like any other committee as far as it can go, but
we do have to move within our jurisdiction.
One idea was to ask GAO to focus just on USDA's work in
international agriculture. There is, of course, a lot of
expertise at the USDA. The thought would be to look at just how
to leverage its resources to support the work of State and
USAID.
This would drill down into their activities in a much more
intense way than this report. Let me get your thoughts on that,
then I have a follow up question.
Mr. Melito. I think there is clearly great opportunities
for the USDA to play a much larger role here in many ways.
Their letter and the report that you requested makes the
compelling argument that in terms of technical expertise, they
probably are the best in the U.S. Government, in terms of their
association with the extension programs and the universities.
They have a lot of national and domestic experts on ag.
There needs to be a way of integrating that into the
international effort. They make a compelling argument both in
the letter and also in our conversations with them, but I do
not know if they have figured out a way yet to do that in
practice.
Ms. DeLauro. That gives us some guidance there.
Another idea was to do more oversight on the food and
agricultural organization of the U.N., the FAO. The Council
believed that its effectiveness has been limited in recent
years and that perhaps USDA could engage more actively in
reviewing its capacity, management, strategy and policy making
and program evaluation.
One, would that be useful? Do you have any sense of the
work USDA currently does with the FAO right now?
Mr. Melito. Yes, without a doubt. FAO, its reason to be is
food security. FAO is the food security agency. It is striking
that they are not a major player right now.
They are, I think, trying very hard to ramp up in certain
areas like in data collection and really monitoring of food
crises, but the FAO has a long way to go. I do not have a good
sense of USDA's involvement in oversight of FAO. I hesitate to
say anything other than yes, oversight of FAO is a good thing.
Ms. DeLauro. Jack, let me just ask one more question in
conjunction with this. Is it a question of resources at FAO? Is
it a question of statute within the U.N. framework? Is it just
lack of----
Mr. Melito. FAO is a complicated organization. It is very
old, in terms of U.N. organizations, it is over 50 years old.
It has a large budget, but I think they would make a compelling
case that they need more money.
Ms. DeLauro. Where does the money come from?
Mr. Melito. This is an organization where members are
assessed.
Ms. DeLauro. Members of the U.N. are assessed.
Mr. Melito. They also get bilateral contributions from some
other members. They had their own internal review last year, I
believe. They came up with a lot of management weaknesses at
FAO. That actually gives a starting point for whether or not
they are taking that review seriously and making those changes.
Ms. DeLauro. Thank you very much.
Mr. Kingston. Do you not think it is going to be hard to
get the FAO to kind of change their culture?
They have a very lofty definition of ``food security,''
``When all people at all times have physical, social, economic
access to sufficient, safe and nutritional food to meet their
dietary needs and food preferences,'' that means chocolate ice
cream, ``for an active and healthy life.''
USDA has a different definition of ``food security.'' Yet
it would appear that the definition of FAO can almost make it
harder for the United States to be seen to have a long-term
sustained commitment to food and global security.
It would appear to me at some point we are just going to
have to agree to disagree with them.
Mr. Melito. Those definitions are really more the goals.
Ultimately, those goals are fairly compatible with each other.
FAO also has a particular operational goal which gets into
minimum caloric levels. That, I think, could be overcome.
FAO should be the agency that has the expertise on Africa,
for example, ag development problems. They should be either a
repository of what works and what does not work and that should
be the go to agency, and they need to get to that place.
Mr. Kingston. Do we have a definition of ``food security''
that we would measure?
Mr. Melito. When we talk about an operational definition in
our report, we are not actually talking about the goal. They
are saying basically everyone has a sufficient amount of food.
We are talking about something a little bit more green eye
shaded in what we are talking about here, where you have these
budget categories and you have these processes and programs
that the U.S. Government has, and they aspire to do five
things.
It is getting them to really sit down and say okay, this is
related, this is not related. This sounds boring but really, we
are trying to be efficient in the U.S. Government and we are
trying to deploy our resources.
How do we know what resources we have to deploy? The answer
is we do not know what resources we have to deploy.
I find a planning and strategizing exercise where you
actually do not know what you have to be somewhat bizarre.
Mr. Kingston. On the host country situation, you are saying
it is very awkward but then you also say it is promising. I
think you are darned if you do and darned if you do not.
There still should be some measurement of host country
cooperation, you know, we are going to do it your way, but
inasmuch as we are donating so much, we have to have certain
results and it has to be moving in a certain direction or we
are out of here.
Mr. Melito. Yes. That is to be expected. What we are doing
is trying to anticipate some of the likely conflicts and make
sure there is a process in place to deal with it.
Some countries like Ghana, I think they have a pretty
healthy relationship between the donors and the country. I
think there are some models they can use, but it is going to be
case by case, country by country.
Ms. DeLauro. Mr. Kingston, because I was going there next,
let me just add a couple of points. I think a number of the
agencies involved in this report indicated in their comments
that they believed you leaned too heavily toward the downside
of a country-led approach. They indicated their plan is to do
this in two phases, doing a lower level of funding initially
and reviewing it before moving forward.
Does that sound like a sound approach to you and are there
other steps that the agencies are taking to minimize this risk?
What steps should they be taking? It is a conflict.
Mr. Melito. That is clearly one of the important steps.
That, I think, helps GAO with the first issue which is the
sustainability of projects, the capacity of the host
governments themselves. Some of them are just not ready yet.
Some are ready and some are not ready yet, and to
differentiate, not to treat them the same is the right way to
go.
It does not address the lack of expertise within the U.S.
Government. That is something we have to do ourselves.
To try to create some sort of process or sophisticated
internal dialogue about when we disagree, when is it material
and when is it not material, a successful process is going to
have disagreement.
If you are really going to energize the host governments,
they are going to come up with home-grown approaches which at
times we are not going to approve of.
What are we going to do about that? You do not want to
necessarily pull the rug out every time that happens.
They are correct in saying they are starting to approach
this but we have not seen the final document and we really want
to make sure they stay on top of this.
Mr. Kingston. One of the questions I had is there is not a
consistent goal for food aid that we have, correct?
Mr. Melito. The goal of food aid is emergency food
assistance, to mitigate the crisis in a relatively brief
period.
Mr. Kingston. That is emergency food aid.
Mr. Melito. Eighty percent is emergency. Twenty percent of
food aid has development purposes.
Mr. Kingston. We do not just stick with a natural disaster
or war.
Mr. Melito. Sure.
Mr. Kingston. The next question is the State Department has
a FACTS Book that has incomplete data. Is it called the ``Green
Book?'' USAID has U.S. overseas loans and grants.
Mr. Melito. ``FACTS'' is an acronym they use for their
database, Foreign Assistance Coordination Tracking System,
FACTS.
Mr. Kingston. What does that track? What is included in
that?
Mr. Melito. It aspires to be what you would want right now.
It aspires to comprehensively show U.S. international
development efforts across many different categories across the
U.S. Government.
The database itself is currently only populated by the
State Department and USAID, and then they have resolved some
ambiguities in terms of how to characterize things, but a lot
of the ambiguities, they have not, and then we highlight also
they do not necessarily have a great process for keeping it up
to date.
Mr. Kingston. If I were to look for the ten best case
scenarios, would it be in that book?
Mr. Melito. That does not provide you with performance, but
it can give you pretty detailed expenditure information.
Mr. Kingston. It appears to me that we ought to have this
is the case. Today on television, I saw something called the
Urban Prep Academy in Chicago where four years ago or five
years ago, a very small percentage of the kids even graduated
from high school. Today, something like 100 percent go to
college. It is the story everybody is looking to find.
I want to hear that on food aid. Are there not some really
bright spots?
Mr. Melito. This is a drum that I keep beating and I am
going to keep beating it. We do not have a good monitoring and
evaluation process.
GAO did a report that came out at the end of September
which looked at USAID's ag development efforts and found that
while certain efforts are monitored in certain ways, they
really do not do good lessons learned, they do not have a good
approach for then taking the lessons learned and integrating it
back into how the program works.
Mr. Kingston. Is that in your report here or
recommendations?
Mr. Melito. That is in our report that came out in
September.
Mr. Kingston. Could you make sure that I have a copy of
that?
Mr. Melito. Certainly.
Mr. Kingston. In your observation, and you are not going to
be comfortable answering this, meeting State Department kind of
diplomacy people on the ground, USDA people, PEPFAR people,
USAID folks, there is a culture within each agency.
Who do you think is the most effective or the most
entrepreneurial in terms of look, we are going to get this
thing done and we are going to cut some corners?
I do not want you to really answer that.
Mr. Melito. Thank you.
Mr. Kingston. You are way too young to involuntarily
retire.
Mr. Melito. That is exactly right.
Mr. Kingston. It does appear to me that there are different
cultures. I have been impressed with PEPFAR but I have been
impressed with USAID on the ground and USDA.
Mr. Melito. I can easily tell you I do work with multiple
international agencies of the U.S. Government and I have found
good people in all of them.
Mr. Kingston. I have, but I know good people can be
constrained by bureaucracy. If the bureaucracy is a little bit
more flexible--I heard a great summary of communism in China,
and that is what works. They just want to do what works. That
is what I would kind of look for on the ground, what works.
Just do it.
I want the person in Ghana to say hey, we got it done.
Ms. DeLauro. Just a footnote. It does not come under our
jurisdiction but State is asking for $14 million for the
monitoring and evaluation of their global food security
initiative. That is in the 2011 budget. I think that is very,
very positive.
Mr. Melito. I agree.
Ms. DeLauro. Obviously, we will wait to see what happens. I
think we ought to encourage the Appropriations Committee
responsible for that to move forward.
Maybe Mr. Kingston, the two of us could write to that
subcommittee and indicate the necessity for this as we try to
move forward.
Let me just ask a question. In the letter that I wrote in
December talking about a request for the report, I commented
that from the 2008 report, the GAO had recommended that a
coordinated and integrated government-wide U.S. global food
security strategy is necessary to address many of the
underlining factors that cause food insecurity.
GAO also recommended that the Administrator of the USAID
program prepare and submit an annual report to Congress on
progress toward implementation of the first recommendation
here, which was that GAO found the efforts to reduce global
food security have been hampered by fragmented and
uncoordinated nature of U.S. assistance efforts.
Did we ever get a report from that recommendation and is
that recommendation a part of the current report if we did not
get one?
Mr. Melito. The answer to your first question is no, you
did not get a report. We consider those two recommendations to
not yet be closed. We think the current effort is a possible
means to create that strategy, but there is not any vehicle yet
for them to report regularly to Congress, and we think that is
essential.
Ms. DeLauro. I would concur. Let me ask a question about
food aid in Haiti. GAO visited Haiti as part of your field work
effort for this report. Haiti is so close to the United States,
and as your report points out and I quote ``It is the least
developed country in the western hemisphere and one of the
poorest countries in the world.''
You note that the number of undernourished people in Haiti
ranges from 4.5 to 5.4 million and will probably grow due to
the recent earthquake.
I have three questions in this regard. Would you share with
us GAO's observation from that trip? Were you able to assess
food aid efforts in Haiti during the trip, and can you suggest
steps that could be taken to improve Haiti's food security?
Mr. Melito. I was not part of that trip but my team had an
excellent visit to Haiti. We were looking at ag development
projects. This is again a case where they came back with some
good stories and some not so good stories. Again, we try to
look above that to try to understand systems.
The team did have a strange encounter with a Government
official in Haiti in terms of monetization of food aid. We were
surprised to learn that actually Haiti had a Bureau of
Monetization, which its sole purpose was implementation of
monetization of U.S. food assistance. We would like to look
closer at that. We actually are going to do some monetization
work in the future.
What is surprising about Haiti is for a western hemisphere
country, it has a hunger rate that is among the worse in the
world. It is over 50 percent. That stands out among some of the
worse cases in Africa.
Ms. DeLauro. It did not get to that point because of the
earthquake.
Mr. Melito. No, not at all. I hesitate to give you a quick
and easy answer. I believe there is governance issues. This is
not something that is in my expertise. I have sent teams to
Haiti several times. GAO has done Haiti related work a lot. We
are actually going to do probably a large reconstruction based
on the earthquake.
I do not know how you differentiate the difficulties of
development from the difficulties of Haiti. It seems like
everything is magnified when you talk about Haiti.
Ms. DeLauro. Mr. Kingston.
Mr. Kingston. I know we are kind of going over and over
again on this important accountability, but it is important.
You did list in your report the numerous agencies that work
on global food security, but did you say what kind of food aid
is most effective?
Mr. Melito. As I mentioned earlier, I do not think anybody
knows yet.
Mr. Kingston. Would you ponder that issue?
Mr. Melito. Yes. I want to address something which
Chairwoman DeLauro mentioned earlier, which was the letters
from the agencies said we might have been too harsh about the
country-led approach.
We are not too harsh. As the letters came in, we added a
little more positive language to make sure we are not saying it
is wrong.
The donor-led approach to food assistance did not work.
That is mostly what is preexisting. Telling the governments to
do X, Y and Z did not seem to have any long-term effect.
Engaging the governments in that as a partner is the sense
that maybe this can have some long-term effects, but really we
are embarking on that path now. That is for the future.
Ms. DeLauro. Just a quick follow up on that. Does that mean
we are dealing with different levels of abilities, stabilized
nations, we are dealing with a whole variety of countries which
have a whole different set of circumstances that they are
engaged in?
In terms of looking at the approach you are talking about,
what you are saying is there needs to be involvement with the
host government, so we are clear up front as to what we may
confront in that effort, we are going to work, there may be two
steps forward and a step backward, we are trying to calibrate
how we work together or in some instances, are we likely to
look like we have not done the right thing?
Mr. Melito. That is beautifully stated. I could not have
said it better than you just said. I would only add success is
going to be a slow, grinding long-term effort.
Ms. DeLauro. That success is going to take trying of some
things that may in fact not be successful and instead of saying
we are done, we are finished, it is over, that we try to figure
out another way to integrate the systems.
Mr. Melito. To give you a sense on the same observation.
The Gates Foundation has made food security one of its top
priorities. They are spending as much as 20 percent of their
budget on monitoring and evaluation because they recognize they
went in using a private sector business model, and I do not
know, meaning ``I'' the organization, do not know what works
and does not work.
What do I do now? I better be spending a lot on R&D. I
better really create a body of knowledge that we can build
from. That is their approach. I think we should be taking the
same approach.
Ms. DeLauro. Thank you.
Mr. Kingston. Let me ask you this. A donor-led, is not Food
for Education donor-led?
Mr. Melito. Food for Education has a donor involvement. I
would not necessarily say ``donor-led.'' We are actually going
to be looking at the program as well in the months ahead, so we
will see exactly how the rhetoric and policies are working.
There is donor involvement.
Mr. Kingston. You are not sure how effective it is; right?
Mr. Melito. I do not think there has been yet a systematic
evaluation of the effectiveness of that program. There has been
a lot of anecdotal success stories on that program.
Mr. Kingston. How about a farmer-to-farmer approach?
Mr. Melito. We have not looked into that at all. That is a
very small program.
Mr. Kingston. I know it is small but that might be a small
bright shining light.
When would we get this follow up on the report back, which
you just mentioned to the Chairwoman? When would we get some
more info from you in terms of this getting better and would
you recommend that we bring the Gates Foundation in here and
ask them the same type of questions we have been asking you in
terms of their monitoring?
Mr. Melito. The answer to your second question first, I
think you would find discussion with the Gates Foundation group
quite rewarding. We met with the Gates Foundation, high level
officials including Mr. Shah, when he was there. It was a very
stimulating afternoon that we had with them.
They are providing lots of resources. This is not a small
effort. They are providing tens of millions of dollars for food
security.
Ms. DeLauro. It is overwhelming.
Mr. Kingston. Another thing, should there not be a
graduation kind of idea/concept to this food aid?
Mr. Melito. The humanitarian assistance is situational.
Mr. Kingston. I understand that.
Mr. Melito. On the development side, that is almost what
they are doing with the tiering, the two tiers. There are
countries that are performing well and countries that are not
performing well.
In the back of their own minds, I think, the best
performance eventually will be no longer need assistance, but
they are obviously working currently with those countries that
need assistance.
I think successful development requires graduation.
Mr. Kingston. I think so. Who is your Congo expert?
Mr. Melito. Actually, I think none of my current team have
gone to the Congo. We have people who have gone to the Congo
back at headquarters.
Mr. Kingston. Do you have any comments on it?
Mr. Melito. Sad. It is a very discouraging situation.
Mr. Kingston. Under the topic of roads, that is one of the
biggest challenges.
Mr. Melito. Yes, it is an enormous country.
Mr. Kingston. It is very big. Madam Chair, I have about
five kind of wrap-up questions which are just sort of for the
record, if you are ready to wrap it up.
Ms. DeLauro. I am. I would just say to you with regard to
your comment on graduation, Mr. Kingston, I think one of the
strengths of the McGovern/Dole program has been countries do
graduate, they become donor countries, but then they become
countries that provide resources in order to assist in this
project.
Mr. Kingston knows, I am a strong proponent of the
McGovern/Dole program. I think it does not get its just due.
That is not just with regard to resources, which it does not
get, but in terms of its success rate, and that is particularly
true with women and girls. I think we need to do some
investigating of that program and how that can be utilized to
do some other things.
Mr. Kingston.
Mr. Kingston. I just wanted to give some closing remarks,
some closing thoughts, that are just reiterations.
I would be very interested in your rating of NGOs, who is
effective and who is not, and I would be interested in going to
a source who could give me that if you are unable to, and if we
need to come back to you and task that or whatever way we could
get there.
And why again, because as in my opening comments, I am just
convinced there is going to be a real budget fury coming up
more and more in the years ahead, and foreign aid people back
home do not consider it their top priority, so the more we know
about what works, the better.
The other thing is the U.N. rating system. If anybody has
any ideas about that who wants to weigh in on it, it is
something that I am trying to figure out. It is just such an
awkward system.
Number three, poll your folks on the ground. I feel a real
sensitivity that is what you are doing, you are aware of that,
but I want to make sure that in Washington, D.C. they are
listening to the people who really have country expertise.
It would be so good if we had five or ten great success
stories that say okay, here is a country, here is a region that
really turned around because this was U.S. aid at its finest.
We certainly owe it to ourselves and the taxpayers on that.
You have given us some reform ideas, but there are a lot
more that I feel you know that could be done. We would like to
work on that.
The Chairwoman and I, the opportunity you have is whenever
I vote ``yes,'' she votes wrong and votes ``no'' when we are up
on the House Floor.
You have two people who are really philosophically at
different ends of the spectrum, but we both stand for so much
in common when it comes to trying to do it right and get
reform.
If you could get the two of us, there are a lot of people
in between. Things we could live with.
Again, just coming back from Afghanistan, whatever you can
add would be so important to the war effort. There is just so
far that the men and women in uniform can take this thing.
Victory in Afghanistan is more in the hands of civilians than
military at the moment.
Mr. Melito. That is true.
Ms. DeLauro. Thank you. When we do both get to the Floor, I
vote in the correct way and my colleague votes wrong. It is a
``yes/yes'' and ``win/win'' on this issue.
We are really committed to this. That is why we are
interested in some of the reforms that you proposed. We are
interested in following up on this evaluation and monitoring of
the agencies that have the responsibility, and those that have
a prime responsibility, and we are trying to work within the
jurisdiction of this committee, which as it affects this issue
I think is significant in where we can have a role.
I know we will follow up on how we leverage the work of
USDA and how we take a look at FAO and what opportunities are
there.
Jack has done a lot more traveling in this regard than I
have and has seen the hunger. We are also experiencing domestic
hunger at this juncture.
I think we both at our core believe that we have a moral
responsibility to be engaged in this effort, and as I said
about Afghanistan, if the Taliban is providing food for your
children, I do not care who you are, and you cannot take care
of your children, you will accept food, and you will swear
allegiance.
This is a national security issue. The more we make that
reality known to our colleagues and to the people we represent,
I think the more buy-in we have on this issue.
Thank you so much for being here. Thank you for the report.
We appreciate it.
I think I have to formally close the hearing.
Thursday, March 25, 2010.
FARM AND FOREIGN AGRICULTURAL SERVICES
WITNESSES
JIM MILLER, UNDER SECRETARY, FARM AND FOREIGN AGRICULTURAL SERVICES
JONATHAN COPPESS, ADMINISTRATOR, FARM SERVICE AGENCY
JOHN BREWER, ADMINISTRATOR, FOREIGN AGRICULTURAL SERVICE
WILLIAM MURPHY, ADMINISTRATOR, RISK MANAGEMENT AGENCY
SCOTT STEELE, BUDGET OFFICER, U.S. DEPARTMENT OF AGRICULTURE
Ms. DeLauro Opening Remarks
Ms. DeLauro. The hearing is called to order. Let me begin
by welcoming Jim Miller, the Under Secretary for Farm and
Foreign Agricultural Services. He is joined by Jonathan
Coppess, John Brewer, William Murphy, Administrators of the
Farm Service Agency, the Foreign Agricultural Service, and the
Risk Management Agency, respectively; and Scott Steele, Budget
Officer. Thank you all for being here today with us.
This is one of the most important budget hearings that this
subcommittee convenes each year, because of the enormous
portfolio that is covered among the agencies before us today.
Everything from farm assistance to food aid to exports and
that's why we rescheduled the hearing from earlier this week on
the day that the President signed the health care legislation
that we just passed. We want to try to give the subject the
attention that it deserves.
The Farm Service Agency, as you know, administers farm
credit, commodities, emergency assistance, some conservation
programs for farmers and ranchers. And through its network of
county offices, it is, as under secretary Miller notes in his
testimony the agency that the majority of farmers and ranchers
interact with most frequently.
First, I want to congratulate FSA on what appears to be a
swift and efficient implementation of the 2008 Farm Bill. I see
from today's testimony that FSA has provided nearly $6 billion
in direct and counter-cyclical program payments, $1.7 billion
in conservation reserve program payments, and over $318 million
for the Livestock Indemnity Program, Livestock Forage Disaster
Program, and the Supplemental Revenue Assistance payments, the
SURE program.
I am particularly impressed with how quickly the agency set
up the Dairy Economic Loss Assistance Payment Program that we
established in last year's appropriations. Within three months
of the passage of the program, it already issued $270 million
to struggling dairy farmers, and I and they thank you for the
competent implementation of this program. It was really a
matter of survival for so many of the dairy farmers.
What I would like to do is to urge the Under Secretary and
Mr. Coppess to continue to work in every possible way to ensure
that the civil rights violations that occurred at FSA as well
as other USDA agencies are remedied and that they don't occur
again. I am glad that the government has reached an agreement
with African-American farmers who were discriminated over the
years.
However, remedies for other groups on the receiving end of
what was systematic USDA discrimination such as Hispanics,
women, Native American farmers, remain to be provided. We need
to provide assistance there, and I ask you for your help and
your assistance with those groups as well.
Just as a note, Congresswoman Eshoo and myself have
introduced legislation providing a process by which women
farmers who were victims of discrimination can make claims
against a compensation fund appropriated by the Congress. It
also requires USDA to institute some reforms. One of the issues
facing the FSA in the past several years as we all know is the
severe deterioration and the consequent performance problems of
its IT infrastructure, and I know you know that.
If this year's budget request is met, Congress will have
appropriated $250 million to fix this, so it is important that
the subcommittee gets an accounting for our investment. In
addition, crop insurance is an area that should be and is a
great interest to this subcommittee, particularly given the
concerns about the potential fraud in the program. This hearing
provides us an opportunity to ask RMA what they are doing to
combat wasteful spending in the crop insurance program.
Switching gears, I am also very concerned about the flat
funding of P.L. 480, the Title II program, the McGovern-Dole
program in the 2011 budget at a time when we have over a
billion people who are now going hungry or who are ill-fed, and
the world is looking to us for some kind of moral leadership. I
do not believe we should be turning away from our strong,
bipartisan commitment to international food aid.
So, Mr. Brewer, I would say to you I'll be curious to hear
your thoughts about these funding levels. The flat funding of
food aid is in marked contrast to the substantial funding
increases for programs under the title of the National Export
Initiative. I share the President's desire to increase U.S.
agricultural exports, and we will be holding a hearing on how
trade agreements affect the public health in the near future.
And, as an aside, it seems to me that if we really want to
increase our agricultural exports, one of the easiest ways to
do it would be to open trade with our neighbor, Cuba.
Fifty years, 11 Presidents after setting up an embargo
policy that has failed to change the political dynamic there,
it seems to me that it's time to shift U.S. policy toward
greater engagement and a greater opportunity for our export
markets and a greater opportunity for our farmers. So a number
of wide-ranging issues on our plate this morning as befitting
the considerable diversity of responsibilities that are handled
by these agencies, I look forward to hearing from you today on
how we can continue to refine, to improve our performance in
these areas to make good on our commitments to Americas farmers
and ranchers.
Thank you very much for being here this morning.
We look forward to hearing your testimony, and with that,
Mr. Kingston, I'd like to yield to you for your comments.
Mr. Kingston Opening Remarks
Mr. Kingston. Thank you, Madam Chair. It's great to have
all you guys here, and Scott Steele's there would never be a
hearing here without you being present, and you get to hear so
much of us. So this is the way the chair and I like this, by
the way, when no members show up so we get the microphone
time.[Laughter.]
Ms. DeLauro. That's right. We can do all that.
Mr. Kingston. This is going to be a good hearing. We are
eager to hear what you have to say, a couple things I want to
mention.
While the chair and I disagree on Cuba, I think certainly
she has made a good point in terms of trade and opportunities
for our farmers; and that's why I'm astounded, absolutely
astounded that this President keeps talking about the South
Korean trade agreement and the Columbian Trade Agreement
without moving forward to it. In fact, I don't even know who
the USTR is these days.
You know, it used to be a household name under President
Clinton, President Bush, somebody who was dynamic out there
explaining markets and opportunities. And I'm being serious.
You can say, well, that's your fault, but I can tell you that
the Clinton and the Bush USTRs were far more active, and so we
have opportunities for agreements with Panama, Columbia, and
South Korea. South Korea was one; and Mr. Brewer you know well
having your AIG days look to global threats what a great ally
that is in the Pacific Rim. And for us to be ignoring that,
it's to me unbelievable.
The Foreign Market and Development Cooperation Program--I'd
like to know about the overlap with MAP and what your thoughts
are what we should do about that. I'd like to hear some success
stories with the technical assistance and specialty crops in
terms of trade, and we hear a lot from MAP and some of the
other ones, and be interested in that.
Another thing that I'm very, very interested in having
served on the Defense Committee and recently gone to
Afghanistan and gotten briefed by some of your folks over
there, we have some--not really opportunities, but absolutely
must-do assignments in terms of getting Afghanistan off of the
poppies. And I think it's something like 200 million in cash
crops with everybody in Afghanistan getting some form of the
benefits from there.
I'm not sure how we do it. I will tell you that I have
asked top military leadership what are we doing about the
poppies, and I cannot get a good answer from them. They
absolutely, all, everybody agrees it's a huge problem that kind
of the culture, it's like a toxic to all of them. So we've got
to come up with some things, and I'm hoping USDA might be able
to bring some new angle or fresh thinking that the military has
not been able to capture in our eight years there.
And then, Mr. Brewer, kind of going back to you in terms of
P.L. 480 or whatever the food aid programs are--and we're not
asking questions right now, but Paul Theroux, who as you now is
a traveling journalist, lived in Africa about 40 years ago.
He's recently written a book that I'm reading called ``Dark
Star Safari,'' where he talks about how despite many years,
four decades of food aid--not food aid, but all aid--that so
many countries have not made any progress whatsoever, no
permanent progress or benefited from it.
So you have a lot of familiarity from the private sector
and from what you're doing now, and I'd like to hear what are
some of the success stories that we've had, so a lot of good
stuff. I've talked and I'll yield the floor, madam chair, and
again welcome all of you.
Ms. DeLauro. Thank you very much. And Mr. Secretary, Mr.
Miller, if you will proceed with your testimony, the testimony
in its entirety will be part of the record and you are free to
summarize it any way you would like. Thank you.
Under Secretary's Opening Statement
Mr. Miller. Well, thank you very much, Chairwoman DeLauro,
Ranking Member Kingston. It's a real pleasure to appear before
the Committee today to present the 2011 budget proposals for
the Farm and Foreign Agricultural Services at the Department of
Agriculture.
You have already acknowledged the three administrators
representing the agencies within our mission area as well as
Scott Steele with our Office of Budget and Program Analysis,
and I am very appreciative of these gentlemen participating in
this hearing with me. With your permission I would like to
summarize the statement that I have submitted for the record.
And following my remarks, we are certainly happy to respond to
any comments or questions that you may have.
First, let me thank the Subcommittee for the support you
have provided to our mission area and its programs in the past.
The President's 2011 budget provides the resources needed to
meet our mission area's priorities next year, and so I'd like
to begin with the Farm Service Agency. As you noted, the Farm
Service Agency is the lead agency for delivering farm
assistance to our producers throughout the country.
The 2011 budget request for FSA funds essential program
delivery expenses. For FSA salaries and expenses the budget
provides $1.7 billion, a net increase of about $116 million
over the 2010 enacted level in order to sustain essential
program delivery. This total includes about $95 million to fund
our IT modernization projects, which we'll discuss further, I'm
sure, during the questioning period.
The Committee is aware of FSA's longstanding need to
upgrade its aging technology and we certainly thank you for
providing $117 million through the Recovery Act as well as the
2010 annual appropriations to engage in these activities. This
funding will enable us to continue our modernization efforts.
After severe performance problems a few years ago, and while
challenges certainly remain in order to complete this task,
important steps are in fact under way to transition FSA to a
modern, centralized, web-based IT system. Continuation of these
efforts is our top priority in our 2011 budget request.
FSA also plays a very critical role for agriculture
producers by providing direct and guaranteed credit for farm
families who would otherwise be unable to obtain the financing
they need for their operations. The 2011 budget proposes a
total program level of about $4.7 billion for these programs.
Of this total, over $1.5 billion is requested for direct loans
and nearly $3.2 billion for guaranteed loans offered in
cooperation with private lenders.
Turning to the Risk Management Agency, as you are well
aware, it administers the Federal Crop Insurance Program, which
is our primary risk management mitigation program for our
producers. Our current projection for 2011 shows the value of
insurance coverage will remain relatively constant with what we
have seen in recent years at about $84 billion of liability,
while insuring over 260 million acres.
The 2011 budget request of $83 million for discretionary
administrative expenses for RMA includes additional funding for
pay cost and for the maintenance of the RMA IT system. The 2011
budget also includes a mandatory request reflecting estimated
placeholder savings of $8 billion over 10 years resulting from
changes to the terms in the Standard Reinsurance Agreement with
our private insurance providers. That agreement is currently
under negotiation with our private insurance company partners,
and we expect to complete those contract negotiations by June
30th of this year.
The RMA IT modernization project is in its third year. To
date, approximately $35 million of the $54 million four-year
project provided in the 2008 Farm Bill has been obligated under
a two-phase approach. Phase 1 will conclude this summer. Phase
2 is scheduled for production next year.
The Foreign Agriculture Service is the lead agency for the
department's international activities, and it is at the
forefront of our efforts to expand agricultural trade and
enhance global food security. Let me begin by expressing my
appreciation to the Committee for providing additional 2010
funding for the Foreign Agriculture Service that has helped
address the financial concerns experienced by the agency in
2009.
For the 2011 budget we are proposing FAS have resources
that represent American agriculture on a global basis and
create new overseas market opportunities. The budget provides a
program level of $265 million, an increase of $78 million over
the 2010 enacted level. This includes $54 million for increased
export activities as part of the President's National Export
Initiative. $10 million of this funding will support expansion
of several FAS export promotion activities. A portion will also
be used to meet higher, non-discretionary operating expenses at
the agency's overseas posts, and the initiative also includes
over $34 million to double the funding for our Foreign Market
Development Cooperator Program.
In addition, the initiative provides an increase of $9
million for the Technical Assistance for Specialty Crops
Program, which doubles overall funding available for TASC in
2011. The increased funding for TASC reflects the importance of
specialty crops in our export strategy moving forward and the
need to resolve barriers that restrict the trade in those
crops.
For the Cochran and Borlaug fellowship programs, the budget
includes increased funding of $1.5 million. These programs
provide important training and collaborative research
opportunities in the United States for our trade partners in
order to advance food security and to address U.S. trade policy
objectives. In addition, funding of $14.6 million is requested
for FAS in recognition that it has assumed full management of
USDA's reconstruction and stabilization activities, including
the provincial reconstruction teams in Afghanistan and Iraq. Of
this amount $13 million is moved from Department Management
where it was funded in this year's Appropriations act.
For the McGovern-Dole Program, as well as for Food for
Peace Title II assistance, the budget provides funding at the
2010 enacted level of $210 million and $1.7 billion
respectively. These funding recommendations represent sizeable
increases over the 2009 levels for both programs. In
conclusion, I would like again to express our appreciation to
the Subcommittee for the support it has provided our mission
area and programs.
We look forward to working with you as you review our 2011
budget proposal, and we will be pleased to provide whatever
assistance you may require as you review this proposal. Thank
you very much.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
FSA IT STABILIZATION AND MODERNIZATION
Ms. DeLauro. Thank you very much, Mr. Secretary. Let us
begin here. As you pointed out this is with regard to the Farm
Service Agency. The budget requests an additional $59 million
for the agency's ongoing IT stabilization and modernization
initiative. As I said in my opening remarks, if we move in this
direction, we will have seen about $250 million spent in this
effort.
Let me just ask you this, because as I again pointed out,
there is a growing bipartisan concern about how long this is
taking and what more is needed to complete it. On the first
question, when will the project be completed?
Mr. Miller. Jonathan, would you like to give a specific
answer?
Mr. Coppess. Sure. Thank you. And we anticipate if the
funding continues that the last contracts will be let out in
2013 and that the bulk of this project will complete in 2014.
So we're looking at three and a half, four years, to get
through the modernization part of this.
Mr. Miller. Madam Chairwoman? If I might, let me point out
that progress is being made in a very significant way and we
expect ongoing improvements. For instance, the Farm Loan
Program delivery system has lowered the loan processing time
from 41 days to 25 days. Our National Receipts and Receivables
System is finally beginning to speed payments to producers, and
we expect after some glitches this year in the transfer that
that system will be much improved in this interim period.
Ms. DeLauro. I don't mean to be flip about this. I think
people were concerned that we were going to put an entirely new
healthcare system together between now and 2014. We haven't
been able to get this system up and running for a number of
years now, so, let me follow-up with a question that I have.
Quite frankly, we have not been able to get clear answers
from FSA about how much additional funding is needed to finish
the project, which is of concern. We are told now that the
funds we provided specifically for stabilization and
modernization are being used for other purposes and are not
remaining in the base for use just for this initiative. We did
run numbers ourselves.
Committee staff did that for me and we are assuming that
the total cost of the project as projected by FSA is about $454
million. If we provide your 2011 funding request and if
previously appropriated funding remains in the base for this
initiative, then you need only about $15.3 million in fiscal
year 2012 to reach full funding. Alternatively, if you don't
keep the previous funding in the base and you spend it on other
things, that will mean another $203 million, or you'll fall
short by that much.
There's a difference of $188 million, and we just don't
have that kind of money. So we need a commitment from you today
that funding provided for this initiative will be kept in the
base for this initiative and nothing else, and it will only be
used for this initiative. And I'm going to ask you for your
commitment today on that.
Mr. Coppess. And my understanding is the number on MIDAS,
about $305 million for this whole project, has been consistent,
that that is the estimate for the full project. And our
commitment is to absolutely use this funding to modernize our
systems, our processes around those systems, and get it
completed as soon as we can. As the Under Secretary mentioned,
the National Receivables System that we started using this year
is a big step forward, and we are learning the problems as we
go with that. So we're committed to putting this funding to
that.
FUNDING COMMITMENT
Ms. DeLauro. But I want a commitment that the funding that
we provide is not used for anything else, that the base number
stays the same and we build on it. And then we just don't add
to it. That is essentially, and again, we've had a difficult
time getting the answers. I don't know what it's going for. If
you know where it's going to, but money is not staying in the
base account and it's being used for other things. So we can't
allow that to happen here.
Mr. Coppess. I understand.
Ms. DeLauro. Because the money is just, you know, just
can't be filling the gap--and you using money to go someplace
else. So do we have your commitment?
Mr. Coppess. Yes. We're not moving that money around.
Mr. Miller. Chairwoman DeLauro, there are two critical
elements to this project that I know you're very much aware of.
One is to stabilize the existing system so we can continue to
deliver programs under the agency. The other is to create the
modernization, which is both a software and hardware issue, so
we can get the advantages of these new efficiencies.
Those projects are, in fact, moving forward and it is our
top priority. We are committed to utilizing the funding that is
made available to the agency to ensure that we can move ahead
with this project and that we can complete it and deliver the
benefits to our stakeholders.
Ms. DeLauro. I understand that. The commitment for this
committee is imperative, and this is on the bipartisan basis.
We've been asking this question for, you know, last year, the
year before. And there's a January report that was due to lay
out where the money is, and to my knowledge we do not have that
report yet. So we would like to get that report and we would
like that commitment that says this money is here. It's going
nowhere else.
Mr. Miller. Let me make sure that we get that report to you
as soon as possible. I believe the report is, if not concluded,
is very close to conclusion and then we will be very happy to
come up and speak to you.
Ms. DeLauro. Because the next one is due April 1st, and,
Mr. Secretary, your commitment on not moving the money out of
the base.
Mr. Miller. No, you have that commitment.
Ms. DeLauro. Fine, thank you. Thank you very much. Let me
go ahead and yield to my colleague. Start with another
question.
Mr. Kingston. Thank you, Madam Chair.
Mr. Coppess, I just want to say that I think this goes back
to Henry Bonilla, maybe even Joe Skeen. I was chair of the Leg.
Branch Appropriation Subcommittee when we were building the CVC
project that was supposed to be like $260 million, take one or
two years, maybe three, and it ended up taking seven years. It
is really, truly not even completed, and it is well over, I
think, $650 million. And the only way we got any progress out
of him was just somebody has to be the mean SOB. Is that you?
You don't look like one, you know? [Laughter.]
Mr. Coppess. I tried to be too mean.
Mr. Kingston. Well, Scott's pointing at you. And maybe Rosa
and I together can constitute a two-headed monster, but really
and truly, it's just one of those things where nothing has
happened. Every year we could practically record your testimony
and play it back through all the other Administrations and
people have sat in your seat, and we've been hearing it. And so
you've inherited a long legacy of this is going to happen.
Mr. Coppess. Yeah, there's a few of those, and I want to
echo the commitment that we're putting behind this to get this
moving, simply because as I've come onto this job and gone
through and met county offices and see what's going on, it is
absolutely vital that we get this system up and running in the
modern environment. I mean we cannot continue to serve farmers
and ranchers if we don't do it. So I'm committed to it, and
it's absolutely something we want to complete and complete on
time.
Mr. Kingston. And the other thing that you're facing as you
know is the technology vision of three to four or five years
ago is obsolete. Things are changing so rapidly these days
that, you know, you're now building a system that was
yesterday's system. So, you know, you have to cajole. You have
to embarrass. You have to fire some people. I mean you just
have to get in there and get it done.
AFGHANISTAN
Let me switch to the Secretary. Are you familiar with our
military strategy in Iraq that is a ``Shape, Clear, Hold, Build
and Transfer''?
Mr. Miller. Very roughly, sir.
Mr. Kingston. Okay, well those are the five buzz words that
we are hearing over and over again from our military
commanders. And, of course, Shape would be identify your next
area, which is Kandahar, that we are going to take over. And
then Clear is the military; Hold; and then you come in, really,
the last two phases, which would be to Build and then Transfer.
And then actually you're staying there once the transfer
happens. And as you also know we have four ambassadors in
Afghanistan. The reason is to sort of offset the military
presence with the diplomatic presence and make sure, you know,
the two and three stars have kind of the civilian equivalent in
the State Department, but also with USDA.
And I would like to make sure that, number one, if you guys
don't feel you're getting enough love from the military-State
Department side, if you let our committee know. Mr. Boyd and I
serve on the Defense committee, and they don't listen to us any
more than they listen to anybody else.
I think they might listen to him, but, you know, we want to
make sure USDA is in the forefront of thought when it comes to
the build and transfer side of the phase. But I would also like
to see from you what your plan is, because when I was in
Afghanistan on the 8th talking to your folks over there, and I
felt that they were very competent, but we're still giving
technical assistance and it's very hard to get things up and
running when, you know, the big money is in poppies.
So what I would like to see, if possible, is if you could
tell us kind of what you're going to do about poppies, because
I am just not getting an answer from the military. And then
what is your plan, as well, because we want to be able to
support you. You are going to have in this budget, which I will
support, I think, all Republicans on this side are going to.
You are increased from 14 to 64 people.
And as I understand it, in order to get the USDA people
there, you basically have to double their salary when it comes
to costs and expenses. Because it is a voluntary thing and they
are leaving their home--leaving, you know, their families--and
they're going into a war zone, so, you know, that sort of thing
is to be expected. But we want to make sure that while they're
on the ground they're doing a good thing. So I guess my quick
question is could you give us periodic reports, maybe even a
quarterly update on what USDA is doing in Afghanistan, how you
identify the problems and how you're going to attack them.
And I want to say, because I am absolutely convinced we can
have military victory, but it's not going to mean anything
unless we can grow the civilian part of that government; and,
as you know, it's a very tough part of the world.
Mr. Miller. Well, Mr. Kingston, let me respond this way.
Certainly the attitude of Secretary Vilsack in the Department
of Agriculture, and I believe the attitude across government is
second to the outstanding job that our men and women in uniform
are doing in Afghanistan. I think we recognize that if we are
going to be able to declare real success at some point in that
part of the world, we have to ensure that the Afghan government
is capable of governing the country. And that means it has to
find ways to get more support out in the countryside, and we
have to ensure that there is economic stability and opportunity
for the Afghan people in the countryside.
AGRICULTURAL ISSUES IN AFGHANISTAN
You raised the poppy issue. Certainly, shifting the
agricultural production in--Afghanistan historically has been a
significant agricultural producer prior to all the turmoil that
it's been engaged in. Shifting the focus from poppies to other
commodities, creating market opportunities, and that's more
than just raising crops. That's providing infrastructure.
That's providing the opportunity for them to export to what
had been some traditional markets that had been abandoned for
years. It's a critical objective for our success. As you
indicated, USDA is planning on increasing the number of
individuals that will participate in our Provincial
Reconstruction Teams in Afghanistan, up to 64.
Many of those people will be going out into the country
into the provinces of Afghanistan working in cooperation with
the locals, first to identify what do they need in order to be
successful. It does very little good for us to try to impose
something on them, so it is really a question of finding ways
to work with the people, find out what they need to rebuild
their communities, to rebuild their agricultural economy, and
then finding the wherewithal in initial phases.
That certainly is technical assistance, but find the
wherewithal to work with the Afghan people in their government,
to rebuild that country and create the stability we all would
like to see. We are happy to provide regular reports to the
subcommittee in terms of our progress in that areas, because I
think our work in cooperation with U.S. AID, State Department
and Department of Defense is a very positive story in a very
troubled area. Thank you.
[The information follows:]
The first report on Afghanistan is expected to be provided in the
fourth quarter of FY 2010, with subsequent reports on a regular basis.
The reports will include information on the status of our funding and
programs for Afghanistan.
Ms. DeLauro. Mr. Boyd.
AGRICULTURAL POLICY
Mr. Boyd. Thank you, Madam Chairwoman. And I want to start
by associating myself with the remarks that you made relative
to the modernization of the technology.
I guess many know that I have had a lot of experience as a
customer dealing with Farm Service Agency offices, and
certainly understand that there are some issues there that we
need to resolve.
Secondly, Madam Chair, I want to say for the record in this
committee that in the last couple of years we've seen
significant attention given to a couple of severe problems in
this country. Summer of 2008, we had gasoline, because of the
rising cost of oil, go to $4.25, $4.50 a gallon, one of the
largest single factors that put this country in a recession in
the summer of 2008.
Now we are in the middle of a very heated polarizing debate
on another issue that is gripping this country in terms of its
costs and effectiveness, and that is its health care system.
I want to remind the Committee members and everybody in
this room that of all the public forums I have attended--over
the hundreds of public forums I have attended over the years, I
have never heard a constituent come to me and complain about
the lack or access to quality, affordable food supply on the
shelves of our supermarkets.
I say that because I hear a lot of people fussing about our
national agricultural policy, that we have had a policy that
has worked well for this country for years and years and years.
I just wanted to go on the record, Madam Chair, as
supporting that policy, and warning folks about being too
aggressive in changing significantly that policy.
FSA AND NRCS COUNTY OFFICES
Having said that, I will move to a quick question, and that
question, I think, Mr. Under Secretary, either you or Mr.
Coppess could answer it, has to do with the workings of the FSA
and NRCS Offices, and those two systems, it appears to me, work
separately.
I always thought or at least the people around me, the
folks who use those offices, believed the FSA Office works from
the bottom up, that is from the farm advisory committees up,
and the NRCS Offices worked from the top down.
There has been a lot of talk over the last number of years
by a lot of folks, including folks in Congress, about a way to
modernize the way those offices worked together.
My question really is, I understand a legislative change is
not necessary to shift administrative work entirely into FSA,
so that NRCS can get back to doing what they are best at, which
is technical expertise, technical advice.
Is this something that you consider or you think the USDA
should consider doing?
Mr. Miller. Mr. Boyd, let me respond this way and then I
will ask Mr. Coppess if he wishes to provide any more specific
comments in terms of the interaction that his agency has with
NRCS.
I believe that over the last year, there has been a
dramatic change in the way the Department is interacting with a
variety of agencies that exist down there.
This is something that Secretary Vilsack has been very
insistent upon, and I think the relationship, the breaking down
of barriers or stovepipes, whatever you may wish to
characterize them, has changed significantly.
We cooperate with our colleagues at NRCS on a day-to-day
basis while we implement a wide range of assistance programs
for farmers. We are also engaged through the Conservation
Reserve Program and in some ways through the new BCAP in
conservation program administration through FSA as well.
All of these programs really become interrelated at the
farm level, as you very well know. We believe it is imperative
that we have a good working relationship.
It is interesting that in many of our county offices, NRCS
and FSA are co-located. They are just down the hall.
We are working hard both here in Washington, D.C., as well
as out in the country to ensure that there is greater
collaboration between the two agencies to ensure that the
programs that are available, that the benefits that are
available, and as you note, the important technical assistance
that can be made available, is in fact being delivered to the
producers.
Also, I should point out that I think as we resolve this IT
problem, that is going to in a lot of ways improve our ability
to interact with other agencies within USDA. Just our ability
to share information and share databases is extremely
important. Quite frankly, right now, FSA, RMA, NRCS, we are all
working off different databases.
Mr. Boyd. Mr. Under Secretary--if I could follow up
briefly, Madam Chair--I hear what you say. Just being co-
located down the hall, and I am sure many offices are, I am
sure most of them are, but if the customer has to go to the two
separate offices to do the administrative work, the
administrative procedures are different in one office than they
are in another, being co-located really does not give you much
advantage.
FSA AND NRCS OPERATIONS
My question really goes to how they work and how they
operate. NRCS is best at technical supervision. I have said
this before in this meeting.
I have a farm that I can show you pictures of coming out of
the Depression that you would not believe is the same farm that
it is today.
Much of that is a result of the work that NRCS helped with,
with technical advice, and the FSA, then called something else,
helped us implement.
My question really is administratively, is this doable,
that we can shift most of that administrative burden into FSA,
which they seem much better at--you seem much better at than
NRCS. That is really the gist of my question.
Mr. Miller. Again, I think your point is well taken in
terms of we have to get better at ensuring that we are
providing an improved level of service to our farmers, that we
make it as easy and convenient as possible, and to the extent
possible, that functions between various agencies utilize
similar forms and other administrative tools.
I cannot suggest at this point that FSA is willing to
assume all of those functions from NRCS other than the
technical assistance, but I do believe it is entirely possible
for us to develop a much closer working relationship where we
can streamline processes and make it easier for our
stakeholders.
Jonathan, do you have any additional comments?
Mr. Coppess. I think you have made pretty much all the main
points. Certainly, Chief White and I have talked many times and
are continuing to push in an effort to make our coordination
better for things like land coming out of CRP and going into
other programs.
I think both agencies have incredible resources and the
ability to work together is the first and most important step,
and as the Under Secretary mentioned, I think as we get
ourselves in this modern environment--we cannot share
oftentimes across counties--so to be able to share from a
centralized database information and work that way in better
cooperation with other agencies is going to be a big part of
it.
Mr. Boyd. Thank you, Madam Chair.
SUPPLEMENTAL REVENUE ASSISTANCE PROGRAM (SURE)
Ms. DeLauro. Thank you. Let me ask you, Mr. Coppess, I want
to turn to the FSA's implementation of the SURE program. As I
again mentioned in my opening statement, it is encouraging that
the regulations were published at the end of last year and the
payments have been going out.
I am concerned that it is 2010. The payments that are going
out are for 2008 losses. That is a long time for these folks to
have to wait for assistance.
By the way, the 2008 Farm Bill, this was to be the
permanent disaster fund, and what Congress did was to say let
us have a permanent disaster fund so that we do away with this
ad hoc disaster program.
2010, we are dealing with losses in 2008. When the
Secretary appeared before our subcommittee last year, he said
he would see if there was any way the process could be
accelerated.
Can you give us an update on the implementation of the
program? When do you expect the payments for the 2009 losses to
begin going out? Why has the process taken so long?
Mr. Coppess. Thank you. Certainly, we expedited this
process when we came on board to move things up. I agree with
you completely that it is very difficult for farmers who had
losses in 2008, and a bill that passed in 2008, to just now be
getting payments.
We expedited that and put a lot of effort behind that--in
fact, in front of software issues--so that we are actually
calculating these in the offices and getting the payments out.
Farmers began signing up for the 2008 losses this January,
and we have paid out, I believe, over $2 million to date for
2008. 2009 will begin this year.
One of the things about SURE is because we have to wait
until the crop year is done and calculate the national prices
and everything in the statute, it will not be sort of a
realtime disaster response.
It is a supplemental program. You have to have NAP or crop
insurance. That is sort of closer to the disaster part of the
safety net. Then we calculate that after the crop year is over
and then know the prices, know what all the pieces of that
calculation will be, and then it will generally pay out a year
to 18 months after the disaster.
Ms. DeLauro. Are there other steps that we can take to
accelerate the process?
Mr. Miller. Let me just remind the Chairwoman of a couple
of things and then let's discuss how we might be able to solve
this problem.
If you recall, it took three years before disaster payments
began to be calculated in the last ad hoc programs.
Ms. DeLauro. I am aware. We made some promises to people
and quite frankly to ourselves because we are going to be
continuing to do this, but also to continuing to look at ad hoc
disaster relief programs because people cannot wait as long.
You will then see supplementals continuing to do this.
The goal was to have a permanent disaster relief fund. I am
well aware. As I say, I applaud what you have done but I have
been out there and I have heard people talk about how difficult
it is for them, some of the small folks, they cannot survive if
they have to wait all this time.
Mr. Miller. As you have noted, we do have the program out.
Quite frankly, the development of the crop disaster program did
not really begin until the new team at USDA was in place, less
than a year ago.
As Jonathan indicated, this became the top priority for
FSA.
I do expect within the requirements of the statute, and
that is for crop losses, that we need to have the average
market year prices in order to calculate the payment, but we
will be getting payments out more quickly in the future now
that the program----
Ms. DeLauro. The program is up and running.
Mr. Miller [continuing]. Is up and running. It is still
going to be at the end of the marketing year, not directly
associated with the production year.
In terms of the other elements of the disaster program,
however, we are able to make those payments, again, because of
the provisions in the statute, much more quickly--the livestock
indemnity program, as well as the livestock forage program.
Those payments were implemented earlier and payments began to
flow to producers who were eligible much earlier.
It is a range, but yes, we have this issue in terms of
timing, primarily because we are complying with the statutory
requirement.
SURE PAYMENT PROCESS
Ms. DeLauro. Is there anything we can do to accelerate it?
Anything that we can help with? Is there anything else you need
or are there any tools that you need that could help accelerate
this process?
Mr. Miller. If it is the desire of Congress to find a way
to accelerate the process, there are a couple of things that
could be considered. I am not advocating them. I am providing
some technical guidance.
One, you could consider that we develop a way to provide
advance payments. That would be a partial calculation of what
an estimated disaster payment would be.
Another is to potentially reconsider what we are going to
use for the pricing of these commodities. Right now, we are
waiting until the end of the marketing year. We are calculating
prices based on average prices received by producers consistent
with the statute. That is an element that Congress could
potentially review if the goal is to find a way so we can make
these calculations and thereby deliver assistance sooner.
All of those are going to come at some cost, as you are
well aware.
Ms. DeLauro. Thank you very much. Mr. Kingston.
FOREIGN AID
Mr. Kingston. Thank you, Madam Chair.
Mr. Brewer, I wanted to talk to you a little bit about the
foreign aid and the effectiveness of it as much as anything
else.
I want to preface that by something that I have learned
recently, that revenues in our budget cover Social Security,
Medicaid, Medicare, interest on the national debt, and then
essentially we borrow about 37 cents on the dollar that we
spend, which would include agriculture, military, education,
transportation.
That is not a political statement. I would attribute that
to both parties.
The twist in here, the irony, is that we are borrowing
money for foreign aid, including borrowing money to give some
to China, and we are borrowing money from China, which I think
has a certain twist.
Again, I am not trying to be political. I am just saying
this is reality and both parties have dug this hole, but we are
in it.
That is statement one. Statement two, I was watching
Morning Joe today. They had an excellent show on education.
They had Mayor Bloomberg and Al Sharpton, and kind of a star
studded bipartisan eclectic group of people who were there, who
said the new mantra of New York City is actually to challenge
the status quo.
They were really emphasizing charter schools, saying they
have 10,000 kids in charter schools, 30,000 on the list.
It is kind of an interesting type dialogue that we need to
see more of in public policy.
SUCCESS STORIES
My question to you on foreign aid and with your private
sector background, where do you see the success stories? Where
are we moving the best on alleviating food insecurity? Talk to
me about U.S. food aid versus host country food aid.
Let me just ask you the big picture philosophical questions
on that.
Mr. Brewer. Congressman Kingston, thank you for this
opportunity to talk to you about it. The way you posed your
question really is very expansive, but let me bring it down----
Mr. Kingston. You have two minutes. [Laughter.]
Mr. Brewer. A couple of our programs--I think where you
will see the success stories for us will be in our programs of
McGovern-Dole as well as Food for Progress.
Let me say how much we appreciate the Congress' efforts to
work with us to provide budget authority and increase those
programs by $500 million in 2010. We appreciate that. We are
working hard to make those funds effective.
MCGOVERN-DOLE PROGRAM
As you know, with the McGovern-Dole program, that is linked
to education. We work very hard to make sure that program is
going to bring this year, we anticipate it will help feed up to
five million women and children. That McGovern bill was
definitely a success story.
Mr. Kingston. Just in terms of our dialogue, and if we go
over, I intend to come back to you and give you more time on
this, and this is a long discussion, I am aware, but just
because we are feeding that many people, that does not
necessarily mean success.
To me, another question would be well, what else are we
doing for them in order to help them help themselves. Not that
that is the focus of the program per se, but I am kind of
talking to you philosophically.
Again, thinking about Morning Joe and this group and they
are putting their best thoughts together, that is what I am
trying to get to.
Mr. Brewer. Again, I apologize if I cannot go as
philosophical as you want. With regard to McGovern-Dole, it is
not just that we are feeding people. It is the innovation. We
are linking it to education. That education is the innovation
and the success story. It is the manner in which we are
providing that food that is leading to education, which we all
believe is the foundation for success and innovation.
FOOD FOR PROGRESS PROGRAM
Also, with regard to our Food for Progress program, again,
the way in which we provide our assistance, we are doing that
through the providing of commodities, which those countries
then are able to sell in an effort to provide economic
development, economic development opportunities for investment,
et cetera.
At the philosophical level that you are talking about, it
is the way in which we are managing our programs.
One thing I do want to add is remember in the area of food
aid, we are part of a whole Government effort. We are working
with partners in USAID and State. That whole Government
approach is again an innovative way in which we are providing--
we are complementing each other's programs.
I think the way we link our aid to certain areas which lead
to economic development and advancement of countries as well as
our comprehensive and collaborative approach are where we are
making progress in the area you are referring to.
Mr. Kingston. I am out of time now. I will yield some more
time to you on my next round. In the next round, one of the
questions I would like to ask you is what are some of the
countries that you see with your background in Africa that are
moving forward, where we are more successful and where we are
not making progress.
Thank you, Madam Chair.
Ms. DeLauro. Thank you, Mr. Kingston. I, too, have
questions with regard to our food aid programs.
I am glad to say, Mr. Brewer, I think we share the
experience of going to the London School of Economics; some of
the best years of my life was at the LSE.
Mr. Brewer. I am sorry Congressman Bishop is not here,
after Morehouse, it is the best.
NATIONAL EXPORT INITIATIVE
Ms. DeLauro. I will tell him. Let me ask about the Export
Initiative. Fifty-three and half million dollars is the
increase for the National Export Initiative. It was included as
the USDA component of the President's initiative, and doubling
the exports in five years, which is the goal, and to support
two million jobs.
To fund the initiative, the budget request increases for
FAS exporter assistance and in-country promotion activity, the
Foreign Market Development Program and the Technical Assistance
to Specialty Crops Program.
That is $53.5 million in discretionary increases. That
would be in addition to $43.5 million in mandatory funding,
which will also be provided for two of the programs, the
Foreign Market Development and the Technical Assistance for
Specialty Crops.
It is about $97 million. What data, and I think my
colleague, Mr. Kingston, mentioned this earlier, what data do
you have showing the impact that these programs have had on
exports to date and how will you measure the success of this
initiative? How will we know if it is working? What are the
standards that we have now that intimate that these programs
are working?
What data do you have showing the impact these programs
have had on exports to date?
Mr. Brewer. The data we have been primarily using
particularly with TASC and FMD has been the metrics we have
been using to justify what we have been doing with these
programs that are currently existing, the FMD program and TASC
program are currently funded through CCC funding.
Ms. DeLauro. That is mandatory funding.
Mr. Brewer. Yes, ma'am. That is mandatory funding that we
are talking now. The NEI program or the proposal doubles those
current mandatory programs.
Ms. DeLauro. I know that. What I want to find out is how do
we know, tell me about how we have expanded this export
capacity and how an additional $53.5 million is going to
further expand that capacity for exporting? I do not have a
sense of that.
Mr. Brewer. Let me answer that question through some of the
success stories that were referred to earlier.
In the area of TASC, in 2009, using TASC funds, our
cooperators, our partners, were able to open up the market for
U.S. seed potatoes in Thailand. That led to an additional
potential of $1 to $3 billion in additional export sales. That
assisted the States of Washington, Idaho, Oregon, and
California.
We also used TASC funds to assist us in opening a market in
Mexico for stone fruit, which was very useful to the stone
fruit producers in California.
Our efforts to open up markets and those success stories
are just two examples of the metrics we use or the way in which
we determine that these programs are useful.
There are other success stories that I would be happy to
provide.
PROGRAM PERFORMANCE CRITERIA
Ms. DeLauro. I think it is important to deal with the
success stories. I would like to see what we view, when we are
looking at goals that we are trying to reach, how is this
additional $53.5 million going to deal with our part, ag's
part, of contributing to doubling the exports, two million
jobs.
I would like to know what the criteria are that we measure
the success of these programs with. As I said earlier, I want
to increase our ability to export, but I want to know if what
we are doing now is successful, what are the measures that
calculate that success. I also mentioned, and I will come back
again on this, opening up a market to Cuba. We refuse to open
up a market to Cuba, for a whole variety of reasons, which
could increase our exports, but we are going to look at $53.5
million to expand programs.
What I do not have, and I do not know that the Committee
has, is any way of judging the use of the current funds, both
the mandatory funds and discretionary funds, that allow us to
get to that goal.
If you can provide us with that, the criteria, we will let
you know what it is specifically that we would like to have in
order to look at how we try to treat the $53.5 million for the
next year.
[The information from USDA follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Kingston.
FOOD ASSISTANCE
Mr. Kingston. Mr. Brewer, I do want to emphasize that I do
think we are very interested in which ones are more effective
and which ones are not.
One of the things--MAP, for example, has been described as
corporate welfare in the past, so we do need to be able to get
back to people and say look, this is where the dollar invested
brings a dollar return.
I wanted to go back to you on the food assistance in Africa
and some other places, on which countries does it seem to be
working the best and what is our progress, and then anywhere
else around the globe.
I know you have a pretty big world vision.
Mr. Brewer. Thank you, Congressman. A couple of places, and
again, I want to expand this a little bit beyond food aid,
again, we are in this whole of Government approach. I will
expand it a bit further just to aid in general.
I think Botswana is certainly a country that has, in part
through U.S. assistance, has moved from a position of being one
of the poorest nations on the continent to one that is in the
middle tier, middle income tier.
Mr. Kingston. I want to mention, right now, they cannot get
developmental aid because they actually have done so well. They
are working on a huge water project in the north of the country
and they cannot get any of our aid on it.
I raised that question with Secretary Vilsack. You and I
may want to pursue that. Sorry to interrupt.
Mr. Brewer. No, that is quite all right.
Again, Botswana would be one. Just to kind of reach out, I
will expand a little beyond Africa and go to Indonesia,
certainly a country which started off as one of the poorer
nations and has moved forward. Lebanon.
When we are dealing with a situation as we often are of
having scant resources or limited resources and a lot of
demand, we really have to kind of set some criteria, and one of
the criteria we do use is trying to determine where are
countries within the income spectrum.
As I say, Botswana, Lebanon and Indonesia are clearly
countries that start off needing and receiving a great deal of
assistance and have now gotten to a level, an income level,
where that U.S. assistance is not needed as much, so we are
able to try again to focus our assistance in areas where we can
work effectively with our partners and get the best bang for
our buck.
Mr. Kingston. There are so many other countries that are
out there.
Mr. Brewer. A great deal.
Mr. Kingston. I think we are giving them aid but there is
no real rhyme or reason where we are going with it or why we
are going there or whatever.
NON-GOVERNMENTAL ORGANIZATIONS
I know in Haiti, the USDA put out a request recently, this
week maybe, on aid for Haiti, to NGOs.
Which NGOs do you think are the best ones?
We always kind of shy away from that. I know they all mean
well, but certainly, just like with basketball teams and
corporations and politicians, you got some who are better than
others. I think it is time that we start talking in terms of
what NGOs are really good and effective and not just good P.R.
people and not just good politicians, but who actually are
making something happen.
Mr. Brewer. Congressman, the best way I could answer that
one now, quite frankly, is I will refer you to the process we
use. When we are out trying to identify our partners in Haiti
and in whatever countries we work with and use non-profits as
partners in those countries, we have a very vigorous compliance
as well as application process of how we identify our partners.
If they are successful in our very vigorous process to
become a partner for us, we see them as a valuable and
effective partner.
I think I will leave it there. I do not want to name names.
Mr. Kingston. Someone could hit a grand slam in one area
and strike out in another country, and that is actually to be
expected.
I think what would be good in-house is for you with your
business background to take country-by-country looks. In some
areas, host countries are probably going to be the best way to
go, and in others, they are not.
You know, kind of figure out what is working and what is
not. I think we give foreign aid maybe to too many countries
too efficiently, and maybe we should every three years take a
look at the whole thing from ground zero, which ones did it
really make a difference and were we making progress.
Mr. Brewer. We are certainly taking steps to do that,
Congressman. One of the things we are doing and certainly
paying a great deal of attention to is our monitoring and
evaluation efforts, our compliance efforts, so we have a
program certainly of compliance and monitoring and evaluation.
It is not as strong as we want it to be, but we are
certainly taking steps to do that. We certainly agree with you
wholeheartedly, what you are suggesting, and we are in the
process of doing that. We are doing that and seeking to improve
it. Again, not only within USDA and our food aid programs, but
whole Government wide, working closely with our partners, again
to collaborate, monitor and evaluate our programs.
We are right on the same page with that.
Mr. Kingston. Thank you.
Ms. DeLauro. Mr. Latham.
Mr. Latham. Thank you very much. I apologize for being a
little late. I had another hearing going on this morning.
CROP INSURANCE
Mr. Murphy, I just wanted to ask you, I know you are in
negotiations, I think, as far as contracts with the crop
insurance folks, and I guess rather than get into specifics
about where you are, unless you want to comment, what do you
see long term as far as where the Department wants to go?
We have seen the Federal Government take over direct
student loans, huge expansion of a lot of different areas of
Government takeover.
Do you see it remaining in the private sector? What is your
long-term plan?
Mr. Murphy. Yes, I think myself as well as everybody in the
Administration I have dealt with would like to see it stay in
the private sector, sir; yes. It has been a very efficient
system.
The participation numbers are at some 80 percent
participation, very high levels of coverage. It has been due to
the private agency system, I think.
Mr. Latham. There is no discussion of----
Mr. Murphy. There are always people who have different
ideas of delivery systems. There always has been. What has been
a concern lately has been the increasing cost of delivery,
which is expressed in the administrative and overhead subsidy,
as well as the underwriting gains.
In 2006, those costs combined were $1.8 billion. This year,
2009, it is just short of $4 billion.
I think the primary concern of everybody is trying to get a
handle on the costs while ensuring that the program continues
to be delivered in a very efficient manner across the country.
Mr. Latham. Okay. Do you have any update about where you
are?
STANDARD REINSURANCE AGREEMENT
Mr. Murphy. Yes. We just issued the second draft late
February. We are currently meeting with the companies this week
in Kansas City. Next week, here in Washington, D.C. That is
getting their input on the second draft.
We are going to break out into smaller groups. We just
agreed with the industry to put together some four or five
small groups to try to take care of low hanging fruit, where
there is some minor disagreements. That is going to occur in
early April.
We expect to have the final agreement out on the street at
the end of April, that is what we are looking at now.
LEGISLATIVE PROPOSALS
Mr. Latham. Thank you. I am not sure who to direct this to,
probably FSA. In the budget request, there is talk again about
limiting farm payments, storage payments on cotton and peanuts,
of course, more taxes for businesses in the form of new fees.
Can I just ask, is there specific legislation you propose
to change the current Farm Bill that is not that old to begin
with? The request is going to have to go to the authorizing
committee to make those kinds of changes. Are you proposing
anything?
Who wants that? Probably nobody. [Laughter.]
Mr. Miller. Congressman, thank you. Yes, sir. There are a
number of proposals in the budget. I think as you will note,
compared to last year's budget, the suggestion concerning
payment limitations is significantly different than what was
included last year.
We believe this is certainly consistent with what the
President had talked about throughout the campaign and since he
has been in office. This is an issue that has already been
discussed at various times by the authorizing committee.
It is a way, we believe, to more clearly target the limited
resources that we have for commodity program payments to those
most in need and reducing the number of producers based on an
adjusted gross income calculation from being able to receive
full benefits under the commodity program.
There are a number of other, as you suggest, revenue
proposals in terms of fees. This Administration has reviewed
those options and we have looked at what other Administrations
have proposed in that regard as well.
We believe this represents reasonable fees for the services
that the Federal Government is providing.
We are happy to work with the authorizing committees. We
have indicated to them our willingness to work with them as we
find ways to deal with ensuring we can move ahead with a very
solid foundation in terms of our farm programs and domestic
assistance to producers while at the same time recognizing the
fiscal situation that we currently find ourselves in.
Mr. Latham. I see I am out of time. If I could follow up
here just for a second.
Ms. DeLauro. Yes.
Mr. Latham. Thank you. I guess the frustration you are
going to see, you know the authorizing committees have not just
said no, they said hell, no. They are never going to adopt this
kind of stuff.
Knowing that, why do you continue to make these kinds of
requests? It is not going to happen. You know that.
Mr. Miller. First of all, we are not convinced it is not
going to happen.
Mr. Latham. Have you spoken to the chairman over there?
Mr. Miller. We believe that it is an appropriate approach
to the farm programs, and quite frankly, there was substantive
change in the payment limitation regime contained in the 2008
Farm Bill.
We believe it should go somewhat further. It is not like we
are suggesting that the commodity payment programs be
eliminated, but we are suggesting some additional movement in
that regard.
Mr. Latham. Unless you have a news flash, it ain't
happening. Thank you.
FOOD AID AND DEVELOPMENT ASSISTANCE
Ms. DeLauro. Thank you. Mr. Brewer, earlier this month, the
Subcommittee heard testimony from GAO. This was on a new report
of evaluating the Government wide global food security
strategy.
One issue that was identified in the report was a shortage
of expertise at USDA. GAO found that FAS generally oversees
food aid programs from its headquarters and regional offices.
The report cited a USDA review of staffing that concluded that
additional positions are required to support food security
priorities.
The witness from GAO also indicated that in reality, FAS
had been all about trade, not development assistance and food
aid. He said when his staff visits FAS, staff in the field, and
this is a quote, ``They come back with stories about basically
the person has done very little on the development side because
his portfolio is on the marketing side.'' That is from the GAO.
Given the conclusions in the GAO report, why is it your
budget does not propose to hire any new staff?
Mr. Brewer. Although USDA does not have development--
dedicated foreign service staff, our foreign service officers
in the field have the ability to employ the significant
technical expertise residing in other mission areas in USDA as
well as in our U.S. land grant university system when we have
issues of development going on, as well as, again, going back
to our collaborative work with AID. We--so we have--while that
assistance can--does not--or that expertise does not sit in our
offices, per se--and I question the extent of the GAO report.
I think our people through just the work that they have to
do, particularly in particular countries, they have a knowledge
and a working understanding of development issues. But that
certainly can be supplemented by our contacts and relationships
within our land grant university system as well as our partners
in AID. So I think more collaboration, more effective use of
that.
Ms. DeLauro. Do you see your role or the role of the agency
as to be focused on the marketing and the trade side, versus
the oversight of the--if you will, of the food aid side and
that effort.
Mr. Brewer. No, ma'am.
Ms. DeLauro. Where do you see your priorities?
Mr. Brewer. I see our priority as both. I think that we
have a responsibility, and our mission is to open export
promotion and the management of food aid. So our priority is
both, and I believe we are doing both, but can effect--can
certainly do it more effectively by our--the relationships that
we are building and the contacts that we have among our
partners in government and outside of government.
FAS STAFFING
Ms. DeLauro. I understand Land Grant and USAID. There is
nothing in the budget that shows an increase in staff for work
on hunger security. And then you've got an increase of $53.5
million for an export initiative, but you actually have no
staff attached to that as well. It looks as if the FAS budget
shows no increase in staffing over 2010. Is that inaccurate?
Mr. Miller. Madam Chairwoman, let me respond. I think
you've raised a couple of issues here. First of all, in terms
of the food aid or more broadly speaking, the food security
initiatives, as Mr. Brewer has pointed out, we're now looking
at a whole of government approach. Just last month, the
Secretary appointed within his office a food security
coordinator who will be working with our folks at FAS that are
directly engaged in food aid, food security and capacity
building initiatives. And we do have a rather robust program
there, and we do have a group of people that are dedicated to
those activities. The purpose of the food aid security
coordinator in the Secretary's office is in fact to ensure that
we are coordinating our activities with our other partners in
this, which are primarily State and USAID. We believe there are
significant synergies that can be developed by that kind of
coordination. So that we avoid the possibility of duplicating
activities, we work together to more clearly identify many of
the areas where we believe we can achieve success, as Mr.
Kingston suggested we should be doing. And so we are already
dedicating personnel to this effort.
In terms of additional personnel, at this point we believe
that with the assistance of the Secretary's office and the
other agencies involved, that we can satisfy those needs and
actually be more efficient and more effective at ensuring that
our food assistance and food security dollars are achieving the
results that we all would like to see.
Ms. DeLauro. I--I'm sorry, Mr. Brewer. I didn't mean to----
Mr. Brewer. I'm sorry, Madame Chairwoman, if I could just
add to----
Ms. DeLauro. Sure. Sure.
FAS STRATEGIC RE-ENVISIONING
Mr. Brewer [continuing]. What the Under Secretary said, as
well as your question about additional staff. One thing that we
are doing currently underway in FAS is our re-envisioning
effort. That is an effort to restructure the agency more
efficiently and effectively. Part of that effort is to also
make sure that we are staffed at the appropriate levels. So we
are underway. That's been going on for the last year, and the
effort of looking at the way we're structured, our personnel in
our various program areas. And we are addressing our staffing
issues through that initiative as well. So we are looking at
and paying attention to whatever we're asking for within our
program areas and with our--in our export initiative we are
certainly making sure that we have the proper staff levels to
do that, so that's being handled on an ongoing process. We're
hiring now and have been doing that, and see through that
process to continue to do that.
Mr. Miller. Could I follow up with one more comment?
Ms. DeLauro. Sure, sure.
Mr. Miller. We focused this in terms of our budget for next
year and looked at it in terms of what we are doing just within
the U.S. government and how we deliver on these programs and
try to achieve success. I also want to point out that this is
an international effort now, and I think Secretary Clinton's
initiative supported by Secretary Vilsack suggests that there
is new emphasis on greater international coordination and
collaboration in this effort. Quite frankly, I think we all
recognize that efforts in the past have certainly not met the
expectations of the United States or other developed countries
who are very interested in this. I see now a much greater
effort in again ensuring that we have a collaborative process,
that we can do things better maybe in the United States in some
aspects. Other countries bring other things to the table. We've
got to find a better way to coordinate that effort.
COORDINATION OF TRADE AND DEVELOPMENT PROGRAMS
Ms. DeLauro. I understand that, and I think that that's--
and I really do, I applaud the initiatives in this area. But I
will also say I think you do have to come to grips with what
the GAO said, and it would appear that the people who are on
the ground in these areas view their portfolio and their
mission as one that is market oriented, trade oriented and not
oversight of food aid programs.
I would also suggest that--and in keeping with something
that my colleague Mr. Kingston has talked about, I think in
terms of coordination, we need to take a look at the
coordination of the trade promotion programs and have a
coordinator that's looking into those and see where duplication
is occurring or not occurring. Because we are--and I want to
promote trade, but it would appear to me just on the surface,
and we haven't examined that, that we're looking at serious
duplication in these programs, and we're not looking at--we
are--and we will continue to do it, emergency aid.
But part of the mission is to look at development,
development of these--of agricultural development here and--so
that you allow these people to be able to produce, produce
better, get better yield, better crops, to be able to deal with
their own economic security, rather than us just providing
emergency aid. And I see, quite frankly--this is not you. I
mean, this is historically here. I see very little emphasis on
the development side. And not only from the United States.
But overall, if you take a look at the Chicago Council's
report, they have said that development assistance from not
only the United States, but more broadly, internationally, has
seriously declined over the last several years or the last
decade, putting these countries in the position of just being--
asking for a handout in order for them to be able to survive,
which ultimately causes us a national security threat. Because
if they can get food from elsewhere, they're going elsewhere,
to whomever it is. And what we need to be doing, and I take
it--you take it seriously--I do, the mission of the USDA is to
build on the side of production and the development of their
capacity to be able to grow food and to be able to be
sustainable. There's--and I think we share that mission, though
I don't see a document or a budget review that gets--moves us
in that direction. Sorry, Mr. Kingston. It's----
INTERNATIONAL FOOD AID
Mr. Kingston. Well, thank you, Madam Chair. I wanted to say
also, you know, on that, I believe the USA gives 50 percent of
all international food aid. Isn't that correct?
Mr. Brewer. It's a high number. It sounds right.
Mr. Kingston. And I think----
Mr. Miller. It's in that range, yes, sir.
Mr. Kingston. And I think Japan is second. And it--do you
know where China is?
Mr. Brewer. I do not.
[The information follows:]
In 2008, food aid to all countries totaled more than 6 million
metric tons. The United States provided 51 percent of all food aid. The
European Union provided 6.4 percent, Japan provided 6.0 percent, and
China supplied 0.64 percent of the total.
Mr. Kingston. You know, China is doing a lot of, I don't
know, economic adventurism around the globe, South America and
Africa. And it seems like while we're feeding the folks,
they're building the structures, the roads, the bridges, and
maybe that makes a louder statement, because--and I'm not
certain that it is or not. But people get agitated that we
don't have enough forces in the coalitions in Iraq and
Afghanistan. They ought to look at the food aid. We don't
have--we really don't have enough international community
support in that either. And I don't know if you want to react
to that. I just want to mention that. But I think what the
Chair is saying is right. I mean, you know, we keep doing the
short gap food--and I've worked at the homeless shelter at our
church. And you know, I always say, okay, you want to put on
your halo, dust it off for the day and feel good about
yourself. You know, it's a quick fix for you. But--and I just
don't know if in the long run you're doing as much as you could
be doing for the people who are getting the aid.
Mr. Miller. Let me say generally----
Mr. Kingston. And I would certainly not hold any of you
guys responsible for this direction. I'm just saying as a
country we need to----
Mr. Miller. No. I think----
Mr. Kingston. We need to start having these discussions.
DEVELOPMENT ASSISTANCE
Mr. Miller. I think we would agree generally with your
comments. And I think we are in the process of making what
could be some very substantive changes in what we viewed both
as emergency food aid in the past, versus developmental
assistance, as I believe that's the point the Chairwoman was
getting to. We are going to continue to provide emergency food
assistance. The disaster in Haiti is a critical example of
where that is sorely needed, where the United States, whether
it's through USDA, USAID or other agencies, is going to
respond. We need to respond. It's our global and moral
obligation to respond.
But I think also looking at development assistance is
something where we've been having a very substantive discussion
just in recent months as part of Secretary Clinton's global
food security initiative. And I think you raised a very good
point, Mr. Kingston. We need to be looking at this in terms of
first of all, how can we enhance productivity in many of these
countries? And that's something the Secretary is very
interested in accomplishing, rather than just providing them
assistance year to year, and creating that kind of dependence.
I think you've also identified a key aspect of our whole of
government approach, as well as what we're trying to do in
terms of international cooperation, and that is just producing
an additional quantity isn't adequate. We have to find a way to
control post harvest losses, which are a huge problem in many
developing countries, where in some cases half or more of the
production is lost due to insects, due to the lack of adequate
storage. We need to help those countries figure out ways to
build marketing systems, to have input supply systems, to have
financing if we want farmers to be able to farm and
consistently raise crops. Those are issues that we're beginning
to tackle on a very large scale. You know, can we do this for
everyone in need around the world all at one time? No. I think
we all recognize that that is impossible.
AFGHANISTAN DEVELOPMENT EFFORT
I think the activities that we have going on in Afghanistan
with our provincial reconstruction teams and the effort there,
again across the government effort, is a demonstration of some
new thinking in that it's not just enough to provide food. It's
more important that we provide them the opportunity to produce
food for their own country, potentially to reestablish what had
been historical markets for their commodities, and improve the
economy and stability in a country, whether it's Afghanistan or
somewhere else. And as I often told my friends in commercial
agriculture who want to trade, the best thing we can do is
improve the income levels in countries if we want good
customers commercially in the future. And I think that----
Mr. Kingston. Have you had a chance to get to Afghanistan
yourself?
Mr. Miller. I have not, sir.
Mr. Kingston. You know, you have a great wheat background,
and that's the most promising crop. It would be--I think it
would--you know, when you can, I think you would really be
valuable on the grounds there, yeah.
Ms. DeLauro. Mr. Latham.
MARKET ACCESS PROGRAM
Mr. Latham. Thank you very much. And actually, I want to
commend the department for actually being a part of what I
think will be the long term solution in a place like
Afghanistan. I will never forget talking to some of my National
Guard people who had come back from Iraq, and I asked them,
``What's the one thing that you think we needed''--this is back
when things weren't going so well, that we needed actually for
the government to do that they weren't doing. And he said,
``Basically, you know, the followup. Where's the rest of the
government?''
Because the--there was--they would go in and fight these
battles, clear out the bad guys, and there was no fill behind
it at all and--with USDA. And I think that's our best
opportunity in those areas. I think there's other things that
are involved security wise for those families that are farmers
over there, that is maybe a larger issue than what crop they
plant sometimes too. But I digress. I'm sorry.
But I am concerned about the cuts in the Market Access
Program. And apparently while I wasn't here you mentioned
something about how--what the payback is on this. I know the
wheat people--and I think it's the study that came out--came
out of FAS, that said that there is a $23 return for every
dollar invested as far as market promotion, in the wheat
industry, anyway, according to this article. And I just don't
understand. At this point in time when you would want to
promote exports to promote sales--we've got pending trade
agreements out there that's being stalled for various, various
reasons, but--you know, which is something that we could open
up some markets and maybe we wouldn't have to have quite as
much market promotion, if in fact we were able to sell stuff
without tariffs overseas. I don't--can you elaborate on the
thinking behind this? It just seems like the investment is
certainly well worth what it costs for the return we get.
Mr. Miller. Mr. Latham, let me respond this way. First of
all, as you're aware, the budget includes significant new money
for 2011 for a variety of export promotion activities. In terms
of MAP, consistent with what the President proposed last year,
yes, there is a modest cut proposed in the Market Access
Program funding. But at the end of the day the level of funding
for the MAP program is still substantially higher than its
historic average over a period of time. It would be at $160
million, so that's not an insignificant amount.
I am familiar with many of the studies such as the one from
U.S. Wheat Associates concerning the effectiveness of MAP. I
talked with our cooperators and other MAP participants on a
fairly regular basis, and yes, they clearly can provide
information to show their level of success and returns in terms
of utilizing that as well as our Cooperator--Foreign Market
Development Cooperator Program. I think the issue with MAP is
one of if we accept, and I do, that there has been a good
return to the industries from the MAP dollars that have been
expended, that the industries could and should probably be
willing to put a little money of their money into the program
still with U.S. assistance.
Secondly, we face some additional challenges in global
trade that just promotion are unlikely to resolve for us,
particularly in the areas of sanitary and phyto-sanitary trade
barriers that are erected that are not based on science. This
has a big impact on our livestock exports and a big impact on
our speciality crop exports, one of the reasons for the
suggested increase in the Technical Assistance for Specialty
Crops program. We believe we can be more effective in resolving
a number of those issues with additional funding for FAS to
directly engage in those kinds of discussions, with additional
funding for the TASC program and through the Cooperator
program. In addition, we believe the----
PENDING TRADE AGREEMENTS
Mr. Latham. If I might just interrupt. I ran out--okay,
thank you. We've got three trade deals sitting there that could
be done tomorrow with Korea, Columbia, Panama. Is there no one
at USDA yelling and screaming and saying, ``Let's do these
things,'' to push this, to open up those markets, so that we
can have, you know, a fair basis? Obviously, the stuff that's
being brought into this country, there's no tariff, but for us
to sell into them, there's a tariff on our goods coming in. I
mean, I would think someone at USDA would be just going nuts
over there saying we're spending all this money on market
promotion and we've got these deals here that would expand our
markets dramatically. Is there anybody saying, ``Let's move
these things?''
Mr. Miller. Mr. Latham, USDA has been supportive of
concluding the negotiations on those three agreements and
getting them passed. That was true of the previous
Administration and is equally true of this Administration. But
we also recognize that while we believe that there are
significant benefits to U.S. agriculture that could occur under
each of the three pending trade agreements, we're also
cognizant that there still are some outstanding issues
related--different outstanding issues, but outstanding issues
that are related to those agreements.
We also know that pushing Congress to consider those
agreements when the time is not ready is not a recipe for the
success that I think we would like to see regarding the final
conclusion to those. But the President has indicated his
interest in those agreements. My experience with USTR is that
they also would like to get to the point where we could
consider ratification and would, in fact, ratify those three
outstanding agreements. But it does require, I think
realistically, that we resolve the remaining outstanding issues
with those countries. For Agriculture parochially, I think we
believe that each of those agreements conveys significant
benefits to U.S. producers and exporters.
Mr. Latham. Okay, thank you.
Madam Chairwoman.
CUBA TRADE EMBARGO
Ms. DeLauro. Just on that note, I would ask my colleague
Mr. Latham and I'll ask you, Mr. Under Secretary, do you think
that we ought to lift the embargo on Cuba to open up markets?
Mr. Latham. Well, I think as far as agricultural sales, we
have that. And it's just a matter of how the credit is applied,
so that's already in place.
Ms. DeLauro. Well, no. I mean, Cuba is under severe
restrictions and there isn't any other country in the world
that's under those restrictions with regard to the credit, and
the--cash on the barrelhead as well. It's a very, very
different set of circumstances. Let me ask you, Mr. Under
Secretary, and I didn't get to this--do you think we ought to
lift the embargo on Cuba to open up new markets?
Mr. Miller. Madam Chairwoman, let me respond this way.
First of all, in my previous life I was a farmer and actually
produced crops that would be exported----
Ms. DeLauro. Right, exactly.
Mr. Miller [continuing]. Potentially to Cuba.
Ms. DeLauro. Yes, sure.
Mr. Miller. So I fully----
Ms. DeLauro. Connecticut, we can't send tobacco, because
they--that's not, you know, so--but rice and wheat and a whole
bunch of other things.
Mr. Miller. But I do fully understand--
Ms. DeLauro. Chicken.
Mr. Miller [continuing]. The interest of U.S. industry and
exporters in the Cuban market, and appreciate their desire to
see that market open more fully. Just in the last year, with
the help of Congress, some strides have been made to make trade
with Cuba easier. But we all recognize the situation with Cuba
is complex. It is extremely sensitive. It has significant
foreign policy implications that I think extend well beyond
just agricultural trade with Cuba that we recognize as I
believe you indicated lasted through 11 Presidents. So, you
know, I'm also cognizant of that. But yes, we believe there are
significant agricultural opportunities in Cuba, but we're not
there yet.
Ms. DeLauro. We certainly are not, and well, that's an
issue for another time. But there are those of us who are
working on that aspect of it as well.
OIG RECOMMENDATIONS FOR RMA
So let me move to RMA and let me take a look at some of the
OIG recommendations, Mr. Murphy. We asked the OIG to give us a
list of their recommendation in the FFAS mission area that have
not been implemented, so that we could review them before the
hearing. There were a few open recommendations for FAS and for
FSA, but there were a number with regard to RMA over the last
eight years. The open recommendations about key issues such as
quality control, incorrect loss determinations, improper
payments, failure to act on a company's material deviation from
RMA policies and practices.
Perhaps the most serious were the many recommendations
following the IG's conclusion last September that--and this is
the IG, this is not me, RMA lacks a comprehensive, systemic and
well defined strategy for improving the integrity of the
federal crop insurance program. Instead RMA's primary focus is
on program delivery, providing and expanding crop insurance
coverage for producers. Disturbing finding, I think you would
suggest. So--and disturbing I think--you know, we have--the
subcommittee has, by the way, supported giving RMA additional
funds for program integrity. But the concerns that are raised
by the report don't suggest that the money is being well spent.
What is the problem getting to closure on the recommendations
and more fundamentally, to building integrity into the crop
insurance program?
Mr. Murphy. Well, I'll address the findings first. Some of
the findings go back quite a few years.
Ms. DeLauro. Right. I'm not suggesting they're your--on
your watch.
Mr. Murphy. Right. Unfortunately, I've been with the agency
quite a few years, so----
Ms. DeLauro. Okay. Well, then maybe it is on your watch.
Then maybe it is on your watch.
Mr. Murphy. I think a lot of them are being implemented.
One of them is the combination product that we're bringing out
in 2011. Final rule is going to be published next week. I think
that will address--some of those issues go back quite a way. I
think integrity is a major issue with the agency. I think it's
institutionalized and in all parts of the agency. Now as to
whether we have a written overall comprehensive strategy, we do
not. However, this is a point that the Secretary has taken his
own time to discuss with me, and we are working with OIG to get
a written strategy put together for them.
RMA COMPLIANCE FUNDING
Ms. DeLauro. What happened with the $1.8 million that we
provided? The House did, Senate didn't. We prevailed in the
conference, and I have to tell you, it wasn't an easy lift to
prevail in the conference for this effort.
Mr. Murphy. Right.
Ms. DeLauro. But no mention of any of that in any of the
testimonies, et cetera. How has the--how has this helped to
deal with increased compliance and oversight?
Mr. Murphy. We are in the process of hiring 10 additional
compliance investigators to assist. That will be a great help
to us overall. One of the issues we have is that we're a very
small agency. We have less than 500 people, and we have a huge
program, a $90 billion insurance program we have to provide
oversight to. So that's one of the issues. But I do thank you,
Congress, for the work you did on that help. But we are in the
process of hiring those right now. We do have many parts of the
agency that address--and systems. One of them is data mining.
This is a project that we have going on. It costs about $4
million per year. But since 2001, we've gotten about a $700
million return on it. It is a project that we work with FSA on.
They are closely involved in it and they assist quite a bit.
The companies are involved in it. We work with the companies on
requiring quality controls. We verify those quality control
programs they have. That's--the last reinsurance agreement got
into that very deeply.
CROP INSURANCE OVERPAYMENTS
Ms. DeLauro. I'm going to address one more piece of this if
the--let me ask my colleagues to--because this is a--I want to
just finish the questions with regard to RMA. And again, this
is data that is in the public domain. Federal crop insurance
programs' accuracy rate is declining, and the amount of
overpayments grew by 23 percent from 2008 to 2009. Let me give
you a specific example. Again, an OIG report--this is from
2007, so I--but I guess you were there--reviewed 21 citrus
indemnity payments, and found that erroneous loss adjustment to
determinations were made on 15 of those claims. RMA has stated
it has not been able to identify any trends or policy concerns
surrounding its overpayments and that it may be several years
before it can identify what the ongoing problems are.
You know, look, I sit in these meetings and we all do.
Just--and you may--we often talk about the Supplemental
Nutrition Assistance Program. It has about a 95 percent
accuracy rate. It improves every year. The program is required
to have continuous improvement in accuracy or it penalizes
states that fail to meet the grade. And that--SNAP is the
former Food Stamp Program, as you know. We keep focusing on
improper payments that go to programs that assist low income
populations. But FNS has strong measures in place and they are
consistently improving that accuracy rate. We need to focus on
programs that aren't showing this kind of an improvement.
Explain to me, if you can, why we see the rate of
overpayments rising dramatically in the federal crop insurance
program?
Mr. Murphy. Well, I--Madam Chairman, any waste or abuse in
a government program is a problem.
Ms. DeLauro. Any.
Mr. Murphy. I agree a hundred percent. This is taxpayers'
money. We have to be good stewards of that money. I think when
you look at the work we have done improper payments at, is that
our percentages aren't that high compared to other agencies. We
need improvement. I agree----
Ms. DeLauro. They appear to be growing, though. That's
what--that was troubling when I read that.
Mr. Murphy. Well, I think what OIG was doing there is
looking at an area that had a known problem, and they went
down--we do a lot of that ourselves, judgmental selection of
policies to review when we are aware of an issue. And we do
find it. We do deal with the companies when that happens.
Financial penalties, a number of other penalties. We have
threatened pulling companies out of the program unless they
made improvements to their quality control programs. So we
continue to do--but I agree, we have to do better.
Ms. DeLauro. Okay, thank you.
Mr. Kingston.
BIOMASS CROP ASSISTANCE PROGRAM
Mr. Kingston. Thank you, Madam Chair. Mr. Under Secretary,
I wanted to ask you about the BCAP program. And I got to say,
I'm really distressed on it. I think Mr. Murphy just said, you
know, we need to cut out waste wherever we can. And much of the
waste in government certainly is not intended to be there, but
sometimes we do something on paper. It looks good, and in
practicality it really isn't.
And you may remember the tax change for black liquor. I
come from paper mill country, but it was a $6 billion,
basically a mistake, given to paper mill companies for the
black liquor, classifying it as an alternative fuel that
they've been using all along.
The BCAP program is not that much different from that. You
know, for years people in the wood business have always
collected and gathered and transported materials to paper mills
for reprocessing or transporting one way or the other. Now
we're paying them $45 a ton to do it. This program started out
with a projected cost of $70 million over five years and of
course it's exceeded that. You're asking for $479 million now.
And I think our better bet is to just say, ``We just don't
need this program.'' We're paying people to do what they did
all along. There's nothing remarkable about free money. You
know, people are, you know, very excited about this program.
And what I'm concerned about is if we don't kill it now, it
will have its own lobbying group. It has a constituency
growing, and you know how difficult it is to get out of things
like this. But it could give you, you know, money for other
things, so talk to me about it.
Ms. DeLauro. Would the gentleman yield for a second?
Mr. Kingston. Yes.
Ms. DeLauro. Because I had a question in this area as well.
This is a program--there's an escalation in program cost of 30
times more expensive than the original CBO scoring for this
program. I just throw that on the table. That is really
astounding.
Mr. Kingston. And on paper it looks good, but, you know, if
you come from paper mill areas, you know this is what they've
always done. But now--and I kind of say now we're basically
paying the mileage for kids to get the beer on spring break. It
just wasn't necessary.
Mr. Miller. Mr. Kingston, let me make a couple of comments
and then I'd also like Jonathan Coppess to comment on this.
This is a program that is administered by the Farm Service
Agency that was a new program in the 2008 Farm Bill. Last
summer we issued a Notice of Funds Availability for the first
half of the BCAP program. It really is divided into two
sections. One that I believe you're referring to is the
Collection, Harvest, Storage and Transportation program.
Mr. Kingston. Correct.
Mr. Miller. And then the second part is an incentive
program that has yet to be implemented, to encourage and to
help resolve kind of the chicken and egg problem we have in
terms of renewable energy production utilizing advanced
biofuels. The NOFA was issued. There are a number of facilities
that signed up to participate in this program, and that has
become the basis for the budget estimates that you're alluding
to.
Just recently in early February, we did issue the proposed
rule for full program implementation. At the time that that
rule was published the ability to participate or to sign up to
participate under the rules of the NOFA were eliminated. Now we
do have some outstanding contracts. We're letting those run.
Under the proposed rule, significant changes have been made in
this program, recognizing, I think, a couple of points that you
have made.
One, we have responded to the concern by many in the
industry that products that had significant value added
capacity within the industry were--that the government was now
subsidizing their use for energy rather than to make particle
board or some other value added product. We have addressed that
in the proposed rule.
Mr. Kingston. And I want to point out, though, a lot of the
wood pellets used for energy are not used in America. The
market is generally European, and so we're actually subsidizing
European fuel.
ADDITIONAL RENEWABLE ENERGY PRODUCTION
Mr. Miller. Let me point out the other major change before
I ask Jonathan to comment further, is the issue of well, are we
effectively subsidizing mills for what they were going to be
doing anyway. We have now put a provision in the proposed rule
for which we're seeking comment that basically requires that
any payments be subject to additionality. In other words, we're
trying to find ways to accomplish a number of things. First and
foremost, we want to get products out of the forest that are
causing disease and potential forest fire problems. That was
kind of the initial background of the----
Mr. Kingston. But now Mr. Secretary, and I'm not arguing
with you, because this is a Congressional program that we
started. But foresters do that. They're not dummies. They don't
need the government to come in there and say, ``Cull your
forest.''
Mr. Miller. What we were trying to do is get the slag and
slash out of the forest that they do leave behind. We recognize
that they take a lot of that out. They're already utilizing it
in many cases just to produce energy. We're tightening that up
significantly. We still want to encourage the forest industry
to participate in this program, but we want to ensure that what
we're getting is additional renewable energy production and not
paying for what they were doing otherwise.
Jonathan, do you want to----
Mr. Coppess. Yeah. I think to Jim's point, to the Under
Secretary's point, it's important that this was a temporary
aspect and we learned quite a bit as we've gone through this
NOFA. Our proposed rule attacks--it goes right at some of these
issues, the additional energy production, whether or not these
products can go on to higher value. You mentioned black liquor.
I do want to be clear that we're not paying for black liquor,
and we made certain that that's not part of that.
Mr. Kingston. No. It's not part of BCAP. I was just saying
that's a similar program.
Mr. Coppess. Yes.
Mr. Kingston. But that was a $6 billion fiasco.
BCAP POTENTIAL
Mr. Coppess. Right. And we certainly have no interest in
seeing that with this program. This program has incredible
potential. What we're seeing--when you talk about pulling out
diseased trees or slash, there's not much of a market. And with
the economic downturn, you're watching timber industry take a
big hit. There is no place to go with a lot of this. This has
actually spurred some efforts. I mean, we've seen it going into
schools that have switched from fuel oil to wood chips and wood
pellets, so it's beginning to move some of that. There are some
really good stories that come out of this. But it is a new
program and we have to learn what the statute says and how some
of these pieces work with each other, the renewable biomass
definition with what was eligible material, and that's what we
saw in this NOFA. So we were able to adjust that as we write
this proposed rule, and bring that in----
Mr. Kingston. But in your world, which is our world of
tightening budgets, you're still paying people to do what they
were doing. And it might be accelerated now because they're
getting paid for it, but, you know, it was happening out there.
And I'm real curious about schools that are now switching to
wood chips. You're telling me there are a lot of schools that
have gone to wood chip heating?
Mr. Coppess. I'm just giving another example on the good
side of this. I don't have a lot of them that are doing it. I'm
saying these are some of the things we've seen happen.
Mr. Kingston. Well, I mean--but, you know, here's where we
kind of get off. We have this, ``Oh, yeah, a lot of people are
going to wood chips.'' You know, they either are or they're
not. I mean, you know, this is your dollar and my dollar too at
work. The projected 10-year cost of this is $2.6 billion. And
I'm just saying, ``Hey, gosh, if we can't cut this one, what
are we going to be able to cut?''
And I don't know why you all are defending it, because it
was put on you by Congress. It's not like was the
Administration's baby that they said, ``Oh, this is a great
program.'' I mean, I think we can say, ``Look, there were a lot
of things in the Energy Bill that we did that we supported.''
In fact, I was one of the Republicans that supported one of the
Democrat Energy bills, and I'm very interested in a lot of
these things. And Mr. Latham and I have had discussions about
ethanol, which he doesn't approve of, you know, in terms of my
position. But I'm just saying good gosh, this is one that we
need to not just take back to the drawing board, but we need to
kill it.
Mr. Coppess. Well, again, I think we've put some very
significant restrictions in the proposed rule. As we finalize
that, I think that will be an important part of it. I guess I
would be cautious about wanting to kill a program that we
haven't even gotten implemented fully and up and running to see
what it does. We're talking about one part of it.
Mr. Kingston. Yes, but remember--and I don't want to say--
and I'm arguing with you in a good way, but here, as soon as
you get this developed, you know what happens in this town,
association group, lobbying group, and it's--they're never
going to let it go away, never. So it's not like, well, let's
give it three or four years and see what happens. The folks out
on K Street don't care. They know what's happening. They're
getting free money out of something that they were doing
already, and these are my peeps.
Mr. Miller. Well, in----
Mr. Kingston. They're not in Connecticut.
Mr. Miller. I understand that, Mr. Kingston. But also I
don't think it's our view certainly within my mission area, and
I don't believe it's the view at USDA, that we were in the
position to selectively determine which aspects of the 2008
Farm Bill or other legislation that we want to implement
because we like it. Congress did mandate this in the 2008 Farm
Bill. We did issue a NOFA. We learned a lot from it. We have
proposed very substantive changes in this BCAP program.
I hope you will provide your comments during the comment
period, which is still open. Those will be certainly taken
under significant consideration. But it's our goal to try to
meet the intent of Congress and learn as much as we can, while
fulfilling I think the real goal of Congress, and that is to
move us to the next step in terms of renewable energy
production, and that's what we're attempting to do, sir.
Ms. DeLauro. Mr. Latham.
Mr. Latham. I guess I was somewhat taken aback when you
said you can't pick and choose what part of the Farm Bill--you
know, in our previous conversation about how you wanted to
change the Farm Bill that's in place, and--but now you can't do
that. I was just----
Mr. Miller. And we are implementing the Farm Bill, we
believe as it was written. But if there is legislative action,
sir, we will certainly do our best to implement that, and we
have proposed some changes.
PORK LOAN FIELD GUIDANCE
Mr. Latham. Mr. Coppess, I hate to leave you alone over
there. A few questions on the pork industry concerns on this
loan guidance that you've initiated, regarding your proposal to
expand poultry loan guidance to include pork operations. It
seems that USDA is about to regulate the pork industry the same
way that you do with the poultry industry. Everything about
pork is dramatically different. I'm sure you're probably aware
of that, the types of contracts, the length of contracts,
lending requirements. And I would tell you my pork producers
out in the country, and if--I don't know how much time you've
spent in Iowa, but we have about six, you know, hogs for every
human in Iowa, and so it's a huge industry, obviously.
In the past, you know, several years, pork producers of all
kinds have voluntarily and sometimes involuntarily left the
industry because of the prices and very bad economic climate as
far as a pork producer and livestock producers in general. And
it's impacted both producers and the growers alike. A lot of
the--some of the smaller operations have in good faith built
buildings and started producing for some companies that then
went bankrupt and they're sitting there with buildings half
paid off, and this is going to be a problem as far as them
securing any kind of credit going forward if these fluctuations
is out there. They really believe that it will make it more
difficult for lenders to work with the farmers until they can
get a contract started and start generating some income in
these buildings that are empty now. Tell me, doesn't this make
it more difficult for the pork producers? There is a lot of
pushback, if you may not be aware, with the pork producers on
this.
Mr. Coppess. I am very aware of it, and thank you, sir. We
actually met with a group of pork producers yesterday to
discuss this further.
I want to be clear, and when we talk with them, explain
this as well: This is not a new regulation or anything on the
pork industry. What we're trying to do is with the lending
programs that FSA provides--and it's a limited pool of money
that we have to be able to help those producers that have
generally been turned down by other credit institutions to have
a chance. It's the first opportunity oftentimes to get into
farming, get started, get up and running.
So we certainly are very aware of the credit situation and
the concerns that are out there. What we're putting out is
really guidance to our lending officers about how we evaluate
these in light of the credit situation, and how we can serve
with our funding pool.
So what we're saying is that, in sort of a business
justification for making these loans, to make certain that when
we loan to a pork operation or new pork farmer, that there's a
contract in place that we then have the justification, we have
the certainty that those loans can be repayed, and that that
farmer is set up to be successful, and not have a problem.
So it's really just evaluating the length of time of the
contracts, that they can be terminated only for cause, and that
they are guaranteed sufficient opportunity when they put a barn
up, that the pigs will be there, that they make money and pay
back the loans.
So this is really internal guidance on how we do our
lending decisions.
PORK AND POULTRY DIFFERENCES
Mr. Latham. The concern is the recognition that maybe a
chicken is different than pigs, you know, and that the industry
is entirely different. And if you're going to use the poultry
model, it probably will not work in the pork side?
Mr. Coppess. Yeah. I understand that very well. And if we
mischaracterized it a little bit--we did this kind of guidance
earlier last year for the poultry industry. So while the
guidance is the same, we're not trying to put the two in the
same--we understand there are a lot of differences, and it's
really----
Mr. Latham [continuing]. You release it does.
Mr. Coppess. Understand.
Mr. Latham. Yeah.
Mr. Coppess. And the goal or the point here is just helping
to further guide the field as they make these decisions in a
very tough credit environment, to make certain that the loans
we're putting out, the loans we're making we can get them paid
back, and that those growers have a chance to be successful.
And so it's really a part of that.
We also announced in that advance notice of proposed rule-
making to get comments in now to help us begin to re-evaluate
how we look at these across the board. Are there other things
that we need to be thinking about in terms of how the situation
in farm counties change over the years?
Mr. Latham. I would just be sensitive to the differences--
--
Mr. Coppess. Absolutely----
Mr. Latham. Make sure that the pork producers are involved
in the whole process. And if you're doing something like this,
to reflect their needs, not just to try and fit them in with
somebody else.
Mr. Coppess. Absolutely.
Mr. Latham. Thank you.
Madam Chairwoman.
DISCRIMINATION BY USDA
Ms. DeLauro. Thank you.
Secretary Miller, it's been alluded to--I mentioned this in
my opening comments--and I think you would agree, I know the
Secretary has when he's been here about a kind of a long and a
sorry history in USDA of discrimination against African
American farmers, women, Hispanic, Native American farmers.
And there are efforts on a number of the fronts to provide
some long-overdue remedies to these individuals, and efforts
that I personally strongly support.
One area where discrimination has been pervasive is in the
farm loan programs at USDA. I bring up this issue, because I'm
looking at some of these settlement costs, which are
significant. And I think we have to, you know, it's a judgment
and it's a legal settlement.
So we're then faced with how do we find the resources for
these very, very legitimate difficulties? Let me just ask you
what actions are being taken.
As I say, this particularly has happened. It's been
pervasive at the farm loan level. What actions are being taken
to ensure that such discrimination doesn't happen again? What
mechanisms that are being put in place for this?
Mr. Miller. Chairwoman DeLauro, you raise a very important
issue, one that the----
Ms. DeLauro. And I know it's a sensitive issue, and I
know----
Mr. Miller. One that the Secretary has spoken to a number
of times.
Ms. DeLauro. Mm-hmm. Right.
Mr. Miller. And during my confirmation hearing on the
Senate, it was an issue that I addressed as well.
Ms. DeLauro. Mm-hmm.
Mr. Miller. I would have to say that when I went down to
USDA personally, I didn't realize how big a problem and the
scale of the backlog that we had.
Ms. DeLauro. Mm-hmm.
Mr. Miller. But the Secretary has certainly recognized the
problem, both in terms of the class action or proposed class
action issues, as well as individual cases.
Ms. DeLauro. Right.
REMEDIATION OF DISCRIMINATION
Mr. Miller. We're working very hard to resolve those, as
you know.
Moving forward, we are taking a number of actions, both
within our national office, but more importantly out in our----
--
Ms. DeLauro. In the field----
Mr. Miller [continuing]. Local offices, both through the
Assistant Secretary for Civil Rights' office, as well as FSA,
to first of all go out and see if we can better determine what
is the root cause of these problems. And the Assistant
Secretary for Civil Rights is heading up that operation that's
going on right now.
We're providing training to our FSA personnel throughout
the country. We are trying to instill upon them that one of the
true benefits we have in this country, one of the real assets
of being in the United States, is the diversity and how
important that is.
I think we're seeing great progress. Many of these cases
are old cases, and we just need to get them resolved and move
forward.
I think we have seen the page turn at USDA, and I believe
also at FSA; but it's something that we're going to monitor on
a day-to-day basis, I think, for the foreseeable future.
Ms. DeLauro. If you can provide us with--I don't know if
anything like this exists--but where the complaints have come
from. In other words, across the country I know that this
involves, you know, maybe most of the states, et cetera.
But I think it would be interesting to see visually where
these problems are coming from, if you can do that, and provide
us with that kind of information of where particularly things
have been a problem.
Mr. Miller. I'll be happy to work with the Assistant
Secretary for Civil Rights in getting you the information.
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Ms. DeLauro. Sure, thank you.
Mr. Kingston. Also, I think what would be of interest is
the lessons learned in the litigation. Can we save that step
through a legislative solution, rather than court solution, for
the next round, for the women and the Native Americans?
Ms. DeLauro. Well, yeah. And there is legislation, as I
said in my opening comments. There is legislation that would
address a process, and there is a dollar amount affixed to that
with regard to the women.
Okay. Thank you.
FOOD AND AGRICULTURE ORGANIZATION OVERSIGHT
Let me--and I guess this is, Mr. Brewer, or Mr. Secretary,
let me just, I'm going to try to take this as a whole.
The Chicago Council on Global Affairs, they've been a major
contributor on key global policy issues. And they were kind
enough to prepare a memo for me that raised some possible areas
for work, for our subcommittee, and that we could do with
programs that were under our jurisdiction.
They had several suggestions. And let me just get your
reaction to them.
First, they suggested there should be more oversight of the
Food and Agricultural Organization of the UN. The Council
believes that the effectiveness of FAO has been limited in
recent years and that USDA should engage more actively in
reviewing its capacity, management strategy, and policy-making
and program evaluation.
In your view, should USDA do more oversight of FAO? And can
you tell us what oversight you currently do with FAO, and what
other work you do with them?
Mr. Brewer. Sure. Thank you, Madam Chairwoman.
We believe that the reform process is underway at FAO, and
provides a unique opportunity to transform the organization
into a more relevant, focused, and effective organization to
tackle global food security issues.
We at USDA take it very seriously and have made it a main
priority to see that FAO carries out its reforms and its----
Ms. DeLauro. What kind? Can you lay out for us what kinds
of things have been done to get to that point?
Mr. Brewer. Sure. A couple of things is the agreement that
is already underway to recraft FAO's Committee on Food Security
as a forum for sharing best practices and developing metrics of
agricultural development success. That's one of the main ones
we're working on right now.
The other is also to provide vigorous oversight to make
sure that FAO fulfills the number of functions that overlap
with USDA's strategic objectives. That includes in the
international regulators the Codex, the IPPC, to make sure that
FAO establishes the SPS phyto----
Ms. DeLauro. Phytosanitary----
Mr. Brewer. Phytosanitary, thank you, related standards,
and to support the capacity building in developing countries.
Ms. DeLauro. Who will handle that for you? I mean, who is
going to do that?
Mr. Brewer. Within USDA?
Ms. DeLauro. Within USDA. Who will do the oversight?
Mr. Brewer. Well, we have an office----
[Discussion was held off the record.]
Mr. Brewer. Our mission area, Under Secretary? Is it FFAS?
I believe we'll handle that.
So that would be under us. We have an office for Codex, as
well as within our agency. So let me make sure of that.
Ms. DeLauro. Okay. But if you can't--just if you can----
Mr. Brewer. I can get you the exact----
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Ms. DeLauro. Right.
Mr. Kingston, do you mind if I ask just a couple related
questions in this area? And then I will turn it over to you?
Yeah, that would be helpful, because that came out in
there. And I think that, you know, I think you would concur
with the first view that we need to have a better oversight of
what is happening at FAO, and then what are the measures and
the steps that we're going to try to take to get there?
Mr. Brewer. Absolutely.
Ms. DeLauro. So.
Mr. Brewer. The Secretary, the Deputy Secretary are often
at the FAO conferences. We have a USDA representative, the
Secretary has a representative there, so we're taking that very
seriously and working hard to do that.
LOCAL AND REGIONAL FOOD PURCHASES
Ms. DeLauro. Okay.
The Chicago Council as well talked about McGovern-Dole. And
as a matter of fact if I can just have some quick reaction to
the suggestions that they made with regard to that program.
One, buy some food for the program locally and regionally.
Let me just get a quick reaction from you on that?
Mr. Brewer. Madam Chairwoman, we have started, and last
year we started a local and regional pilot procurement program
that involved three countries in Africa.
Ms. DeLauro. But that's not from McGovern-Dole, that was
for--I mean, you're in Tanzania, Mali, and----
Mr. Brewer. Malawi.
Ms. DeLauro. Malawi. Right. But I think that that's for the
P.L. 480 program. Or maybe, you know, you tell me. I think
that's P.L. 480.
Mr. Brewer. I apologize, ma'am.
Ms. DeLauro. Is that right? Yeah, it's P.L. 480, so now I'm
looking at McGovern-Dole to look at, you know.
Mr. Brewer. Is this coming out of a GAO report, you're
referring to?
Ms. DeLauro. Oh, no, no. You know, the Chicago Council on
Global Food Security did a report, and I thought it had some
good suggestions in some areas. I just want to run them by you,
to see if, you know, if you have a quick reaction, you know, we
can do it for further reaction, if you want.
Mr. Miller. Well, let me react to that.
Ms. DeLauro. Sure. Mm-hmm.
Mr. Miller. First of all, in the 2008 Farm Bill, Congress
did express an interest in looking at local and regional
purchases and establish some authorities to do that.
Ms. DeLauro. Mm-hmm.
Mr. Miller. We're happy to--and the Secretary is very
interested in looking at local markets, as well. We also, I
think, would agree that this is consistent with our long-term
food security goals for these countries.
So I think it's something that we would be happy to
explore.
MCGOVERN-DOLE PROGRAM
Ms. DeLauro. Right. Please. That's all. I know I'm just
looking for ways in which we can better target our funds, or
how we can expand our--you know, I'm a strong supporter of
McGovern-Dole and these efforts. And I think that they succeed.
They further suggested that maybe we'd require some of the
program funds to be used to support maternal and child health
work. This is McGovern-Dole.
Mr. Miller. I'd be open to exploring that as well.
Ms. DeLauro. Okay. Provide funds specifically for technical
assistance on school feeding and maternal child health programs
in developing countries.
Mr. Miller. Under McGovern-Dole, we can look at----
Ms. DeLauro. Okay. Can we get this information to you, and
then have you take a look at that? That would be helpful.
FOOD AID PROGRAMS
Let me just get to the last piece here, which is--I'm
really pleased, Mr. Brewer, where you talked about in your
testimony, the leading role that the U.S. does play in
addressing hunger, malnutrition, global food security. I think
it's one of the most important priorities in the bill. And we
have provided significant increases for these programs in
recent years.
I am concerned that while your budget proposes a $78
million increase for FAS, and it would appear that it is
largely for trade-related work, that it does not request any
increases in P.L. 480, the Food for Peace Program, or McGovern-
Dole.
I am all for creating jobs through fair trade. I want to
protect U.S. workers, public health. But you say in your
testimony that we may see the second-highest-ever level of U.S.
ag exports this year. And that would be without the increases
that you're requesting for 2011.
And yet hunger is not going away, and it is not
diminishing.
I just think we need to think about, and you need to think
about, rebalancing the priorities in the request. And I don't
understand why you don't request--that the request doesn't
include increases for the P.L. 480 program or for the McGovern-
Dole program.
We've got, and I'm apprised by staff, that the--P.L. 480--
Administration has just asked for an increase in the
supplemental of $150 million for P.L. 480. And that's for
Haiti, I understand what it's for. But we're asking for an
emergency designation for Haiti, as we should do, as we should
do, in my view.
But this budget request is zero. I mean, flat. I view that
as zero in terms of where we're going. It's flat-funded.
So I ask you, why doesn't it include increases in these
areas?
Mr. Miller. Madam Chairwoman, I appreciate your comments,
and I know you look at those programs very passionately, and I
equally appreciate your passion for them.
Ms. DeLauro. Mm-hmm.
Mr. Miller. But when we look at what this Administration
has proposed for the two programs, McGovern-Dole and P.L. 480,
that we're discussing, compared to the 2009 level, I believe
the McGovern-Dole program was increased slightly over 100
percent, going into 2010. And we certainly thank Congress for
agreeing with the Administration's proposal and providing that
funding.
For P.L. 480, again, compared to the 2009 levels that were
agreed upon, the P.L. 480 Title II program was increased 38
percent. So I don't think in any way this suggests a lack of
interest or commitment to those programs by the Obama
Administration. Because we have supported significant increases
in both of those programs, compared to where we were in 2009.
Ms. DeLauro. My only point on this--and I want to yield to
my colleague--is that I think when the request was made in
2010, there was the sense that we weren't then going to have to
ask for anything more from supplementals.
Well, here we are, we have a supplemental. And it's not
unlike what happens in terms of that disaster relief side,
where we've got this over here to avoid this over here, and now
that this is inadequate and we're moving here--which is what's
happening.
Mr. Kingston.
Mr. Kingston. Thank you, Madam Chairwoman.
I think these are my last questions. But it is interesting
that I was reading the Gospel of John the other day. I've
always been curious about this line that after the
Resurrection, He saw his disciples fishing, and instructed them
to throw out the net in a certain area, and they caught 153
fish. And you're giving food aid to 154 countries. And my
friend always keeps saying that this is a moral obligation. And
I wonder if it's not a Biblical context there.
But I've always been curious about that line, why they
named this specific number of fish.
TRADE SANCTIONS
Now my question though, is just kind of an interesting
question. Do you think we should continue the sanctions against
Zimbabwe? And the reason why I say that, you know, we have
sanctions against Cuba that we've discussed, and that one is a
little bit tougher politically, because we're really doing it
on behalf of Great Britain, because of the confiscation of a
lot of their farmers.
But any thoughts on that?
And Mr. Brewer, I always keep calling on your resume from
the private sector.
Mr. Brewer. Congressman, thank you. You're kind of pulling
me into the yard of the State Department. Although I worked
there early in my career, I would never presume to speak for
Foggy Bottom.
You know, our activity in Zimbabwe is what we've alluded to
several times earlier in this, is we are looking at,--our food
aid responsibility there is to look at the needs of the native
population. There is a need there for food assistance.
Mr. Kingston. Mm-hmm.
Mr. Brewer. And so believe that it is appropriate for us to
provide that assistance to Zimbabwe.
The larger political implications of sanctions are just
simply something that is--I would feel more comfortable if that
comment----
Mr. Kingston. You know what? The question really I'm just
asking you, because you have some knowledge of it.
Mr. Brewer. Yeah.
Mr. Kingston. But you know what? Maybe if you feel like it,
call me some time.
Mr. Brewer. Why don't we talk about----
Mr. Kingston. Because I'd like to--I've been there twice,
we've met with Mugabe on it. I don't know if it helps or not to
work with someone like that. And you know, I'm just thinking
about our situation in Cuba.
We deal with a lot of very tough countries that have
governments that do all kinds of things. But you know,
sometimes if the money's right, we still deal with them.
Mr. Brewer. I'd really enjoy talking to you off line about
that.
TRADE ISSUES
Mr. Kingston. Well, that would be great.
And then my question also is on China. We've worked real
hard to open up the poultry. Ms. DeLauro and I have worked hard
on making sure that the poultry is sanitary. And now they've
slapped a 64 percent import tariff on American poultry going
there. At the same time Russia has decided there's an issue
with the way we process poultry and chlorine in the water and
things like that.
Are you guys working with your Russian and Chinese
counterparts to try to figure this out?
Mr. Miller. Mr. Kingston, let me respond to that. Last week
I was in China. We were there talking about some market opening
opportunities for U.S. commodities. But quite frankly, every
conversation I've had with the Chinese over the last year has
been one that sooner or later they do raise the chicken and
poultry issue.
And so we are working on that with China. I indicated to
the Chairwoman before the hearing started that we had been
having conversations, we've impressed upon the Chinese their
need to be fully compliant with the U.S. requirements, if they
expect us to open that market.
But I think we also recognize, while no one may wish to say
it, whether it's the Chinese, whether it's the Russians, or
whether it's the United States, there is always a certain
amount of linkage between each of these trade problems that we
face with other problems that are out there.
We, I believe we've announced the agreement on pork access
to China. We are also at the point where I believe we can have
substantive discussions on beef. And I also think that if--and
this is still a big if--but if we can find a way to resolve the
Chinese desire to export poultry to the United States, assuming
they become compliant with U.S. standards--and we have that
equivalency--then I expect that we may see some Chinese
reaction to the poultry situation there.
Three weeks ago I was in Moscow. We've had an ongoing
discussion with our Russian counterparts on the situation of
U.S. poultry exports to Russia. We are negotiating what we
believe can be a successful agreement to re-establish that
market.
But I can also tell you, these are very difficult
negotiations with the Russians. But we are continuing to have
conversations, and I'm hopeful that we will get this issue
resolved very quickly, so that we do re-establish our market
access into the Russian market.
Mr. Kingston. Well, thanks. Thank you.
AGRICULTURAL CREDIT INSURANCE FUND
Ms. DeLauro. Let me ask, Mr. Coppess, this is about ACIF,
the Agricultural Credit Insurance Fund.
Let me just tell you where my concern is. I'll try to be
concise. The 2011 budget proposes to decrease the level of
funding available in the ACIF programs. Budget documents assume
a decline in the demand for the loans and for financial and
economic conditions to improve.
We're already beginning to hear that the level provided in
2010 may not be sufficient to meet the needs of farmers who are
struggling and looking for assistance through this program.
Let me put a couple of questions forward here.
What is the status of the program for fiscal year 2010? And
do you have enough funding to meet the demand now?
Mr. Coppess. Thank you, Chairwoman. We have a report coming
soon to the committee, in fact hopefully within days, on the
status of 2010 funding and our estimates for that year, or for
this fiscal year.
Ms. DeLauro. Right.
Mr. Coppess. So I will refer to that report as soon as we
can get that out and to you guys.
[The information follows:]
The Agricultural Credit Insurance Fund quarterly report is going
through the USDA clearance process. As soon as that process is
completed, the report will be transmitted to the House and Senate
Subcommittees.
Ms. DeLauro. Okay. Sure. But again, just because 2009 we
had problems in getting information about ACIF running out of
funds. And that presented a problem.
So you talked about the quarterly report, and I'm going to
presume that the Department will let us know if we are going to
run out of funds by the end of the year.
And again, I don't know if you're going to answer this
question in there as well, is do you still maintain that the
program level of $4.7 billion will be sufficient to meet the
program needs in Fiscal Year 2011?
Mr. Coppess. That is our estimate.
Ms. DeLauro. That's, and it's part of this?
Mr. Coppess. The fiscal 2011 budget, yes. We estimate that
$4.7 billion to $4.8 billion should meet the need. That would
put us even above 2009 level. I think we spent $4.5 billion in
2009.
Ms. DeLauro. Okay. So you know, we'll get the report and
take a look at it and see where we are.
Mr. Coppess. Yes.
TRADE ADJUSTMENT ASSISTANCE FOR FARMERS PROGRAM
Ms. DeLauro. Let me ask this first. And this is to
Administrator Brewer. This is on Trade Adjustment Assistance
for Farmers.
Mr. Brewer. Yes, ma'am.
Ms. DeLauro. It looks as if over the five-year period, this
program has been authorized at $459 million, but had an outlay
of only $47 million; $9.5 million of that was for
administrative costs. And in the same time period, only 30
commodity petitions were certified as eligible for assistance
and payments benefited a mere about 8,400 producers.
Congress made changes to the program in ARRA. Do you
believe the changes in the March 10th interim rule will result
in more technical and financial assistance to the producers
that need it the most? Will they improve the program? And
finally, do you believe that these changes will enable a
variety of commodities to take advantage of this potentially
useful program? Or will a couple of commodities continue to
receive the vast majority of the funds that are distributed?
Mr. Brewer. Madam Chairwoman----
Ms. DeLauro. If you can't answer the question now, if you
can please get that to us. My experience with trade adjustment
has been to, you know, workers who found themselves in
difficult predicaments because of being displaced by trade or
by overseas developments, et cetera.
And quite frankly, I've found that Trade Adjustment
Assistance Program vis-a-vis workers to be woefully inadequate,
and not meeting their needs. And I don't know if that's the
case with this Trade Adjustment Assistance, but it seems that
it's not something that we've focused on very much at all. And
I would like to see what the program is about, how it's
running, how it's functioning, and who's benefitting, and why
haven't--we've used--as I said, $47 million out of $459 million
over a five-year period.
Mr. Brewer. So we'll get that answer to you.
[The information follows:]
The new Trade Adjustment Assistance (TAA) for Farmers program has
been implemented. USDA conducted extensive outreach to provide
opportunities for producers most in need to access the program. Key
changes were instituted including broadening of the eligibility
criteria and providing more benefits to eligible producers. In
addition, the program now provides more technical assistance with the
objective of keeping producers and fishermen in either farming or
fishing. Benefits provided under the 2002 Farm Bill program focused on
retaining opportunities outside of agriculture.
While the broader eligibility criteria provide more opportunities
for producers and fishermen to qualify for benefits, petitioners still
must demonstrate that increased imports during the most recent
marketing year compared to the previous 3-year average contributed
importantly to their hardship.
USDA received a total of 17 petitions under the 2010 TAA for
Farmers program announcement, which ended on April 14, 2010. Several of
the petitions received were from similar producer groups that benefited
under the 2002 Farm Bill program, including shrimp and other
aquaculture sectors in the Gulf States and Atlantic seaboard. While
this segment of the agricultural industry continues to show
considerable interest, other more traditional commodity groups that
submitted petitions include prunes, asparagus, cut flowers (lillies),
apples, cranberries, lamb meat, wool, and pelts.
The TAA statute requires that applicants complete all phases of
training within 36 months after a petition has been certified. It will
take as long as 5 years from the date that a petition is certified to
determine whether the benefits of the program have achieved their goal
of making U.S. producers more competitive vis-a-vis imports. To track
the results of the program and its effectiveness over time, USDA has
procedures in place through the National Institute of Food and
Agriculture (NIFA) and the University of Minnesota.
EXPORT PROGRAMS
Ms. DeLauro. And again, I know we have talked about this.
My colleague, Mr. Kingston, has talked about it, and it does
include the Market Access Program as well.
But let me just catalogue. We have Foreign Market
Development Program, Market Access Program, Technical
Assistance for Specialty Crops Program, Quality Samples
Program, Emerging Markets Program. These are all programs that
we are engaged in. They appear to all have the purpose of
promoting exports, and the programs appear to be similar. And I
may be wrong about that.
You know, my questions are, why do we need so many
different programs for a similar function? Are some of these
programs essentially doing the same thing? And can you describe
the process you use to coordinate the activities of these
programs? And what steps do you take to avoid a duplication
with this effort?
And how do we coordinate some of these efforts? Well, I'll
get to that in a second.
This is a Market Access Program. And I'm sorry Mr. Kingston
isn't here. But there is a cut in that program. But $166
million I think over five years.
The reasons cited in the budget for the cut were that MAP
is duplicative of other FAS programs, and ``MAP's economic
impact is unclear, and it does not serve a clear need.'' That's
end quote.
There again, I would like to know why you believe it is
duplicative and why the economic impact is unclear, and why it
does not serve a clear need, and why we continue to support
this proposal?
Mr. Miller, let me ask you that question.
Mr. Miller. First of all, with any of these programs, as
you're aware, there are a number of various metrics that can be
used to measure the success of the program.
Ms. DeLauro. Mm-hmm.
Mr. Miller. And not only does USDA engage in a process to
try to measure the impact of these programs, but a variety of
our cooperators, those who participate in the programs, do the
same thing. And Congressman Kingston provided some information
on that.
So there is a lot of information out there.
Ms. DeLauro. Mm-hmm.
Mr. Miller. We do believe that in some instances and for
some of the commodities that participate in both the Foreign
Market Development Program, as well as the MAP program, that
there may, in fact, have been some duplicative efforts that
we're trying to avoid.
Ms. DeLauro. Mm-hmm.
Mr. Miller. We also believe that the Foreign Market
Development Cooperator Program provides a greater opportunity
in the future, particularly as we seek new cooperators as well
as small and medium sized businesses that may want to get into
the export business, as a way to help expand our exports,
create new jobs, and gain more economic activity out in the
country.
In terms of the variety of export programs that you
identified----
Ms. DeLauro. It's about $5.9 billion for trade promotion--
--
Mr. Miller. Several of those are very specific in order to
address concerns that have been raised by specific sectors
within the agriculture community, and Congress has seen fit to
delineate the program. Such as TASC.
We believe that program is completely separate from what
might occur under for-market development, or MAP.
Ms. DeLauro. Right. But I'm just saying to you--and I've
asked the question in a way--look, we're going to do trade
promotion----
Mr. Miller. Yes, we are----
Ms. DeLauro. That is for sure. I understand that. But you
have suggested in this program a cut for the various reasons
that you have laid out.
We have a series of these programs. I would very, very much
like the analysis of the programs. And are they duplicative?
COORDINATION OF EXPORT PROGRAMS
You'll get a whole variety of programs that come from this
side of the table, that, you know, tell you that we need to do
this and we need to do that. All of that is fairly subjective,
in many instances, as to, you know, what our particular
interests are.
You have a responsibility and a mission to see how these
programs play out. And that's why I asked: How are these
programs coordinated? Are the activities of the programs
coordinated? What steps are taken to avoid duplication?
I think they're reasonable questions. You know?
Mr. Miller. No, I would agree. And we're happy to provide
you additional information on both the process as well as the
analysis we've done on these.
Let me point out generally, several of the programs that
you pointed out, such as TASC and the Quality Samples Program
and the Emerging Markets----
Ms. DeLauro. Emerging Markets, right----
Mr. Miller [continuing]. Do have some very unique
characteristics to them in terms of the way they're
administered, in terms of what would be viewed, I believe, as
the two large cooperator programs----
Ms. DeLauro. Probably the Foreign Market Development----
NATIONAL EXPORT INITIATIVE
Mr. Miller. The Foreign Market Development Program, and the
MAP Program. That is a case where we have made a determination,
and it's reflected in the President's budget proposal that
there may, in fact, be some duplication there, that the
benefits--while we believe that to a number of commodities the
benefits under MAP, for instance, are still significant--it may
be a program that could be reduced to ensure that we can use
limited dollars more effectively in other areas.
And we do believe that the Foreign Market Development
Program can be used to serve not only our traditional
cooperators, but can also be used to stimulate additional
export activity among small- and medium-sized enterprises. New
exporters.
And if we're going to meet our National Export Initiative
objectives, we need to encourage new exporters, or those that
may be exporting to one country and to small markets to expand.
Ms. DeLauro. But this is where, you know, I think there's a
request for what, somewhere around $34.5 million. And that's on
top of the mandatory.
Mr. Miller. Correct.
Ms. DeLauro. You know, and I've got the sheet here of who
are the beneficiaries of those programs. And I think basically,
what I would like to know is: Who and what organizations, who's
getting these dollars?
And you know, repeatedly, who is--the unique
characteristics of some of these other programs and how that
translates? You know.
And we go back to where Mr. Kingston and I share this view,
is what has been the result of this? What are the results?
We're looking for a new result of doubling; but are we on a
solid ground with what we have done, that says that adding
$34.5 million on top of the mandatory money, and that that's
going to get us where we want to go--when you all may very well
have the data and the information, this committee doesn't have
the data and the information that says ``proven track record,
this is how we have expanded our exports. These are the areas
in which it's been done.'' And now we come to you and say, ``If
you give us $34\1/2\ million more to the Foreign Market
Development Program we are going to get you to our agriculture
responsibility for doubling those exports.''
At the moment, we have zero information as to how we can go
from A to B.
So that would be helpful.
Mr. Miller. We'll be glad to--organizations have been
recipients of Foreign Market Development, and MAP money in the
past. We're also happy to provide you our view of how the
additional funds could be used to achieve the objective of the
National Export Initiative----
Ms. DeLauro. I want to know on what are the bases for--what
is the success rate? Where is the--you know, I deal in a world,
and when I can't get something quantified, I get very nervous.
I apply that to myself. When I go to my staff and I think
about my election campaign and what they are doing, and I say,
``How many people have you talked to?, and they say to me,
``Don't worry, we're talking to them.'' I'm worried about who
I'm reaching and how they view what I am doing vis-a-vis, you
know, their comfort level with me. I want to see how we have
used the money that we have provided, and what is that doing?
What is its success rate? And I would like to see that. I think
this entire committee would like to see that.
Mr. Miller. Well, we'll be happy to provide that to you
along with the performance metrics that we've used historically
to judge the programs.
Ms. DeLauro. Right, that's great.
Mr. Miller. And the new performance metrics that we're
developing.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeLauro. Terrific. That would be great.
I think--is not the only one here, my good colleague, Mr.
Kingston, trusts me not to go crazy.
But so the hearing is concluded, and I thank you very,
very, very much for your candor and for the good work that you
do, and we look forward to working with you.
Thanks much.
Mr. Miller. Thank you, Madam Chairwoman.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Wednesday, March 10, 2010.
FOOD AND DRUG ADMINISTRATION
WITNESSES
MARGARET A. HAMBURG, COMMISSIONER OF FOOD AND DRUG ADMINISTRATION
PATRICK McGAREY, DIRECTOR, OFFICE OF BUDGET, FOOD AND DRUG
ADMINISTRATION
NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET, HEALTH AND HUMAN
SERVICES
Ms. DeLauro Opening Remarks
Ms. DeLauro. The hearing is called to order. Let me welcome
Dr. Margaret Hamburg, who is the Commissioner of the Food and
Drug Administration in her first appearance before the
subcommittee. She is joined by Patrick McGarey, Director of the
FDA's Office of Budget and Norris Cochran, Deputy Assistant
Secretary for Budget at HHS. As I've said many times over the
years, and I'm sure you agree that funding the FDA sufficiently
is one of the most important responsibilities under this
subcommittee's purview. The American people expect the FDA to
ensure the safety of the food they eat, the drugs they take and
the medical devices that they rely on. They expect us to
provide the resources that the agency needs to fulfill this
fundamental mission on behalf of our nation's families.
With that in mind, I am proud that since taking the chair
of this subcommittee, we have continued to address our
responsibilities in this arena, and starting in 2007, this
committee and Congress have worked in a bipartisan fashion to
increase the FDA's total budget by more than $878 million. And
last year, our final conference report funded the FDA at $2.3
billion, $306 million above 2009.
We do this because food and medical product safety is
crucially important to our national welfare. It is in short a
national security issue. I'm very proud that the agency has
been able to hire thousands of new employees, scientists,
inspectors and analysts doing critical work as a direct result
of those increased resources. And I'm glad to see the newly
proposed initiatives like the FDA Transparency Task Force that
will help to improve in my view the functioning and the
credibility of the agency, and I think that under Commissioner
Hamburg's direction, the FDA will invest resources smartly,
improve its efficiency and streamline its organization and that
the agency's original emphasis on protecting the public health
will be restored.
Looking ahead to 2011, I am encouraged by the
administration's $2.5 billion request for discretionary
resources provided by this committee, an increase of 6 percent
over last year. I am also glad to see that many of the agency's
most important consumer safety initiatives are seeing positive
funding increases in this budget. The Center for Food Safety
and Applied Nutrition is slated to receive an additional 9.2
percent. The Center for Drug Evaluation and Research and the
Center for Biologics Evaluation and Research both see their
funding up by 4.2 percent. Other centers are slated for smaller
increases.
We will look at the requests for all the centers to make
sure the budgets proposed are well founded and sufficient to
enable it to do their critical work. Taken as a whole, this
budget represents a strong commitment to building on the
historic levels of investment this committee has made over the
last four years. Coupled with $1.5 billion in estimated user
fees, this would give the FDA over $4 billion to meet its
responsibilities to the American people. And they will need
every penny.
In just the past month, we have seen new revelations
suggesting that the diabetes drug Avanti is unsafe and should
not have been approved. We have new research from the Yale
Medical School that even brief exposure to Bisphenol A, a
common ingredient found in plastics and aluminum cans, causes
increased risks of breast cancer and uterine cancer for those
exposed to it before birth. We learned that the radiation
treatments that cancer and other patients rely on for help are
in some disturbing cases causing harm. We have witnessed a
salmonella Montevideo outbreak in crushed pepper that has
already sickened 245 people. And just yesterday we found out
that a processed foods company in Las Vegas, Basic Food
Flavors, knew their plant was contaminated with salmonella and
decided to proceed with business as usual.
These recent situations demonstrate again the sheer variety
of responsibilities that the FDA must continually live up to,
and the need for resources to ensure the safety of these
products.
I also have some concerns about the contingency of budget
increases for food inspections on the authorizations of user
fees. As you know, these fees are authorized in the House Food
Safety bill, but not at the same level in the Senate version.
So it's an open question how the agency intends to meet these
fundamental inspection obligations if user fees at the level in
the budget are not authorized in the final legislation.
So as we move forward with the budget process this year and
continue the process of revamping, of innovating at the FDA in
order to have it meet its mission in the 21st Century, I hope,
Dr. Hamburg, that you will continue to keep in mind the four
guiding principles that we have laid down last year. First, we
must continue to increase funding to support the FDA's mission.
Second, we must improve the management of the agency and hold
it accountable. Third, we must push back against potential
industry influence over the agency. And finally and perhaps
most importantly, we must let the scientists do their work,
guided by science and not political interference.
I should say that the Commissioner's budgeted initiatives
to improve the regulatory science capabilities of the FDA are a
good step in this final direction. These are the four
guideposts that I have used and I will continue to use in
judging our progress and in evaluating this 2011 budget
request.
Dr. Hamburg, I look forward to hearing how you believe the
FDA plans to move toward these broad guidelines in the year to
come. I look forward to hearing about new initiatives such as
the recently established Center for Tobacco Products will fit
into this vision. And thank you very, very much once again for
joining us. I would like to recognize my colleague, Mr.
Kingston, but he is not here at the moment. Mr. Latham--he's on
his way?
Mr. Latham. I just want to welcome the Commissioner and
thank you for coming by yesterday. I appreciate that very much.
I yield back.
Ms. DeLauro. Okay. I think what I would like to do if Mr.
Kingston is on his way, then I would, if you wouldn't mind, I
would like to wait for him to make an opening statement and
then we can proceed to your testimony, Commissioner. And with
regard to the testimony, the entire testimony will be made part
of the record. Feel free to, you know, summarize or paraphrase
it, what you would like to do.
Dr. Hamburg. Thank you.
[Recess.]
Ms. DeLauro. I made my opening remarks, Mr. Kingston. The
floor is yours.
Mr. Kingston Opening Remarks
Mr. Kingston. Well, I had an opportunity to meet Dr.
Hamburg and talk to her in the past. I think she's got a great
record of not just public service but service to individuals
with medical needs and have a great respect for what you've
done.
I have expressed to you my concern with FDA as that in the
last several years you've gotten a large amount of money and
I'm very concerned any time the government grows so rapidly as
it has, and expressed those concerns, and that will probably be
one of the things that I keep talking to you about.
The other thing is, I do support user fees and believe that
you can objectively do research on medical devices and drugs
and not be tainted by user fees. I think that your firewall of
integrity alone is going to be high enough, but I also think
that there will be structural firewalls to make sure that your
scientists in the back room are not influenced by people who
are trying to get rapid approval. However, I think that those
who are benefitting from these products should pay more of a
fee to get them approved as a way of just easing some of the
burden on taxpayers and the general treasury.
So with that, Madam Chair, I'll yield the floor.
Ms. DeLauro. Commissioner Hamburg, we can proceed with your
testimony and then we'll proceed to questions.
Dr. Hamburg Opening Statement
Dr. Hamburg. Okay. Thank you very much, Chairwoman DeLauro,
Representative Kingston and members of the subcommittee. I am
very pleased to be here to present the President's Fiscal Year
2011 budget for the FDA. And with me is Patrick McGarey, as you
noted, from FDA's Budget Office, and Norris Cochran, the Deputy
Assistant Secretary for Budget at HHS.
My testimony outlines FDA's 2011 budget request. It also
includes a summary of recent developments related to our new
responsibilities to regulate tobacco products and some other
important FDA initiatives. As you noted, this is my first time
before this subcommittee and I look forward to working with all
of you. I deeply appreciate the support that you've given to
FDA, and I know that you share my determination to make sure
that our nation can count on a strong, fully functional FDA.
FDA is an essential and unique agency, a science-based
regulatory agency with a public health mission to promote and
protect the health of the public. We're responsible for
programs and activities that affect every American every day in
very, very fundamental ways. The 2010 appropriation reflects
your commitment to FDA and the health of the American people.
Those funds will allow FDA to make real progress across a wide
range of public health initiatives and priorities which are
essential to health, quality of life, safety and security for
all of us. So thank you again.
The proposed Fiscal Year 2011 budget includes $4 billion
for FDA programs, which represents an increase of $755 million,
with $601 million in user fees and $154 million in budget
authority. We're proposing three major initiatives in areas
vital to our mission: transforming food security and safety,
protecting patients, and advancing regulatory science. These
initiatives are crucial for the modernization of our agency in
response to the challenges of the 21st Century.
The Transforming Food Safety initiative reflects President
Obama's vision of a new food safety system to protect the
American people and is based on the principles of the
President's Food Safety Working Group: Prioritizing prevention,
strengthening surveillance and enforcement, and improving
response and recovery. FDA proposes an increase of $326 million
for Transforming Food Safety, with $88 million in budget
authority and $238 million for new user fees, including $200
million for food registration and inspection.
The Fiscal Year 2011 resources would allow FDA to establish
a foundation for an integrated national food safety system
focused on prevention. Key elements include setting standards
for safety, expanding laboratory capacity, piloting track and
trace technology, strengthening import safety, improving data
collection and risk analysis for foods, and increasing
inspections.
This initiative will allow FDA to make the kinds of changes
needed to deliver the promise of improved food safety and
reduce illnesses caused by contamination of the food supply in
the years to come.
The Protecting Patients initiative reflects FDA's pressing
need to modernize our approach to the safety of medical
products. This is a time when science and technology offers new
promises for disease prevention, diagnosis and treatment, as
well as new protections for safety. This is also a time when an
increasing number of drugs, devices and biologics are being
manufactured abroad. FDA must act as a strong and smart
regulator, addressing medical product safety challenges in the
years ahead.
The budget proposes an increase of $101 million for this
initiative, including $49 million in budget authority. The
balance is for two new user fees, generic drug fees and fees
for reinspecting medical product facilities. The Protecting
Patients initiative focuses on four vital areas: Import safety,
high-risk products, partnerships for patient safety, and
generic drug review. These activities will have a significant
impact on public health across the nation. This science-based
strategy will build new and greater safety capabilities. They
will result in fewer import safety emergencies and fewer
serious adverse events associated with drugs, devices and
biologics.
As the Chairwoman noted, FDA is proposing a new focus on
Advancing Regulatory Science with an increase of $25 million
for this much needed initiative. Regulatory science represents
the knowledge and tools we need to assess and evaluate a
product's safety, efficacy, potency, quality and performance.
It is fundamental to all of our work at FDA, from supporting
the development of new food and medical technologies to
bringing new treatments to patients. In many ways, it
represents the gateway between discovery, innovation and
opportunity and actual products that people need and can count
on. Building a strong, robust regulatory science capacity is
vital to the health of our nation, the health of people, the
health of our health care system, the health of our economic
and our global competitiveness.
During the past two decades, research has dramatically
expanded our understanding of biology and disease, yet the
development of new therapies has been in decline, and the cost
of bringing them to market has soared. New approaches and
partnerships in the emerging field of regulatory science are
urgently needed to bridge the gap between drug discovery and
patient care.
Investing in regulatory science will yield better tools,
standards and pathways to evaluate products that offer
promising opportunities to diagnose, treat, prevent and
hopefully cure disease. It will also improve product safety,
quality and manufacturing more broadly, including new
opportunities to better protect the food supply and support the
development of healthy foods and healthy food choices.
I'd like to update you quickly also on our progress
implementing the Family Smoking Prevention and Tobacco Control
Act law, which gave FDA important new authority to regulate the
manufacture, marketing and distribution of tobacco products.
I'm pleased to report that so far we have met or exceeded the
statutory deadlines in the Tobacco Control Act. During Fiscal
Year 2011, we will continue to implement the Act, including
overseeing and enforcing the reissuance of the 1996 rule to
prevent smoking and smokeless tobacco use among young people
and proposing graphic health warning labels for cigarette
packages and advertising.
Finally, I'd like to take this opportunity to mention
briefly some of our accomplishments in response to the recent
H1N1 influenza pandemic. During the past year, FDA was able to
license five different H1N1 vaccines in record time, and now
more than 80 million Americans have been safely immunized. FDA
also authorized the emergency use of antiviral drugs in
circumstances for which they hadn't been licensed but where
they might save lives. These decisions were based on careful
review of the scientific data available for these products. We
also conducted an aggressive proactive strategy to combat
fraudulent H1N1 products.
So to conclude, FDA's Fiscal Year 2011 budget contains
important funding for vital public health priorities, including
Transforming Food Safety, Protecting Patients, and Advancing
Regulatory Science, as well as to implement the Tobacco Reform
Act and other key activities. Achieving these priorities and
critical needs is possible because of your support for the Food
and Drug Administration, and I thank you.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
ENFORCEMENT ACTIVITIES
Ms. DeLauro. Thank you very much, Commissioner. Let me make
one comment and then move to a question. This is on the
enforcement activities within the agency. And very quickly,
during the last Administration, it often seemed that a warning
letter or a confiscation of tainted goods or decisive action to
protect the public was a last resort. I want to tell you that I
am personally just reassured about the contrast, very honestly,
and a different approach. On February 3rd, 2010, seizure of a
product from a company following inspections in November-
December 2009, of January 2010, again a seizure December 2009,
FDA issues the first ever debarment of a food importer,
stopping the individual from importing food into the United
States for 20 years. August 1st, 2009, FDA seizes contaminated
product after a company refused to destroy them following a
June 2009 inspection.
So there seems to me to be a priority on enforcement, which
is I say, very reassuring. I will get back to that because I
want to ask a budget question, get back to you with your vision
for improved enforcement, and I know you've spoke to this issue
as well. Let me--but I think that that reflects truly a new
environment and for me personally, nothing could give me again
more assurance that we're on the right track.
This is a complicated budget, Dr. Hamburg, and there are
lots of moving parts. We've got cross-cutting initiatives,
multiple pieces, multiple centers, current law user fees,
increased proposed new fees. In the foods area, the budget
depends heavily on getting, as I said, $220 million in user
fees that would be provided in the House bill. This is really
in two parts. What I'd like to do is if you can, briefly walk
us through the bullet points in the foods area to give us a
sense of what is funded by budget authority, what is funded by
fees. There is the assumption of the fees, as I said in my
opening remarks, the Senate bill doesn't include the
registration fee that makes up most of the total amount that's
in the budget. That bill raises only $65 million. I want to
also walk through this piece but also ask you to talk about
your commitment in terms of fighting for the House level when
this bill goes to conference.
2011 BUDGET
Dr. Hamburg. Well, thank you for the question. It's a very,
very important issue, and, you know, we certainly have
appreciated the support given by this committee to our food
safety activities and also the passage of the food safety bill
by the House, and we are hoping to see it go forward on the
Senate side swiftly. And it will be very important in terms of
giving us additional resources and authorities.
It is a complicated budget, and as you note, there are
elements of our proposed budget that rely on new user fees that
don't yet exist. In thinking about how we structured the 2011
budget, we felt that we needed to be prepared for the
possibility that we would have to go forward without the
passage of the bill and without those additional dollars and
resources. The budget authority component is more limited, $88
million, as you know.
We have targeted it in certain key ways, and perhaps a
couple of examples, you know, are important, and we can
certainly sit down with you and go through, you know, the
entire food program. That would probably take up our whole
session. But let me just make a few comments. The budget
authority in the 2011 budget is really being targeted to
building essential infrastructure to support program expansion
and the shift to a preventive approach from a reactionary
approach, recognizing that you've already made some critical
investments that have helped us to start the process of
staffing up, which is very, very key. Now we want to make sure
that there's a sort of core infrastructure for that staff to do
their important work and that as we go forward, there's an
integrated, comprehensive program.
INSPECTIONS
So in one key area that I know is important to you, the
area of inspection, in terms of use of budget authority, there
is going to be less emphasis on inspection. We would be
targeting our--we would have three FDAs--three FTEs that would
be hired with budget authority, and they would really be
targeting on tissue residue inspections, which is a gap. In
terms of domestic food inspections and foreign food
inspections, we have, you know, a pretty significant number of
new investigators in the pipeline. We've hired about 700 new
investigators, thanks to your recent investment. So it takes
some time for training to get them up and running in the field.
So we anticipate that in 2011, they will be moving into the
field and able to meet some of the demands of inspection. We
would love to be able to enhance them with additional user fee-
based hires in the inspection area, but we do believe that in
terms of the program needs, they're in the pipeline, and so
we're going to be focusing the budget authority in other areas
to support those activities and also the transformation of the
food program and our activities. For example, it's very, very
important that we strengthen the integration of our food safety
program in terms of relationships with states and localities.
And so we would be targeting a big chunk of the budget
authority dollars, $15.2 million, to our work with states on
food inspections and regulatory activities, and that's very,
very important. We hope to be able to supplement that with user
fee dollars as well. But they need money straight away to help
them partner with us in these important activities.
FOOD SAFETY ACTIVITIES
We also do need additional money right away to help with
our expansion of some of our food safety activities in terms of
import safety and our work to harmonize standards and
approaches, our work with other regulatory agencies and our
work to strengthen our international presence as we're dealing
with an increasingly globalized world and food imports coming
in from over 150 countries and, you know, literally several
hundred thousand facilities and producers.
So, you know, we recognize that this is a challenging
science with uncertainty. We're going to work very, very hard.
I have meetings later today on the Senate side to discuss the
food safety legislation and try to encourage that it moves
forward. It will be vital in terms of both the additional
resources and also, as you know, new authorities for FDA to be
able to do its job better.
Ms. DeLauro. My time has expired, but I would just say
this. I want to sit down with you or with your staff and go
through the food safety piece and what is budget authority and
what is user fees because I think unless we have the Senate
move in the direction that the House did that we are going to
see difficulties. And we should not proceed to a major
legislation and reform of the system and then doom it to
failure from the start. That in my view would be a serious,
serious error. I think my colleagues, you know, on this
committee believe that. And if we have that information, I
don't know what the timetable is, though I hope it is soon on
the Senate side, that what we would want to do is to sit down
over there as well and try to talk about this issue so that we
can not find ourselves moving backward instead of forward in
this area.
Dr. Hamburg. I so appreciate your support on this issue.
Ms. DeLauro. Sure. Mr. Kingston.
Mr. Kingston. Thank you, Rosa. I want to yield to Mr.
Latham, who's got another committee meeting that he needs to
get to.
Mr. Latham. Thank you, Jack. And again, welcome.
Dr. Hamburg. Thank you.
ANTIBIOTICS AND LIVESTOCK
Mr. Latham. I do appreciate the fact you came by yesterday.
As we talked about yesterday, farmers supplying consumers with
probably the most safest, most consistent source of protein
anywhere in the world, and our producers know that confidence
in their products is critically important. And again,
yesterday, we talked a little bit about this, but one thing
that concerns me a lot is the fact that as we go through some
these issues, antibiotics and livestock, that there is an
element, at least the farmers would be involved in the process,
and I actually would invite you to come out to my district. We
have the National Animal Disease Center, the Veterinary
Biologics Center. It's all in my district. We have one of the
largest animal antibiotic producers, Fort Dodge Labs, has two
large facilities in my district, and you'll come to Iowa and
find out that there's 3 million people, but we have about 17,
18 million hogs in Iowa. That's about three to one, or excuse
me, about six to one actually of hogs to people. So it is
obviously a major issue for us and all the livestock
production, largest as far as egg production in the country
also.
But let me just ask you straight out. Is it FDA's
intention, and I've got, you know, the testimony here or a
story from the New York Times back last July 14th, Dr.
Sharfstein saying that he wants to ban antibiotics in
livestock. Is the FDA's intention?
Dr. Hamburg. I don't believe he actually said he wanted to
ban antibiotics in livestock. But I think that the issue you
raise is a very, very important one. It's a major public health
concern and we must work together to preserve the effectiveness
of important antibiotics for both human health and animal
health. And I think that, you know, what we need to do as an
agency is work closely with all of the stakeholders and develop
a science-based approach so that we can in fact ensure that we
have the antibiotics needed to treat important diseases. And I
think you've probably read the stories or know from even
personal experience that this is a real world problem in terms
of antibiotic resistance in hospitals, you know, having
patients with disease that can't be treated because----
Mr. Latham. Right.
Dr. Hamburg [continuing]. All of the traditional therapies
have developed resistance. I grappled with this as New York
City's health commissioner with a devastating problem of TB
resurgence and drug resistance.
So we are moving forward on a path----
Mr. Latham. Is there any science that says there's a
connection?
Dr. Hamburg. Yes there is, there is.
Mr. Latham. Where? Can you----
Dr. Hamburg. And we know that there are certain antibiotics
that have been very much associated with the development of
resistance in terms of their use in animal populations. But we
want to ensure judicious use----
Mr. Latham. Can you get me that information?
ANTIBIOTIC RESISTANCE
Dr. Hamburg. Okay. One example is the fluroquinolone drug
class, which is very, very important for human health and
animal health. But it actually had to be withdrawn from use
because of the seriousness of the resistance concerns. We'd be
happy to provide you with more information.
[The information follows:]
There are a number of medically important antimicrobial drugs that
are used in food-producing animals. Some examples include the
fluoroquinolones, third generation cepahalosporins, and macrolides.
These classes of drugs are critically important therapies for
treating foodborne bacterial infections in humans. Therefore, if
foodborne bacteria become less susceptible or become resistant to such
drugs, the effectiveness of these drugs for treating foodborne
bacterial infections in humans would be impaired or lost.
The fluoroquinolone and third generation cephalosporin drugs
currently approved for use in food-producing animals are limited to
uses that involve administration to individual animals for therapeutic
purposes and require the supervision of a veterinarian.
But let me just reassure you that, you know, we are
committed to a science-based approach to do what's necessary to
support judicious use of antibiotics. That does not mean an
across-the-board ban. It does mean that the use of antibiotics
for growth promotion alone really needs to be scrutinized very,
very carefully. But for the treatment of infectious disease in
animal populations and for the prevention of certain disease
conditions in animal populations, antibiotics have an
appropriate and necessary use.
We need to engage the veterinary community and the animal
agriculture community completely in our efforts, and we've been
reaching out to stakeholders, meeting. I should come out and
visit. I have engaged in some visits, as has Dr. Sharfstein.
But it's a very, very important area for public health, and the
position FDA is taking is consistent with the World Health
Organization, with the CDC, with the American Public Health
Association, with the American Medical Association, and the
list goes on. You know, this is one of the foremost public
health concerns in the nation.
Mr. Latham. Are you waiting for congress to address the
issue or are you going to be proactive? I just have grave
concerns about the link supposedly between keeping healthy
animals, and you're talking about promoting growth. Basically,
a healthy animal does grow better, yes; but, there's no growth
hormones or anything being involved, you know. And I honestly
think that the American people would rather eat products coming
from healthy animals than maybe animals that are sick.
Dr. Hamburg. Well, we definitely want to prevent illness in
animals. We want to prevent illness in people, but we do need
to do this in a thoughtful way, science-based, that preserves
essential antibiotics for health and disease prevention. We are
working closely with industry, listening to their concerns.
We are not going to move forward and institute a policy
that we have not been able to base on sound science and
evidence, and explain to industry and work with them towards
solutions. There also are regulatory pathways that we're
looking at in terms of how we would move forward, potentially.
And, of course, there is a legislative pathway that could be
pursued as well.
And, as you probably know, there is one bill that is under
consideration at the present time, which the administration
doesn't have a formal policy on. We take a somewhat different
approach than that legislation in terms of how we think about
the problem of judicious use of antibiotics, whether for
treatment prevention or growth promotion, but this is a very
important issue. I'm very happy to continue this discussion.
Mr. Latham. Our time.
Dr. Hamburg. Our time. I apologize for giving a lengthy
answer, but it's important and I know it's of great concern to
you and your constituents.
Mr. Latham. Thank you.
Ms. DeLauro. Thank you. Mr. Hinchey.
FRONT OF PACKAGE LABELING
Mr. Hinchey. Thank you, Rosa. Commissioner Hamburg, I want
to thank you very much, because all the things that you're
doing are improving the FDA and making it more responsible, and
making it better and stronger for the people of this country.
But there are a number of other things that I think really
still need to be done, if you haven't been there all that long.
But I wanted to ask you about a couple of them.
Taking the initial step, for example, to rein in the food
manufacturer and the misleading claims about the nutritional
value of those products, and the fact that they can under the
existing set of circumstances be 20 percent wrong, be 20
percent mistaken. That's something that really needs to be
addressed. The FDA developed this margin of error after the
bill was passed back in 1990, but it made no provision
whatsoever that there could be that deep margin of error. So
I'm wondering why that happened, and, even more important, the
fact that that should be changed.
So I just wanted to ask you. Do you think the margin of
error, 20 percent, is much too high? Or, do you agree with most
of us, along with what Dr. Susan Roberts of Tufts University
said recently, that a 20 percent permissible margin of error
was too high and should be lowered to a maximum 10 percent.
Dr. Hamburg: Well, I appreciate your question, and we are
putting a lot of new attention and focus on front of package
labeling and various kinds of nutritional and health claims on
food products. The 20 percent margin of error question, I
think, relates to the issue of calorie counts; and I think
there are some technical issues in terms of, you know, calorie
counts vary, and also the technology. But I think this is an
area where we want to be as precise as possible, because it
really matters to people as they try to make healthy choices
for their diets. I think it's an area where we can bring new
technology and advances in how we make these assessments to
bear, and that's part of our Advancing Regulatory Science
initiative.
NUTRITIONAL INFORMATION
I think that along with addressing those kinds of questions
and how can we sort of tighten up and make more accurate our
presentation of information, we are looking at other important
components such as serving size, because that can be quite
misleading. I think very few people eat six tortilla chips, but
that's what's, you know, sort of given as, you know, a serving
size in some instances. I don't know if that's an exact
example, so we are looking at those issues very seriously now
trying to update our nutritional guidance on standards, and
also looking to how we can better present nutritional
information on the front of packages and also talking with
industry about concerns of inappropriate or inaccurate or
misleading claims that may be made on food packaging. And, you
know, we just recently, I think it was just last week sent out
some 20 warning letters concerning inappropriate----
Mr. Hinchey. So you're determined to improve this
situation?
Dr. Hamburg. We are determined to improve it. We have a
team working very actively on it. We're working with industry
so they understand our concerns.
Mr. Hinchey. What about the 10 percent? Do you think that
that 10 percent is achievable quickly?
Dr. Hamburg. You know, I would have to get back to you on
the specific details. You know, perhaps even look at the paper
that you're referencing, but it's something that our team would
certainly be eager to look at and get back to you on.
[The information follows:]
The 20 percent figure is not a margin of error. FDA's compliance
criteria, including the 20 percent allowance for variation in naturally
occurring nutrients, were developed as part of the 1973 final rules for
nutrition labeling. In the January 19, 1973 Federal Register, FDA
published a regulation which established a statistical approach to
determine compliance with nutrition labeling requirements. The natural
variation in the nutrient content of food products was well recognized,
and the need to set practical limits of variation in nutrient levels
for compliance purposes was the subject of extensive discussions. In
developing the nutrition labeling system, it was important to provide a
sufficient tolerance so that manufacturers could provide useful
nutrition information on the label while meeting consumers'
expectations that nutrition labeling would honestly represent the
composition of the products that they purchased. The objective of the
regulation was to secure compliance with requirements for average
nutrient levels for units in a lot with only as much variability among
units as is inherent in the naturally occurring nutrients when foods
are processed under current good manufacturing practice. FDA is
currently working on updating the nutrition facts label, and this is
one item that we may consider re-evaluating based on more recent
science. However, additional research on the variability of nutrients
within foods may be needed to determine if the 20 percent figure could
be modified.
PHARMACEUTICAL INDUSTRY
Mr. Hinchey. Okay. Well, I appreciate it if you would and I
would appreciate all the things that you are doing. And if you
would continue to focus on this kind of situation, and
additionally among a variety of others the relationship between
the pharmaceutical industry and FDA.
Over a course of time there has become a very sort of close
relationship between these two operations: the pharmaceutical
industry and the Food and Drug Administration who is supposed
to oversee the pharmaceutical industry. A lot of the funding
for FDA comes out of the pharmaceutical industry, which brings
about a relationship which is inappropriate and really
shouldn't be allowed to be there. The close relationship
between the pharmaceutical industry and the FDA is something
that is not being helpful to the people of this country. And I
think it is hurting the FDA's ability to be objective and
careful, and overseeing and engage in the right kind of
oversight that is going to make the pharmaceutical industry's
products safe and secure.
POSTMARKET DRUG SAFETY
Now, we have seen a number of examples of that just
recently and we continue to see them over time as to the kinds
of dangers that can occur if the operation is not as effective
as it should be. So there should be an improvement in the
agency's post-market drug safety operations, and I am sure that
you agree with that. And I am just wondering what kind of
activities may be intended to be engaged in to bring about the
very effective separation between oversight and the
pharmaceutical industry and the fees on drug company
advertising to better monitor some of the ads that are put out.
And when these ads are not accurate and not nearly as accurate
as they should be, and, in effect, provide false information to
people who makes them make decisions that may not be in their
interest. So I know it's a complex set of circumstances, but I
would appreciate it if you could give us some idea as to what
the FDA might intend to do now to overcome this cozy, close
relationship, instead of the oversight between FDA and the
pharmaceutical industry.
Dr. Hamburg. Well, thank you for the question, and I do
understand and appreciate your concerns. I think you actually
asked about six questions there, so I'll try to see if I can
capture all of them.
CONFLICTS OF INTEREST
Mr. Hinchey. Well, we have a few minutes. So, you know.
Dr. Hamburg. But your opening component focused on how can
we assure that we have appropriate firewalls and that we have a
decisionmaking system that is based on the best possible
evidence and sound science, and not undue, external influence
from industry or other sources. That is very, very important to
me, and, you know, I feel very strongly that our agency must
have the resources that we need to fulfill our important
mission, but that we have to be grounded in science.
You know, examining the integrity of our decisionmaking and
assuring that it is free from conflict of interest and other
concerns is one of the most essential elements of FDA being
able to do its work, being able to have the trust and
confidence of policymakers and the public, and certainly one of
my highest priorities. So we take it very seriously.
We have established firewalls in terms of the use of user
fees. We are committed to a science-driven decision-making
process, and it's a dynamic concern. We can't just sit back and
say our systems are in place. Move on to the next issue. It's
something we have to continually be monitoring, continually
responsive to concerns as they're raised and ensuring that we
have the right checks and double-checks.
ADVERTISING
With respect to your question about advertising and the
volume of advertisements to be monitored is huge, and some of
the investments that this committee has helped to support to
expand resources in that key area and others has been very,
very important. We are not able to review everything in as
timely a way as we would like, but we are strengthening our
staffing in that area and expanding our capabilities.
I think we also are trying to work with companies around
how they can be more responsible in terms of their advertising
strategies and messages, and hopefully bringing in some public
health education about disease conditions as well as
advertising their product and strengthening our capabilities
around risk communication in terms of these issues as well. But
in a world where we now have the internet as another
advertising arena, it only is getting more complex and more
challenging.
Mr. Hinchey. That's another example of why it really needs
to be overseen. So I am introducing some legislation, which
deals with the subjects that we've just been talking about and
some other things that really need to be addressed in the
context of ensuring the safety and security of the people of
this country.
I would appreciate it deeply if you wouldn't mind taking a
look at it and giving me your impression and how you might
follow through on the recommendations contained in this
legislation. And thank you very much.
[The information follows:]
FDA will be happy to review your draft legislation and provide you
with FDA's views.
USER FEES
Ms. DeLauro. Let me just make a point that this committee--
is it two years ago--actually appropriated funds and quite
frankly refused to deal with user fees in this area by the
companies overseeing their ads, which I would continue to
oppose. I am glad to see it is not in the budget, but we were
willing to provide resources in order to address this issue and
would continue to do that. And I won't get into it. Maybe Ms.
Emerson does, but in fact we do have legislation with regard to
directive consumer advertising and moratorium. With that, Mr.
Kingston.
Mr. Kingston. Thank you, Madam Chair. I wanted to touch
base a little bit more on Mr. Hinchey's questions, because one
of the concerns that we have and, I think, you just need to
always be mindful of that firewall.
I am actually okay with the user fees, but I agree with
everyone on the firewall issue. And one of the things that
blurs is the revolving door of FDA employees leaving and going
to work with a pharmaceutical company, or whatever. And, you
know, we certainly are always accused of that in congress.
So what do you do to prevent that? Do you have as members
of congress have a one-year ban on lobbying if they assume
another job? Do you have anything like that?
Dr. Hamburg. No.
FDA EMPLOYEES
Mr. Kingston. And is it a common practice for FDA employees
to go to work for somebody that they had been regulating?
Dr. Hamburg. You know, I am sure that we have some numbers
on that. I don't know. One of the things I've been struck by is
how many employees come to FDA and stay at FDA throughout their
professional careers, despite the fact that they could in fact
be making much more money on the private sector side. But,
certainly, there are people who leave FDA and go to work for
industry. But, you know, we can go back and try to get you some
numbers.
[The information follows:]
There is no data that can be extracted from the FDA Central
Personnel Data File to identify FDA employees who have left the
organization to work for private industry.
It is only possible to identify FDA employees who have left FDA to
work for another government agency. Such employees can be identified if
the FDA agency code is maintained by the Office of Personnel Management
and is listed in the employee's Central Personnel Data File.
Former employees are subject to certain restrictions once they
leave Federal service. The post-employment restrictions are contained
in Title 18, U.S.C., Section 207, a criminal conflict of interest
statute.
18 U.S.C. 207(a)(1) prohibits a former employee from making any
communication or appearance on behalf of another, with the intent to
influence, before any employee of the United States in connection with
a particular matter involving specific parties in which the former
employee had personally and substantially participated as an employee.
This is a lifetime prohibition.
18 U.S.C. 207(a)(2) prohibits a former employee from making any
communication or appearance on behalf of another, with the intent to
influence, before any employee of the United States in connection with
a particular matter involving specific parties that was pending under
the former employee's official responsibility during the former
employee's final year of government service. This prohibition lasts for
two years from the time the employee teminates government service.
18 U.S.C. 207(c) prohibits a former ``senior employee'' from making
any communication or appearance on behalf of another, with the intent
to influence, before an employee of his or her former agency for one
year after terminating the senior position. This restriction applies to
any matter pending in the agency on which the former senior employee
seeks official action on behalf of another and is not limited to
particular matters involving specific parties.
All of the above restrictions apply only to communications or
appearances made on behalf of another with the intent to influence
official action. The statute contains less common prohitions, such as
prohibitions involving trade or treaty negotiations and former senior
employees aiding or advising certain foreign entities. The statute also
contains a number of exceptions, such as exceptions for actions taken
as an elected official of a state or local government.
Under a separate statute, 41 U.S.C. 423(d), there is also a one-
year ban on contractor compensation for certain employees who had
worked on a contract in excess of $10 million.
But I think your point about appropriate firewalls is
absolutely key in terms of the use of the user fees and in
terms of the relationships with the industry. It is important,
obviously, that we work with industry, since we're reviewing
products produced by industry and products that have huge
benefits for public health.
TRANSPARENCY INITIATIVE
I believe that an area where FDA can do better and we are
starting down that road is in terms of transparency, being much
more clear and explicit about what we are doing, how we are
doing it, what decisions we have made, how we've come to those
decisions. We have a whole transparency initiative, which is
moving forward, and the first stage of it is in place in terms
of just a sort of a FDA, ABC, or FDA 101, were on the web.
NUTRITIONAL CLAIMS
Mr. Kingston. Well, let me ask you this. I think that it
is. The system has been working a lot better than it was 10
years ago, so I think a lot of progress has been made.
Mr. Hinchey also talked about advertising, and, you know, I
love seeing these: ``Buy the little purple pill and then you
too can dunk the basketball like LeBron James,'' even though
you're 80 years old, and you're dancing and riding bicycles,
and doing extreme sports. But, you know, it's not just
pharmaceutical companies driving that.
A lot of times you look at the food packaging, and
something's called light or low fat or healthy choices. And I
read a nutrition action newsletter, and it always will look at
a label of a specific product and say why it is misleading. And
I'm not one for bigger government and more lawsuits in this
world, but where is the line, and do you have oversight over
packaging like in terms of the promises?
Dr. Hamburg. Well, we do have a responsibility to look at
health and nutritional claims, and we do work with companies to
try to assure the accuracy of those claims, and we also do take
certain, more aggressive actions, when they are not in
compliance with the requirements around appropriate claims. And
we recently, as I said, sent out warning letters about
nutritional claims, health claims that we thought were
inaccurate, misleading or fraudulent.
HEALTHY CHOICES PROGRAM
You mentioned the healthy choices program. You know, when
that first came out, we looked at it and we were very concerned
about some of the products that were getting a healthy choice
check. And we wrote to industry and expressed our concerns, met
with industry representatives, and they actually did withdraw
that program because there were concerns that it wasn't
providing consumers with the accurate information that they
needed. And we're now working towards a more science-based and
more easily understood program for front of package labeling.
Mr. Kingston. And I don't think that there's necessarily
any sort of deviousness on the part of the food industry. It's
just that we live in a culture where if somebody eats two
donuts instead of three, they feel like they're ahead of the
game. It would never occur to us to eat an apple. So, you know,
I think if somebody said, ``yeah, look. This is lower
calories--lower calories than what you've been eating, fatso.''
Dr. Hamburg. Right.
Mr. Kingston. And it's a step in the right direction, so I
don't know that it is really disingenuous. It's just that it is
culturally, we don't.
Dr. Hamburg. No, I think that's right. And I think, you
know, I also have to underscore that what we do with respect to
nutrition is just one component of a comprehensive program that
will really make a difference in terms of education and access
to healthy foods and other things.
Mr. Kingston. Okay. Well, thank you, ma'am.
Ms. DeLauro. Mr. Jackson.
BPA
Mr. Jackson. Thank you, Madam Chair.
Dr. Hamburg, I would like to applaud the FDA as you have
reversed the agency's position on the safety of BPA to express
concern about possible health risks and provide information to
consumers on how they can reduce their exposure to this
chemical, which is commonly found in plastics and canned goods.
The ``Journal of American Medical Association'' reported
last year that humans with higher levels of BPA in their blood
have, and I quote, ``an increased prevalence of cardiovascular
disease, diabetes and liver enzyme abnormalities.'' As a father
of younger children I know I share the concerns of parents and
other individuals on the safety of BPA. I understand that the
FDA has planned a targeted, two-year study to determine what
actions are necessary to protect public health. Could you
please elaborate on the plans of the $30 million study of BPA?
Dr. Hamburg. You are very correct that FDA has recently
reviewed the scientific literature. And we have, I think,
enhanced our level of concern about BPA based on emerging,
scientific studies, also identified some critical gaps in our
knowledge about BPA and the need to address them, and working
with colleagues in government, the NIH and the CDC undertaking
research activities. It's a $30 million research undertaking,
as you know.
And it's to try to better understand how data that's
emerged from low level exposure studies in animals actually
relates to the effect of BPA and those exposures and human
beings. The animal models are not exactly equivalent to humans.
The animals metabolize BPA differently. It recirculates more in
the animals than in humans that excrete it more quickly. So we
need to understand, you know, how to compare the animal models
with the human models.
And there are some additional studies that need to be done
as well; and, of course, there is ongoing research beyond what
we are doing and funding that needs to be reviewed. And we are
going to be looking at the totality of the data going forward.
In the meantime, we do recommend that consumers that are as
concerned as you are, understand how they can reduce their
exposure to BPA, especially mothers of newborns who are very
concerned about baby bottles. We've been encouraging industry
and working with industry to eliminate BPA from baby bottles
and sippy cups. And most American bottle manufacturers have
done so. Also, recommendations, you can find them on our
website about other ways to reduce exposure to BPA, but it's
very, very important that they will have that information.
Ms. DeLauro. Would the gentleman yield for a second and
then I'll provide you additional time?
Mr. Jackson. I appreciate that. I would be happy to.
Ms. DeLauro. On this issue, because I have a question as
well, and I mentioned this in my opening statement. How long is
this study going to take, Dr. Hamburg?
Dr. Hamburg. Well, we expect to have results in 18 to 24
months.
YALE BPA STUDY
Ms. DeLauro. So it's up to two years. Now, I will tell you.
I started to read the report. I am not a scientist, so I will
get it translated for me into lay person's language. But it is
just a group of scientists at Yale University School of
Medicine, Department of Obstetrics/Gynecology/Reproductive
Sciences. It was recently published, ``Journal of the
Federation of American Societies of Experimental Biology.'' It
found that exposing a fetus to BPA can cause serious damage.
One of the researchers likened BPA exposure to DES, which
is deeply disturbing. This is on the front page of the ``New
Haven Register'' just this week: ``Yale study details how and
why of BPA's danger.'' They specifically talk about women and
infertility and uterine cancer. Again, what I don't understand
about this, and I would just add to what my colleague, Mr.
Jackson, has said here is that in the interim while we move at
this we proceed very cautiously.
I am not against proceeding cautiously, but two years to
deal with this issues, and we take as our guidepost, it would
appear, the science that is developed by the industry. Instead
of taking the science that is developed by academics, et
cetera, who have serious concerns about this and say, okay,
industry, we're going to stop this while we examine the
academic science that is telling us that we've got some serious
problems here. That is very, very troubling with this issue,
and we've been going round and round on BPA now for a while. So
you'll get your time, Mr. Jackson, but I thought it would be
appropriate to, you know, add that question at this juncture
with regard to your concerns about this mission.
RADIATION EXPOSURE
Mr. Jackson. It is more than appropriate, Madam Chair.
Recently, the Chicago City Council voted to ban BPA in bottles
and sippy cups in May of 2009. I have a final question
regarding this.
I recently met and the chair recently met with the CEO of
Green Planet Bottling Company, an Illinois-based company, which
produces petroleum-, chemical- and BPA-free bottles that are
completely biodegradable. I am wondering what more the FDA can
do to direct concerned parents and their families to options
that are BPA and chemical free. Does this committee and/or this
congress need to statutorily require the elimination of BPA in
these bottles? And let me ask one final question given my time
constraints.
Dr. Hamburg, last month the FDA announced that it would be
implementing steps to more stringently regulate medical
regulation, specifically forms of ionizing, radiation,
including CT scans, nuclear medicine studies, and
fluoroscopies, which increases a person's lifetime cancer risk.
The average American's total radiation exposure has doubled in
the last three decades, according to the FDA. Last month many
of the manufacturers of CT scanners announced that they will
begin installing safety controls, which would alert machine
operators when the settings exceed recommended levels.
REGULATION OF MEDICAL RADIATION
Commissioner, what steps will the FDA take to better
regulate medical regulation, and what protections are currently
in place to ensure that patients received the smallest dose of
radiation necessary for these tests? Also, Homeland Security
and TSA recently announced the addition of full body scanners
at many of the nation's airports. What role, if any, will the
FDA play or has played in ensuring that these devices will be
safe once they're installed?
Thank you, Madam Chair.
Dr. Hamburg. Well, a very important question. FDA cares
very deeply about this radiation safety concern and in fact has
been quite proactive in responding in terms of recognizing when
some adverse event reports came in about evidence of
inappropriate, excessive exposure to radiation from CAT scans
that there might be a broader issue here and really started to
look at it in more depth.
We are working with companies that make these machines to
try to move towards having systems that are less prone to
error. You know, it is human error in terms of the dosage
delivered; but, there are ways, you know, sort of systems
engineering, to help reduce the likelihood of such errors
occurring. So working to improve the quality of these devices
and the safety of these devices is very, very important.
Putting out information for healthcare providers and those
that are operating these machines is also very, very key, and
we have been moving forward in that arena, continuing to
monitor for problems as they occur, and, of course, educating
consumers and providing information. We would like to move
towards a system where actually individuals could keep track on
a personal level of their dosage exposures over time, because I
think that's important information, you know, for their own
safety, and also to be able to provide their medical providers
since people often move from one physician to another.
TSA SCANNERS
So that's another area where we think we can help be a
catalyst to activities that will improve patient safety. With
respect to the role of the scanners used in airports, the level
of exposure is much, much less. We are talking on the medical
side, equipment that has to penetrate the skin to visualize
organs. The TSA scanners are really looking just very
superficially. They're not penetrating in the same way, so the
level of exposure is markedly lower. So the risk is really
minuscule.
Mr. Jackson. Does the FDA have a role in that? Given that
the number of people who travel through the airports, and will
be exposed to the machines?
Dr. Hamburg. You know, even with multiple--I know many of
you travel frequently.
Mr. Jackson. It is a concern.
Dr. Hamburg. It is a concern that I would understand, but
in terms of the level of exposure, it is minuscule, because it
is not penetrating in the same way. But we would be involved in
terms of any indications of medical complications or adverse
reactions to that scanning technology.
[The information follows:]
There is no indicator of excessive exposure on Transportation
Security Administration passenger screening scanners. The
Transportation Security Administration's Rapiscan Secure 1000 Single
Pose backscatter x-ray systems, used in passenger screening, have
engineered safety systems to prevent a dose above the manufacturer's
specification.
Mr. Jackson. Well, that's an important question. I don't
honestly know the answer, but I will go back and ask that
question and I hope we can address it.
Ms. DeLauro. Thank you very much, Mr. Jackson. Mrs.
Emerson.
ANIMAL ANTIBIOTICS
Mrs. Emerson. Thanks, Madam Chair, and Dr. Hamburg. Thanks
for being here today and thank you again for coming to my
office yesterday. It was good to visit with you there.
Let me just ask a very, very brief, or mention a very brief
follow up on the issue of animal antibiotics. I've got a very,
very, very rural district and so I will have counties that
might have a hundred thousand, a hundred fifty thousand head of
cattle or what have you and maybe one large animal
veterinarian. And so, it puts us into a real dilemma as you all
develop new policies with regard to the use of antibiotics. And
I just would like to have you, as you proceed, you know, keep
that in mind that it's, that it is an issue in many
circumstances for, and I would imagine that our colleagues who
live out in Montana and Nevada and New Mexico, you know,
they've got much farther areas with which to deal and probably
have the same issues with regard to lack of large animal vets.
So, let me make that comment.
COUNTERFEIT PRESCRIPTION DRUGS
Let me go onto my question, which deals with the existence
of counterfeit prescription drugs within our borders. And I do
remain very concerned about the fact that we still have big
problems with this. And you know, it's obvious that the high
prices of many name brand drugs make counterfeiting well
worthwhile and this is an extremely important safety issue for
millions of American consumers.
I'm also told that counterfeit drugs are produced and enter
our system from both outside and within our borders and I'm
also told that the counterfeiters have gotten so good and are
so adept now at not only replicating the look of the pills they
are trying to impersonate but as well as the packaging and even
the bar codes on the boxes can scan at the pharmacy checkout
without sending up any kind of red flags.
So, I have three questions with regard to this issue.
Number one, how prevalent is the problem in your opinion? Can
you talk a little bit about the efforts undertaken and planned
by you all at the FDA to locate counterfeit drugs and get them
out of the U.S. supply chain and tell me what kind of measures
are needed to continue to reduce the opportunities for
counterfeits to get into the hands of American patients. And
then I guess at the very end, how do you all share this
responsibility with the state boards of pharmacies? Thank you.
Dr. Hamburg. Thank you for the question. This is a huge and
growing concern and it's a problem within our borders. It's
also a problem around the world and, in fact, in some parts of
the developing world some studies suggest that between 30 and
50 percent of some of the drugs available actually are
counterfeits, so this is really a huge concern that affects the
health of us all.
We take it very seriously and we do undertake
investigations to try to identify counterfeit products and
their manufacturers. We welcome input from all sources when
concerns are raised. When we do find problems, of course, we
work with the appropriate enforcement agencies to take serious,
swift, and decisive action and also to provide information to
consumers about the risks. You are absolutely right that both
the volume and the quality of counterfeits is increasing and it
adds new challenges and I think FDA has a special role to play
there and has made contributions already but some of the
investments in science can help us to do a better job.
We have developed new technologies so that we actually, and
we've put out guidance around, substances that can be put into
pills that aren't harmful or affect the use of the product but
can enable validation of the authenticity of a product.
We've also developed technologies, I was recently at JFK
where a lot of important drugs come in, and they had me put on
some funny glasses and use, you know, special light where you
can actually scan products to determine if they're counterfeit
or not. Because often the pills themselves look exactly right.
Some of the counterfeits you see coming in are laughable and
you wonder why anyone would possibly take this product if, in
fact, they ordered it and it was presented to them.
But it's really a very, very serious problem. It's one that
I think the answer has to be undertaken on an international
basis because it's their products that are produced
domestically but a large part of the flow is coming in from
imported drugs. And the World Health Organization is actually
taking this up at its World Health Assembly this spring and of
course, we'll be participating, but working with other
regulatory authorities and law enforcement worldwide, as well.
RESOURCES TO PREVENT COUNTERFEIT DRUGS
Mrs. Emerson. Do you have any suggestions? Well, first of
all, any suggestions about what type of technology might be
helpful in abating the problem of the counterfeiting, number
one, and number two, do you have within your budget the means,
let's say hypothetically, that you've come up with this idea,
whatever it might be, you know, using those funny glasses or
what have you. Do you have enough money in your budget to
really monitor every kind of drug coming into this country? And
that obviously is what is produced here.
Dr. Hamburg. Yes. We do not have enough resources or the
complete authorities that we need to really address this
problem worldwide and I hope that over time I'll be able to
work with all of you to address this important issue. It's a
huge concern.
I should have mentioned also that unique identifiers and
the ability to really have a pedigree to assure authenticity is
very, very important. And that's, you know, something that we
are trying to move forward on, but it's also an arena where
some additional authorities would be necessary.
But this is so key and it's only a growing problem and it's
a tragedy that, you know, people are counting on drugs to treat
serious medical problems or to prevent important conditions and
unknowingly, you know, are taking something that at best will
do no harm, but may actually make their condition worse or make
them sick.
Mrs. Emerson. So what kind, what specific authority might
you need from us?
Dr. Hamburg. Well, I think, you know, number one, we need
to continue to be able to expand our global presence in terms
of being able to monitor products and how they're made and to
be able to assure the supply chain in ways that are critically
important to prevent counterfeits, but also to prevent economic
adulteration and other forms of contamination of products. We
need also to have the ability to really track and assure
authenticity of products through a pedigree approach.
We need to be able to continue to strengthen our, you know,
inspectional capabilities at the border, but recognizing that,
you know, the volume of stuff coming in, you know, will always
make that a challenge, but we are now developing ways to target
in a more risk-based approach and including strengthening our
intelligence networks, so it means working with other partners
to have a better sense of manufacturers and importers that have
had problems in the past and to share information with other
regulatory authorities when problems emerge.
Mrs. Emerson. Well, we certainly, I know, Madam Chair, it
would be helpful for us to be able to work with you to try to
come up some good solutions to this and we'll look forward to
working with you. And thanks for letting me go a little bit
over.
Ms. DeLauro. Sure, no, thank you, and it's an important
area and we'll work with you on what kinds of authorities are
needed. Mr. Bishop.
SALMONELLA
Mr. Bishop. Thank you very much. Welcome, Dr. Hamburg. As a
result of recent FDA investigation into a case of salmonella in
Tennessee, it was found that hydrolyzed vegetable protein was a
source of the salmonella, which was found to be a commonly-used
ingredient and a flavor enhancer for many processed foods
including soups, sauces, chili, stews, hot dogs, gravies,
seasoned snack foods, dips and dressings.
My first question is, how would the administration's new
standards of food safety have prevented this latest case of
salmonella and in particular, its potentially far-reaching
penetration in the food chain?
FOOD INSPECTION METHODOLOGY
Secondly, I wanted to ask, with regard to the possibility
of creating a new federal food inspection methodology, that
based on the fact that many people are of the opinion that the
FDA is not able to exert the needed leadership accountability
on food safety issues because it has no single official whose
full time job it is, and who has a line authority over all the
elements of FDA's food safety program?
So, my second question would be, given that view, don't you
think that it's time, and it would be appropriate, for Congress
to change the way that we currently manage the food safety
program?
And my third question has to do with reaction versus
prevention with regard to food safety. The newly adopted
inspection regime, which is basically an audit program, and
you've got an additional $396,000 in one new employee to try to
address that through audit with the prevention. And my question
there is, how will this new prevention program with just one
employee and just $396,000 actually work to accomplish our food
safety, your food safety, mission?
Dr. Hamburg. Okay. First question, I'm happy to be----
REPORTABLE FOOD REGISTRY
Mr. Bishop. One additional, I should mention.
Dr. Hamburg. Right. I'm happy to be able to tell you that
with the recent salmonella contamination of the hydrolyzed
vegetable protein product, there was actually a new program
that had been put in place, our reportable food registry, that
enabled us to quickly identify the contamination with this
product and actually to act before there were any human
documented cases of disease associated with it.
So, I think it's a good example of being more preventive
than reactive. We also, I think, can learn from this case about
how important the----
Mr. Bishop. You reacted soon enough to prevent further
damage.
Dr. Hamburg. Prevent human cases, which is--. There has
been no disease associated with it. There has been a
significant cost to industry in terms of product that can't be
used, but we were able to get out a bit in front. Our goal is
to get out even further in front in terms of preventing these
problems in the first place. And with the passage of the new
food safety legislation and with some of the activities that
we're doing to transform our food safety program, we will be
working with companies in order to put in place preventive
controls so that we can identify where are the points in the
life cycle of a product that are most vulnerable to
contamination and how can we shore those vulnerabilities up and
prevent the contamination from happening in the first place.
So, it is our hope that we will be able to make sure and
steady progress moving forward, especially with additional new
resources and hopefully with some additional new authorities to
really have a preventive program in place.
DEPUTY COMMISSIONER OF FOODS
With respect to your concerns about the organization of
food safety activities within FDA and accountability and there
being no single person at a high level in charge, I'm happy to
say that one of my first actions as the new Commissioner was to
address that problem. And the individual is sitting right here,
Mike Taylor, who is Deputy Commissioner for Foods. He has my
ear 24 hours a day. He is responsible for aligning all of the
different components for food safety and nutrition within FDA.
He is responsible and accountable.
It also, by having this higher level individual, gives us,
I think, a higher level of coordination with other critical
partners inside government and outside government. So, I think
that the establishment of that position and his recruitment,
and now the operationalization of a much more coordinated
program has benefits and will continue to accrue benefits.
Mr. Bishop. Was his assumption of those duties just by
designation, by regulation, or by statute?
Dr. Hamburg. It was a formal reorganization, which came up
to the Hill for approval or sign off----
Mr. McGarey. Notice. Notice.
Dr. Hamburg. Or notice.
Mr. Bishop. So it was regulatory? It was through----
Dr. Hamburg. It was bureaucratic is all I can say. I mean,
I couldn't just come in and do it, I had to, through the
department, and then with notice to Congress, undertake a
formal, official reorganization.
Mr. Bishop. APA, the Administrative Procedures Act, is what
you used?
Dr. Hamburg. You know, I turn to----
Mr. McGarey. I'll comment and say that we did, subsequent
to sending the notice to Congress, submit the full details in
the Federal Register. So, they were published under that
document.
Mr. Bishop. All right. Okay.
Dr. Hamburg. And your last question, I sort of answered in
my earlier answer about the importance of moving towards a
preventive rather than a reactive approach, which saves lives
and saves money.
FOOD SAFETY
Ms. DeLauro. Thank you. I know Mr. Kingston is coming back
but we'll proceed on. I do think in some ways Mr. Bishop
endorsed, if you will pardon me, a single food agency hearing
his comments. So, thank you, Mr. Bishop.
I want to ask some questions about food safety. We get lots
of references from the administration to the membership of the
food safety working group and they talk about major
departments, agencies, several offices of the White House
participate. My understanding, and I want to put on the record
that, in fact, one of those offices is the Office of the U.S.
Trade Representative. And I personally find it troubling that
the USTR has said, and I've got his citation here.
USTR
``The USTR is the lead agency for matters relating to
international trade and therefore plays a significant role in
food safety issues as the United States both imports and
exports significant quantities of food. As such, USTR is an
active member of the President's food safety working group.''
What expertise does USTR have on food safety?
Dr. Hamburg. You know, I can speak to the FDA role in food
safety far better than I can speak to the USTR. What I can say
is that clearly, issues of food and food safety are important
trade issues but that my first priority, and I think, you know,
what the American people, you know, really care about is that
they can have confidence in a safe and wholesome food supply.
FOOD SAFETY WORKING GROUP
Ms. DeLauro. What role does it play in the working group?
Dr. Hamburg. To date, the issues that have been taken up in
the working group, you know, have really focused on the
framework for the program defining the pillars of the program
in terms of strengthening prevention, inspection and
enforcement and response and recovery. I don't believe, but I
haven't been at all the meetings of the working group, that
specific trade discussions have been undertaken at the working
group. I'd be happy to find out and get back to you.
[The information follows:]
The President created the Food Safety Working Group on March 14,
2009, to promote a public health-focused approach to food safety based
on three core principles: prioritizing prevention, strengthening
surveillance and enforcement, and improving response and recovery.
Consistent with these principles, the Food Safety Working Group seeks
to promote better coordination in Federal efforts to improve food
safety and to develop short and long term strategies to make food
safer. The FSWG is chaired by Secretaries Sebelius and Vilsack, and
participating agencies include the Food and Drug Administration, Food
Safety and Inspection Service, the Centers for Disease Control and
Department of State, the Environmental Protection Agency, and several
offices in the Executive Office of the President, including OMB, OSTP,
and USTR. Each of these agencies is called upon by the Food Safety
Working Group to offer input to their areas of competence in
furtherance of the overarching goal of ensuring that the nation's food
supply is safe.
CODEX
But, you know, I think there has been, you know, a
continuing dynamic, both domestically within the government and
internationally through CODEX and other entities, about these
issues of the relationship between public health and trade
concerns and my feeling is that at the end of the day, the
public health voice must be very clear and very strong because,
you know, protecting the health of the public is the first
priority.
TRADE VS. PUBLIC HEALTH
Ms. DeLauro. Well, I think you know, and Mr. Taylor knows,
as well, my concerns in this area. What we've seen over the
years is that, in fact, trade has trumped public health. And I
will go back, just in some recent history about a working group
under prior Administrations, in the Clinton Administration, and
I just don't want to speak off the top of my head to see if the
trade representative, you know, participated in those. I don't
think so, but I'm not sure, so I don't want to talk about what
I'm not of. But I think that immediately sends off, and I'm not
asking you to comment, this light bulb's in my mind, in terms
of what, where our priorities are. Clearly, our priorities need
to be about the public health.
With regard to the working group, is that just going to
continue on or is it going to make a series of recommendations
and then that will get implemented or this just an ongoing
group?
COORDINATION AND COMMUNICATION
Dr. Hamburg. My sense is that it will be ongoing. It offers
an important forum for coordination and communication of
activities. As you well know, there're many components of
government that are involved in food safety issues. I think
fifteen different components of government are part of the
working group. It's chaired by HHS and USDA and, of course, FDA
and USDA represent, you know, the bulk of the food safety-
related activities.
But, there're other important components and I think it
does give an important venue for coordination and communication
that otherwise probably wouldn't happen even with the best of
intentions.
EQUIVALENCY PROCESS
Ms. DeLauro. Let me, and I'm just going to make a comment
on this because I think it's an item for another time. I don't
know where you're going on the equivalency system, like USDA
has for imported meat and poultry. I remain very concerned
that, in fact, this approach compromises public health for the
sake of trade. I've just seen so much of it over the years.
Last year, this subcommittee held a hearing about the
equivalency process and trade at USDA. This is an issue that
I'm going to continue to follow very closely and intend to have
future hearings which address the influence of trade on our
food safety and our public health. And I think, quite frankly,
I think our trade agreements, and some of those that have
already been passed, and when we have not taken due
consideration of public health in a formidable way and we find
ourselves in a position where, if we want to correct those
things after the fact and knowing about what the adverse
conditions are, that then we find ourselves in a position of
subject to litigation. So, my view is that we ought to
anticipate these issues, be very stringent with regard to our
food safety, as it applies to our trade agreements and have a
hearing that is solely focused in that area so that we can look
at it and make some recommendations.
My time has elapsed, but I do have three or four other
questions with regard to food safety but we'll come around
again.
Ms. Emerson. Why don't we go to you?
FOREIGN FOOD INSPECTIONS
Mrs. Emerson. Let me go back, if I could, Madam Chair. We
were talking a little bit about the food safety bill. Yesterday
we talked about the number of foreign, the additional 1,900
domestic food inspectors and 150, well, maybe it's 1,900
additional domestic food inspections, and 150 additional food
inspections done internationally.
And I guess I'm a little bit concerned about the low number
for the international inspections, particularly given the 20
percent or so of the food consumed in the United States is
imported.
Do you think that we're dedicating enough resources to
inspecting foreign food?
Dr. Hamburg. Well, I think we need, you know, more
resources and more activities to address the overall import
safety concerns. I think it is important to recognize that what
we're asking for in fiscal year 2011 is part of a comprehensive
strategy to use the additional resources that you have given us
over time and that it's not that we think that domestic
inspections are more important than foreign inspections, but
it's that we have teed up in our hiring pipeline and new FTEs,
individuals that will be enhancing our international
inspections.
So, our overall number of inspections that will be
accomplished in fiscal year 2011 will be more than----
Mrs. Emerson. The number of inspections?
Dr. Hamburg. The number of inspections that are mentioned
there in terms of additional new dollars. In addition, you
know, we have created a cadre of experts in foreign inspection.
They're not the only ones that will be doing foreign
inspections, but they have expertise around an important set of
issues that have to do with food safety and foreign
inspections. So, those resources will augment what we're doing.
IMPORT SAFETY
And I think, realistically in terms of dealing with the
import safety question, we have to recognize that we have to
have strategies that extend much beyond simply doing
inspections. We really need to work with other regulatory
authorities to try to ensure that the standards of production
are equivalent to what we're undertaking. We need to work with
international bodies to try to put in place, you know,
harmonized standards and approaches. It's going to have to be a
multi-layered strategy because the challenge of import safety
is just so huge and growing. So, we're bringing a range of
different tools to bear, expanding our foreign presence, also
expanding our inspectional capability.
INSPECTIONS AND USER FEES
Mrs. Emerson. Will the addition of more inspectors and/or
inspections be contingent on new users fees, for example?
Dr. Hamburg. Some of our inspectional capability, in terms
of the fiscal year 2011, is very much linked to, I mean, almost
all of it is very much linked to the new user fees. And, of
course, the new legislation is quite prescriptive in terms of
inspectional responsibilities, particularly on the domestic
side. So, you know, if we are to meet those goals, as outlined
in that legislation, we're going to need resources to do so.
Mrs. Emerson. So, is it, I mean, in your opinion, do you
think it's too prescriptive with regard to, for example, a
southeast Missouri vegetable farmer as compared to a Chinese
food processor?
RISK-BASED APPROACH
Dr. Hamburg. You know, I think that the number of
inspections, as laid out in that bill, you know, clearly put,
you know, a more rigorous focus on domestic inspections, but I
think that how we target inspections should really be using a
risk-based approach. And that one of the opportunities that we
now have as we move towards transforming our food safety system
and really trying to have a preventive approach and a more
risk-based approach, is to use what will always be limited
resources in terms of the contrasts between, you know, the need
and what we might like to do in the best of all possible worlds
and what we can do, you know, we want to be wise about how we
do it. And we want to apply the best possible science and
technology so that we can make inspections more efficient, as
well.
Mrs. Emerson. I just got a little bit worried perhaps that
we could've been a wee bit overly prescriptive just because I
keep remembering in my head, watching that 60 Minutes report on
some of the fish that is farmed over in southeast Asia and, you
know, I'm always now very label conscious when I buy any kind
of seafood. And so those things make me nervous. And I think,
you know, that is generally more of a problem than the guy in
my district who does actually grow vegetables or cantaloupes,
or watermelons, or the like, and so I just want to make sure
we're doing enough with the increased importation of food.
Dr. Hamburg. It's a huge area of interest and concern to me
and I look forward to working with you as over time, you know,
we shape this program.
Mrs. Emerson. Thank you. Thanks, Madam Chair.
RISK-BASED AT USDA
Ms. DeLauro. Before I yield to Mr. Kingston for a special
introduction, let me just say, and we can't go into it now, but
this is by way of, by testimony because the Commissioner just
started to talk about risk-based inspection and that's in the
budget. Risk-based does not currently have, FDA does not have
current, currently have adequate data-gathering tools and
systems comparative risk evaluation models, or the internal
structure needed to apply risk-based approach to recognizing
response to the emerging evolving food safety issues and
problems.
We can't talk about it now, but we need to talk about that.
I've watched risk-based at USDA and it was, they had to stop
what they were doing because, in fact, there wasn't the
adequate data and the research, et cetera, on which to be able
to make that kind of risk-based determination.
You're a student of this. We cannot move forward without
data and analysis before we deal with risk-based. And I believe
you agree, and so we will continue to talk about that. And with
that, Mr. Kingston, let me just yield to you. This is very
exciting. Mr. Kingston, go ahead.
Mr. Kingston. Thank you, I don't know why I said that.
Ms. DeLauro. Well, we were talking about food. So----
[Laughter.]
Mr. Kingston. But it's a great pleasure for me to introduce
one of the greatest athletes in the United States' history. And
that is Hershell Walker, Heisman Trophy winner, and national
championship--Hershell from the University of Georgia.
[Applause.]
Mr. Kingston. And Hershell, the reason why he's so relevant
is we spent so much time in this committee talking about
childhood obesity, childhood hunger, nutrition, physical
fitness, and getting these kids away from the Nintendo game.
He's also with Larry Franklin of the Franklin Glove Company
and Bill Sales of the Sporting Goods Manufacturer's
Association. And they've been all over this, trying to get kids
healthy and active.
And I want to let Hershell say ``Hello.'' But one thing I
want to say that he will not tell you. At the age of 47, he
decided to take up the mild pansy sport of mixed martial arts.
And he defeated in two minutes and 17 seconds most recently a
26-year-old professional boxer.
So he doesn't sit down. And Hershell, do you want to say hi
to everybody?
Mr. Walker. I didn't know I was going to get put on the
spot. So first, you know, I'm glad you guys are here, because,
you know, what I'm here doing is talking about obesity.
You know, as a kid growing up, I was a little bit
overweight, chubby, fat, or whatever you want to call me. And I
also had a speech impediment. But I was very fortunate to have
two parents, and also to have a PE coach that talked to me
about being physically fit.
And because this PE coach gave me a program to do, I became
valedictorian of my class. Because it gave me confidence, and
because I had the right parents. They gave me the right things
to eat and the right things to keep me healthy.
And so that's what I'm here to do, is to talk about that we
got to continue to get all the kids healthy, continue to keep
them healthy. Because I think a fit kid is a fit adult. And I
think that's going to help a lot out in the long run.
My mother always say, ``Why don't we take care of these
small problems first? And it won't grow into a big problem?''
Because no matter what everyone thinks, that baby is the
prettiest, no matter how ugly the child may be.
[Laughter.]
Mr. Walker. But that's one thing we have to do.
I want to just thank all of you for giving me this
opportunity, because you guys got a lot more important things
to do than to listen to me talk about this here.
But I want to thank you. And you know, Mr. Kingston, we've
known each other for a long time. He's helped me out in so many
things. And I want to just say thank you, God bless you.
Thank you, guys, for giving me this chance.
Ms. DeLauro. Thank you.
[Applause.]
Ms. DeLauro. Mr. Hinchey.
NUTRITIONAL CONTENT
Mr. Hinchey. Thank you very much, Madam Chairman.
I just want to return briefly to this 20 percent issue. And
first of all, I just want to thank you once again for all the
work that you're doing.
This Food & Drug Administration is so critically important
to the safety and security of the people of this country. That
20 percent margin of error is on the nutritional content of the
products, the overall nutritional content of the products.
So it's very, very important. And that 20 percent margin
was initiated by the FDA. I wonder if you know why the FDA did
that long before you got there?
Dr. Hamburg. Right.
TWENTY PERCENT MARGIN OF ERROR
Mr. Hinchey. Why they did it? What was, you know, the
origin of that? And do you think it would be reasonable to
require food manufacturers to add a disclaimer on a nutritional
content label, that would just let the people who are buying
the product know that the FDA allows a 20 percent margin of
error in determining the accuracy of the nutritional content of
the material that they're buying and eating?
Dr. Hamburg. Well, I think that the best answer to your
question is for me to actually go back and get you the real
information to your specific and rather technical question. I
mean, I can imagine that it was established, based on the
technical capacities of laboratory tests to determine. I mean,
there's always a margin of error.
But I don't know. And so we will get back to you on that.
[The information follows:]
The 20 percent figure is not a margin of error. FDA's compliance
criteria, including the 20 percent allowance for variation in naturally
occurring nutrients, were developed as part of the 1973 final rules for
nutrition labeling. In the January 19, 1973 Federal Register, FDA
published a regulation which established a statistical approach to
determine compliance with nutrition labeling requirements. The natural
variation in the nutrient content of food products was well recognized,
and the need to set practical limits of variation in nutrient levels
for compliance purposes was the subject of extensive discussions. In
developing the nutrition labeling system, it was important to provide a
sufficient tolerance so that manufacturers could provide useful
nutrition information on the label while meeting consumers'
expectations that nutrition labeling would honestly represent the
composition of the products that they purchased. The objective of the
regulation was to secure compliance with requirements for average
nutrient levels for units in a lot with only as much variability among
units as is inherent in the naturally occurring nutrients when foods
are processed under current good manufacturing practice. FDA is
currently working on updating the nutrition facts label, and this is
one item that we may consider re-evaluating based on more recent
science. However, additional research on the variability of nutrients
within foods may be needed to determine if the 20 percent figure could
be modified.
But I agree with your underlying concern that it's very
important that consumers get accurate information, established
when making choices for health. And I think that we have an
important role to play in making sure that the information
that's provided is as accurate as possible.
And then I think we have to work with others, including
people like we just heard from, in terms of educating the
public about making healthy choices. And so I think, you know,
it's an important question, and we'll get back to you.
Mr. Hinchey. Okay. And if you wouldn't mind, take a look at
that situation, to make a determination as to whether or not
that would require them to put a disclaimer on the product that
they're manufacturing. So people just know what they're
getting. And maybe reduce that 20 percent to at least 10
percent as soon as possible. And that would be a very positive
thing to do.
Dr. Hamburg. Okay.
FOSAMAX
Mr. Hinchey. If I could just ask you one other question. As
we know what happened with ABC News, and how they ran a story
on Monday, which talked about Fosamax, a drug used by women to
prevent broken hips and, you know, how all of that process got
so complicated and people got seriously ill as a result of--
cause of--broken legs in a number of women.
The story also said that Merck, the manufacturer, did not
change the labeling on the drug for 16 months, to reflect the
side effect after the FDA raised the issue. So the FDA raised
the issue with them, told them what they saw was going on and
their concern about it, and that it was 16 months before Merck
did any change in the labeling to inform people.
So I'm wondering why it took so long for Merck to take the
appropriate action, and why the FDA didn't require Merck to act
sooner? And what are we doing now? What do you think the FDA
should be doing, or is doing now to really address this issue?
Dr. Hamburg. Well, this is obviously a situation of
enormous concern. Many woman take this product in order to
protect their bones. And we want to ensure that there are not
complications, such as you were just describing.
It is also one of those situations, where it's very, very
important to look at the science and take a thoughtful
approach, and whether it is very clear that a large number of
women taking this medication did have fractures. I think what's
less clear is whether the medicine was the cause of the
fractures. And that's the question that has to be critically
examined and answered. And there is a team at FDA looking at
the data we need, I think to move as swiftly as we can, looking
at all of the available data, to make determinations.
I know that in an earlier point in discussions with Merck
around labeling, I think, you know, actually that Merck was
prepared to go forward with the label, but that the group at
the FDA did not feel that the data actually demonstrated this
enhanced risk.
But it's an area that we will be working on very
intensively. I think it is very, very important that we ensure
within FDA that we have a strong approach to assuring drug
safety.
DRUG SAFETY
I'm moving forward with some strategies to enhance how we
address drug safety, because especially as we strengthen our
activities in the post-marketing surveillance area following
the 2007 enactment of the FDAAA, we got additional authorities
to strengthen our ability to follow a drug, beyond the time of
approval, to really understand its use in people in the real
world, you know, that we're seeing an increasing number of
safety signals. We need to be able to respond as quickly as
possible and as authoritatively as possible to emerging safety
concerns, always, always, always bringing the best signs to
bear on those critical decisions.
Mr. Hinchey. Well, I appreciate that very much, and I thank
you for everything that you're doing. But I just think that
these things need an awful lot of attention. And I know that,
you know, you haven't been here very long, I mean, on this
particular job. And the things that you're doing are exemplary,
as far as I know. And that's something that really, really
needs to take place.
But why it would take somebody, you know, like Merck to
take a year and four months to make the kind of correction that
could be critically important for the safety and even the life
of some people, is a mystery to me. And I think it's something
that really needs to be overcome. And there needs to be a very
more effective, perhaps relationship between the Food and Drug
Administration and the agencies that are being overseen.
And I know that over time, there has become a very close
sort of relationship, including the funding that comes out of
those agencies to Food and Drug Administration.
And all of things, I think, really need to be looked at
more carefully, and hopefully improved, so that the safety and
security of people in this country can be improved, as well.
And I thank you very much, for everything you're doing.
Ms. DeLauro. Mr. Kingston.
TOBACCO OUTREACH AND EDUCATION
Mr. Kingston. Thank you, Madam Chair.
Dr. Hamburg, on the tobacco outreach and education money,
it would appear that with the decline in tobacco use and all
the other efforts that are out there through the Master
Settlement Agreement, that that would not be the best use of
FDA's funds. Since you are going to have the regulatory burden
already, it would appear to me that the education issue is
somewhere being handled.
I know a government agency would never turn down an
opportunity to expand its budget. But it just seems that that's
not necessarily the best expenditure of the dollar.
Dr. Hamburg. Well, I appreciate your question. You know, a
couple things. One is that, you know, we are not seeing the
continuing declines in tobacco use that we would like to see in
this country, and it has huge implications for public health.
So I think we need to continue our overall tobacco use
prevention and cessation activities. In terms of the FDA role
that the Tobacco Act actually requires us to address a couple
of key areas that are not specifically education, but in fact
it's on marketing, labeling, and the manufacture and
composition of tobacco products.
So I think we will actually be, through this activity,
making a unique contribution in some key areas. For the first
time, for example, we will actually have information about the
ingredients in tobacco products and be able to really assess
scientifically the health implications of these products.
We also will have authorities to address some of the
labeling issues, which are very, very important in terms of
getting information to consumers about products and----
Mr. Kingston. Well, I understand that aspect of it. But it
would appear whether you could coordinate the education and
outreach through some other recipient of MSA money, rather than
you need to do it yourself.
Dr. Hamburg. And we're not actually undertaking through
this set of activities education and outreach activities, per
se. We are working in coordination with other parts of
government and also, you know, with state authorities and
others, in terms of some key aspects of the law, the education
and outreach being one. And also you know, some of the
enforcement activities will be undertaken at the state level,
as well.
But your point is well taken about assuring good use of
resources. But we actually, you know, talk about prescriptive
pieces of legislation. There's a very clear set of activities
that we are required to undertake, under the law. We are very
pleased to have this new responsibility, and believe that we
will make a real difference in public health, reducing
preventable disease, disability, and death.
But we are really targeted in a couple of key areas, some
of which really are novel in terms of government regulatory
activity.
Mr. Kingston. Also, I wanted to give you some numbers that
I had from your budget from 2007; that in 2007 there was a 6
percent increase, 2008 14 percent, 2009 23 percent, and in 2010
17 percent, and the proposed I think 23 percent for the
request.
And that's just so out of whack with the household budgets
and the recession that, you know, that is where my concern
about money in the big picture comes from, is just there have
been some healthy increases, which I wish I had that in my
retirement account. I wish I had that in my own salary. I wish
I had that in my own household budget. As do most American
people at this point.
But you know, that's not keyed into the economy.
Dr. Hamburg. Well, what I can tell you is that in all
honesty, I think that the budget increases that FDA has
received in the last couple of years and the request in 2011,
is vitally necessary and appropriate in terms of the essential
and unique mission of FDA and what has, in fact, been a history
of chronic underfunding in many, many vital areas to protect
the health of the public.
I think when you----
Mr. Hinchey. Now let me kind of, having said that, and I
know my time's up, but these numbers come from the CDC: 76
million food-borne illnesses are reported a year, 76 million, a
big number. Three hundred thousand hospitalizations, 5,000
deaths. Although the deaths aren't always attributable to food-
borne illnesses.
Dr. Hamburg. Mm-hmm.
Mr. Kingston. But 5,000 associated deaths. Big numbers. CDC
numbers. Three hundred million Americans, though, eating
approximately three meals a day, never snacking.
Dr. Hamburg. Unlikely.
Mr. Kingston. That would be 900 million meals a day, or 328
billion a year. So if we divide 76 million by the 328 billion,
we'd have a food-borne illness rate of 0.0002 percent, or 99.98
percent success rate, in terms of what we're consuming.
CDC numbers standard math, no editorial in there. Now I'll
begin the editorial comment, which we all share a great goal of
food safety here. But if funding is always inadequate,
something's going on beyond the government. And thank goodness
that funding, that concerned is the private sector, that even
if they didn't care, that want your repeat business, and
they're not going to get if they're poisoning you.
So there's a lot going on in terms of food safety well
beyond Washington, D.C. Otherwise, we wouldn't have such a
remarkable success rate.
And so often, when we talk about increasing budgets,
because of, you know, some processing plant having salmonella,
we sort of overexploit that, overdramatize it, in order to beef
up budgets here.
And it's good politics for everybody, and it actually
certainly comes a lot more from us than it does from you. But I
always like to inject those numbers in the record. And I know
I'm out of time.
Dr. Hamburg. Can I comment? You know, I think these are
very difficult economic times. We have to be very responsible
stewards of our resources.
But I really think, you know, that this is a major public
health concern. We're talking, numbers are, you know, not
completely accurate. They vary. But, you know, using your
numbers, 5,000----
Mr. Kingston. No, not my numbers, CDC numbers.
Dr. Hamburg. CDC's, okay. I'm sorry. But, you know, we're
talking about, you know, preventable deaths and a lot of
preventable illness. We're talking about additional costs to
the health care system. We're talking about lost productivity
in the work place, because of these illnesses. We're talking
about very significant costs to industry, because of food-borne
outbreaks, when there was the Georgia peanut contamination
problem with the Peanut Corporation of America. And it costs
the peanut industry a billion dollars.
Mr. Kingston. But that actually was a criminal activity.
Dr. Hamburg. Well, you know, sadly some of what we see in
terms of food safety does have to do with intentional, you
know, contamination. And we've seen that internationally, and
we've seen that there is irresponsible-becoming-criminal-
activity, that has allowed contamination situations to develop
and persist.
But I think that, you know, this is really a very, very
important problem that has to be looked at and measured in many
different ways.
And you know, I've been very frankly surprised and
encouraged by how much the food industry actually supports the
idea of a strong, fully functional FDA, because they see it as
in their best interests. I think we all recognize that the
problem is large, that the responsibility is shared. But the
benefits in terms of improving health and strengthening the
economy is real.
PEANUT CORPORATION OF AMERICA
Ms. DeLauro. Just--and you can get back to us on this, Dr.
Hamburg--what's the status of any criminal prosecution of those
involved with the Peanut Corporation of America? So that if
somebody could get back to us on that? Because as my colleague
pointed out, it was a criminal activity.
[The information follows:]
In accordance with DOJ policy, the U.S. Attorney's office for the
Middle District of Georgia is responsible for answering any questions
about any open investigations about this matter.
I would just say that in Iraq after 9-11, where we were
surprised with the deaths of, you know, 3,000 people or more,
we went to war in Iraq, and we spent trillions of dollars to do
that. We know that 5,000 deaths are preventable. That we did
not know was happening. We know 5,000 people die or roughly
that number every year.
I believe we ought to go war, and that responds to this
effort as well, because we know that these deaths are
preventable.
Ms. Kaptur.
ACCOUNTABILITY
Ms. Kaptur. Thank you, Madam Chair. Welcome very much.
Really glad to have you here, doctor. And wish you well in your
work on behalf of our country.
I wanted to just compare something that's happening with
invasive species and the cost to the American taxpayer of trade
agreements that are terribly flawed and do not account for
environmental health, and an analogy to your agency.
If we look down the list of what USDA in its role has in
trying to control invasive species, everything from Emerald
Ashborers, which are destroying 20 million trees in our area,
due to their import, on landscape material, it is staggering.
We're losing ten percent of our tree cover. And all the costs
of that remediation are being born by the U.S. taxpayer.
Asian longhorn beetle, destroying our hardwoods. Same
thing.
We don't deal very effectively with holding those
responsible accountable. We put the cost on the taxpayer. It's
a great deal if you can get it. That means the importer's not
responsible, the foreign company's not responsible. All the
people that made money, not responsible.
There's no international tort system that actually would
place the blame where it belongs, and rigorously, then, control
that behavior, because they would actually be made to pay for
the harm that they've done.
As I look at your responsibilities, I look at things like
heparin being imported, or recently now this hydrolyzed
vegetable protein recall. And I'm asking myself the question--
I'm looking at your budget, and you're asking for a lot more
money--$747 million, nearly a billion dollars, three-quarters
of a billion dollar's increase--and I'm saying to myself, so
we're going to put inspectors in China, we're going to put
inspectors in Mexico.
Who's going to pay for all this?
We've got more imports, bad stuff. Melamine in pet food,
heparin killing people.
And my big question to you is, how do we hold them
accountable? What's the system to hold them accountable? Rather
than our taxpayer money going into paying for their wrongdoing
and never holding them accountable? Because that's a great
deal.
They'll just keep doing it; they'll do more of it, because
they don't get caught that much.
So my first question is that.
CHINA
And my second one is related to China, since a lot of
what's been happening relates to countries that don't have
really good environmental standards. How can FDA assure, in
working with undemocratic countries like China, that don't have
transparent legal systems, they don't have environmental
standards--who would want to live in all that pollution,
anyway--how do we hold those who are profiting off that very
clever system of non-responsibility? How do we get at them?
Dr. Hamburg. Well, I think, you know, we need enhanced
accountability in both cases that you describe and very
important challenges.
In terms of our ability to hold people accountable, with
respect to food and medical products, you know, there are
varying ways that we can do it, and varying strengths of legal
leverage that we have. And it varies by product.
HEPARIN
Ms. Kaptur. Well, let's take heparin. Let's take heparin.
How do we hold responsible--maybe describe the process to me,
and I'll ask additional questions for the record. How much of
heparin's ingredients are imported versus manufactured
domestically? Who does it? And what would your guess be, would
most of the ingredients for heparin be manufactured in the
United States now?
Dr. Hamburg. Well, with heparin, you know, an important
precursor product was being manufactured in China, and still is
largely manufactured in China, from what I understand.
An American company was responsible for the ultimate
product; but they, with the heparin contamination case, had the
problem that the supply chain had this contamination upstream.
Now there are much more rigorous systems in place, recognizing
that type of problem in terms of trying to assure the safety of
the supply chain, which industry has the responsibility for,
and we have a responsibility for----
Ms. Kaptur. I'm going to interrupt you, Commissioner,
because I've only got 26 seconds here. You know how you diagram
a sentence--Maybe you're too young--back when we were taught in
school we learned how to diagram a sentence.
Dr. Hamburg. Right.
Ms. Kaptur. How can you diagram for me what happened with
heparin? From the American integrator, U.S.-based integrator, I
guess, and all the component parts that went into heparin--
let's just take that one----
Dr. Hamburg. Yeah.
ADDITIONAL AUTHORITIES
Ms. Kaptur. I'd ask you for the same on melamine, if you
can do that in the pet food disaster. How do we figure out
who's the subject of the sentence? Who are the dangling
participles? Can you do that at FDA?
Dr. Hamburg. You know, I think one of the reasons why we
are so eager to get the additional authorities that would come
with that food safety bill--and we talked about earlier the
need for some additional authorities as well as resources on
the import safety, is that securing the whole supply chain is a
complex issue, and it's getting more complicated in our
globalized world.
Ms. Kaptur. Well, could I ask you, then--you say wait for
this food safety bill. Well, right now I don't want to wait for
that bill. I support it, I support Congresswoman's DeLauro's
leadership on this so much.
But can you provide, just with one product, can you diagram
for us what happened? Does FDA today have that capability?
Dr. Hamburg. You know, I don't know whether going through
heparin is the best way to get at what I think you're asking
for, which is accountability in terms of when there are
problems, what actions can be taken----
PRECURSOR PRODUCTS
Ms. Kaptur. I want to know just what happened in this
situation. Which companies are responsible? Which
subcontractors are responsible?
Dr. Hamburg. Yeah. The problem was that the precursor
product--and you know, I wasn't at the agency at the time, so I
don't know all the details--but the precursor product was
coming from many different sites, with very little regulatory--
--
Ms. Kaptur. More than 100 sites, would you guess? More than
100?
Dr. Hamburg. You know, I just don't know. I'd be happy to
have someone brief you on the whole heparin situation----
Ms. DeLauro. Great.
Dr. Hamburg. But it's coming in. There was adulteration
that was quite deliberate, and actually, you know, fairly
sophisticated in terms of the compound that was used to sort of
extend the volume of material, and reduce the cost of
production.
So there was a contaminant that was introduced. There was
not an appreciation that that had happened. It was able to go
undetected by the existing screening methodologies. And we
learned of it when people started getting sick.
The additive that was used caused allergic reactions in
people.
PRIVATE INTERESTS
Ms. Kaptur. You know, Madam Chair, what I would really
appreciate--because this is complicated--but if we could take a
product, like heparin, and track it back and see what happened,
then we can better understand where your systems break down,
and where you are not able to guarantee public health and
safety.
And we can look at the private interests that are doing
this to us. Right now, we're all talking generally. But if we
could have a couple examples--I'm thinking of heparin and
melamine as the two that are really important to us here--if
you can help us unwind that, I think it would greatly
illustrate what we're trying to get to here.
Mrs. Emerson. Will you yield just for a second?
Ms. Kaptur. I yield to the gentlelady.
Mrs. Emerson. Because before you got here, Marcy, we
actually talked about, you know, what authorities would the
Commissioner need in order for us to better track, if you will,
all of the different ingredients, et cetera, that go into the
chemical makeup, if you will, or the parts of a pill or however
the medicine is delivered.
And so we're going to work real closely on that, because
that hopefully would then solve the problem that is very
prevalent in some cases, that you're talking about today.
So----
Ms. Kaptur. Thank you.
Mrs. Emerson. So maybe you would help us do that too?
Ms. Kaptur. Yes, I'd be glad to work with the gentlelady on
this, obviously. Thank you very much.
Mrs. Emerson. And I would welcome the opportunity to work
with you on this, because it is, you know, such an important
issue. And I think, you know, whether you're looking at heparin
or melamine, it's emblematic of a much larger set of concerns,
where we really need, you know, a new paradigm for our
approach, and we need to make sure that we have the tools and
resources to do the job.
Ms. DeLauro. Thank you. Mrs. Emerson.
And then----
LABELS
Mrs. Emerson. Thank you. I just have one more question, Dr.
Hamburg.
And it's something that I brought up with you yesterday,
but I'd like to go back into it a little bit more. And it has
to do with a potential rule published in the unified agenda of
FDA that the law that defines a label as written, printed--I
have to read this--or graphic upon immediate container, for
prescription drugs. And I know that you all at FDA have
announced a safe use initiative to reduce preventable harm by
identifying the specific preventable medication risks and
developing implementing--this is in your written description--
``implementing and evaluating cross-sector interventions with
partners.''
However, the unified agenda announces FDA's intention to
make professional prescription inserts electronic only, without
any backup system. And I mean, we all remember with great
sadness what happened during Hurricane Katrina. And we just
really need to think about that to illustrate, in my opinion,
the inadvisability of having no printed information backup
system in place.
ELECTRONIC INTERESTS
Because we have cable malfunctions, you have electric
outages, minor storms. I mean, I couldn't get my Internet to
work in my house this morning at 7:00 a.m.
So anyway, these things happen. And the fact that we have
in my district a very heavy senior population that these folks
don't use computers.
And so going to simply electronic inserts to describe side
effects of medicines and the like, to me, well, it scares me,
number one. Because I think that it could cause huge problems.
But can you explain why you all want to change a step as
important as that labeling in the patient professional
prescription process, at least before you even do a risk
analysis?
Dr. Hamburg. Well, yeah, I think and talk to people. You
know, obviously, our goal is to try to meet the information
needs of people and to help support people in the safe and
appropriate use of medications that they need. I don't think
the intention is to not make that information available to
people through other means, but their important benefits from
having a system that is electronically based, the benefits are
that number one, it's more easily accessible.
You can't lose it. And it can be rapidly pulled up by
physicians at the time they might be prescribing a drug and
very significantly it can be updated in a way that paper
inserts cannot be. So if new safety information on a product or
new recommendations for appropriate use emerge, it can be
rapidly modified on an electronic label. But we also want to
have what is referred to as a single patient leaflet, which is
an informational that can be given to a patient at the time
that they are prescribed a drug that contains the up-to-date
information on the use of that drug.
But, you know, it's important enough that I raised the
question after our conversation yesterday, but I will be
getting more information on it to make sure that I fully
understand the issues at hand, and I certainly take your
concern about the older Americans that may not be computer
savvy and have no interest in ever becoming computer savvy.
And, of course, those are among the people that are using the
most drugs. And under the most complicated circumstances in
terms of appropriate use, so we have to be sure that we are
reaching those senior populations with the best, most accurate,
and understandable information about appropriating this.
Mrs. Emerson. Well, I mean I am assuming that. So what
you're basically saying is that people will not go without
getting some kind of extra little piece of paper in their
little bag with their prescription outlining the side effects,
et cetera. But if you need more up-to-date information, you
would be able to then electronically get it.
Is that what you're saying? Because I would think that the
pharmacist would go ahead and print out for you, if that
person, the pharmacist, is asked to do so, which I think has
got to be mandatory here, because, you know, when you're taking
six different drugs, you just don't know necessarily they react
with one another.
Dr. Hamburg. What's going to be electronic, the in-package
insert, is actually, I think, viewed by most people as not what
the patients use, but many do. But there's other guidance, of
course, about appropriate use of medications that come with the
drug, the prescription, and can be made available to patients.
But the information is very important to have access for
providers and that's where having it electronic, it also can
link it in to other databases that are important for full use
of the information. So having it electronically is clearly a
benefit, especially in terms of this ability to update as new
guidance emerges and all of that.
Mrs. Emerson. Sure. I have no problem with that whatsoever.
Dr. Hamburg. But it's absolutely key that patients that are
actually using these medications have ready access in whatever
form they are likely to use to the material and that's what I
will, as I said, go back and ask additional questions. But on
my first foray into understanding the issue that you raised
with me, I was told that the intention was not to prevent
people from getting access to paper information about the
appropriate use of the medications, the contraindications to
use.
Mrs. Emerson. Right.
Dr. Hamburg. And other, really important and risk-related
information.
Mrs. Emerson. No. I appreciate that and I look forward to
working with you. I just want to make sure.
Dr. Hamburg. Yeah. No. We aren't going to make assumptions
that people will know to ask for something.
Ms. DeLauro. Sorry. Mr. Farr.
Mr. Farr. Thank you very much, Madam Chair. Thank you very
much for being selected, an honor to have you here as the
``drug czar,'' I guess.
Dr. Hamburg. The drug and food czar, and cosmetics and
tobacco.
FDA AND USDA
Mr. Farr. Yeah, everything. Well, I got elected to Congress
and learned after going through local government and state
government that Washington as the Federal Government is what we
do here is silos. And when you think of silos you think of
agriculture. Right? So, this committee, and, in fact, this
committee does a lot of silos itself, but it's the only
committee in the House or the Senate that has jurisdiction over
both USDA appropriations and FDA appropriations. So this is
really the only chance to have one stop for what I think
frankly is very awkward. And I doubt that my wife could tell me
the difference between what the Department of Food Safety and
Inspection does and what FDA does.
I don't know how many people in this room know the
difference, you know, and you think when you see the Department
of Agriculture, it relates to food. And you see the agency that
says the Department of Food Safety that it has to do with food,
everything in food, but indeed it doesn't and it's only meat,
poultry and eggs. A lot of the discussion here, frankly, is
because the issues of drugs and drug safety is so keen, and we
are dealing with food safety. And I apologize for not being
here during that dialogue. I was actually at Homeland Security.
We were talking about FEMA and about One Stop. And it seems
to me that ideally we'd have one stop for food. We wouldn't
have two different departments administering these things,
because it just becomes awkward. But on the other hand, the
majority of the food safety aspects, other than what USDA does
is in your department. And the emphasis in the department has
been probably more on drugs than on food, in reality, and
frankly your incredibly distinguished background. And the
experiences you have have been more of the urban side of
medicine and the delivery of medicine. And I was thinking that,
you know, in FEMA I mentioned this morning what we try to do
for responding to this kind of thing is to prevent it from
happening in the first place, and there's a lot of emphasis in
the FEMA budget to do prevention.
In essence, I mean, if you're doing your job, which is to
prevent these wrongs getting into the process of allowing
illnesses to develop, it is in the prevention business. So, in
medicine, you don't have a national emergency room response.
Emergency rooms are on the local level. So what I am trying to
get at is that I think you have an incredible role. We
discussed this in my office, a little bit of trying to bring
together. And, frankly, Madam Chair, perhaps in the future we
ought to have the hearing on the USDA food safety at the same
time we're having the hearing, so we can really get into the
entire range of food safety, because you have now the
responsibility, as we do this new food safety bill, of building
credibility.
I represent a really incredible amount of productive
agriculture and it's really fresh. I mean there isn't a kill
step when you go to lettuce. You know. You don't cook lettuce
and eat it. You can wash it with chlorine, but so the emphasis
is now on growing practice. It's the prevention. And I would
really love to see you be that crossover director that can
bring both USDA and FDA together on food safety, because I
don't think it's ever been done. And whenever there's an
outbreak, you know, it's a crisis between who's supposed to
respond.
CRISIS COMMUNICATION
And, frankly, as I've said, I think there's a whole need to
do crisis dialogue, crisis communication. Because when the
spinach, which most of the spinach in the United States is
grown in my district, 70 percent of all the spinach, and there
are certain seasons and months when spinach can come in from
other states and other countries, but year round. So we got
hit, probably lost $200 million in private investment. A lot of
people went out of work.
A lot of farmers and poor people were out of work. Farm
workers couldn't get jobs. And the problem is we just did a
voluntary recall, so the companies didn't collect on insurance,
because it was voluntary. You didn't have a disaster. If this
had been declared a natural disaster they would have had
disaster insurance. If it had been declared that we have to
condemn it, we would have had a takings payment, but voluntary.
And so all these people voluntarily took all the spinach off
the shelves and buried all the spinach in the fields and dumped
all the spinach in the trucks, and did all that stuff, and then
found out nobody would help them.
So then it got into, you know, maybe the call. The message
didn't come out very well, the disaster message, and perhaps we
should have thought it through before we just said--because
frankly to this day we've never recovered the consumption of
spinach and a lot of other leafy greens were affected, so I'm
not going to ask any questions right now other than because
I've submitted some to you and we've talked some in our office.
FARMERS AND FDA
My point here is I think you have a remarkable role and
this committee is the place to really bring this crossover
between USDA, because the farmers don't trust FDA. They have
never worked with FDA and you've only been there as the bad cop
in a sense, and so I think we have to win. How do we make the
FDA the support group for food safety and agriculture, because
we're going into ways that we've never done before. And what
I'd like you to do is use the ability to have a level playing
field across this country for agriculture, if indeed the best
management practices and food safety practices are being done
in some states, then require all the states to do that.
That will make for equal competition and equal reliability
in food safety. Thank you.
Dr. Hamburg. Thank you.
FOOD SAFETY--GAO
Ms. DeLauro. Thank you, Mr. Farr.
Let me try to just run through a series of questions, if I
can, because I've got a lot of questions. And again with regard
to food safety, August 2009, GAO called for changes by both
USDA and FDA, and how they act when calls involving school food
take place.
Recommendations: FNS, FDA, should complete an MOU on how
they are communicating during investigations and recalls that
might involve school food. Have FDA revise its recall audit
checks to make sure schools are adequately represented. Where
do you stand in terms of implementing these recommendations?
Dr. Hamburg. You know, we are working I think really quite
closely with USDA. My sense is, you know, it's a more
coordinated effort than in many past years. We have the luxury
of having high level people on our staff that used to work at
USDA and they have high level people that used to work at FDA,
so there is already an openness and understanding of culture.
It's very, very important.
Ms. DeLauro. Are we going to implement those
recommendations at FDA that we mentioned with regard to the GAO
report?
Dr. Hamburg. You mentioned a memorandum of understanding. I
don't know precisely what that is. We can get back to you.
[The information follows:]
In its report, the GAO Report stated: ``We recommend the Secretary
of Agriculture direct FNS and that the Secretary of HHS direct FDA to
jointly establish a time frame for completing a memorandum of
understanding on how FNS and FDSA will communicate during FDA
investigations and recalls that may involve USDA commodities for the
school meal programs, which should specifically address how FDA will
include FNS in its prerecall deliberations.''
FDA and FNS have collaborated to develop a Memorandum of Agreement,
or MOA, that will address the GAO's recommendation. Specifically, the
MOA is between the Department of Health and Human Services, Food and
Drug Administration and the following agencies within the United States
Department of Agriculture: the Agricultural Marketing Service, the Food
and Nutrition Service, and the Farm Service Agency. The MOA is intended
to strengthen and facilitate the exchange of information among the
participating agencies during investigations and recalls that may
involve USDA commodities such as those offered through the National
School Lunch Program, and the Woman, Infants, and Children Program.
The basic framework of the MOA is complete and is under review by
the agencies. Final clearance will follow, with a targeted completion
date of the summer 2010.
Ms. DeLauro. Okay. If you can get back to us on the
implementation of those recommendations that came out of the
GAO report in August 2009.
Dr. Hamburg. Yeah. Yeah, but we take those kind of
recommendations very seriously and, you know, see that that
partnership is key. And, especially as Mr. Farr was saying, you
know, get more involved in terms of activities dealing with
farms and agriculture.
Ms. DeLauro. Okay.
Dr. Hamburg. It's essential.
BINDING STANDARDS
Ms. DeLauro. You talked in your testimony about binding
food safety standards and funded by $4.5 million, and budget
authority $21.5 million in user fees. I am delighted to see
reference to binding standards. Would these only be possible if
new FDA food safety regulation is passed or are you
contemplating some way to do them under the authorities you
have now?
Dr. Hamburg. I think we want to move forward under
authorities that we have now. There may be some elements that
would be greatly enhanced by additional authorities, but I
think that there are avenues for us to pursue. You know, I'm
not exactly sure what all you're looking at there in terms of--
--
Ms. DeLauro. Well, we've always dealt with guidance, and I
tell you. If I see the word, I want to scream when I see the
word ``guidance.'' We have dealt with that for so long. You now
started to talk about binding standards, binding food safety
standards. So if you can let us know there again with regard to
that what your reference is in terms of its binding and the use
of current authority to do some of this versus having to wait.
[The information follows:]
FDA is planning to propose regulations setting clear, enforceable
standards for fresh produce safety at the farm and packing house. FDA
intends to propose a rule with the purpose of reducing the risk of
illness associated with contaminated fresh produce. FDA intends to base
the proposed rule on prevention-oriented public health principles and
incorporate what we have learned in the past decade since the agency
issued general good agricultural practice guidelines entitled Guide to
Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,
known as the GAPs Guide.
Dr. Hamburg. Okay. I hear you on guidance. I have to also
in the spirit of full disclosure say that as I've been in this
role, I can see the real utility of guidance in terms of being
able to move much more swiftly than in other domains, so that
we're going to have to have a balance.
Ms. DeLauro. You're going to have to redefine guidance for
us and happy to be open to that. But I'm up to here in guidance
for the last several years.
Dr. Hamburg. Okay.
GENERIC DRUG USER FEES
Ms. DeLauro. So, as you know of not getting us anywhere,
you know, and I appreciate the new translation of guidance.
So generic drug user fees are $38 million. 2011 proposed a
number of times. Predecessors have been optimistic about it. It
has gone nowhere. So I know about the backlog and what we need
to do to move forward and I believe in trying to move this
process forward. I would like to see a generic user fee
enacted, but without the kinds of strings attached that we have
with PDUFA.
It is my view that the performance standards have imposed
unreasonable deadlines on FDA drug reviewers and it is bad
morale, bad for public health. We recently had an executive of
one of the major generic manufacturers who is quoted as saying:
``We support user fees. The only thing we ask is performance
metrics.'' Referring to the brand name companies he said, and I
quote: ``They pay their $1.2 million and they get their files
acted upon. I would like assurances that we would not go down
that path with a generic user fee.''
Dr. Hamburg. I would only underscore ``acted upon'' doesn't
necessarily mean approved.
Ms. DeLauro. There is so much pressure on the reviewer, and
we have seen some of the adverse reactions to that recently and
have talked about them. And so I would really like the
assurance that we are not going to go that same road.
Dr. Hamburg. Well, you know, we're just beginning those
conversations. I am guardedly optimistic. I hope I won't fall
into the category of my predecessors of hitting a brick wall.
You know, I think we clearly have a situation at the present
time that's not sustainable. It is not acceptable to have
backlogs, especially when these generic drugs represent very,
very important drugs for people at affordable prices. So we are
about to begin those discussions and we will be mindful of your
concerns and the concerns expressed by others on this
committee.
Ms. DeLauro. Exactly, because we have gone down not a good
road.
Dr. Hamburg. Right.
Ms. DeLauro. And the other direction should be visited.
Dr. Hamburg. And I think, you know, the other aspect of
this is that we want to have accountability in everything we
do, but we also don't want cumbersome metrics that actually end
up slowing the process and distracting us from the ability to
actually address the review process and the backlogs, and make
the decisions that need to be made. So I think, you know, those
are going to be certainly issues for me going into these
discussions.
BLOOD COLLECTION AND THE RED CROSS
Ms. DeLauro. A quick question. First of all, I applaud the
work of the Red Cross, and I think they do just wonderful,
wonderful humanitarian work. On the other hand, we have for a
quarter of century the FDA has really grappled with issues
related to blood collection by the Red Cross.
FDA has two consent decrees, assessed the Red Cross at
least $20 million in fines. The problem still seems to be
unresolved. How do we fix this?
Dr. Hamburg. You know, this has been a saga that has
persisted for much too long. We have been in intensive
discussions. We see measurable progress and that's encouraging,
but we haven't gotten far enough. We are trying to really sit
down and figure out a systematic oversight mechanism so that we
can be extremely explicit about what we expect and how we are
going to measure their progress towards those goals. And, you
know, we are going to use the other tools, regulatory tools we
have in terms of fines as we also work with them.
Ms. DeLauro. Red Cross deals with 40 percent of the
nation's blood supply. Look. This is an October 30, 2009 letter
to the Red Cross. FDA said about 231 significant violations at
12 Red Cross facilities across the country. As I say, you know,
they're the first on the scene. There's all kinds of
humanitarian great work that they do, but this smacks of a very
serious problem that they have. They oversee 40 percent of our
blood supply.
Dr. Hamburg. Right.
Ms. DeLauro. So, you know, this is not one where I think--
you know, we've got to get it done. It's got to get done fast.
Dr. Hamburg. You know, I hope that very soon I can report
back to you that we have made the kind of measurable progress
that you're looking for. You know, we have asked them to do
some very rigorous changes in their program management and
oversight. They have modified, you know, their systems and
their governance. We are still, you know, watching and working
with them very carefully because they are not where they need
to be. And, you know, it has been surprising to me to look at
the record and how long this has persisted. And I share your
concern that this cannot go on as it has been going on.
Ms. DeLauro. Well, and continue to let us know how we can
be helpful in this regard. I mean, this is outrageous that this
has gone on for so long.
Ms. Kaptur.
ECONOMIC COSTS OF VIOLATIONS
Ms. Kaptur. Yes. Thank you, Madam Chair.
Commissioner, how does one quantify the true economic cost
to our country of the food and safety violations that your
agency regulates? Has GAO ever done a study on that?
Dr. Hamburg. You know, I don't believe that there's been
that kind of comprehensive analysis. You know, we have talked a
little bit about how that kind of analysis would be helpful to
us in terms of I think talking about, you know, the funding of
FDA and the resource base, and our ability to fulfill our
mission, I think if people really understood the broad,
economic consequences and inability of FDA to fulfill its
important roles and fulfill them well, you know, I think
perhaps it would be more understandable why the kind of
investments that have been made in the last couple of years are
appropriate and necessary, and are moving us towards getting us
to where we need to be.
Ms. Kaptur. Thank you. I think, Madam Chair, this is an
area we ought to think about encouraging to take a look at the
full, weighted cost of this, and the budget that the FDA has,
because we have the costs of obviously illness, people not
being able to go back into the workplace. There are all kinds.
There's a quantification that one could be of what the true
costs really are, and perhaps we can ask the GAO by letter to
do that as a part of our work.
Ms. DeLauro. With regard to that, I understand that there
was a peer study that has done some work in that area, and why
don't we take a look at that and see how comprehensive it is
and see what else we might be able to do.
Ms. Kaptur. Then I have a series of questions. You may not
be able to respond to all of them, but you'll get the trend of
the thinking, and perhaps the agency can respond.
Dr. Hamburg. Okay.
HEPARIN
Ms. Kaptur. Okay. Describe to us what Heparin is medically
used for. What is its cost to the average patient who is billed
under Medicare for that product? How many pharmaceutical
companies supply the final product in our marketplace? Would it
be more or less than 10 companies? And give the names of those
companies. How large is that market in this country, the
dollars annually expended for the procurement of that product?
How many companies do the separate ingredients come from?
That goes back to my sentence diagramming I referenced in the
prior questioning period. And what percent of Heparin's
ingredients are domestically produced versus foreign produced?
Do you have a feel for any of that at this point, any one of
those questions or how you could obtain that information?
Dr. Hamburg. Well, I can tell you what it's medically used
for.
Ms. Kaptur. Okay.
Dr. Hamburg. I can't answer your questions about cost or
number of producers.
Ms. Kaptur. Is FDA able to get inside information?
Dr. Hamburg. We can certainly give you a much more
comprehensive and informed response than if I tried to answer
now. I mean it's an important drug in terms of its medical use
for thinning of blood and preventing clot formation that can
cause stroke and pulmonary embolism and other complications. It
is a product that has a supply chain that involves
international sources for the precursor products. It has, I
think in terms of the production. I think there's one U.S.
manufacturer at the present time, but, you know, I think we
should get back to you.
Ms. Kaptur. Yes. Would anyone on your staff know that and
be able to state it for the record at this point? And that so-
called provider would actually be an integrator of components
that come from somewhere else. Am I hearing this correctly?
Dr. Hamburg. Yeah. I mean many of the drugs that are used
in this country are composed with components that come from
other places. Actually, about 80 percent of the active
pharmaceutical ingredients in drugs that we use in this country
come from overseas, so Heparin is not unique in that way.
Ms. Kaptur. I am hearing you.
Dr. Hamburg. But I think we'd be happy to provide you with
a detailed response.
PHARMACEUTICAL COMPANIES
Ms. Kaptur. If you could give us straight what's going on,
and I'm very interested in looking at the Medicare payouts and
the Medicaid payouts for the use of these pharmaceuticals, and
who is benefiting in this marketplace. When I find the name of
the company, companies, then I'm going to go to the stock
exchange and see if they're there, and what their profits were
last year.
I am very interested in this marketplace and who actually
controls it. If it's only one supplier, wow. That's pretty
amazing. I thought, I mean, there obviously aren't a hundred
suppliers of Heparin is what you're saying to me from your
knowledge.
Dr. Hamburg. You know, I am reluctant to be specific
because I don't actually know the details. That information
exists. I'd much rather go back and get you accurate
information, and I think we can supply that.
Ms. Kaptur. As a physician, do you know if I am in the
hospital and I am a patient, how many bags or how does this get
injected into the patient? Do you need it forever?
Dr. Hamburg. No, you need it in an acute setting.
Ms. Kaptur. An acute setting?
Dr. Hamburg. It is intravenous medication.
Ms. Kaptur. And what would be the cost of that? As a
physician do you happen to know in New York City if you have to
have Heparin how much are you charged in the hospital?
Dr. Hamburg. It's been more than a decade since I've
administered or prescribed Heparin, so, you know. Let me get
back to you with, you know, the concrete data that you are
asking for, because that information exists.
Ms. Kaptur. Okay.
Dr. Hamburg. But I would be fishing if I tried to provide
that to you now.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Kaptur. Thank you very much. Thank you, Madam Chair.
Ms. DeLauro. Mrs. Emerson.
DIRECT CONSUMER ADVERTISING
Mrs. Emerson. Dr. Hamburg, let me follow. The Chair had
started the discussion about direct consumer advertising, and
let me just discuss it a little bit more in detail and ask you
a couple of questions. There's a ``New York Times'' article of
March 5th that talks about the amount of money that drug makers
spent in advertising in 2009. It says that the drugmakers spent
a combined $4.51 billion on directed consumer ads for
prescription medicines. Two-thirds of that or $3 billion went
for TB. Another 1.9 billion was spent on magazine ads, with
both levels nearly the same as they had been the year before.
Newspaper ads increased by 11 percent to 162.6 million.
Radio ads jumped by 112 percent to 46.3 million. Spending on
Internet ads, which has doubled over the last five years, hit
117.4 million, up 31 percent, while 7.6 million was spent on
outdoor ads such as billboards. Now, I do know on the Internet,
I mean I have more spammed drug ads coming to my BlackBerry
than I know what to do with. But, anyhow, be all that as it
may, the Chairwoman and I are sponsoring legislation that would
ban direct consumer advertising for new drug and device
products in the first three years after approval of the
product.
And certainly now, just by looking at these ad numbers, it
is probably not something that is particularly popular among
the drug industry and our broadcasting and media friends. But
we are only one of two countries in the world, with the other
being New Zealand, that do allow DTC.
So my question is: What are you all doing about these ads
to make sure that they are accurate and properly warn consumers
about the side effects? What are you doing to make sure that
FDA's increased resources are protecting the public from
misleading ads? Has the FDA used its increased resources to
hire more people to review the direct-to-consumer ads for
devices and for prescription drugs?
Dr. Hamburg. A very, very important set of questions. And I
have to say I was startled when I learned that we were one of
two countries in the world that had direct-to-consumer
advertising.
And I think that we have expanded our activities in terms
of review in the direct-to-consumer arena thanks to additional
resources. But it has been an area of FDA activity that has
been very minimal in terms of staffing vis-a-vis, you know, the
volume of products.
I think you raise another important question about the
timing of when ads go up. And we certainly do know that most of
the advertising is focused on new products, and that is early
when we know less about potential safety issues that may
emerge. You know, so that is something that I have been
thinking about and worrying about.
We do review the ads and can take action when we think
that, you know, there are misrepresentations or inadequate
presentation of risks, et cetera. But the volume makes this
very, very difficult, the fact that, you know, we don't review
them, sign off, and then they go up, so we are sort of always
running to keep up.
I think it is an area that requires more scrutiny.
Obviously, there are important First Amendment issues here and
other things. But from a public health perspective, you know,
we want to make sure that people get information to help them
make the right choices to protect their health.
ADVERTISING AND THE PUBLIC HEALTH
Advertising certainly is a very effective way of
communicating messages. I would like to see advertisements
contain more fundamental public health information, even if
they are advertising a product; it is an opportunity to
potentially provide some basic information about the underlying
medical condition to help consumers know more and make better
choices.
But, you know, it is a very important area. I think it is
an area where we are strengthening our activities. But I cannot
say that I think that we have reached the appropriate,
necessary system in terms of our oversight ability. And also, I
think further discussions with many partners--you know, the
public policymakers and industry about how we can address this
issue in a way that, you know, really makes sense for the most
important people, which are----
Mrs. Emerson. Well, half the time--no, I shouldn't say half
the time; that is an exaggeration. In some instances, you know,
it seems that I, at least personally, have learned about new
diseases that I never knew existed simply because now there is
a drug being marketed to tell us about like restless leg
syndrome.
For example, I mean, seriously, if I got a crazy horse in
my leg at night, I got a crazy horse in my leg, got up, walked
around, and it was gone. I mean, it is just--I just--I feel
real strongly that it needs to be--I mean, the oversight
probably needs to be much tighter.
But I also am a little bit concerned, too, about the
proliferation or the possible proliferation of these ads on
social networking--Twitter accounts, Facebook, I mean, all
sorts of things where there is really no ability to provide any
kind of--what do you have, 40 characters or 40 words? There is
no way to say, you know, this side effect has blah blah blah,
like all the TV ads do.
So, I mean, it is very worrisome to me.
Dr. Hamburg. No. There are real issues.
Mrs. Emerson. And I think we need to have some special
attention focused.
Thank you, Madam Chair.
BPA
Ms. DeLauro. Thank you. Let me again try to run through a
whole bunch of questions.
As a quick followup on the BPA discussion, Commissioner,
are you aware of the study that was done by the Yale
scientists?
Dr. Hamburg. You know, I have not looked at it directly. I
understand that it was a study that was done in mice, and using
much higher doses than humans would normally be exposed to.
But, you know, I think----
Ms. DeLauro. I know you will read it. Let me just--or have
your folks take a look at it. I would love to be able, you
know, to review the findings and see what we have there. I
think that would be helpful.
Dr. Hamburg. It is very important, you know. You and I
share a commitment to having our decisionmaking be driven by
data and evidence. And we need to look at everything that is
out there, assess it, engage in a robust discussion of the
science, and then hopefully make the best possible decisions.
SALMONELLA MONTEVIDEO
Ms. DeLauro. Great. This Salmonella Montevideo recall, this
is an interesting one because we are dealing with, I think,
salami and black or crushed red pepper. And excuse me for
saying this again. This is, you know, being reviewed by two
different agencies, USDA and the FDA.
But there is a likelihood that the pepper was imported. Can
you tell us where the pepper--what country or countries the
products in question came from?
Dr. Hamburg. I believe that there were a couple of sources
for the pepper, and that they were international sources. I
hate to start pointing fingers when I don't know. Vietnam was
one of the sources--and Mike Taylor has disappeared. But, you
know, we can get you the specifics.
[The information follows:]
The FDA, working with the Centers for Disease Control and
Prevention, the USDA Food Safety and Inspection Service, the State of
Rhode Island, and other states, are investigating the recent Salmonella
Montevideo outbreak associated with salami products. During the
investigation, FDA collected 238 samples of black pepper, red pepper,
environmental samples and other spices. Of the samples collected, 211
were negative for Salmonella, 6 were positive for Salmonella Montevideo
matching the outbreak strain and 6 were positive for Salmonella
Montevideo which did not match the outbreak strain. FDA is still
processing fourteen samples.
All positive Salmonella samples were collected at the manufacturer
of the salami products, Daniele International. The positive samples
traced back through different supply chains to Vietnam, India, and
possibly China.
Based on the evidence it currently has, FDA has not been able to
conclude where in the supply chain the contamination may have occurred.
as part of the investigation and as a precaution, FDA established
additional import controls on spices from firms or countries associated
with these supply chains. As a result of these import controls, FDA has
found one positive sample involving a strain that is not association
with the outbreak.
Ms. DeLauro. That is fine.
Dr. Hamburg. But there were international sources, and
there were, you know, multiple sources in terms of the
companies involved.
Ms. DeLauro. Okay. Now, I also understand that FDA started
a risk profile on spices last spring. When do you expect that
to be completed?
Dr. Hamburg. Again, I need to get back with you on that.
But spices do represent, you know, a special concern because
once they get into the food supply, they are everywhere.
[The information follows:]
FDA is in the process of taking a closer look at the
handling of spices from farm to table. In the spring of 2009,
FDA began work on a spice risk profile. A risk profile is
designed to capture the current state of knowledge related to
an issue under FDA's jurisdiction and identify any knowledge
gaps.
This particular risk profile focuses on microbiological
contaminants and filth issues related to spices. Some members
of the spice industry have already agreed to provide data to
FDA for the risk profile. The risk profile will provide vital
information to FDA officials who make risk management
decisions. The information will also help FDA determine the
best way to mitigate foodborne illness issues associated with
spices. Specifically it can help FDA determine how to allocate
resources, whether guidance for industry or for FDA inspectors
is appropriate and whether there is a need for new rulemaking.
CLINICAL TRIALS
Ms. DeLauro. Right. A quick question on the oversight of
clinical trials and your acknowledgment that FDA currently
inspects less than 1 percent of clinical trial sites. And, you
know, the issue is that without inspecting these sites, it is a
matter of time before we have bad data that might lead to bad
decisions.
There is also, as I understand it--we have got, you know,
the outsourcing of clinical trials, which is posing--and
offshoring the trials, which has been--at least, newspaper
accounts talked about some concerns about the lack of
safeguards for the participants.
I was pleased to see that in the budget, you are looking at
the problem. The request is for $500,000 in one FTE for
bioequivalence in generics. Let me just ask you: Don't we need
more to deal with this?
Dr. Hamburg. You know, this is why I gave Congressman
Kingston my response about, you know, I don't see our budget
increases as being excessive. I think that, you know, we have
such a depth and breadth of responsibilities, and
responsibilities that are so essential in so many different
ways.
And, you know, in many instances--in most instances--we are
undertaking activities that nobody else is prepared to do if we
don't do them. And so, you know, yes, there is more work to be
done. You know, we are building on a foundation that has been
strengthened thanks to the investments that this committee has
helped to spearhead for us in recent years.
We have to be realistic about how much we can absorb each
year in terms of really putting those dollars into practice in
a responsible, accountable way. But, you know, I cannot come
before you and say that we don't need to keep continuing to
expand in some essential areas that are a priority for health.
GRAS
Ms. DeLauro. Yes. Well, it would seem to me that that would
be one of them.
Let me ask a question about GRAS substances. A GAO study
again, how FDA handles what are referred to as generally
recognized as safe. I have real concerns about some of the
substances that are allowed in the foods through the GRAS
process.
I have looked at the diacetyl issue, you know, for the last
several years, diacetyl in popcorn and lung disease. The system
is voluntary. Companies can make these decisions without
informing the FDA. To me, that is unacceptable.
What is your position on reforming the GRAS system?
Dr. Hamburg. Well, you know, I think it is one very
important area of, actually, a number of arenas of activities
where I think we have a responsibility to sort of systemically
look at how, in the modern era, we need to upgrade, modernize,
or modify our regulatory frameworks.
And some of that, of course, will require ongoing work with
Congress. Our new general counsel, Ralph Tyler--who was here, I
think--and I have had the discussion about how important it is
that we look at some of this because, you know, FDA has a
wonderful history. But many of our authorities and our
procedures and our legal framework was put into place in a very
different era. And we need to address that.
NANOTECHNOLOGY
Ms. DeLauro. Because, I mean, I think we are also looking
at the regulation of nanotechnology materials in foods under
that GRAS determination. You know, if this is all voluntary, we
have no way of knowing what foods contain nanotechnology.
I am going to maybe answer the question I asked you. I have
to imagine that it is an affirmative. Do you think this is a
safe way to regulate materials that we know little about? I
mean, the answer to that--how can it be, you know, a safe way
to do that?
Dr. Hamburg. You know, I think it may be useful in certain
categories, but for other categories, it is not. And I think we
have to look at that, you know, and ask just the questions that
you are asking. I share your concerns.
Ms. DeLauro. But let me ask this: Has FDA decided to allow
these materials in food with no warnings or labelings before we
have had adequate research on these? Are we allowing
nanotechnology?
Dr. Hamburg. With respect to nanotechnology? Well, you
know, nanotechnology is present in a whole range of products.
We take very seriously our responsibility to look at the
emerging technology in terms of safety concerns, short-term and
long-term safety concerns. But it is an issue that we need to
address with respect to foods, with respect to cosmetics, with
respect to drugs and devices as well.
And we are--you know, this budget has requests for
additional dollars to strengthen our nanotechnology activities.
And, you know, we have a program that was put in place. We are
also working with some external experts to help us look at the
data and ask these questions, too.
DIETARY SUPPLEMENTS
Ms. DeLauro. I would just say this. I think that if we are
looking at funding to check into this and doing the research, I
don't think we can do two things at the same time. We need to
get the research in order to do it, in order to say they are
safe, and so you can say that without equivocation.
And so that is what I would just, you know, offer, to say
this: You can't do both things at the same time. Let's get the
research and then make the determination as to whether or not
they are safe. And it seems to me that we don't have the
research now that allows for them to be designated as safe,
which again calls into question this area, which I take you at
your word that you are investigating.
Let me move to dietary supplements, a GAO report on FDA's
work on dietary supplements, January 2009. This has all kinds
of statistics on how rapidly growing the industry is. I found
interesting that there was no reference in the budget for
additional funding for dietary supplement work by the FDA. You
know, is that correct? And if so, why?
But also, I wanted to get your view on the bipartisan view
in the Senate, Dorgan and McCain, that would require supplement
manufacturers to register with FDA, to disclose all the
ingredients in their products. It would also give FDA mandatory
recall authority to remove dangerous products from the market.
This is a recommendation of that 2009 GAO report. Do you
think you should have these powers?
Dr. Hamburg. I haven't had a chance to review that bill.
But, you know, I share your concern about assuring that these
dietary supplements that people take, assuming that they are
safe and will actually promote good health, we need to make
sure that they are in fact what they purport to be and that
they will not do harm.
DSHEA
You know, we got new authorities through DSHEA, and we are
still moving towards full implementation on the good
manufacturing practices side. For example, we expect that all
of the businesses, including the small businesses, will be on
board by 2010. But that is very important.
Ms. DeLauro. The safety issues are critical.
Dr. Hamburg. The adverse event reporting has been very,
very important. You know, I think it was in 2007 you gave us
that additional authority. And based on that, we have taken
enforcement actions. You raised that in the beginning, you
know, removing some dangerous products from the shelves and
providing consumer information as well.
I think that we do have money in the 2011 budget, and we
had additional new money in the 2010 budget. So we are
continuing to expand activities in that area. And of course,
the inspectional activities are part of that.
But, you know, I will look with interest at this bill in
terms of what additional authorities are----
FOOD LABELING
Ms. DeLauro. I will tell you what I think I would like to
do in this area. And I think that in the course of our hearing
process is to--I mentioned earlier we will do one on trade and
food safety. I think we need to do a hearing on dietary
supplements. I think we need to look at this area.
When you have got 50,000 safety violations or incidents a
year and issues, I think that merits us taking a look at what
is happening here. And this is not--I just think it is a very,
very big issue that hasn't been discussed at all, you know. And
so we need to really move in that direction.
Affirmative labeling. Front-of-package nutrition labeling.
And I guess a couple of my colleagues have mentioned that. You
know what a strong advocate I am of your role in regulating the
packaging and the issue of confusing and misleading labels. And
I commend you for the actions that you have taken. And we went
through this issue with the Smart Choices piece.
But there is a guidance letter, I guess, in 2009 regarding
food labeling. You say that the FDA will proceed with
enforcement actions against products that have false or
misleading labeling. The guidance document, can you update us
on the activities of that?
Dr. Hamburg. Last week, we in fact sent out 20 warning
label letters, I think, on that topic.
Ms. DeLauro. That is right. You said that.
Dr. Hamburg. So we are, you know, taking it very seriously.
Ms. DeLauro. One of the concerns--you have got the Journal
of the American Medical Association carried an article
suggesting that the problem of front-of-package labels has
become so serious that we should consider banning claims from
the front of packaging. What do you think about that idea?
Dr. Hamburg. Well, there certainly are a lot of claims on
the front of packaging.
Ms. DeLauro. Right.
Dr. Hamburg. You know, every available space is used for
something. You know, I think----
Ms. DeLauro. I know you are looking at developing criteria
in this area, and part of the budget document is----
Dr. Hamburg. Yes. I think that the front-of-package
information is mixed in its value. I mean, I think there is a
very positive, proactive value to providing accurate, science-
based nutritional information on the front of the package. I
think, you know, the concern is about the sort of cacophony of
other messages, you know, that are on the front of package.
Ms. DeLauro. Right.
Dr. Hamburg. And I think, you know, the question about a
ban obviously extends far beyond, you know, the
responsibilities of FDA and get you into other domains.
But I think, you know, it is very, very important that we
have the opportunity to provide important nutritional
notification that people want. I think it is very, very
important that that not be clouded by claims that are
misleading, inaccurate, or fraudulent.
Ms. DeLauro. Are you going to put together a regulation in
this area? Is that what you are going to do? And what is the
timing on that?
Dr. Hamburg. Well, we currently are undertaking some
consumer research about how people respond to information. We
are working on, you know, and looking at sort of different
models for presenting information.
We are working on standards for nutritional information
that would be used in whatever presentation format was decided
upon, where we are trying to work with industry, with
manufacturers and retailers, to find a presentation approach
that they are comfortable with. Actually meeting with the
Grocery Manufacturers of America later today to talk about some
of these issues.
We are trying to learn from the experience of other
countries that have moved, either voluntarily or mandatorily,
to different types of front-of-package nutritional labeling. So
we are moving forward. I mean, I hope by the end of the year we
will have a strategy well established and even beginning to
implement.
SMART CHOICES
Ms. DeLauro. As part of this discussion, when I--and this
was on the issue of the Smart Choices debate that we had--when
I talked to the folks from Smart Choices, you know, several
months ago--and obviously you moved in a very aggressive
direction here, which was laudable--one of the things they said
that they were dealing with was nutrients to limit--total fat,
saturated fat, trans fat, cholesterol, added sugar, sodium, in
some cases calories. And they were following that guide.
And the point I want to make here is that they said, in
particular, the limitations set for saturated fat, cholesterol,
and sodium are equal to or lower than FDA's healthy
regulations, and the level set for trans fat is consistent with
FDA policies, where no governmental level has been set.
Regarding added sugars, it is important to note that FDA
does not restrict added sugar levels in any of its applicable
nutrition-related regulations. So by addressing added sugars,
the Smart Choices criteria go farther than FDA regulations in
this regard.
Are you looking at that?
Dr. Hamburg. We are looking at the issue of added sugar,
and we, I think, plan to have that as part of our updated
standards.
INDOOR TANNING
Ms. DeLauro. Great. Thank you. Thank you.
A couple more areas here. Indoor tanning devices, which we
have talked to. And there again, I believe you have an advisory
committee meeting coming up some time this month?
Dr. Hamburg. Yes. Yes. Yes. Yes.
Ms. DeLauro. Assuming the advisory committee confirms the
new data and finds that there is an increased risk of using
these devices, what are the next steps the agency intends to
take, and what would be the timetable for those next steps?
Dr. Hamburg. Well, you know, of course, I am not going to
jump in front of the advisory committee. But we will take very
seriously their recommendations, and I think we will move
towards action steps quickly. This issue, as you know, has been
out there for a while, and I think we do need to take
definitive action.
And I think, you know, as you have pointed out, there are
issues around the adequacy of the warning, and there are issues
around the safety of the procedure.
Ms. DeLauro. Right. In addition to examining the
possibility of reclassifying the devices, you are going to look
at the current labeling requirements for indoor tanning
devices. Is that right?
Dr. Hamburg. Yes.
Ms. DeLauro. Okay. Let me--really, I truly only have a
couple more questions, I promise you. So----
Dr. Hamburg. No one can accuse you of being disinterested.
ANIMAL BIOTECHNOLOGY PRODUCTS
Ms. DeLauro. Animal biotechnology products. Whoa. I can
start by saying that this is--your budget requests $1.9 million
to build expertise for the regulation of these animal
biotechnology products. It is not a large amount of money. It
is large in comparison to some of the other increases in the
budget.
Understanding the value of these products, I hesitate when
I read that: ``This investment will create a regulatory pathway
for animal biotechnology.'' I think--I mean, I know FDA over a
year ago approved the first biological product produced by
genetically engineered animals three weeks after issuing
guidance on the regulation of such animals.
So I have a question there: Shouldn't the pathway already
exist and have been used for the February 2009 approval? How
will this pathway differ from the regulatory pathway for other
drugs to treat human disease? And how many applications are
already in the queue at the FDA? Can you talk about which
stakeholders the FDA plans to work with on this initiative, and
how you hope to increase public confidence in the FDA's ability
to regulate this technology.
Dr. Hamburg. Well, you are right. There was, you know, the
action that you cited taken at an earlier time. But there are
different--we are talking about sort of different products and
uses here so that there isn't one common pathway because there
is the possibility of products that are produced by animals
using these recombinant technologies, and there is also the
possibility of these technologies being used for food
production.
Ms. DeLauro. Right.
ADVANCING REGULATORY SCIENCE
Dr. Hamburg. You know, these are areas of emerging science.
And this is why, you know, those investments that we talked
about before in Advancing Regulatory Science are so important
because, you know, these are areas where we need to have the
in-house scientific capability to assess fully these emerging
technologies.
We also have to have the access to appropriate outside
experts. They do raise, you know, complicated issues that go
beyond simply the science of safety as well. You know, you
appropriately addressed the issues of confidence of the public
and openness of information to consumers.
So it is a complicated area. And I think, you know, we are
moving forward in a stepwise, thoughtful, and science-based
way. But, you know, there definitely is a need to address this
in a way that isn't a cookie cutter approach or just, you know,
a stamp it kind of bureaucratic approach.
And it is an area where, while there is a limited number of
products that have come before us, you know, I think we can
only sort of anticipate that as science advances, that we will
be asked to look at more products and different types of
products.
Ms. DeLauro. I think I just want to say on this, and maybe
it would be a more informal gathering because, really, I mean,
there are, you know, new dimensions. And for the entire
committee, both side sort of the aisle, maybe we could do
something in an informal way that talks about--an informal
meeting where you can lay out for us some of these new areas.
You know, I am not a scientist, so mysteries to me. And I
look at, you know, a chart like that and I say, whoa, you know.
Where are we going?
Dr. Hamburg. Yes. Yes.
Ms. DeLauro. But, you know, I mean, I think that there are
new areas. And we need to stretch the edge of the envelope in
terms of that research. But I also think it would be enormously
helpful for those members of the committee, again, on both
sides of the aisle that would like to get the benefit of
understanding what those new areas are where we can ask
questions about it and have everybody be able to ask questions
about it.
Dr. Hamburg. Okay. I think that would be useful for
everyone.
FOOD SAFETY REGULATION
Ms. DeLauro. I essentially have one more question. I
actually have two. But the food safety legislation, I just want
to ask you, because the Senate is going to act, what are the
critical pieces of what has happened in the House that you
believe we have to come out with in the Senate?
Dr. Hamburg. Well, you know, I do think that the user fee
issue is absolutely essential in order to give us the resources
that we need to undertake the job. I think mandatory recall
authority is essential in order to have the kind of swift
action and accountability that we all know is important.
I think routine access to records is critically important
so that we can really assure a preventive approach in
compliance with these activities. I would say those are
probably the most essential.
TRACEABILITY
Ms. DeLauro. For my purposes, the performance standards and
the, you know, traceability process----
Dr. Hamburg. Yes. Yes. Absolutely.
Ms. DeLauro [continuing]. I think are absolutely critical
to getting us where we need to go, and recall authority,
obviously; we have been talking about that for a long time. So
obviously, we are going to--you will. We are going to keep a
close watch on what is happening in the Senate.
OFF-LABEL ADVERTISING
A final question is the off-label marketing guidance that
was issued at the end of the last Administration, six days
before it ended. This is about guidance to facilitate off-label
promotion of drugs and medical devices by drug and medical
device companies.
I don't know what your views are on that policy. And will
you move to withdraw it or to revise it?
Dr. Hamburg. You know, I am not prepared to speak
specifically to the question that you posed, but to say that I
take the issues of off-label advertising and promotion very
seriously because, you know, I think it is moving health care
providers and consumers to understand that a use of a
medication is proven when, you know, it hasn't been approved by
the FDA for that indication.
In the practice of medicine, you know, there has always
been the flexibility to provide medications based on your best
clinical knowledge and experience. But I think to mount, you
know, campaigns to encourage use and provide what is often
limited scientific studies to support a perspective that isn't
fully vetted and hasn't had the benefit of formal review, I
think is not good for patients. And I think the legal system
has also demonstrated that it goes beyond the boundaries of
what is appropriate practice and legally sanctioned.
Ms. DeLauro. Well, I hope you will give it some thought and
see what you will do either to revise or to withdraw the
guidance. And we can talk further about that.
Dr. Hamburg. Okay.
Ms. DeLauro. With that, I want to say thank you to you for
your candor, for your clarity, and for elucidating a number of
issues. And I appreciate it. Look forward to working with all
of you.
I applaud all the initiatives so far, and the
aggressiveness with which you are approaching, if you will, a
restructuring of the FDA and bringing it to what both sides of
this committee have talked about for a long time, is restoring
that gold standard to the Food and Drug Administration.
Thank you very, very much. Appreciate it.
Dr. Hamburg. Thank you.
Ms. DeLauro. The hearing is concluded.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Wednesday, April 28, 2010.
DRUG SAFETY
WITNESSES
HON. CHUCK GRASSLEY, RANKING MEMBER, SENATE FINANCE COMMITTEE
HARLAN KRUMHOLZ, M.D., MSc, HAROLD H. HINES JR. PROFESSOR OF MEDICINE
AT YALE UNIVERSITY SCHOOL OF MEDICINE
DR. SIDNEY WOLFE, DIRECTOR OF THE HEALTH RESEARCH GROUP AT PUBLIC
CITIZEN
Ms. DeLauro. The hearing is called to order. First I want
to welcome today's speakers. On the first panel we have the
Ranking Member of the Senate Finance Committee, Senator Charles
Grassley of Iowa. And on panel two, Dr. Harlan Krumholz, Harold
H. Hines Jr. Professor of Medicine at Yale University School of
Medicine, Dr. Sidney Wolfe, Director of the Health Research
Group at Public Citizen.
I want to say a thank you to all three of you for being
here today for your hard work on the issue of drug safety. And
Senator, I want to say a particular thank you to you for taking
the time for joining us on this side of the Hill. I'll be
honest, members here who don't often see senators cross the
divide and come and do hearings on this side. I want to thank
you for your leadership as well in producing the staff
committee report that will be discussed today. And also
personally I would just say is you and I have interacted on the
drug safety issue, but also on the farm bill when we sat
together for all of those hours trying to do what's best for
this nation with regard to its farmers and to rural America. So
it's an honor and it's a pleasure to have you here with us
today.
Regarding this troubling report, first--let me just say
this. The report poses many questions, and as the subcommittee
with jurisdiction over the FDA, it behooves us to look at it,
to address it. While we did not invite representatives from
Glaxo and the FDA to discuss the matter today, on account
specifically of their own pending negotiations, we do have the
senator with us of course. We have two independent experts to
help us to sort through the information today.
Regarding the troubling report, let me first say that by
bringing lifesaving drugs to the marketplace, pharmaceutical
companies are applying our country's greatest resource, its
innovative spirit to help people live longer, healthier, more
productive lives. Most people at some point experience the
direct reach and the power of these drugs to cure illness, to
heal wounds or to halt disease. I am here today as someone who
has felt that power when more than 20 years ago I was diagnosed
with and survived ovarian cancer. And so when the FDA is
weighing whether or not a particular drug is safe enough to be
on the market, I understand that there are often many competing
issues in play. Sometimes people suffering from a given illness
after consultation with their doctors will willingly accept
some extremely severe side effects for a chance at relief or
recovery. Case in point, chemotherapy, where we factor in some
truly terrible consequences only because the disease of cancer
is still more life threatening than the cure.
So as both the preeminent guardian of the public health and
an agency whose mandate emphases innovation, part of the FDA's
responsibility is to carefully weigh these sorts of pros and
cons before coming to a conclusion about the safety of a given
drug. But to be able to make these important, indeed life or
death decisions on behalf of the public health, the FDA
scientists and regulators need to have all the pertinent
information about a given drug at their disposal. They need the
regulatory tools and the regulatory science capacity to draw
their own independent and unbiased assessments of a drug's
safety. And if a drug is in fact deemed unsafe by the agency,
the agency needs the structural and the political capacity to
ensure its recommendations are subsequently put into action,
followed and enforced.
Which brings us to the case before us today concerning the
diabetes drug Avandia. As you all know, the Senate Finance
Committee staff investigative report revealed that for many
years the manufacturer knew much more about the risks of the
drug than it revealed to the FDA. This report poses several
troubling questions for this subcommittee. Most obviously if
Avandia is unsafe, how did it ever get on the market in the
first place? For that matter, why is it still on the market
right now? What does the case of Avandia tell us about the
FDA's current ability to conduct its drug safety
responsibilities?
Looking at the details of the Avandia story, the major
studies suggesting this drug was safe was the Record trial, R-
e-c-o-r-d, sponsored by its makers GlaxoSmithKline. As we now
know and as the Senate committee staff report reaffirms,
serious questions have been raised about this clinical trial's
scientific merit. And last month the Mayo Clinic released an
analysis which found 90 percent of the scientists who published
articles supporting Avandia had financial ties to Glaxo.
Astonishing to me is the fact that in June of 2007, two
scientists at the FDA's Drug Safety Office, after going over
all the evidence recommended that Avandia be removed from the
market. But nothing came of this decision, and in fact, Avandia
is on the market right now, pending the findings of the TIDE
study which is expected to be published in 2015. 2015. We
should not take so long to study a drug about which such
serious safety issues have been raised. As the Senate report
and others have noted, lives are at stake, and one has to
wonder what is the purpose of a drug safety office if its
recommendations are ignored at the agency.
Consider how long this process has already taken. When this
drug was approved in 1999, the FDA requested that Glaxo conduct
a post-market study, the ADOPT study, which finally came out in
2006. In the intervening years, Glaxo continued to praise their
new drug even as scientists on their staff began to recognize
and flag serious problems with Avandia. And now we are talking
about waiting until 2015 before a reevaluation. Simply put,
this process should not take 16 years, and particularly not
when the drugmaker in question has a record of promoting a drug
even in the face of dire warnings.
We are here today to ascertain what the Avandia case tells
us about drug safety at FDA, but in many ways, this is not a
new story. We saw similar problems with Merck, who used
ghostwriters to promote their own studies of their pain
medicine Vioxx, or consider Trasylol, the heart surgery drug
linked to kidney failure that the FDA failed to remove from the
market in a timely fashion, resulting in an estimated 22,000
preventable deaths. Cases and controversies like these, or
Ketek, that goes on. It's alarming to all of us, and with every
new case they look less and less like outliers and more and
more like symptoms of a dangerous and a systemic failure in our
regulatory apparatus.
In testimony before the Senate Finance Committee in 2004,
Dr. David Graham, an epidemiologist at FDA, testified that
because of the culture at the Center for Drug Evaluation and
Research, the U.S. was virtually defenseless against another
drug safety disaster like Vioxx, and it would be a question of
time before another disaster would strike. It may be that
Avandia is that disaster. From every indication we have seen,
this looks like an instant replay of what transpired with
Vioxx.
So I hope that today we can work toward identifying exactly
what happened with Avandia, what went wrong, when, who knew
about it, and more importantly, hope we can begin to figure out
ways to address the continuing drug safety problems with the
agency. On one hand, we clearly need to establish more
independent regulatory science capability so that the agency
can make evaluations about drug safety free of industry
pressure. We obviously need more disclosure, transparency from
the pharmaceutical companies themselves so that we do not have
another situation where the only safety assessment of a given
drug is the one, as what appears to be clearly compromised as
the Record trial.
In restructuring the FDA towards a more scientific bent and
in mandating the industry post-summary level results of
clinical trials online, the FDA amendment that we passed in
2007 has and should continue to make a difference on these
fronts. But as we know, increased scientific capacity and more
industry transparency are only part of the solution. We need to
change that culture at the FDA, make it more proactive rather
than reactive, to assure that there are clean, consistent, well
defined, delineated lines of communication between the
scientists examining the drugs and the regulators making
decisions.
In this last regard, the evidence suggests that we should
look into strengthening either the independence or the powers
of the FDA's Drug Safety Office so that its recommendations no
longer go unheeded.
Senator Grassley, thank you very, very much, and I thank
Dr. Krumholz and Dr. Wolfe for being with us today to help us
get at these continuing problems. And with that, let me ask our
Ranking Member, Mr. Kingston, if he would like to make a
statement.
Mr. Kingston. Thank you, Madam Chair. And Senator Grassley,
it's great to have you here. And I am--have read your report,
and I am very interested in the fact that during this period of
time since 2007 to now, FDA funding has actually gone up
substantially, and yet it seems like the results--I'm a
believer that funding isn't the FDA's biggest issue as much as
reform is, and I think this is all part of that. So I look
forward to hearing your comments and I yield back.
Ms. DeLauro. Okay. And with that, Senator, let me just say
that throughout your career you have really been a champion of
improving both the FDA and our drug safety in particular. We
owe you a debt of gratitude for your steadfastness in this
area. You've been a member of the Congress for 35 years, a
senator for three decades. You've worked to cultivate an
independent and transparency at this agency and to restore the
preeminence of scientific inquiry on which it was founded. So I
commend you on this proven record of leadership. And also let
me just say thanks to you for being here today, and
particularly after a 5K run this morning. Bless you. And
Senator, we'd love to hear your testimony this morning.
Senator Grassley. My time was nothing to brag about.
Chairman DeLauro and Ranking Member Kingston, and of course all
the distinguished colleagues who are here, I appreciate very
much the invitation to speak and the kind words that the
chairman has expressed. Far too often we read press reports
about partisan warfare and a do nothing Congress, so I'm glad
to see both the Senate and the House, Democrats and
Republicans, coming together to work to protect the American
supply of pharmaceuticals.
As Ranking Member of the Senate Finance Committee, I have
made it my job to look into various aspects of the health care
industry. I do this to protect the public's health and to guard
the taxpayers' pocketbook. As part of this duty, I've taken a
keen interest in the Food and Drug Administration and the
pharmaceutical and device industries.
Back in May of 2007, Senator Bachus, who I've had the
privilege of working with on ten years on this committee, four
years that he's been chairman, six years that I was chairman,
anyway, we opened up an inquiry into Avandia, a drug sold at
GlaxoSmithKline to control glucose levels in diabetes. We
started this inquiry because the New England Journal of
Medicine published a study which found that Avandia may cause
heart attacks. Obviously, this was bad news because one of the
things diabetics are most at risk for is of course heart
attacks.
The Finance Committee staff spent over two years combing
through hundreds of thousands of pages of documents. So I will
give you the opportunity to decide what you want to do with the
staff report, but I'll leave it with you. Back in 1999 when
Avandia first came on the market, executives of GSK intimidated
a physician. I want to emphasize, intimidated a physician at
the University of North Carolina. The physician was worried
that Avandia might cause heart attacks. To suppress his
comments, top officials at GSK called his superiors and had him
sign a form that he would no longer criticize the drug. Senator
Bachus and I released a report on this finding, and I will
leave that document for the record if you wish. The 2007
study----
Ms. DeLauro. Without objection.
[The information follows:]
[The report can be found at: http://finance.senate.gov/newsroom/
chairman/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4.]
Senator Grassley. Okay. Well, thank you. So this 2007 study
that first caught the committee's attention was submitted to
the New England Journal of Medicine by Dr. Steven Nissen,
professor and cardiologist at the Cleveland Clinic. However,
GSK got a copy of the manuscripts before it was published. One
of the experts who was peer reviewing the study found the New
England Journal of Medicine leaked it to GSK. This allowed GSK
to launch a public relations campaign to undermine legitimate
concerns that Avandia might cause heart attacks.
Then last February, Senator Bachus and I published a
committee staff report on Avandia. This report is about 15
pages long and contains another 300 pages of attached internal
documents, charts and e-mails. With this report, we wanted to
let the people of America know what the company knew and when
the company knew it. Here is what we found. Shortly after GSK
got a copy of Dr. Nissen's study, they had their own
statistician dissect it. GSK's statisticians found the study to
be scientifically sound. However, GSK immediately drafted
talking points to undermine Dr. Nissen's study. At times, these
talking points run counter to legitimate concerns of Avandia's
very own safety that was raised in e-mails by GSK's own
scientists. In an internal e-mail, GSK's head of research
discussed, quote/unquote, ``take home messages'' of the
research on Avandia.
If you look through the report that the Finance Committee
released, you'll find this e-mail on page 163. In that e-mail,
GSK's head of research pointed out that Avandia has an
increased risk of cardiovascular death. So let me emphasize the
word ``death,'' cardiovascular death. Not heart attack, not
heart failure, but death. Well, the American public never knew
about this risk until the committee released the Avandia
report. And you still can't find any mention of quote/unquote,
``cardiovascular death'' in the warning section of Avandia's
label.
There are other findings in this report, but I would also
like to discuss some internal FDA documents that we came across
during our inquiry. When concerns were first raised by the
safety of Avandia, the FDA responded by requiring GSK to do a
safety study. Well, some safety, drug safety experts inside FDA
looked at this study that GSK was doing with patients, and
wrote that it was, in their words, ``unethical.''
Here's the troubling thing about the study. The patients
that enrolled in that safety study never learned that FDA's own
safety experts thought that the trial was unethical. At least
they didn't know this until the Finance Committee made the
internal FDA documents public in February.
This is not the first time questions have been raised about
whether or not a study sanctioned by the FDA was ethical. In
2006, I inquired about FDA's decision to allow a study of the
blood substitute Polyheme to proceed without adequate prior
informed consent from the potential study participants. I
raised questions about the FDA's decisions, especially in light
of the fact that another office within HHS, the Office of Human
Research Protections, disagreed with the FDA. In particular, I
was concerned that during this study when subjects arrived at
the hospital after being treated with the blood substitute and
a real blood became available, the real blood was withheld from
the patients as part of the study protocol.
To end, I would like to highlight that I feel that we can
all learn from FDA's handling of the drug Avandia. Because I
think that we all want to move forward and make this agency
better. The Avandia case is another example of why I twice
introduced legislation to establish independent Office of Drug
Safety at the FDA, and this is something I could talk about for
as long as you want to listen, but we don't have time for that.
So I will concentrate on what I was trying to accomplish in
this legislation.
The center, the legislation proposed a center of post-
market drug evaluation and research. And it would tackle the
lack of equality between the Office of New Drugs, which decides
whether to approve a drug in the first place, and the Office of
Surveillance and Epidemiology, and I'll refer to that as OSE.
OSE is the office that monitors a drug's safety once it's on
the market and being sold to the patients, and maybe it's
better to say just post-marketing surveillance.
The imbalance between the Office of New Drugs and let me
just say post-market surveillance, was apparent in the Vioxx
controversy about six years ago, and we can see it today in
instances involving Avandia. Individuals in the office
responsible for post-market surveillance should be allowed to
provide an independent opinion based on best available
evidence. FDA employees dedicated to post-market surveillance
should be able to express their opinions in writing and
independently without fear of retaliation, reprimand or
reprisal, and we run into that all the time. And thank God that
there are really people within the agency that want the public
to know, and when they don't get the attention of the people
within the FDA, they have guts enough to come forward to people
like me and probably like you, Madam Chairman.
Instead, the FDA physicians and scientists committed to
post-marketing monitoring of drugs have sometimes, as I've just
indicated, been suppressed. In the case of Avandia, it appears
that they have been worse than suppressed. They've just simply
been ignored.
Before I conclude my remarks, I'd like to call to your
attention another matter related to drug safety. As you may
have seen in press reports over the last two years, FDA has
been taking action against some unapproved drugs. The problem
is, FDA does not have a complete and accurate list of all of
the products sold on the U.S. market, including unapproved
drugs. So the agency can't take appropriate enforcement action.
I hope that we can work together to ensure that the FDA has the
resources and tools to ensure that the drugs in our medicine
cabinets are safe and effective and approved for use by FDA.
This concludes my testimony, and once again thank you for
the invitation, but also to tell you that I look forward to
working with you as you continue your oversight of our
country's pharmaceuticals, which remain vital to our public
health. And I appreciate your leadership and the work of the
committee in this area. Thank you.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeLauro. Thank you, Senator, and we appreciate again
your leadership. I know you are pressed for time. I know my
colleague, Mr. Kingston has a, he says a very quick question
here, so I'll do that because I don't want to hold you up.
Mr. Kingston. Thank you, Madam Chair. I'm going to yield my
time to you because I think the senator covered my question
with the 2006 incident, because what I wanted to know is how
often does this sort of thing happen, and your testimony did
mention 2006 and also Vioxx, so that was my question and I'll
yield to you if the senator has time.
Ms. DeLauro. What I would love to do, Senator, if what we
can do is you do have a piece of legislation that dealt with
the restructuring of the agency in this regard, with regard to
the Office of New Drugs and surveillance and epidemiology, and
I think that the committee would be very interested in taking a
look at that document to see--you make very, very valid points.
The report does. There have been GAO reports, others who have
intimated that that is a direction that we ought to go in.
I think there is indicative of the approval of Avandia in
1999 the particular person who signed the approval in fact is
now the person who is reviewing the process. So, therefore, you
inherently build in difficulty to start with, and you don't get
the kind of independence that you need. So we would love to
work with you on that.
Very, very quickly, with regard to the TIDE study, and I
noted in your letter to Commissioner Hamburg that you expressed
concern about the safety of that study. Do you have any
thoughts as to whether or not that ought to continue, whether
that should stop, or are you taking a look at that?
Senator Grassley. Well, we're taking a look at it. I
haven't drawn any conclusions yet. But I think that you--
there's some evidence of the same concerns that we have
throughout, whether it's Avandia or other things that we have
studied and looked into, and, you know, you're trying to get at
the basic culture of the organization and trying to change that
culture. And one of the ways I think is the best way to change
is to make sure that there's a clear separation between post-
marketing surveillance and approval of the drug beforehand.
I just think it's human nature for people that approve a
drug to ride herd on those that, after it's out in the public
and millions of people are using it instead of tens of
thousands of people in the study, that you're obviously going
to have some reactions that ought to be taken into
consideration, and that there shouldn't be any obstacle to that
being made public and warning people about it. And then you
have kind of the people that approve the drugs not wanting egg
on their face if they've originally approved it. And we found
that so often, and so many good people in post-marketing that
are willing to come forth and tell us that they think things
are wrong, and they've been right so often, you know. And
there's so much intimidation, you know, on publishing papers of
some of these people that I could go into a whole history and
give you all sorts of intimidation that comes in that area. And
maybe it's a problem throughout government, you know, but you
can't look at every agency in government, but, you know, it's
typical of people to want their agency to look good, and I just
think that the more that you try to cover up things, the more
you end up when the truth finally comes out.
So the idea is to get people to think in terms of working
for the American people and not just working for their agency,
and for agencies to think in terms of well, we're all in this
game together. We ought to be pulling together for the
taxpayers and the American people as opposed to worrying about
our--like one agency I referred to as ``our institution.'' And
it wasn't the FDA, and I won't name the agency, but ``our
institution.'' And I said, you know, that's what's wrong with
you. It's not your institution. You work for the American
taxpayers, and we're all in this together, and the people are
our boss, you know.
Ms. DeLauro. Mm-hmm. Well said. And I would say even with
regard to other agencies, and this is where you have really
made a mark is the fact that this agency particularly with
regard to the independent review and the science, this agency
deals with life and death. Some of our other agencies do not do
that. And so the consequences are severe.
Senator Grassley. And if people have respect for the
scientific process, the scientific process, sound science is a
heck of a lot better than political science, because it's got a
process that proves itself. You know, every position a
scientist takes is subject to peer review. Let the process work
out, see. But you find too much human intervention in the
scientific process, not just in FDA and a lot in EPA, you know,
in a lot of our trade issues overseas, political issues or
interfering with the so-called safety of a product, you know.
Let science prove itself. We got a whole bunch of scientists in
pairs that say whether food is safe or not, you know, and make
a scientific judgment. But you've got politicians interfering
all the time. So to some degree, you've got, maybe not elected
politicians, but politicians or political views intervening
now. I don't mean Democrat Republican.
Ms. DeLauro. No, I understand. Right. Thank you very, very
much, Senator. We're grateful for your testimony and grateful
for spearheading this report which I think will help to make a
difference. We look forward to working very closely with you
and with your staff in this effort. Thank you.
Senator Grassley. Just call me anytime and I'll come over
to your office.
Ms. DeLauro. Will do. Thank you. Thank you.
Senator Grassley. Not too many senators offer that.
Ms. DeLauro. Right. Not too many senators offer that
effort. We will ask Dr. Wolfe and Dr. Krumholz to join us at
the witness table.
Let me introduce our panelists. Dr. Sidney Wolfe, you have
been a fierce and a formidable advocate for American consumers
and families for decades as both a physician, as director of
the Health Research Group.
I must tell you that I do office hours every weekend and I
go to a library, I go to a stop and shop, and the area is
notified that I'm going that be there, and I had a woman, her
name is Captain Lou Morowitz, who stopped by the office hours
in Woodbridge, Connecticut on Saturday. She had no idea we were
doing a hearing, what we were doing. And she said to me, have
you ever read the newsletters that Dr. Wolfe sends out? And she
handed me the whole sheaf of the newsletters. So, well known,
well known. And this is obviously the document is Public
Citizen's Drug Safety Information pamphlet, so you make a
difference in people's lives, and I applaud you for your
service.
And I also want to introduce Dr. Krumholz, who is the
author of more than 250 journal articles as well as the book,
``The Expert Guide to Beating Heart Disease,'' a member of
numerous cardiovascular care communities, including the
American Heart Association and the American College of
Cardiology. You two have spent a career helping us to better
understand, look after your heart, your public education
efforts on heart disease and your strong advocacy of hospital
reform have done credit to your university and to our state.
Dr. Krumholz is affiliated with Yale University in my home town
of New Haven. And I thank you for joining us today. I thank you
both for looking into these issues of drug safety at the FDA
and sharing your wisdom and knowledge and expertise with us
today.
Dr. Wolfe, if you will proceed, and then we'll move to Dr.
Krumholz. And as you know, your full statements will be part of
the record, so you're free to summarize in any way that you
choose. Dr. Wolfe.
Dr. Wolfe. Congresswoman DeLauro, members of the
subcommittee, thanks for letting me testify on the serious
dangers of the diabetes drug, Avandia. I will present arguments
strengthened by new information since we originally asked FDA
to ban this drug in October 2008 as to why an unethical
international experiment in 14 countries involving the drug
called TIDE requested by the FDA must be stopped immediately.
We're in the process of writing to Commissioner Hamburg going
into some of these details. I'll sketch some of them out today.
And simultaneously, why rosiglitazone must be removed from the
market.
Almost at the same time as our petition to ban the drug, an
expert committee representing the two largest organizations of
diabetes experts in the world, the American Diabetes
Association and the European Association for the Study of
Diabetes, issued a consensus statement based on a careful
safety review that quote, ``Given that other options are now
recommended, the consensus group members unanimously advised
against using rosiglitazone.''
It's of particular interest that one of the members of this
committee was Dr. John Buse, who Senator Grassley referred to
as the North Carolina physician who Glaxo tried to intimidate
out of being critical of the drug and resisting the
intimidation he signed off on this consensus statement that
basically you should not use this drug. So the leading diabetes
organizations in the world say don't use it.
Since then, considerably more evidence since our petition
concerning unique risks and any lack of a unique benefit of
rosiglitazone have been published. But nevertheless, starting
in May 2009, the manufacturer, Glaxo, as ordered by the FDA,
started to recruit for a large 16,000 person randomized trial
to evaluate the cardiac safety of rosiglitazone in comparison
to standard treatment and in comparison to another drug in the
same family, pioglitazone.
Thus in the face of recommendations not to use the drug by
the leading diabetes organizations, a large human experiment to
further establish the dangers of rosiglitazone under the urging
of the FDA has begun. And I'd like to add a little detail to
that, which is something must not be working out very well in
terms of recruiting for the study.
In the last four weeks, that's from March 31st until now, a
number of new places where these experiments are going on have
been added. And I'd like to mention these places. India,
Pakistan, Mexico, Latvia and Colombia. So we are moving into,
amongst other things, some third world countries under the
urging of the FDA to try and do an experiment that is
completely unethical.
I just want to review a couple more recent studies that
point out how dangerous this drug is. One is Glaxo's own study,
referred to by you, Congresswoman, and by Senator Grassley,
called Record. The FDA is reviewing the study. But in the
meantime, under the gun I think of the FDA, the company is
starting to publish some things that are a little less
favorable for the drug than what they did before.
This is a study involving four-and-a-half thousand people.
These are all people with diabetes who weren't being adequately
controlled with one diabetes drug, so they split them in half.
Half of them were given rosiglitazone and the other half were
given another older diabetes drug. And what happened was, a
significant doubling of heart failure deaths, significant
increase in hospitalizations of the group given rosiglitazone,
and although it doesn't appear in the summary of the study, we
did a little statistical analysis, those people admitted to the
hospital with heart failure, there was almost a fourfold
increase in all subsequent cardiovascular deaths in the group
getting rosiglitazone.
This study is extremely relevant for looking at how
unethical the TIDE study is because it answers one of the very
research questions of that study. How does rosiglitazone
compare to standard diabetes treatment? The answer is very
poorly.
Another even more recent study, or this study was done by
Canadian researchers on their Canadian single payor database,
all the people in Ontario over the age of 66, 40,000 people.
This study showed--and this was looking at rosiglitazone versus
pioglitazone--and this study showed that for every 120 people
getting rosiglitazone instead of the other drug, one of them
would be hospitalized for heart failure and there would be a
number of deaths. The conclusion of this study published in the
British Medical Journal in August was thousands of additional
adverse outcomes, including deaths, from the use of
rosiglitazone rather than pioglitazone.
And this study answers the other question of the TIDE
study, which is how do these two drugs compare with one
another. It's an observational study, not a randomized
controlled trial, but the two groups were just about identical.
And finally, Johns Hopkins researchers reviewed 40
different randomized controlled trials looking at a variety of
diabetes drugs, including rosiglitazone and pioglitazone. The
only drug that improved cardiovascular outcomes was the old,
relatively inexpensive drug, metformin. The only diabetes drug
that increased cardiovascular risk was rosiglitazone. It was
not quite statistically significant, but it was an increased
risk of 1.7 times.
In addition, looking back at all of the quote,
``controversy'' about the increased heart attack risk, there
was a study done five years ago showing that if you take
rosiglitazone, you come out much worse in terms of your serum
cholesterol, serum triglycerides than you would if you took
pioglitazone. So there's even some plausible reason why there
may be increased heart attacks.
So in summary, there are many studies showing increased
cardiovascular risk of rosiglitazone compared with
pioglitazone. There's not one study showing the opposite,
namely an increased risk with pioglitazone compared with
rosiglitazone, one of the main purposes of this TIDE study.
And I want to just close by briefly reviewing the reasons
why this trial is unethical and must be stopped before
additional preventable injuries and deaths occur. As was
mentioned by you, Congresswoman DeLauro, this study, which
started recruiting in May of 2009, is scheduled to go until
2015. So during a period of time when it is quite clear that
this drug is dangerous in comparison with old diabetes drugs
and dangerous in comparison with Actos or pioglitazone, they
are recruiting from all over the world, including the United
States and Canada but now recently Pakistan and India, which
from an ethical perspective, it gives our international
reputation a huge step downward to be recruiting people in
countries that we are trying to have good relationships with,
but the study itself is unethical.
Dr. David Juurlink, physician, pharmacologist, head of
internal medicine in Canada at one of the Sunnybrook Health
Sciences, one of the University of Toronto teaching, had a lot
of input into this because he was the principal author of the
Canadian study that showed when you look at rosiglitazone
versus pioglitazone, rosiglitazone comes out much worse. And so
he and I went over some of these reasons why this trial is
unethical.
The primary purpose of this trial is to establish with
certainty whether or not rosiglitazone is indeed more dangerous
than pioglitazone. However, now there are well documented
differences in the risk and I have gone over some of them
between the two demonstrated in several studies in the United
States, Canada and the UK. The TIDE trial defies a basic tenet
of clinical trial design. The trial should be conducted to
determine the balance of risk and benefit and not simply to
provide absolute proof on harm, because rosiglitazone has no
safety or efficacy advantage, not even a theoretical one, over
pioglitazone, and because a wealth of data now suggests
rosiglitazone carries greater list than pio, it is not possible
to advance a cogent argument that this trial is ethical.
Another reason why the trial is unethical is absence of
equipoise, which means in English that when you go into a
study, there should be reasonably equal possibilities that one
arm of the study is going to do as well as the other one. In
other words, it refers to the fact that no subject receive an
intervention known to be inferior to current standards of care.
They're justified only in cases where expert scientific
community is unsure about the comparative merits and
interventions.
This is clearly not the case for rosiglitazone. Several
guidelines and medical reviews have all demonstrated
rosiglitazone has an inferior safety profile to pio and to the
positions of the American Diabetes Association. And the final
reason is unfavorable balance of benefits and risks, which I
have gone over. The risk of harm with rosiglitazone is
substantial, and it's highly unlikely and statistically
improbable that patients in the rosiglitazone part of the study
will derive any additional clinical benefit beyond that
provided by pioglitazone.
As I mentioned before, there is now 137 places in the world
involved in this study. Fifty more were added just between four
weeks ago and now, and it includes a number of countries
including the developing countries I mentioned. And in summary,
the TIDE trial continues to recruit patients despite a lack of
equipoise, exposing thousands of high risk patients, because in
order to get into the trial you already have to be an increased
cardiovascular risk, to a drug with an unfavorable safety
profile with no clinical advantage over its comparator.
It is almost certain that prospective study subjects are
deprived of the opportunity to make a fully informed decision
because the consent form, at least the version we've seen,
doesn't clearly present the kinds of information that we know
about the drugs that I've just gone over.
It is difficult to imagine that a patient would willingly
participate in a trial involving a drug that according to the
American Diabetes Association has concerns--has safety concerns
that leave it with no present day role in the management of
Type 2 diabetes, which is what those organizations concluded.
The TIDE trial can only continue with the misplaced objective
of proving definitively what many studies have already
suggested, that rosiglitazone is indeed more dangerous than
pioglitazone. The price of such definitive proof will almost
certainly be measured in the lives of study subjects who have
been incompletely informed about the available evidence
regarding the risks and benefits of participation.
And just one more thing, which is these are the data
showing that in 2006, there were 11.3 million prescriptions for
rosiglitazone, 11.3 million for pioglitazone. After the
concerns started getting voiced, the last year we have complete
data for, 2008, there had been a slight increase in
pioglitazone, Actos, 12.5 million. Rosiglitazone had fallen to
3.1 million. So aside from being rejected by the American
Diabetes Association, the drug is being rejected by most
doctors in the country. Four times as many doctors are
prescribing Actos than Avandia.
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Ms. DeLauro. Thank you very much, Dr. Wolfe. Thank you very
much.
Dr. Krumholz.
Dr. Krumholz. Thank you for allowing me this opportunity to
prevent testimony about what we need to do to improve
decisionmaking by patients, clinicians, policymakers, about
pharmaceutical products. It is indeed an honor for me to be
here. Thank you very much.
My name is Harlan Krumholz. I am a professor of medicine at
Yale, a practicing cardiologist, and an expert in outcomes
research, a field of investigation that involves practical
research that's intended to guide clinical care in health care
policy. I am also a member of the Institute of Medicine.
While the focus of today's subcommittee meeting is on
Avandia, my focus is a bit broader. The nation's experience
with Avandia makes it abundantly clear that in order to improve
public health and safety, we need to ensure that information
from clinical drug research is available to make sound,
reasonable decisions about the drugs and devices being
evaluated and to improve the communication of trial research.
I would like to touch on just a few of these opportunities
very briefly. First, we need to make sure that the information
from clinical trial research is available to make these sound
decisions that I am talking about. When the public health is
involved, patients, clinicians, policymakers must know what can
be known about these drugs.
We must have access to all available, clinical trial
research for comprehensive analyses to enable us to enable us
to have the most complete understanding of the balance of risk
and benefits of drugs. It's not happening. We too often are
making inferences about drug safety based on inadequate data.
Now, in part, this is because sometimes we lack the appropriate
studies that we need. The studies haven't been completed; but,
in part, and disturbingly, the situation occurs because not all
clinical research is published. It's not put into the public
domain.
Maybe half of the trials that are conducted never go
through peer review, so there is knowledge out there that never
comes before our eyes that we aren't even aware of. And then in
addition not all the data that are collected that are relevant
to questions about safety even among the published studies get
out in front of us so that we can make judgments about them.
These data are rarely available for analysis by independent
groups; not just the FDA rarely has it. But then even beyond
the FDA are independent groups having access to this?
Because science is based on the fundamental ability to
reproduce findings, reanalysis of data by independent groups
ensures that it reflects the truth. It gets out there. You
can't hide it if many people have the data; and, it can't be
done unless those data are available. And I think
Representative Kingston mentioned Vioxx. Vioxx has been
mentioned. It's an instructive example to us. As a result of
the Vioxx litigation our research group was granted access to
all of Merck's internal data. This is outside the trial. We did
this as research, not funded by the litigators, anything, but
we were able to get access because of the litigation.
So we were able to get all of the hard drives of raw data
sent to us, stacks of it, and go through it for every trial
that had been conducted on Vioxx, and actually look at what had
been collected. And it turns out that when you look at that
data and you analyze it carefully, despite the claims by the
company that there was no evidence of harm, you could see harm
emerging from the trials from their own data as early as 2001.
Remember, the drug was approved in 1999. 2001 you can see
what their data--if you had been looking at it--the harm. It's
'til 2004 that it's taken off the market, because that harm
becomes manifest in another trial. Now, I'm not here to say
that Merck was hiding information. I'm not here to say that
they knew that, but I'm saying it is what could have been known
had their data been produced, had independent groups been
looking at it.
I'm going to leave neutral the fact of what was known in
the company. I'm just going to say that this is the kind of
thing that is possible to know, and if you have the privilege
of selling the drug, I think that privilege comes with the
responsibility of sharing the data upon which that drug's
justification is based upon which its approval is based, upon
which our assumptions of safety are based.
Now, take the case of Avandia. There are unfortunately
parallels here. The concerns that are being voiced about
Avandia are based on analysis of data that were only in the
public domain because of the Paxil litigation. If there is no
litigation for Paxil, and Spitzer in his settlement is not
having the company need to put in the public domain all their
data, then there is no opportunity to look at the entire world
experience in the trials of this.
And when Nissen, as you've heard, and his colleague were
able to look at this, it's when the concerns about the heart
attack risks emerged. Now, there was some question about it
earlier, but this was when it began to gain force, and more
people began using this in getting the study. Now, he did that
though without the raw data. This is a much less definitive,
much less authoritative look. I'm here to tell you I still
don't think we know the full story on Avandia.
We have not been able to see the raw data files; and, even
at the FDA, I'm not sure that they have all the files. I know
they have Record. I'm not sure they have all of them. I'm not
sure it's being systematically evaluated. I am sure there are
no academic groups that are having access to this to do this
independently.
Now, here's what I recommend. We need to increase
transparency in the clinical trial research enterprise. As the
``FDA Amendments Act of 2007'' now requires that all summary
level results from clinical trials be posted within 12 months
of study completion, and that was a good move. That was
excellent. It was a move towards transparency. You said that
the results had to be available, but they're raw results. I
mean they are summary results, and they are not always
comprehensive and they are not always easily accessible.
I strongly recommend that raw data files from the trials
that are relevant to these drugs be made available. They can be
made available under data use agreements, but the independent
groups in cases where congress or the FDA or others are raising
critical safety concerns.
Nissen writes his article in 2007 based on the litigation
available summary data. In 2010 we still do not have the
disseminated raw data files for independent analysis to tell us
where we stand with this drug; and, meanwhile, I said maybe
heralding the fact that four out of every five prescriptions
are for actives, the drug remains a billion-dollar drug.
There are millions and millions of prescriptions being
written; and, today, we still do not, I believe, know the full
answer of the risks of the drugs because we haven't been able
to go through the raw data files. Second, if concerns are
raised by congress, the manufacturer, the FDA or by outside
investigators, I believe that we should insist that there be
independent replication of those results that can be done
quickly by groups outside the FDA who are commissioned to do
this work so we can ensure that we can be confident in the
results. This is too important.
We are seeing millions of prescriptions. The chance of this
drug doubles heart failure. It increases by 30 percent risk of
heart attacks. Millions of Americans are taking these pills.
This is, I believe, an urgent situation. It's not one where we
have the luxury to wait a long time; so, quickly, the other
issue for me is about the need to communicate the results. We
need more effective ways of conveying information about what is
known, what we can know; and, particularly, about these safety
concerns.
Many patients assume that treating their diabetes will
improve their outcomes, and they would be surprised to hear the
conversation that we are having today that in fact it may do
the opposite. Importantly, in the ``Patient Protection
Affordability Care Act of 2009,'' Section 3507, there is a
requirement for the addition of quantitative summaries of
benefits and risks to prescription drugs under standardized
format. Bravo for that, but it's going to be the keys to the
implementation.
How is it implemented? What would we improve about the
communication of Avandia? Well, first of all, we might say that
Avandia lowers blood sugar levels and improves the control of
diabetes, but we would want to disclose to any patient taking
it that we have a high level of uncertainty of whether that
makes any difference in terms of their life. And, we have a
fairly good certainty that it doubles the risk of heart
failure. And we are pretty sure that it may increase by 30
percent the risk of a heart attack. And if you look at ads
traditionally, it's in the smallest print.
I mean you've got to have a magnifying glass to read this
kind of information on many of the promotional materials where
it says this drug has not been shown to reduce heart attacks or
improve survival, when in fact we should be saying it may
increase and it should be in big print in any of these
promotional things. So I believe it's our responsibility to
disclose. I wonder how many of the millions of Americans taking
this drug have had that disclosed.
Have they signed an informed consent, ``I am willing to
take this drug,'' in practice? But, I recognize it could have
big risks, so my recommendation is we need to clearly disclose
this kind of information to patients. We have to work hard to
make sure we know what can be known and we make sure that
people know it. And this is going to be the devil's in the
details, but it can be done. These themes about transparency
and communication are resonating throughout medicine in many
parts.
I am very involved in quality care work with CMS and with
the public reporting of outcomes. We are moving in this
direction. I believe it's had very important, positive effects
on quality of care. I believe it can do the same for drug
safety.
Thank you.
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Ms. DeLauro. Thank you both very, very much.
Let me ask you just right off the bat, Dr. Krumholz. Would
this TIDE study that we are moving toward in 2015, and I don't
know the scope of the trial, would that allow for the full
disclosure of the raw data that you are talking about? Do we
know that so as to get at the issue in terms of coming to some
view as to what?
I have of sense of where Dr. Wolfe is coming from with
regard to the TIDE study, but I want to find out if what you
are advocating here, and very strongly advocating, which makes
enormous sense, is that part of this effort. And is that the
direction we are going in?
Dr. Krumholz. Thank you very much. Here is what I am
saying. Almost 50 trials have been conducted with Avandia, and
as of now, I know when I say raw data. It seems like inside
baseball stuff. You know, raw data, what does he really mean by
that?
I am saying that when you are forced to just look at
summaries in spreadsheets and then sort of take the numbers
from the counts that have already been summarized by others,
then you can't standardize the analysis across the studies. You
can't do the kind of sophisticated statistical work that is
really required to make the very best and most definitive
inferences about what it actually shows. So I am saying,
tomorrow.
What I don't understand is the drug is called into question
earlier in 2003, a little bit, 2007 with great force. Why
didn't that mean an immediate call to say you know what?
Tomorrow, we want all the raw data that you have upon which we
made decisions about approval available to the FDA who is going
to conduct their own independent analysis and get two
independent, academic groups.
Maybe we can put drug A, drug B. We don't even have to tell
the groups which drug is which. Tell us what you think these
data show with the very best data that are available to me.
That's the minimum of what we would expect, and we would want
to get a speedy analysis and determination about whether we
have a problem. Now, so, Congresswoman, that's sort of what we
could do with what already exists.
TIDE is just trying to prevent information to us in 2015. I
don't know who would sign up for TIDEs. I mean, I'm trying to
think would any of us sign-up for a trial where we say, first
of all, the comparison with Actos. I mean there are other
options too, so both Actos and Avandia increased the risk of
heart failure by about double. So they both have some problems,
but more than that, I am asking you to sign-up for a trial to
say, you know, I want to make sure one of these drugs isn't
harmful. Would you mind joining the trial?
And, you know, you are going to go to one arm or the other.
And the best result of this study is that you are not going to
be harmed if you're in the group that we're concerned about.
And I don't know how the informed consent writes. It's somebody
says, ``Well, what do I get out of this?'' Well, you may
contribute to medical research and you may be in the group that
doesn't get harmed; or, we may find out, actually, that the
group you're in that we thought was going to harm you didn't. I
mean, it doesn't. I don't quite get how it works.
Ms. DeLauro. Should we stop it?
Dr. Krumholz. I think it should stop. I don't think it will
help us make a determination about the trial.
Ms. DeLauro. Where do you think in terms of the issue of
raw--is this on so I'm not taking up all the time?
Court Reporter. It's on.
Ms. DeLauro. Okay. Dr. Wolfe, do you agree with Dr.
Krumholz about raw data files, publicly available, not just the
summary results, and how are we going to? What arguments are
the companies going to use against such a requirement?
Dr. Wolfe. We have, as Dr. Krumholz has, for a long time
argued that there should be almost immediate and complete
access to all the data. If you were a company and you stand to
gain $5 billion, if the data shows that the drug is safe and
effective, and you stand to lose a lot of money if it doesn't,
you will put your spin on it. And unless people who don't have
a financial spin have access to the raw data, so they can
actually look at it and see what it really shows--not what it
shows in the best financial life of the company--we just can't
trust the process at all.
And, we also as mentioned before have a difficult time
trusting the process at the FDA when the people who approved
the drug and seem too often to tenaciously hang onto the drug,
no matter what kind of safety concerns are raised, are the
decisionmakers. Dr. Jenkins in 1999 was amongst the people
approving the drug, and now he's charged with the FDA's safety
review on the drug. It is not likely based on what FDA has done
so far that he is going to come out in what we would call the
correct posture, which is this drug is too dangerous.
The trial, which is besmirching the reputation of FDA and
this country being done all over the world should be stopped,
so I certainly agree with Senator Grassley and others who
believe that there should be much more independence within the
FDA of people looking at this. And as Dr. Krumholz says, other
people, even outside the FDA in addition should have a right to
look at these data and help make the decisionmaking in a way
that's best for patients or patients in clinical trials that
should not be going on as opposed to what's best for selling
this drug.
I meant to say when I showed or talked about those data
that there four times more prescriptions for Actos than for
Avandia, but that still leaves three million prescriptions in
2008 and probably not that many fewer in 2009. So there are
huge numbers of people being exposed in the marketplace to a
drug and then more in the human experimentation place. It's got
to stop.
Dr. Krumholz. I will just add. I mean I believe that
there's proprietary interest prior to approval. I mean
companies are trying to develop drugs that have made
substantial investments. They want to try to protect certain
strategies that they are undertaking.
Once it's approved, I believe the privilege of selling in
the marketplace, as I said, comes with the responsibility of
providing. What would you want to hide at that point? I mean
the drug is approved. You're out selling it. All of the
information that is available to know about the drug should be
in the marketplace of ideas about, you know, what does this
drug do, what does it provide. And that kind of debate can
occur in an unintimidated forum. And that's what I'm not sure.
I mean, and in this digital age it's not so difficult to pull
together. If you can't as a company, pull together your raw
data files, it makes me wonder about the quality of your
internal research.
Ms. DeLauro. Let me make two quick points, and then I want
to yield to Mr. Kingston. One is that as I understand it, as a
condition of approval that the company was supposed to engage
in a trial--an adopt--that's the adopt. Right. That took almost
seven years to, you know, get done. That in and of itself in
terms of where along the continuum there had been raised
serious issues about what was going on with this drug.
But, I also just want to reinforce something that Dr. Wolfe
said, that this is a testimony from Dr. Jenkins before the
Energy and Commerce Committee--I say this for my colleagues so
that this is not just made up--Dr. Jenkins says, ``I was the
senior member of the review team that reviewed Avandia back in
1999. I actually signed the approval letter for Avandia in
1999.'' Now, again, this is the individual who was doing the
review of the review, so I think the point is well taken.
Mr. Kingston.
Mr. Kingston. Dr. Krumholz, I was wondering. On the raw
data it is proprietary, and so what you're saying is the moment
that the drug is approved and on the market, then it should be
revealed.
Dr. Krumholz. Thank you. So, you know, that would be I
believe the best case scenario that we allow the sort of
transparency upon which the drug is approved. That kind of data
can be available for analysis, but at the very least, when a
threshold of concern about safety emerges from congress, from
the public, from the agency, from other sources, there is some
support for concern as there was in Avandia.
At least at that point, I mean, if we're not going to make
it available on approval and I think that might be a bridge too
far, that would be wonderful; but, let's just even talk about
when concern are raised like this we should spring into action
and say we need to know what can be known based on what's
already done.
Ms. DeLauro. We being the FDA?
Dr. Krumholz. We being the public. We being Americans. I
mean this is being sold. Our mothers, our fathers, our friends,
our neighbors are taking these drugs. There should be people
who can independently pursue this, and there's no reason for
the data not to be available. And that's my principle concern.
And, again, the Vioxx episode was instructive. Had that data
been available, many people looking at it, three years before
it was taken off the market, I think it would have emerged that
there were issues that needed to be addressed; and that's what
I'm advocating.
Mr. Kingston. You know, on the independent groups.
Ms. DeLauro. Dr. Wolfe, congressman.
Dr. Wolfe. Well, finish congressman. Finish your question,
please.
Mr. Kingston. Do you have something on the questions?
Dr. Wolfe. No, just finish what you're talking about with
him. I just have something.
Mr. Kingston. Just inspired, I want to say.
Dr. Wolfe. By you.
[Laughter.]
Mr. Kingston. Well, I'll yield to you in a second. I guess
the question that I have on the independent groups so often in
Washington and Senator Grassley had talked about the
politicians and not necessarily meaning the elected
politicians. But, you know, everybody in this town often has a
bias. And, the independent groups, who would they be that, you
know, because there are a lot of groups who make a living off
``the sky is falling''--and it doesn't matter what the issue
is--they're on all sides of it.
How do you keep it scientifically pure?
Dr. Krumholz. Yeah. I'm glad. I don't think there is such a
thing as scientific purity, and people do come at these with
different points of view and different relationships as well.
That's why even my suggestion was, one, if it's in the public
domain, there's many people who can look at it. You may hear
different views of it, but at least it's getting it out there
too.
If you can get two independent groups where it's even
shielded, then that can give you more confidence about it. But
any group that does it, and it could be there are lots of
groups with expertise, academic groups and also companies that
do this kind of work, they've got to be transparent on what
they do. You know, nothing they do can be like here's the black
box. We did a lot of stuff. Here's the results.
Everything they do has to be able to say here are the steps
we took. Here's the decisions we made. Here's the results we
found, because I don't trust, you know, you can totally
insulate. Everyone's got a little point of view, but that's why
when it's out there, no one's point of view is saying you
haven't seen the data. I have, and here's what it says.
Mr. Kingston. Well, you know, one of the things that's
coming out with the miracle, biological drugs that are coming
out is that we have certain firewalls to keep the FDA approving
the drug, talking to the scientists within the drug community
who's developing it. And I think, you know, that's a well-
intended firewall. Yet, at the same time, some of the stuff is
so specialized that it's almost saying, well, you cannot talk
to Einstein about the theory of relativity, since he developed
it. And so I think that sometimes, that with good intentions we
may have done something that we're not quite thinking through
in terms of scientists. And I just wanted to comment on that.
Dr. Krumholz. I really appreciate that, and here's what I
think when it comes to safety. I mean I should be able to
explain it to my mom. I mean, you know, this isn't rocket
science stuff. I mean I don't need to explain to her the
underlying mechanism of the drug. I don't need to explain to
her the theory of how all this works and what's going on in the
human body. She just needs to be able to count.
Mr. Kingston. Well, no. I'm talking about inside the FDA.
Should the FDA be able to talk to the scientists who developed
it?
Dr. Krumholz. Yeah. I don't believe we should be separating
people in different corners where they can't talk. I mean there
are a lot of discussions about how these kind of interactions
should occur. There are low integrity and high integrity
interactions at every different level of groups, and I think in
the FDA we want to try to promote high level, high integrity
transparent conversations.
Sometimes, they have to occur proprietary, because they're
early in the development. But you want the people, I think, to
be talking to the FDA about what the path is, but the data
needs then to be really clear and open.
Mr. Kingston. I am watching with a lot of interest the
reform of derivatives; and, the more I've looked into that, the
more I've realized how few people know it.
Dr. Krumholz. Understood it.
Mr. Kingston. And so I do think a lot of this is talking to
each other and more information, and trying to keep a high
firewall.
I was going to yield to Dr. Wolfe. I don't know where the
time is. But, I did want to ask you how was Dr. Cruze forced to
sign this paper?
Dr. Krumholz. Dr. Buse?
Mr. Kingston. Buse, excuse me.
Dr. Krumholz. Well----
Dr. Wolfe. Well, the company literally made threats to him
that, ``If you don't keep quiet, we are going to get you in
trouble with your university,'' whatever. It was fairly
intimidating. And I think that, you know, anyone in that
position would be intimidated.
He fortunately, as I mentioned, signed off on this document
saying unanimously, ``Don't use this drug,'' so the
intimidation didn't work very well. But it's very unseemly,
it's----
Dr. Krumholz. Well, they sent somebody of a high level, who
was a prior academic and then in industry, to his boss----
Dr. Wolfe. To try and get him in trouble.
Dr. Krumholz. And his boss talked to him, and I think he
thought it's not worth the aggravation. I mean, what are they
going to do? They're not--there is only so much they can do.
But they can make it uncomfortable for him. And they--according
to documents that came out of the report, they--when your boss
calls you in and says, ``You've got to stop this,'' you can
either say, ``I don't care what you say,'' or you can say,
``It's not worth the aggravation.''
Ms. DeLauro. Let me just--and, Congressman Kingston, I will
make you a copy of this--this was the report that went before
the Finance Committee, ``The Intimidation of Dr. John Buce and
the Diabetes Drug Avandia,'' and it talks very specifically
about who did go to see him, and who communicated with him.
And he wrote--and they referred to his letter as a
retraction letter. They used it, quite honestly, pretty
politically to make a demonstration. He said, ``The company's
leadership contacted my chairman and ensured an ugly set of
interchanges occurred over a period of about a week, ending in
my having to sign some legal document, in which I agreed not to
discuss this issue further in public.''
He ended his--it says, ``I was certainly intimidated by
them. It makes me embarrassed to have caved in several years
ago.'' But I will get you this document so that you can take a
look at it. Thank you.
Mr. Kingston. Thank you.
Ms. DeLauro. Mr. Farr.
Mr. Farr. Thank you very much, Madam Chairwoman. We
appreciate having this hearing. And the FDA is always coming
out in national polls as the one entity of government that
people usually trust. And I think it's got the highest ratings
of anything in the Federal Government. And it's interesting, we
spend very little time on drug issues, because most of it's on
agriculture. But on the whole food safety issues before us, the
concern here is that the FDA would over-react to put small
farmers, organic growers out of business, because it would
require that everything be grown in a sterile environment.
But it's interesting that we are using today's hearing to
talk about, you know, erring on the side of caution on
prescription drugs. As I read the Department's annual--they put
before this committee the whole, you know, explanation of what
they're responsible for, and it says that the Department is
responsible for ensuring that prescription, generic, and over-
the-counter drug products are adequately available to the
public, and are safe and effective. The program is also
responsible for monitoring all drugs that are marketed in the
United States for unexpected health risks, and for monitoring
and enforcing the quality of those drug products.
It seems like Senator Grassley's statement says that the
FDA does not even have a complete or accurate list of all the
products that are sold in the U.S. market, including unimproved
drugs, so that the Agency has no ability to take the
enforcement responsibilities that they have. And you are
pointing out that they're just--they failed to, essentially,
recognize, in approving the drug, just recognize its risks.
So, my question really goes, doesn't this open up a huge
liability issue, if the responsibility for the Federal
Government is to ensure the safety of this? And that our safety
checkers are erring on the job? And what does it do for your--
in your world of practicing physicians who prescribe these
drugs--they still have to be prescribed--what risk does it open
up to them?
It seems to me that this is--could--I mean, it's huge
litigious issues here.
Dr. Wolfe. Yes. Well, I mean I--Dr. Krumholz, I'm sure,
will have something to say on this also.
I am reminded about three or four years ago Congresswoman
DeLauro had a hearing on drug safety. And Dr. Woodcock, who is
head of drugs at the FDA, was a witness, and I was a witness.
And at 8:00 the night before the hearing, the FDA suddenly
announced that they had a new initiative, and it was called,
``Safety First,'' and we all wondered what was going on before
then.
I think the FDA should be leading in drug safety in this
country. And, instead, it's really following in drug safety.
When the American Diabetes Association says, ``Don't use this
drug,'' when most physicians are rejecting the prescribing of
it, where is the FDA? They have had the information. They
really haven't done anything. We warned readers of the
newsletter that Congresswoman DeLauro held up years ago to stop
using this drug. We warned them to stop using Vioxx many years
before it came off the market.
So, when there is enough data to look at it objectively and
say the benefits are clearly outweighed by the risks, why is
the drug on the market?
Mr. Farr. Why would--with that information, why would
doctors still prescribe it?
Dr. Wolfe. Well, the company----
Mr. Farr. Because aren't you at risk in doing that?
Dr. Wolfe. Doctors are frequently influenced by the drug
industry. Some Canadian researchers estimated a couple of years
ago that $52 billion a year is spent in this country
advertising and promoting drugs. And one of the main sources of
information for too many doctors is the drug company, as
opposed to reading articles or going even further. There is a
lot of information on FDA's website, which most people don't
know exists, that the average practicing physician doesn't have
a chance to look at.
So, the prescribing practices are not terrible, but they
could be much worse if doctors got more information, if
patients got more information. Just as we said----
Mr. Farr. So----
Dr. Wolfe [continuing]. No one fully informed about this
TIDE study would ever participate. No patient would knowingly
allow their doctor to prescribe this drug if they knew about
the risks of the drug.
Mr. Farr. Well, yes, and I think that goes to Dr.
Krumholz's point of transparency.
The one question I have--I mean, here we are in politics,
and we--you know, everything we have to do is transparent, to
being a candidate for office, and certainly transparent on
everything, your whole--sources of income, everything like
that.
But what you see in this field is also what you call hit
pieces, where the opposition takes that information and turns
it into a negative. You have a lot of competition out there, a
lot of money to be made on these break-through drugs. And, boy,
if you get one, your company and your stock is going to go
crazy.
What would prevent an adversary company, knowing that there
is about a break-through development, just doing everything
they can to poison the process so that you really don't have
any fair judgement about--I mean, I believe in transparency.
Obviously, we live on it. But on the other hand, I think you're
seeing a lot of misinformation in America right now, and people
believing the misinformation.
Dr. Wolfe. Ten seconds, and then Dr. Krumholz. The point
that Dr. Krumholz focused on, transparency, if things were
really transparent and independent people were able to look at
it, the ability of a renegade company or a company like that to
be able to undermine something like that would be severely
limited. It's because so much of this information is secret and
not available to everyone that things like that could go on.
Dr. Krumholz. Yes, I think that's the best way to
prophylax, is to have information available and have people be
able to use it.
But you know, I think you're identifying a key issue here,
which is that--and that's why I talked about transparency, I
talked about being able to analyze the best data, and I talked
about communication. If you've got three million prescriptions
still going on--I can't--in our area I've talked to the
diabetologists. I said, ``Who is using this drug, still?'' None
of them are using it. But people are. A lot of people still
are. And there is a lot of promotion of the drug still, now.
And you look at azitamide, for example, a cholesterol
lowering drug, I mean, everyone said this should be a drug of
last resort, because we won't know if that drug is safe and
effective until 2013--after the drug was introduced in 2001. I
mean, this is replaying out in many different scenarios. And
even though everyone says, ``Look, it's okay. We don't know if
it's harmful''--we don't have the information on harm like we
do here--but you know, that ``we won't know for a long time,''
it's still selling, you know, two billions of dollars of drugs.
Phenofibrate was just shown in two trials not to be
effective. It's a $1.3 billion drug. I mean--and it's a lot on
the promotion.
So it's, I think, our job to make sure that the data upon
which we have this is out, and that the communication is clear.
And you're absolutely right, there is risk for people doing
things. But the truth is it's on the market. So the assumption
is, if it's on the market, it must be okay. And, you know, we
need to get out clear messaging, I think, and that's----
Mr. Farr. Do you think that Senator Grassley's bifurcation
of the FDA's responsibilities is the right way to go?
Dr. Krumholz. Yes, that's another issue. But I do think
it's very hard for the group that was invested--just cognitive
psychology, you know. You made a decision, and for you to go
against that decision, some of the data which still may have
been even knowable back then, it's very difficult. I think an
independent group that has no dog in the fight, that basically
is empowered--we do have to encourage innovation.
I mean, we have a fine balance here. We don't want to
create so many barriers and difficulties that we can't get new
and important drugs out in the market. So I don't think--you
know, it's this balance we have got to strike. And--but on the
side of safety, that's why I'm pushing for the transparency.
Let us know what can be known, and then let us figure out what
we need to know in order to move forward.
Dr. Wolfe. In terms of the bifurcation question----
Ms. DeLauro. If I could just interrupt for a second,
Doctor----
Dr. Wolfe. Yes, please.
Ms. DeLauro [continuing]. Because we will get to that.
Dr. Wolfe. Yes.
Ms. DeLauro. I want to try to get to Mr. Hinchey's
questions, because Farr's time has run out. And so let me go to
you, Mr. Hinchey.
Dr. Wolfe. We need to talk to more pharmacists.
Mr. Hinchey. Well, I hate to interrupt you.
Dr. Wolfe. No, no, please go on.
Mr. Hinchey. This is fascinating. Thank you very much,
Madam Chairwoman, and thank you very much for drawing attention
to this issue. This is critically important, and it's, in a
perverse way, fascinating. And it's clear that the motivation
of money to be made is one of the driving forces in the context
of dealing with this issue, and dealing with it in ways that
are harming so many people. So, Dr. Wolfe and Dr. Krumholz,
thank you very, very much.
I want to also express my appreciation to Senator Grassley.
And I share his views about ensuring that there is an
independent office within the Food and Drug Administration that
would be responsible for post-market drug safety, and that can
analyze scientific data and solicit the opinion of experts
without fear of reprisal or interference from the drug
manufacturers.
And, coincidentally, I have introduced the FDA Improvement
Act, which creates a center for post-market drug safety and
effectiveness, independently, in the context of the FDA. And--
which will provide an independent opinion about drugs currently
on the market. And I think one of the main reasons that I have
introduced the FDA Improvement Act is because I believe the
relationship between drug manufacturers and the FDA has become
much too close, and it has resulted in action or inaction, not
in the public interest. In fact, as we have seen, very contrary
to the public interest.
Dr. Wolf, I wanted to ask you, can you elaborate on the
results of the clinical trial conducted by GlaxoSmithKline that
was ordered by the FDA? And you talk about it, and you state in
your testimony that many of the participants who took Avandia
died during the trial, as I understand it. Is that correct?
They died during the trial?
Dr. Wolfe. Well----
Mr. Hinchey. Why hasn't the FDA stopped the trial?
Dr. Wolfe. Well, I was talking about the trials that were
finished. In the trials that are finished, both the one that
Glaxo did, the record study, and in the retrospective study
done in Canada, there was an excess of people dying--being
hospitalized. There is no question those studies are over now.
And what I was saying is that the study that the FDA
ordered, the new one, the TIDE study that's just beginning a
year ago, is continuing to do the same thing. In other words,
Einstein made the most cogent definition of insanity, which is
if people keep doing things and expecting different results,
that's what insanity is. Once you have done enough studies to
show the drug is harmful, why do more studies?
And I think it's particularly bad, because the FDA
wonderfully--thanks to the congress--has this new authority in
2007 to order companies to do studies. And they should be using
the authority to order them to do studies that are ethical and
that are going to provide new information. And this study
doesn't do any of that, and that's why the FDA needs to stop it
before people in India or Pakistan or Colombia or the United
States or Canada are further damaged, as the predecessors were
in the studies you're referring to.
Mr. Hinchey. Thank you very much for that. Would you--do
you believe that an independent post-market drug safety office
would help prevent things like Avandia-type incidents in the
future? And what other changes would you have us make, or
recommend for us to make within the FDA, to improve the
oversight of drug safety?
Dr. Wolfe. This is now--I find it hard to believe, myself--
this is the 39th year since I left NIH to start doing this kind
of work. And a chronic theme that has never changed--if
anything, it's getting worse lately--is the lack of
independence of the people who are skilled, expert in
epidemiology and drug safety, to have their views acted upon.
It's always been going on.
They've changed the name of that office four or five times
in response to criticisms, but the function and the dependence
and the subordinate position of that office, compared to the
office of new drugs, has stayed the same.
So, the legislation you've introduced, the legislation in
the Senate, really needs to be passed. It needs to be in the
FDA. There are some people who think that it should be outside
the FDA. I think that's not a good idea. Your legislation says,
``Let's have it in the FDA, but let's have them do things that
can be paid attention to.''
The list of drugs that the people in the office of drug
safety--to simplify its name--have said are dangerous and
should come off the market keeps growing and growing, and it
takes way too long for this to happen. They just--the funding--
you know, this year more than $700 million in drug industry
money--goes directly to the drug part of the FDA. Most of it is
used to pay for the review of drugs.
So, this office of new drugs that keeps putting its thumb
on the safety people is getting a huge amount of money. They
should be getting money to do their purpose, but they shouldn't
be getting it from the drug industry. It's clearly having a
negative impact. So repealing that law that funds the FDA
through the drug industry is just as important as the
legislation you're talking about, which is separating out,
empowering for the first time, the drug safety people.
Ms. DeLauro. That law being PDUFA. Mr. Kingston.
Mr. Kingston. Thank you, Madam Chairwoman. I wanted to get
back to the question on the malpractice, because how exposed
are doctors on this? It would appear to me there would be a lot
of concern in the individual practice. Even though I understand
the influence that the pharmaceuticals might have on them, it
still seems like they would be cautious.
Dr. Wolfe. Well----
Mr. Kingston. And maybe that's what is driving this, as
much as anything.
Dr. Wolfe. Yes, there is a precious small amount of
litigation against doctors for prescribing problems. There is a
small amount of it. But not very much. It is not very big, in
the scope of all litigation brought against doctors.
And, of course, if you are the company, as long as the drug
is on the market and your lawyers tell you, ``Put enough
warnings in there so that if these doctors still prescribe the
drug it will be on their ticket and not on ours,'' that's part
of what happens with labeling. But that, of course, is not the
issue with a drug that shouldn't be on the market in the first
place.
I guess the only--Dr. Krumholz was just talking about
before what would you put on the label of Avandia that would
take care of this, and it should say, ``Do not use.'' But ``Do
not use'' means that the FDA screwed up and left it on the
market when nobody should be using the drug.
So, I think that your point is a good one, that some
doctors may not be prescribing as much, not simply because of a
fear of malpractice on that issue, which isn't very good, but
because they don't want to practice bad medicine. I don't think
any doctor intentionally wants to harm their patient.
And they see studies showing increased heart attack, and
then they see other studies with heart failure and so forth.
They say, ``Why not prescribe another drug that works through
the same mechanism''--Actos, for example--``or why not, even
better, prescribe these older drugs that are safer, we know
more about them, there are fewer surprises?''
So I think that, in the sense that you're talking about,
the marketplace, as in doctors' prescribing practices, are
moving in a better direction--not fast enough, but they are way
ahead of the FDA, which is sort of frozen on this issue.
Mr. Kingston. Dr. Krumholz, let me move to another
question, and let you answer this and, if you want to, backfill
some of this stuff.
In terms of international testing and international record-
keeping, how standard is it and how practical is it to be able
to take Canadian tests or European tests and shed light on a
question like this?
Dr. Krumholz. You mean studies?
Mr. Kingston. Yes. Excuse me, yes.
Dr. Krumholz. Yes, it's not a problem at all. I mean there
are standardized approaches. They are actually getting these
trials together for the FDA. I mean they need to follow
standard principles, in terms of studies, and----
Mr. Kingston. Is their data more accessible, particularly
the raw data?
Dr. Krumholz. In other countries?
Mr. Kingston. Yes.
Dr. Krumholz. I'm not aware that the companies are making--
no, because we would get access to it, too. I mean, nobody is
doing this. And what I don't understand is, again, once
millions of people are taking this, why that transparency
doesn't exist, why we can't promote that.
I want to just quickly--just to give you some insight,
because you may be puzzled, like, ``Why is anyone prescribing
this drug?'' There are a couple of things that happen. One is,
in medicine, we become enamored of making people's lab tests
look good. I mean, this drug makes people's lab tests look
better. We think, if we lower their blood sugar levels, it's
better for them.
The truth is it may or may not be, because some drugs
actually have beneficial effects, some don't. Just like
cholesterol, there are some drugs that lower cholesterol that
actually even can cause harm. Some drugs that lower cholesterol
can have benefit. Drugs have thousands of effects. When we
measure one singular effect, like what does it do to a single
blood test, it doesn't often tell us what it does to the person
in their life. You've got to study that in these kind of
trials.
So, a doc uses it, they're used to giving it to patients,
they see good lab tests come back. Some people are hedging
whether there is harm. Some people have different
relationships. When you have statements that say it's harmful,
they are in documents that, you know, sometimes not everybody
sees. Meanwhile, they are getting a lot of promotional
material. And they are thinking about thousands of decisions.
And so, it's sort of easy to kind of stay with the status
quo, and it takes something strong, some strong messaging, to
overcome that.
Mr. Kingston. Well, let me ask you about the status quo,
because a lot of drugs say, ``Do not take if you're pregnant,
or if you have a heart disease,'' or if you're older, or
whatever. Maybe there is something else that we need to know
about that people should be cautious of, and I don't know what
it is.
But it is true that some drugs work for some people and
they don't' work for somebody else, and we're not sure why,
right?
Dr. Wolfe. Well, I don't think there is any identifiable
group of people for whom this drug has benefits that outweigh
the risk. I think that what you're--we are all in favor of the
FDA maximally using its ability to warn, educate doctors,
patients, for a drug that has some unique advantage. But, as
mentioned earlier, the main thing that adult onset type II
diabetics die of is cardiovascular disease. And, therefore, the
test of a diabetes drug is does it decrease cardiovascular
disease? When it increases cardiovascular disease, something is
very, very wrong, and the drug just shouldn't be around.
So, instead of saying, ``Well, if you could identify a
group of people that shouldn't use it, and others who have
benefit, leave the drug on the market,'' no such group has been
identified. Of all countries--because, in other ways, they are
not that progressive--Saudi Arabia banned this drug recently
because they did not think that there was any evidence that
there was a group for whom the benefit outweighed the risk.
Dr. Krumholz. But let me say it's a good question. I mean,
are there responders and non-responders? And you always want to
look for it. So far, there hasn't been a group.
The other benefits for diabetes drugs could be decreased
amputations, blindness, kidney function, there is a whole range
of things that we're interested in. And so far----
Dr. Wolfe. A lot of them are cardiovascular-related,
though, right?
Dr. Krumholz. And so far, this drug hasn't been shown in
that area, either.
Ms. DeLauro. With regard to FDA standards and the overall--
there seems to be we have got systemic failure here at some
level. But you look at the FDA standards. This is a Wall Street
Journal article recently that said that, ``Senior FDA officials
have asked their staff to review how FDA makes decisions about
drug safety and in particular what evidence it needs about a
drug's risks to take it off the market.''
Now, I commend and appreciate the drug safety decision that
the agency is now making to take a look at that. You know, that
is as I said commendable. But it is a little stunning to read
this. It is a little bit about safety first within less than 24
hours of a hearing on safety. Shouldn't the FDA have known for
years what evidence it needs to take a drug off the market?
What is the systemic failure within the process now that--you
know, which there is Avandia there is Vioxx--there may be,
there are lots of examples of the failure here. How do we begin
to look at addressing that failure so that we are not five
years from now trying to figure out what the process should be?
I think that is the fundamental issue that we need to grapple
with here.
Dr. Krumholz. Thank you. I think that is a very important
comment, and I guess what I wonder as a citizen--I mean I don't
know that I have special knowledge of what they should do, but
I mean where is the emergency?
Dr. DeLauro. You do.
Dr. Krumholz. Well where is the emergency response? You
know, once--where is the predictable triggering of events? It
is sort of like preparedness, right? I mean, we know that even
with best intentions and best data we can approve drugs that we
are going to learn about as they are taken by millions of
people. The companies should want to know with clear
transparency what are the steps that are being taken and what
are the expectations. It is not good for them either to be
uncertain about this kind of thing. And there should be clear
protocols processes.
It is just preparedness saying--you know, no one should be
surprised and when something like Nissen's article released in
2007, we should not be in 2010 saying we still don't have all
the data, we still don't have all the facts, and we are in the
same place we were when this came out. After the companies own
med analysis said there was a 30 percent increase in heart
attacks, after four other or three or four others came out and
said it, and nothing that has come that has come out since has
been sufficiently reassuring to say that this isn't the truth.
Now, it may be that the FDA says well, with kind of risk
and no unique benefit we think it should stay on, and they can
justify that. But it has got to--so, okay. Where is the
process? But that should have correlatively quickly. I just
don't think three years down the line we are still wondering,
what is the exact process by which this should happen? I mean
we should know this is predictably occurring and how do we deal
with it?
Ms. DeLauro. Well, the thing about it--let me just
interrupt for a second. The fact of the matter is, is that as I
understand it, the company Glaxo would not accept the fact of
an independent review by Dr. Nissen, but said that their
statisticians had to examine the information.
Now, what I also want to figure out--yeah, there is clearly
you know, the company piece, but there is also an FDA piece
here. And where we set out the parameters or the guidelines or
the dictates of what needs to get done when you are looking at
those results. And I will make this one point before I kneel to
you Dr. Wolfe--whenever we get into the difficulty and there is
a question asked to the science, the outcome, we always we
always appear to act on behalf of the industry. Whether it was
Vioxx and four years later this drug and now it is a number of
years later. We do not act saying, okay we have a--the notion
is let us leave this go on for another several years while more
people die before we truly do address it and err on the side of
public health.
Dr. Krumholz. Well, so I agree that it is important to be
erring on the side of public health. I want--I envision a world
where we are basically we are not polarizing, we are basically
telling the companies this is the way business gets done. We
want you to make a profit. We want you to do well by doing
good. We want new products that are going to enhance people's
lives, but we also need to work together. And as representative
Kingston said, ``You know, there is no necessarily independence
since we have to bring it out of the companies, we have to get
the real data, we have to say is this all of it? And we have to
decide what it says and then make decisions based on it.''
But you are absolutely right. I mean the tail can't wag the
dog here. I mean basically the public's interest is what should
dominate and--I totally agree with you.
Ms. DeLauro. Dr. Wolfe and then Mr. Farr.
Dr. Wolfe. One place the FDA to my knowledge hasn't begun
to look in this little process you described is other
countries. As you know, because I sent you a copy of this
letter, I wrote to the FDA a couple of months ago saying,
``Here are three drugs. We have asked you to ban all three of
them. None of them have any unique advantage in terms of
effectiveness. Two of the three: Darvon, Darvocet and Meridia
sibutramine, the diet drug, have been taken off the market in
Europe. The third which is Avandia has now been taken off the
market in Saudi Arabia.'' So, why is that other countries have
a mechanism that when for drugs that don't have any unique
benefit there is well documented risk that clearly outweighed
whatever benefit minimal though it may be, they moved to take
these off the market?
The FDA as Dr. Krumholz just alluded to sort of--the
default is, well, it doesn't have any unique advantage. It has
some clear risk but we just aren't quite up for taking it off
the market. I mean I have had many conversations with Dr.
Woodcock about this and she is just uncomfortable being a
regulator. And I think that for someone who is the heads of
drugs at FDA, being uncomfortable with being a regulator is
incompatible with being the head of that division. And example
after example after example are occurring.
We are a laughing stock of other countries for leaving
these drugs on the market. We are going to be more than the
laughing stock of these countries when we are doing what FDA
insisted on in this trial in Pakistan, Colombia, et cetera, et
cetera, et cetera. So I think that there is something wrong
with the decision making but they seem to be approaching it in
a theoretical kind of way and not being that interested in the
individual examples. What went wrong?
I mean, when I was a resident in medicine if someone died
and you didn't understand what was going on, 70 or 80 percent
of the time we had an autopsy done, and you learned something.
The FDA seems very reluctant, resistant to doing an autopsy on
the mistake after mistake after mistake after mistake they keep
making. One thing that they would conclude as just alluded to
by representative Hinchey is that part of the autopsy is
because they didn't listen to some of their own scientists
there. I mean every one of these instances where another
country is taking a drug off the market, we haven't.
There are people in the FDA who said it has no unique
advantage, it has unique risks, get it off the market. No one
paid any attention to them. So, the process is really filed
off. It needs to be changed before more people die from these
drugs. The three drugs that I wrote you about--wrote this to
Commissioner Hamburg and Deputy Chief Commissioner Sharpstein,
25 millions prescriptions a year for the three drugs. More for
anything than--you know, more for Darvon. But, these are people
being exposed to drugs, being injured, killed, with no hope of
any significant benefit.
Ms. DeLauro. Very very quick because my time is about to
run out, but are there other countries that you speak of Dr.
Wolfe, have they separated out the function of new drugs and
then the review process?
Dr. Wolfe. The FDA has more employees and drugs than the
entire rest of the world combined. And I am not sure they even
in some countries get to that level of sophistication. But they
are more attuned to the public health than the FDA seems to be
and are protecting the public instead of protecting companies.
Ms. DeLauro. Thank you. Mr. Farr.
Mr. Farr. I want to follow up on that question, although I
don't want to beat a dead drug but----
Dr. Wolfe. Please do.
[Laughter.]
Mr. Farr. We have experienced where the Secretary of
Transportation in 9/11 that day shut down every single aircraft
in the air immediately over U.S. airspace. We saw the FDA
demand--and it is a voluntary recall of all the spinach in the
United States, whether it was in your refrigerator, whether it
was in the store, whether it was on the way to the store in
trucks, whether it was in the growing fields in my district
because that is where most of the spinach is grown, and they
did it immediately.
When it gets to drugs why can't they just stop it? I mean
why don't--is it a liability issue? We got into a discussion
with them on sort of the crisis communication. I mean was it a
smart thing because we--what happens is that if--I think this
is the case--if the government orders a destruction
particularly in livestock or anything like that, then there is
a taking and you have to compensate for it. They didn't really
have the authority to demand a recall on spinach so it was a
voluntary recall. But everybody thinking, well if the
government asks for this we are going to comply because we want
to be good stewards of the product; a lot of people have died
from this, but we will probably get compensated. And they
didn't. So that was a whole issue of how you do it.
Is that the issue? Is it they are worried that somebody
will file a lawsuit because there is a taking because you have
decided this drug is no longer effective, and it is dangerous,
and it ought to be off the market? I mean you said something
Dr. Wolfe about a number of drugs that are out there that have
already been banned and are still on the market.
Dr. Wolfe. In other countries.
Mr. Farr. Oh, in other countries. But when we ban them in
this country they are no longer on the shelves. I didn't know
whether they----
Dr. Wolfe. Well, right. I mean they may be in people's
houses and everything. I mean, it is interesting you mention
this food example because the thing that precipitated my
writing in March to the FDA was the FDA wisely, cautiously
ordered a recall of thousands of food products that had these
textured vegetable proteins because there were some bacterial
contamination. No one had gotten sick yet, no one had died.
They though correctly from a public health perspective, that is
the thing to do. It is similar to----
Mr. Farr. Err on the side of caution.
Dr. Wolfe. Err on the side of caution. And yet quite the
opposite in the drug area there. Erring on the side of
recklessness.
Mr. Farr. What is that? Why not? Is it a liability issue?
What is it?
Dr. Wolfe. It is bad judgment. Whatever it is, it is
obviously affected in not a case by case basis by taking $700
million a year from the drug industry; there are a bunch of
things. The drug industry has enormous power here. There are
more drug lobbyists than there are total members of the House
and Senate. So they have a huge amount of power in Washington,
and to me it isn't surprising. It should be unacceptable that
this keeps going on drug after drug after drug after drug.
Dr. Krumholz. I will just say it is a very complicated
situation. And in the case of someone eating bad spinach or
meats, I mean you actually can identify the person who dies. In
this case, it is probabilistic. A bunch of people take the
drug, there is a 30 percent increase in risk of heart attacks,
so that gets kind of deluded. You give it to them, their blood
sugar gets better. People are getting lulled into a sense of
security. The company gets out to keep opinion leaders, and
academics are giving talks who don't emphasize the problem.
There are articles that are ghost written, and I am talking
generically within the institute, there is marketing efforts
and this information doesn't always get out.
Mr. Farr. But as you said we have a cop in charge of this.
We have somebody whose responsibility and judgment,
professional judgments are hired for. There has got to be an MD
or I think. Don't they have to be----
Dr. Krumholz. I think it is where the thermostat is set. So
on the food side it seems like the thermostat is set if there
is a concern let's be safe. On the drug side I think the
thermostat said--you know, and I have often said, where is the
burden of proof? Isn't the burden of proof on showing it is
safe not assuming it is safe until beyond of a doubt it is
proven to be harmful? I mean, I think that is too stringent.
I think in efficacy when you are actually trying to show
benefit and you are going to give people drugs, it should be
beyond a shadow of a doubt that it is beneficial. On safety, if
more likely than not this is causing harm, I think I have to
say that we have to wait until we get more information, we can
be reassured. I think there are two different thresholds.
Benefit, you need to really be sure unless it is a disease for
which there are no options, and there is you know, people are
desperate for anything. But in most cases they really need to
have strong evidence about benefit to get out there. Safety, it
shouldn't be probably safe. It needs to be we are very
confident about the safety.
Ms. DeLauro. Mr. Hinchey.
Mr. Hinchey. Thank you again Ms. Chairman. This is very
fascinating and it is something that is very very important.
And one of the things that you keep pointing out I think is the
relationship, well not directly, but the relationship between
the FDA and the prescription drug companies. And I think that
the questions that were just asked show how the FDA can work
very effectively, be very positive, do good strong things. And
how at other times it can be very very bad not doing the kinds
of things that really need to be done.
I was really amazed learning about that problem with
Avandia. That the FDA ordered GlaxoSmithKline to conduct a
safety study, and then it later labeled that safety study as
unethical.
Dr. Wolfe. We labeled it as unethical. The FDA thinks it is
very ethical thus far unfortunately.
Mr. Hinchey. Yeah, right. They do. That is right. So it did
not disclose the opinion of the volunteers participating in
that study. That was--the whole thing just seems to be quieted
down or secret now in some ways. Does the FDA have procedures
that it failed to follow that would have required it to
disclose its concerns to those volunteers and elsewhere?
Dr. Wolfe. Well, what you are talking about is the informed
consent. We have seen the February 2009 informed consent sheet
and there were some things lacking on it. It is said, and we
have not been able to get a copy of it, that the informed
consent sheet is better now. It is not possible that the
informed consent sheet remotely reveals all of the information
that should be there. If it did, it would come to the same
conclusion as the American Diabetes Association which is you
shouldn't use the drug. It would not be recruiting subjects for
an experiment if the conclusion was don't use the drug. I mean
if the American Diabetes Association information was on the
sheet, the informed consent sheet was we diabetes doctors say
don't use it, I don't think a lot of people would sign up for
the trial.
And in fact, even with what I would bet is a less than
adequate informed consent sheet, there aren't a lot of people
signing up for the trial, which is why I think they are
desperately going to all these other countries around the world
to try and recruit more people.
Dr. Krumholz. To be fair and just so you know what others
would say is they did all have to go through institutional
review boards so the--ethics boards that have approved this
study in order for it to go forward. What seems strange is if
we wouldn't use the drug anyway, why would you randomize people
to be on it just to prove that maybe it is not harmful? It
seems to me, I don't understand it but, I mean just to be fair
I am going to let you know that people are going to say that
investigators are going to say we went through institutional
review boards.
Dr. Wolfe. But I am not sure. I think that is absolutely
correct, and I think that the initial decisions by some of
these institutional review boards to approve the study were not
informed now with the new information that keeps coming out on
the newer evidence of risks.
Dr. Krumholz. And they are not expert in this area, and may
have assumed if someone is bringing it forward that it is a
reasonable effort equipoise.
Mr. Hinchey. What do you feel about the post market drug
safety operation? Should that be put into play? Is it going to
be positive?
Dr. Wolfe. Well, 30 years ago as opposed to now, if there
were safety questions about a drug it would be more likely the
FDA would say, okay, well let's wait a minute, let's get the
answer. Now, too often they say, well yeah, there are some
safety problems. Let's approve the drug and do a post market
study. And now the FDA has the authority to fine companies if
they don't do these and so forth.
But the idea of waiting until after a drug is mass marketed
to find out things about it particularly if it doesn't have any
unique advantage, as opposed to finding it out before it is out
of the barn door, just does not seem like a good thing.
Clearly, the number of post marketing studies that have been
recommended or asked for by the FDA has gone way up and in many
cases they should have held the drug up.
Mr. Hinchey. Dr. Krumholz, what do you think?
Dr. Krumholz. Well you know, I think these are critical
studies. There are some things that you can't know until
millions of people take the drug. I think that we need to have
oversight about what the experience is, particularly around
these new drugs with novel mechanisms for which we don't have a
lot of experience and we are uncertain about what is going to
happen to people. I think that information needs to be widely
shared. We need to be able to follow it and there needs to be
independence of that group that is doing it.
I worry about the mice guard and the cheese if you are
really putting it in position where basically you got a company
where they can drag their feet or--I mean again, these need to
be independent efforts in which we are all working together for
the common good. And again, there are many good people in these
companies who want to know the answers. It is when marketing
mingles with science that we get into trouble. But there are
many good respectable highly admirable individuals, and we need
to bring those people out. We need to work together and we need
to create independence of that post marketing experience; it is
very important.
Mr. Kingston. In NASA or space exploration, had they been
in charge of Europe during the days of Columbus, we would
probably still be living in Europe. I feel they have become
very risk-averse.
And, as you know, I mean, that's the tendency of a
bureaucrat, is to--safest way to deal with something is not to
make a decision. And that's a concern that I have. Because, you
know, one of the balances here is that if you're a drug company
and you've got this sweetheart deal of keeping your patent on
the market now for--is it 12 years? Then, you know, really, you
know--no, I think it's been extended now, under the health care
bill, from 5 to 12.
Ms. DeLauro. No, that's Biologic.
Mr. Kingston. Biologic, okay. But you know, you don't
really care if--I mean, you do care, but you know, there is a
monetary incentive not to have a new drug out on the market--
get out there.
And so, if you have FDA, who is too risk-averse, not
wanting to make decisions, and a drug company that maybe can
wink and nod about the whole thing saying, ``Well, you know,
we've got a new drug coming down, but--can't get it done, but
in the meantime we've got our 5-year''--and 12-year, if you're
Biologic--``patent,'' that could also be a formula for
disaster.
So our, you know, concerns could have an effect that we're
not thinking about.
Dr. Wolfe. Yes, I--this is an issue that comes up from time
to time. We are all in favor of drugs that appear to be break-
through drugs, really adding an important thing to what we can
prescribe for patients, getting approved as quickly as possible
and as safely as possible.
It's interesting. The drugs that wind up being discussed
here, none of them are really break-through drugs at all. So
it's really a matter of slowing down, putting the brakes on the
drugs that don't even arguably have some reasonable theoretical
advantage, and letting FDA spend more time, and more quick
time, on the break-through drugs.
This country is really not in any kind of problem because
there are drugs that should have been approved that haven't
been. It's quite the opposite. I mean, there used to be a myth
about 30 years ago called the drug lag. And there was a
commission which Congressman Gore and former Congressman
Scheuer were on, and they could not find any example of a drug
that had gotten on the market--an important drug that had
gotten on the market--in any other country before the United
States.
So, I think that the concern is there. But all the drugs
that get in trouble, by and large, are these me-too drugs that
really don't offer any advantage. And it's--if the FDA
asymmetrically says, ``Let's put the brakes on those, and, if
anything, speed up safely the break-through drugs,'' I think we
will all be fine, and the concerns that you and others have
would just not be carried out.
Dr. Krumholz. Yes, we tolerate safety issues in drugs that
provide unique benefit.
Dr. Wolfe. Cancer drugs, for instance.
Dr. Krumholz. But it's a question of the balance.
Dr. Wolfe. Right.
Mr. Kingston. Thank you. Yield----
Ms. DeLauro. To that end, there are a number of drugs
approved for type II diabetes. So, I mean, it's the whole issue
of, you know, some of the drugs may offer benefits that are
less--where you're at less of a risk. And you know, but yet we
move to these other efforts.
Dr. Wolfe. Well, I mean, this record study that Glaxo did
pretty much showed that. Looked at--old diabetes drugs are
safer, more effective----
Ms. DeLauro. Oh, my God.
Dr. Wolfe [continuing]. Than the new ones. As----
Dr. Krumholz. And, let's just say----
Dr. Wolfe [continuing]. In Rosiglitazone.
Dr. Krumholz. And less expensive. I mean, as the health
care system is looking for value, it's actually the----
Dr. Wolfe. Yes.
Dr. Krumholz. Anyway, those are----
Ms. DeLauro. Let me--a couple of pieces--well, one of the
things that is coming up, can you ever have these post-market
surveys run by the company that--are you going to have some
independence? I mean, there is--you think we can----
Dr. Krumholz. The companies shouldn't be running the post-
marketing surveillance.
Ms. DeLauro. That's--yes, okay.
Dr. Krumholz. Yes, right.
Ms. DeLauro. Again, my--you know, one of the--we're talking
about, you know, independent review and looking at the data and
in the public domain. And yet, what's the function of the FDA?
What is the function? And who at the FDA ought to be reviewing
these, and what about the expertise at the FDA that is
independent?
So shouldn't it be housed at the FDA, rather than having a
company conducting a study? Or either another--or another
independent body looking at it? Isn't that what the FDA----
Dr. Krumholz. Well, this is happening with devices, I
think----
Ms. DeLauro [continuing]. Is all about?
Dr. Krumholz. It's happening with devices more often, but
yes. It should be housed within the FDA, who is finding
contracts and others who can do this under jurisdiction of
high--and with high standards about what that information is
going to be.
Dr. Wolfe. Yes, I mean I--I think, as you--I'm on FDA's
drug safety advisory committee. So, aside from the FDA staff,
FDA has the ability to get people from academia, from
wherever----
Ms. DeLauro. Right.
Dr. Wolfe [continuing]. To augment what they may not know
in certain areas. There are certain specialists in
cardiovascular disease who are brought in by FDA to look at a
drug, to hear an advisory committee.
But I think that the focus needs to be on the FDA, its own
staff, free of conflict of interest, the advisory committees
much more----
Ms. DeLauro. Free of conflict.
Dr. Wolfe. And more than they used to be, freer of conflict
of interest, as opposed to out there with the company, who is
sort of putting their spin on it, and saying, ``Well, I think
this,'' and they don't give you the full raw data, and
therefore their conclusion is difficult to challenge.
Ms. DeLauro. Or they have financial interests.
Dr. Wolfe. Always.
Ms. DeLauro. So let me just--PDUFA, PDUFA. I'm not going to
go through it all. But your views, should we move away from the
reliance on user fees and binding performance that the FDA has
to negotiate with the drug companies in exchange for the fees?
Dr. Wolfe. Well, the law has been in effect for 18 years
now. And it came into being at a time when the budgets were
tight, as they always are, and Congress essentially said, de
facto, ``Hey''----
Ms. DeLauro. Can't afford this.
Dr. Wolfe [continuing]. ``The drug companies are going to
have to pay this money, because otherwise they won't be able to
put in new drug applications,'' so they're sort of like ducks
in a barrel, or something like that.
And whereas the idea of getting more FDA staff to review
drugs and so forth is a good idea, it's too important to leave
to the financing of the drug industry. I mean, the amount of
money, compared even with the NIH budget--and the NIH budget,
which is--I come from NIH, so I like the idea that NIH is
getting adequately funded--but their budget is over $30
billion. Why is it that Congress can't allocate the $700
million, as opposed to $30 billion, that would take away the
industry's financial input into the FDA?
So, I think the law should be repealed. It keeps getting
worse and worse. And originally it was just drugs, then
devices, then biologics----
Ms. DeLauro. Now they're looking at generics.
Dr. Wolfe [continuing]. Veterinary drugs----
Ms. DeLauro. Generics.
Dr. Wolfe [continuing]. And it will--and it's moving in the
direction of generics. I think it's had a lot of negative
influence.
The whole attitude at the FDA is--we surveyed doctors at
the FDA in 1998 to see what impact it was having, and they said
the standards they believe are lower, they are being told to be
more quiet at FDA advisory committee hearings. So I think the
whole culture there is not good, they have lost a huge number
of people who felt that the atmosphere was changed
significantly, once that law was passed in 1992.
Dr. Krumholz. Yes. I mean, here is my quick view. I think,
on the performance side, we need the performance. I mean, we
need the accountability. I mean, we need to be able to move
things through in an efficient----
Dr. Wolfe. Absolutely.
Dr. Krumholz [continuing]. And high-quality way. So that
should be an expectation of government, about how that agency
works.
Dr. Wolfe. Without industry funding.
Dr. Krumholz. The industry funding, I think, is just--is
misplaced. I mean, it's not fair to the companies, it's not
fair to the public. It creates bad psychology, in terms of
relationships. There should be independence.
And, you know, I don't see how that--I see it was a
convenient thing to do. Certainly, though, the companies should
expect, when they're working with the FDA, that they're going
to get timely responses, good guidance, it's going to be
clarity, transparent. They should get--sure, every--that should
happen.
But to think they have to pay for it, and then--it creates,
I think, a dynamic that ends up changing the thermostat even in
ways that are maybe unintended.
Mr. Kingston. Madam Chairwoman, would you yield a minute?
Ms. DeLauro. Sure.
Mr. Kingston. I have asked this question of the FDA many,
many times. And I get assured over and over again there is a
big firewall. And so, I'm interested in your comments.
But it also strikes me that when physicians go on their
continuing education seminars and they're underwritten by drug
companies, that could be a bigger issue, in terms of the use of
things. And I don't know what the practice is now. I think a
lot of them have backed off the ``We'll bring you a lunch for
your entire staff on Friday.'' But I do know that when they go
to the continuing education things, the open bar is sponsored
by ``Blank Pharmaceuticals,'' and you know, some of this other
stuff.
Dr. Wolfe. That's a big problem, there is no doubt about
it. But--and I don't think that there is any drug-by-drug
corruption. I don't think that's what the drug company money is
doing. It's just changed the attitude and the culture there.
And Dr. Krumholz is absolutely right. We should always
expect the FDA to be accountable to the public, to the
companies that are doing these studies and sending them in. It
shouldn't take greasing the wheels with $700 million a year to
do that. Good congressional oversight would do that, even if
the drug company weren't funding.
But I think the continuing medical education is a disaster.
It appears to be getting better. A lot of cosmetic things are
being done. But the companies are still spending a fortune,
because it works, to influence doctors prescribing----
Dr. Krumholz. It's still a big problem. They're paying for
infomercials, they're funneling the money through CME
companies, so that even with the sunshine laws you won't see
it. It's the subject of another hearing.
Dr. Wolfe. Yes.
Dr. Krumholz. I mean it's a huge issue, but it's beyond
this issue about what's going on----
Dr. Wolfe. Yes, absolutely.
Dr. Krumholz. Yes. An important one, though.
Mr. Hinchey. Well, I think--I just want to thank you for
everything that you've done, all that you've said. And I think
that this is something that we really will have to deal with.
The relationship between the prescription drug companies and
too many physicians is not a pleasant set of circumstances----
Dr. Wolfe. Or pharmacists, also.
Mr. Hinchey. Yes, pharmacists also. This is a situation
that----
Dr. Krumholz. All health care professionals.
Mr. Hinchey. Amen, yes. It's creating a lot of problem, and
it's something that we have to deal with.
Dr. Wolfe. Yes, agreed.
Mr. Hinchey. Thanks.
Ms. DeLauro. I think I have just got two or three more
questions, and then we're just so grateful for your time and
your candor with these issues.
This is--and obviously, to the two of you--the OSE, Office
of Surveillance in Epidemiology, and the Office of New Drugs
signed a memorandum of agreement in June 2008. That states
that--FDA's intent for the two offices to contribute equally in
determining regulatory actions related to drug safety.
As part of the agreement, FDA transferred authority for one
pre-market regulatory responsibility from OND to OSE, and plans
to transfer authority for two post-market responsibilities, but
has not set a time frame for doing so. The authority that was
transferred is the pre-market review of proprietary drug names.
Proprietary drug names, looking at the names and the brands.
Do you think that this is an important priority for the
Office of Surveillance in Epidemiology? Are there higher
priority pre-market safety activities that they should--or
post-market activities that they ought to be focusing their
time and attention on?
Dr. Krumholz. I'm not sure of the background of the names.
There is a lot of interest in patient safety, by the way, and
trying to ensure that drugs don't sound the same, so they don't
get confused. I'm not sure that that's a major responsibility.
It's certainly important, by the way, that we not lead to
systems--that lead to easy confusion between drugs, so that
people can be trying to get one and end up with something else.
I mean that's happened far too often.
But I think we're coming together on this idea that, first
of all, particularly in this post-marketing issue, is that once
the drugs are released--and often times, particularly on drugs
that are working on surrogate end points--so this is going to,
I think, become increasingly important. There is going to be an
IOM report next month about surrogate end points, there is
going to be a lot of attention to this. Drugs can be approved,
based on what they do to lab tests, and the assumption about
what that change in lab tests means for their lives.
And yet, we have seen many instances where, as I've said,
changes in cholesterol, changes in blood sugar don't translate
into the expected benefit for patients. And as we are approving
drugs based on that, it puts a great onus on us to figure out
what actually happens when people take this drug. Because all
of the trials are just about saying, ``I gave it to a bunch of
people, and this group had a better lab test.'' But we
sometimes can find that, yes, people die more often with better
lab results in some of these studies when they're looked at
long-term.
And so, it puts a great onus on independence and
concentration of resources in tracking what actually happens to
people when they take these drugs. We haven't talked much about
this issue, but it's relevant to Avandia, because it does make
your blood sugar look better. But the truth is, there hasn't
been one trial that said, ``Does the strategy of using this
drug actually improve patient outcomes?'' I mean, everything we
have said is sort of compared to other things, but there hasn't
been a trial that really lets us know that when it was
approved, it was approved based on what it did with blood
sugar.
And this is--there needs to be a concentration, more hand-
off into this area, and they need to--their views need to be
respected.
Dr. Wolfe. Just----
Ms. DeLauro. Yes, Dr. Wolfe, because my point was there is
that--one of the authorities that was transferred to OSE was
the pre-market review of proprietary drug names. So my question
there was, you know----
Dr. Wolfe. Aren't there more important----
Ms. DeLauro [continuing]. What else are we talking about
here, pre-market and post-market?
Dr. Wolfe. No. I mean what Dr. Krumholz was just talking
about, the--the FDA held this hearing after a number of
diabetes drugs got into trouble. They said, ``Maybe, when we
approve a diabetes drug, we should make sure it doesn't harm
people,'' which is different from saying it actually benefits
people. And they agreed that that should be done, but
unfortunately didn't agree that it needed to be done before a
drug comes on the market.
So, it's still the case that a diabetes drug gets approved
based on its effect on sugar. And then afterwards--not before--
you start doing some studies to find out whether it benefits--
or, more likely, because of recent examples--it actually harms
people. And the last thing in the world, as I said before, that
a diabetic needs is something that increases their
cardiovascular risk, like Avandia seems to do--to a much lesser
extent, Actos Pioglitazone does it.
So, I think the kind of--more trivial kind of delegation to
OSE is sort of, yes, we're giving them more things to do, but
in comparison with the big things, these are not the most
important things to do.
Ms. DeLauro. Well, and just to expand on that for a moment,
this is the GAO study, the November 2009 GAO study. And this
was in conversation with the staff involved in these reviews.
The staff involved in these reviews estimated that
approximately 90 percent of their time is spent on such pre-
market activities, which leaves little time to spend on their
other post-market drug safety responsibilities, such as
analyzing reports of medication errors.
It makes you wonder that, you know, the reason for just
passing this on is just like a pat on the head, ``Okay, go over
and do this, we're still going to maintain our authority and--
over this process.''
And I have--and I will ask you both to comment on this, but
particularly Dr. Krumholz. This was the American Heart
Association and the American College of Cardiology on Avandia.
Understanding that the Heart Association, the--are not
recommending that doctors prescribe Actos over Avandia. The new
story on their view said that the organization said there was
inconclusive evidence of cardiovascular concerns.
Now, these are organizations representing the experts in
cardiology. Why do they think that the evidence is
inconclusive?
Dr. Krumholz. Well, yes, and I was concerned about that.
Actually, I wrote and invited commentary to that statement,
which disputed their findings, because I didn't agree with
them.
I think it gets to what Representative Kingston said, which
is that there are people with different views. I'm not saying
it's biased, but different points of view. A person who led
that group had published an article which had questioned some
of the methods that Nissen had used. I don't think that they
were necessarily apprised of all the new information that was
out, and they were reluctant to make a call on it, you know,
and that's what they came out with.
But again, that's why I think it gets confusing to the
practicing doctor when this statement comes out. I think it
does show that there is some--there are some experts who remain
unconvinced about this, and they came out in that major
statement and failed to identify this as a major problem.
Dr. Wolfe. Yes, and you wonder why, after really careful
review and looking at least at what was available at the time,
which was the end of 2008, all these experts in diabetes, who
actually treat these people--they're the experts----
Ms. DeLauro. Right.
Dr. Wolfe [continuing]. Decided that they don't want to use
the drug. I mean it may not be----
Ms. DeLauro. That's interesting.
Dr. Wolfe [continuing]. 100 percent conclusive. But from
their perspective----
Ms. DeLauro. It's conclusive enough.
Dr. Wolfe [continuing]. It was conclusive enough, and there
are other drugs to use. End.
Ms. DeLauro. Right. Okay. This has been enormously helpful.
I have a housekeeping thing to do here for a moment, but I want
to just say thank you for the dialogue and the back-and-forth
and, again, the candor. And I will speak for myself. I'm not a
scientist. We do have some in the congress, but I don't know
that there are any on this committee. But the way in which you
help us to understand these issues is critically important.
My hope is that we can make some of this information
available, really, to the FDA. They are going to meet in July--
I think it's July 13th and 14th--to do a review here. And I
would very, very much like them to have a sense of what was
debated or discussed here this morning, and that it would carry
some weight.
We also would like to work with you to get your best
advice. This committee has an opportunity to make
recommendations, or to do some things with our appropriations
bill. And, assuming that we will get an appropriations bill out
this year--we did last year--that I think we would like to
address some of these issues, and see not being authorizers,
but appropriators--how far we can go with addressing some of
these issues to make the changes that are necessary to ensure
the safety of these drugs. So, I thank you very, very much.
And now, if I can, we received this morning a statement
from GlaxoSmithKline in response to the hearing, and I ask
unanimous consent to put the GlaxoSmithKline statement into the
record.
[No response.]
Ms. DeLauro. Without objection.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeLauro. Thank you. With that, again, our deepest
thanks to you, and for taking the time. And thank you for what
you do in your professional lives to ensure the public health.
Dr. Wolfe. Can I just make one comment----
Ms. DeLauro. Please.
Dr. Wolfe [continuing]. Which is back in the 1970s and
1980s, when I first started doing this, there was just a
plethora, very importantly, of congressional oversight over the
FDA. One Senate small business subcommittee held 135 days of
oversight hearings on the drug industry and the FDA in the
1970s and 1980s.
Ms. DeLauro. Wow.
Dr. Wolfe. What this hearing represents to me--well, it
seems like too much, but there is almost none. Senator Grassley
held a hearing--now six years ago--on Vioxx, and there have
just been very few hearings that have actually gotten down to
the issue of here is a problem, a drug. What does this say
about, A, the drug; and B, about the general process? And I
just commend you for having this hearing.
Ms. DeLauro. Thank you.
Dr. Wolfe. And I hope that you have more that hold the FDA
to task for what it is doing.
Ms. DeLauro. Yes.
Dr. Wolfe. And the industry, too.
Ms. DeLauro. Yes, we will continue. I promise you that.
Thank you.
W I T N E S S E S
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Brewer, John..................................................... 49
Cochran, Norris.................................................. 153
Coppess, Jonathan................................................ 49
Grassley, Hon. Chuck............................................. 267
Hamburg, M. A.................................................... 153
Krumholz, Harlan................................................. 267
McGarey, Patrick................................................. 153
Melito, Thomas................................................... 1
Miller, Jim...................................................... 49
Murphy, William.................................................. 49
Steele, Scott.................................................... 49
Wolfe, Dr. Sidney................................................ 267
I N D E X
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Food and Drug Administration
2011 Budget...................................................... 172
Accountability................................................... 200
Additional Authorities........................................... 202
Advancing Regulatory Science..................................... 225
Advertising...................................................... 179
Advertising and the Public Health................................ 218
Animal Antibiotics............................................... 185
Animal Biotechnology Products.................................... 224
Antibiotic Resistance............................................ 175
Antibiotics and Livestock........................................ 174
Binding Standards................................................ 208
Blood Collection and the Red Cross............................... 209
BPA.............................................................182,218
China............................................................ 201
Clinical Trials.................................................. 220
Codex............................................................ 190
Conflicts of Interest............................................ 178
Coordination and Communication................................... 191
Counterfeit Prescription Drugs................................... 185
Crisis Communication............................................. 206
Deputy Commissioner of Foods..................................... 189
Dietary Supplements.............................................. 221
Direct Consumer Advertising...................................... 217
Dr. Hamburg Opening Statement.................................... 155
Dr. Hamburg Written Statement.................................... 159
Drug Safety...................................................... 197
DSHEA............................................................ 222
Economic Costs of Violations..................................... 210
Electronic Interests............................................. 204
Enforcement Activities........................................... 172
Equivalency Process.............................................. 191
Farmers and FDA.................................................. 207
FDA and USDA..................................................... 205
FDA Employees.................................................... 180
Food Inspection Methodology...................................... 188
Food Labeling.................................................... 222
Food Safety...................................................... 189
Food Safety - GAO................................................ 207
Food Safety Activities........................................... 173
Food Safety Regulation........................................... 226
Food Safety Working Group........................................ 190
Foreign Food Inspections......................................... 192
Fosamax.......................................................... 196
Front of Packaging Labeling...................................... 176
Generic Drug User Fees........................................... 209
GRAS............................................................. 220
Healthy Choices Program.......................................... 181
Heparin........................................................201, 211
Import Safety.................................................... 192
Indoor Tanning................................................... 224
Inspections...................................................... 173
Inspections and User Fees........................................ 192
Labels........................................................... 203
Mr. Kingston Opening Remarks..................................... 155
Ms. DeLauro Opening Remarks...................................... 153
Nanotechnology................................................... 221
Nutritional Claims............................................... 181
Nutritional Content.............................................. 195
Nutritional Information.......................................... 177
Off Label Advertising............................................ 226
Peanut Corporation of America.................................... 200
Pharmaceutical Companies......................................... 212
Pharmaceutical Industry.......................................... 178
Postmarket Drug Safety........................................... 178
Precursor Products............................................... 202
Private Interests................................................ 203
Questions for the Record, Mr. Boyd............................... 236
Questions for the Record, Mr. Farr............................... 228
Questions for the Record, Mr. Hinchey............................ 248
Questions for the Record, Mr. Jackson............................ 252
Questions for the Record, Mr. Latham............................. 255
Questions for the Record, Mr. Latourette......................... 262
Questions for the Record, Ms. Kaptur............................. 238
Radiation Exposure............................................... 183
Regulation of Medical Radiation.................................. 184
Reportable Food Registry......................................... 188
Resources to Prevent Counterfeit Drugs........................... 187
Risk Based Approach.............................................. 193
Risk-Based at USDA............................................... 193
Salmonella....................................................... 188
Salmonella Montevideo............................................ 219
Smart Choices.................................................... 224
Tobacco Outreach and Education................................... 197
Traceability..................................................... 226
Trade vs. Public Health.......................................... 191
Transparency Initiative.......................................... 181
TSA Scanners..................................................... 185
Twenty Percent Margin of Error................................... 195
User Fees........................................................ 179
USTR............................................................. 190
Yale BPA Study................................................... 183
Farm and Foreign Agricultural Services
Additional Renewable Energy Production........................... 120
Afghanistan...................................................... 94
Afghanistan Development Effort................................... 114
Agricultural Credit Insurance Fund............................... 134
Agricultural Issues in Afghanistan............................... 95
Agricultural Policy.............................................. 96
BCAP Potential................................................... 121
Biomass Crop Assistance Program.................................. 119
Coordination of Export Programs.................................. 137
Coordination of Trade and Development Programs................... 111
Crop Insurance................................................... 107
Crop Insurance Overpayments...................................... 118
Cuba Trade Embargo............................................... 116
Development Assistance........................................... 113
Discrimination by USDA........................................... 124
Export Programs.................................................. 136
FAS Administrator's Written Statement............................ 75
FAS Staffing..................................................... 110
FAS Strategic Re-Envisioning..................................... 111
Food Aid and Development Assistance.............................. 109
Food Aid Programs................................................ 131
Food and Agriculture Organization Oversight...................... 127
Food Assistance.................................................. 106
Food For Progress Program........................................ 101
Foreign Aid...................................................... 100
FSA Administrator's Written Statement............................ 66
FSA and NRCS County Offices...................................... 96
FSA and NRCS Operations.......................................... 97
FSA IT Stabilization and Modernization........................... 92
Funding Commitment............................................... 93
International Food Aid........................................... 112
Legislative Proposals............................................ 108
Local and Regional Food Purchases................................ 130
Market Access Program............................................ 114
McGovern-Dole Program..........................................101, 131
Mr. Kingston Opening Remarks..................................... 51
Ms. DeLauro Opening Remarks...................................... 49
National Export Initiative.....................................102, 137
Non-Governmental Organizations................................... 107
OIG Recommendation for RMA....................................... 117
Pending Trade Agreements......................................... 115
Pork and Poultry Differences..................................... 123
Pork Loan Field Guidance......................................... 122
Program Performance Criteria..................................... 103
Questions for the Record, Mr. Farr............................... 150
Questions for the Record, Mr. Kingston........................... 146
Remediation of Discrimination.................................... 125
RMA Administrator's Written Statement............................ 85
RMA Compliance Funding........................................... 117
Standard Reinsurance Agreement................................... 108
Success Stories.................................................. 101
Supplemental Revenue Assistance Program (SURE)................... 98
SURE Payment Process............................................. 100
Trade Adjustment Assistance for Farmers Program.................. 134
Trade Issues..................................................... 133
Trade Sanctions.................................................. 132
Under Secretary's Opening Statement.............................. 52
Under Secretary's Written Statement.............................. 56
Global Food Security
GAO Report....................................................... 7
Mr. Kingston Opening Remarks..................................... 3
Mr. Melito Opening Statement..................................... 4
Ms. DeLauro Opening Remarks...................................... 1
Drug Safety
Dr. Krumholz's Written Statement................................. 295
Dr. Wolfe's Written Statement.................................... 286
GlaxoSmithKline Statement........................................ 325
Ms. DeLauro's Opening Remarks.................................... 267
Sen. Grassley's Written Statement................................ 274