[Senate Hearing 113-]
[From the U.S. Government Publishing Office]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2014
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THURSDAY, APRIL 18, 2013
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:32 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Mark L. Pryor (chairman)
presiding.
Present: Senators Pryor, Tester, Udall, Blunt, and Cochran.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
STATEMENT OF HON. DR. MARGARET A. HAMBURG, COMMISSIONER
ACCOMPANIED BY:
NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
JAMES TYLER, CHIEF FINANCIAL OFFICER, FOOD AND DRUG
ADMINISTRATION
opening statement of senator mark l. pryor
Senator Pryor. We will go ahead and call the meeting to
order.
Let me call it to order and say that this is my first
hearing as chairman of this subcommittee. So let me start by
thanking my ranking member, Senator Blunt, who has already
proven to be a very good and effective partner and wise counsel
in many, many ways. And I look forward to working with Senator
Blunt and with everybody on the subcommittee staff and the full
committee, but I really value our working relationship.
Roy, thank you for all that you have already done.
I would also like to thank Commissioner Hamburg for being
here and joining us today. I appreciate the working
relationship that we have developed over the last few years,
and I look forward to continuing that work with you. And I know
that you are very serious about working with the subcommittee
and the full committee on a full range of issues. So we want to
thank you for that.
I also want to take a minute to recognize the history and
significance of what we are doing here today. The first
appropriations bill was reported out of the Second Congress in
1791. A lot has changed since then.
To illustrate one example of how times have changed, I have
a copy of that legislation in my office. And the entire bill is
4 pages. Can you believe that? Four pages. Right now, you
couldn't even get the table of contents on 4 pages on an
appropriation bill.
But nonetheless, one of the things that hasn't changed is
our responsibilities to carry out the appropriations of this
country, just like we are mandated in our Constitution. The
function of this committee is actually mandated by the
Constitution. I think that is very significant, and it is a
responsibility that I and I know all the members of the
subcommittee take very seriously.
So what I would like to do is get down to business today,
and that is fiscal year 2014 Food and Drug Administration (FDA)
budget. The President's overall funding proposal for FDA is
probably one of the most robust requests included in his
budget. This is important because the responsibilities of the
FDA are so vast, regulating consumer products worth 20 cents of
every $1 spent.
In Arkansas alone, there is over 1,300 facilities regulated
by the FDA, as well as the National Center for Toxicological
Research, which is a unique and important center within the
agency that employs over 500 people in our State. And it is
really some of the best and the brightest folks in the State.
The total request for FDA is nearly $4.7 billion, which
includes the budget authority that this subcommittee controls,
to establish user fees, and some user fees FDA is proposing.
Within that $4.7 billion, the budget request includes $2.558
billion in budget authority. This is an increase of nearly $48
million over the funding level provided last year without
factoring in sequester.
As we all know, this is a very complicated budget year, and
we only finished our fiscal year 2013 appropriations bills last
month. That means the FDA budget for fiscal year 2014 was
written before you knew what you were getting in fiscal year
2013.
Because of this, it appears that you have asked for many of
the same things this year that we ultimately were able to
provide in last year's budget. We understand that, and we
understand that we are going to have to work through that. But
that includes funding for increased inspections in China,
medical countermeasure activities, and funds to complete a lab
at your headquarters.
So it is very important that we all do work together in the
coming weeks to ensure that the funds we provide to fiscal year
2014 reflect the most up-to-date information and make sure the
taxpayer dollars we are investing are used for the highest
priority needs at FDA. We certainly don't want to pay for the
same things twice, and we look forward to working with you
about these issues.
In addition, I would also like to discuss the impact that
the sequester is having on the agency, including your user fee
program, and I am interested to hear from you regarding the
status of the new food safety user fees you are proposing.
So we have a lot to talk about, but what I would like to do
first is turn it over to Senator Blunt for his opening
statement.
Senator Blunt.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Well, thank you, Chairman Pryor.
I look forward to working with you on this subcommittee. We
are already able to work together and get some things done on
the continuing resolution that allowed us to finish the
business that Chairman Kohl and I started last year, and on
this and other areas, you and I have been able to work closely
together. I look forward to your leadership on the subcommittee
and to working with you.
I want to thank our witnesses for being here today.
Certainly, as we look at FDA and the imprint it has on the
country and on families, it is a significant one. The FDA
budget request for direct appropriations represents an increase
of almost $48 million above the fiscal year 2013 enacted level
and an increase of $174 million above the current operating
level because of the sequestration order once it is taken into
consideration.
As we begin, Mr. Chairman, to formally review the
administration's budget request, we have to be mindful that our
fiscal house is not in order. When we held our hearing on this
budget 1 year ago, the national debt was at $15 trillion.
Today, it is almost at $17 trillion.
Americans are concerned about this, and they should be. And
I think the appropriations process, along with the Budget
Control Act, is going to begin to reflect those concerns this
year, as it may not have in previous years.
Commissioner Hamburg, the agency you head has authority
over approximately, I am told, 20 cents of every $1 spent in
America. Americans expect that the food they eat, the drugs
they take will be safe and effective. Similarly, your private
sector partners expect transparency and certainty from the FDA.
The FDA's reach is vast. The agency has authority over more
than 300,000 foreign establishments, 185,000 domestic
establishments, ranging from food processing plants to
facilities that manufacture lifesaving medications. Almost
2,800 of those facilities are in Missouri, and the others, of
course, are all over the world.
As FDA is implementing new requirements created by the Food
Safety Modernization Act and the menu labeling legislation, the
agency needs to be mindful that burdensome regulations and
requirements can stifle innovation and lead to unnecessary
expenses that limit the ability to create jobs. There is no
doubt that your job is complicated, has many constituencies,
and it is an agency that has to be careful to avoid the
trappings of one-size-fits-all requirements because we all know
that one size almost never fits anybody, let alone fitting
everybody.
Small businesses suffer under the one-size-fits-all
practice, and too frequently, they have limited capital that
doesn't allow them to respond to lots of new requirements. For
example, when implementing menu labeling requirements, FDA
needs to ensure regulations do not overburden businesses while
still improving and providing customers with appropriate
information so they can make decisions.
In addition, FDA is currently receiving comments on two
proposed rules required by the Food Safety Modernization Act.
One of these rules, the produce safety rule, is estimated by
the agency to cost over $460 million annually, which would be
on the average of somewhere between $5,000 to $30,000 per farm,
depending on the size of that operation.
FDA readily admits the final rules resulting from the
proposed rule will have a significant economic impact on a
substantial number of small entities. Recent reports indicate
that some farmers find the requirements impractical and that
the agency misses the mark by focusing on products that have
historically not been the cause of food safety outbreaks. In
addition, some farmers report that some of the proposed
requirements may simply price them out of the market, by making
it impossible for them to compete with imports.
As you are dealing with the final rules, these concerns
should be seriously considered. Our economic recovery is
fragile. 11.7 million Americans remain out of work. The labor
force is at its lowest participation rate since the 1970s, and
we need to be sure that we are not doing things that needlessly
make that problem worse.
Mr. Chairman, I look forward to the testimony. I am also
pleased that joining us today we have the former chairman and
the former ranking member of both this subcommittee and the
full committee, and he continues to be very interested and
involved in the work that this subcommittee does, and we are
glad to have him join us today, I know.
Thank you, Mr. Chairman.
Senator Pryor. Thank you.
Senator Cochran, my understanding you would like to put
your statement into the record?
STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Mr. Chairman, thank you.
I am pleased to join you and our distinguished friend from
Missouri at this hearing.
And thank the Food and Drug Administration officials for
being here and the hard work they do to carry out their
responsibilities.
I ask that the balance of my statement be printed in the
record.
[The referenced statement was not available at press time.]
Senator Pryor. Okay. Thank you, Senator Cochran. Thank you.
Dr. Hamburg, welcome.
SUMMARY STATEMENT OF HON. DR. MARGARET A. HAMBURG
Dr. Hamburg. Well, thank you very much, Chairman Pryor,
Ranking Member Blunt, and Senator Cochran.
And congratulations to you, Chairman Pryor, in your new
important position.
And I also want to thank the subcommittee for your past
investments in FDA which have helped to reduce the gap between
our budget and the demands of our increasingly complex mission.
I am joined today by Norris Cochran, who is the Deputy
Assistant Secretary for Budget at the Department of Health and
Human Services, and Jay Tyler, who is the Chief Financial
Officer at the FDA.
Congress has given FDA responsibility for a vast range of
products that are central to the health, safety, and well-being
of every American. From spinach and breakfast cereals to
vaccinations that save millions of children's lives, to new
medicines that treat major killers like cancer and heart
disease, Americans rely on products overseen by the FDA every
single day.
We also recognize that those who produce our Nation's food
and medical products are vital components of the U.S. economy,
as is a strong FDA. History shows that when the public trusts
FDA's oversight, these industries flourish, and when there are
problems with products, it can result in severe economic damage
across the industry involved, not just to the offenders, but to
non-offenders alike.
I want to mention some of our measurable accomplishments
this past year. In 2012, FDA approved 39 novel medicines, the
highest number in over a decade. The majority of these drugs
were approved in this country before they were approved
anywhere else in the world and some in as little as 3\1/2\
months.
The number of drug shortages were cut in half, compared to
2011. We successfully turned around a decade of lengthening
medical device reviews and backlogs. Working together with 45
State and territorial partners, we have conducted more than
158,000 inspections of tobacco retailers to ensure that they
are not selling cigarettes or smokeless tobacco to minors. And
we just published our first two food safety proposed rules, as
has been noted, as part of the implementation of the historic
Food Safety Modernization Act. All of this indicates, I think,
that FDA is a smart investment and a bargain, in fact.
Consider, as all of you have commented, that the products
we regulate represent more than 20 cents of every $1 that
consumers spend on products in this country. But if you look at
our budget, every American effectively pays only a little more
than $8 a year for our services.
And while FDA continues to oversee a multitude of products
vitally significant to all of us, our job has become
increasingly demanding. First, we are in the midst of dramatic
changes in the ways that food, drugs, biologics, and devices
are produced and reach the American public. We are witnessing
revolutionary advances in science and technology that hold such
promise to improve health and prevent disease, yet also bring
new scientific and regulatory complexities. And we are facing
the globalization of the food and medical product supplies,
demonstrated by a quadrupling of FDA-regulated products over
the past decade. For food, some 50 percent of fresh fruit and
about 80 percent of seafood that we eat here comes from other
countries. About 40 percent of finished drugs and 50 percent of
devices are manufactured elsewhere, but cross our borders to be
used in this country.
Second, Congress has continued to expand our
responsibilities with new laws, including FSMA, the most
sweeping reform of our food safety laws in about 70 years; the
Family Smoking Prevention and Tobacco Control Act, the landmark
legislation giving FDA the responsibility to regulate tobacco
products; and most recently, the passage of the FDA Safety and
Innovation Act, or FDASIA, which, among other things, creates
two new user fees to speed the review of more affordable
versions of drugs, which are essential to holding down
healthcare costs and also puts important focus on important
aspects of advancing medical product innovation.
As we look at our fiscal year 2014 budget needs, we must
respond to the demands of complex and increasing
responsibilities while recognizing the realities of a
constrained economic environment. Thus, we must focus on a set
of key mission-critical programs and activities and leverage
limited resources to the greatest degree possible.
The President's proposed fiscal year 2014 budget request is
for a little over $4.6 billion, which includes $2.5 billion in
budget authority and $2.1 billion in user fees. This represents
an $821 million increase over fiscal year 2012, $52 million of
which is budget authority and $769 million in user fees,
including two new user fee proposals for food safety and
cosmetics.
A central component of the budget request supports our
efforts to implement FSMA and create a modern food safety
system based on prevention rather than responding after a
problem occurs. FDA is committed to working with industry and
our partners at all levels of Government along with the
industry and produce community to put in place the necessary
risk-based flexible system that recognizes and respects the
varying needs of different components of our food enterprise.
I want to thank you for the $40 million in one-time no-year
money that was part of the recent continuing resolution, which
will help us continue our outreach. For fiscal year 2014, our
budget request is for $43 million in budget authority and $225
million in proposed user fees for food facility registration
and inspection and imports.
In addition, we must respond to and harness modern science
to advance the pipeline of new medicines and vaccines. We are
asking for about $18 million to equip a number of already
constructed buildings, including two labs, so that we can carry
out the work needed to accelerate the development, review, and
ongoing assessment of these vital medical products. Without
these funds, the labs cannot be used and the $300 million cost
of constructing them will be wasted.
Also, in our efforts to safeguard a vast and increasingly
hazardous global supply chain, we are asking for $10 million to
expand our presence in China, a major and growing exporter that
has also been the source of contaminated food and medical
products in the past.
PREPARED STATEMENT
I believe our fiscal year 2014 budget efficiently targets
our needs, focusing on programs that are essential to providing
Americans with the safe foods and effective medical products
they expect and deserve. I look forward to answering your
questions today and to working with you in the coming year.
Thank you very much.
[The statement follows:]
Prepared Statement of Hon. Dr. Margaret A. Hamburg
Good morning Chairman Pryor, Ranking Member Blunt, and members of
the subcommittee. I'd like to extend my congratulations to you,
Chairman Pryor, in your new role on the subcommittee. I am looking
forward to working with you and your staff. And I would like to thank
the subcommittee for its past investments in the Food and Drug
Administration (FDA), which have helped us meet the demands of our
broad and increasingly complex mission.
FDA PLAYS A VITAL ROLE IN THE HEALTH OF OUR CITIZENS AND OUR REGULATED
INDUSTRIES
Congress has given FDA responsibility for a vast range of products
that are central to the health and well-being of every American. From
spinach and frozen dinners, to vaccinations that save millions of
children's lives, to new medicines for the treatment of major killers
like cancer and heart disease, Americans rely on products overseen by
FDA every single day. A short list of what FDA oversees includes:
--the safety of most of America's food supply;
--the safety and effectiveness of drugs, biologics, vaccines, and
medical devices;
--the safety of the blood supply;
--the development of medical countermeasures to address chemical,
biological, radiological, and nuclear threats, and infectious
diseases;
--the safety of products that emit radiation;
--the quality of mammography facilities services;
--the safety of dietary supplements and cosmetics;
--the nutritional quality of infant formula;
--the safety of animal food and feed as well as the safety and
effectiveness of drugs for use in livestock, pets, and other
animals; and
--Most recently, FDA has been charged with reducing harm from tobacco
use.
The products we oversee are capable of producing great benefits:
sustaining human life, reducing suffering, treating previously
untreatable diseases, and extending lives. FDA's recent approval of the
first drug to treat one of the causes of cystic fibrosis, as well as
the first bionic eye system for a rare genetic condition, illustrate
the ability of these products to transform lives. Without proper
oversight, however, many of these products are also capable of causing
great harm. We need only look at the recent outbreaks of foodborne
illnesses from peanut butter or the newest report of counterfeit cancer
drugs being imported into the United States to understand those risks.
FDA has a dual responsibility to the public health--to make safe
and effective products available to Americans as quickly as possible,
while at the same time protecting our citizens from those products that
injure or kill. Our citizens' health depends on both.
We also recognize that the producers of our Nation's food and
medical products are vital to the health of our economy--and a strong
FDA is vital to their health as well. Our history shows that when there
is public trust in FDA's oversight, our industries flourish.
Conversely, when food and medical products cause serious harm, the
result is often severe economic damage across the industry involved--to
offenders and non-offenders alike.
FDA CARRIES OUT ITS FAR-REACHING RESPONSIBILITIES WITH FEW TAXPAYER
DOLLARS
FDA is a true bargain among Federal agencies. Added together, the
products we regulate represent more than 20 cents of every consumer $1
spent on products in the United States. Americans each pay about $8 a
year for FDA's appropriations, which is substantially less than the
amount Americans spend each year on snack chips alone.
And putting money into FDA is a smart investment. For about 2 cents
a day, Americans get an extraordinary array of public health benefits,
including: (1) life-saving medicines approved as fast or faster than
anywhere in the world; (2) confidence in the medical products they rely
on daily; and (3) a food supply that is among the safest in the world.
But maintaining this level of performance for the American public,
especially related to food safety, demands a fully funded FDA.
Although FDA continues to be an effective and efficient investment,
our job has become increasingly demanding. We are in the midst of
dramatic technological and market-based changes in the way that foods,
drugs, biologics, and devices are produced--from personalized medicine
and nanotechnology to the globalization of our food and medical product
supplies. Congress has also continued to pass new laws and expand our
responsibilities. While we welcome these new responsibilities, they
don't always come with added resources. These changes force us to
stretch our limited resources, while finding ways to ensure the safety
of a global supply chain. Our scientists must also adapt to, and even
drive, new science and technology so that we can accelerate medical
product innovation rather than impede it.
Let me say a few words about the impact of globalization, which I
believe to be among our greatest current challenges. Not that long ago,
FDA's job was to oversee a largely domestic market of food and medical
product suppliers. Most of the facilities in which these products were
stored and manufactured were within our borders and relatively easy to
inspect and oversee. Most of our producers and manufacturers were
accustomed to operating under the rules of a modern regulatory system
and most lived up to our high standards.
We have now entered a brave new world--a world in which, very soon,
the majority of our food and medical products will come in whole or in
part from foreign countries. In the last 10 years, the number of
imported shipments of FDA-regulated products has skyrocketed--in 2012,
approximately 28 million shipments of imported food and medical
products crossed our borders. That includes 50 percent of our fresh
fruits and 20 percent of our fresh vegetables, around 80 percent of our
seafood, and 40 percent of drugs on our shelves. Eighty percent of the
manufacturers of active drug ingredients are located outside the United
States, and more than half of medical devices are imported. Most of the
increase in imports is coming from China and India, countries with
limited regulatory oversight. Many other imports are from developing
nations with even less regulation.
The vast increase in imported foods raises the risk of
contamination and illness. Of the imported produce and seafood refused
entry at the border, 70-85 percent is for potentially dangerous
violations, including the presence of disease-causing organisms and
chemical contamination.
The global marketplace also increases the threat of deliberate
adulteration, fraud, and counterfeiting. Criminals exploit how hard it
is to inspect and track products through the global supply chain.
Chinese suppliers of heparin, a critical drug to prevent blood clots,
substituted a lower cost, adulterated raw ingredient in their shipments
to U.S. drug makers, causing deaths and severe allergic reactions.
Chinese suppliers of wheat gluten substituted melamine, an ingredient
used in making plastic, which was toxic when it was used in U.S. pet
food and dairy products. The contaminated food sickened and killed pets
across the United States and put many people at risk.
The global supply chain itself is becoming increasingly complex.
Each product may pass through a number of foreign links in the chain,
and each additional link increases the risks to American consumers.
Consider canned tuna. Once primarily canned in the United States, tuna
processing and canning is now outsourced to foreign facilities, and
tuna often takes a circuitous journey through processors and canners in
Southeast Asia, Africa, and/or Latin America, before it is ultimately
shipped to the United States for distribution to our grocery store
shelves.
The world has changed and our historical regulatory approaches and
tools--such as hoping to intercept products at our borders--are
outdated and often inadequate. Border inspections will remain important
but they cannot guarantee the safety of even a small fraction of our 24
million food and medical imports a year. Globalization demands a major
change in the way FDA fulfills its mission. If we are to continue to
promise Americans a safe food and drug supply, FDA must continue to
transform itself--from a primarily domestic agency to one that uses
innovative global strategies to secure a vast global supply chain.
Although challenges lie ahead, we have already made strides toward this
goal using the resources you have provided.
FDA IS DELIVERING RESULTS THAT HELP AMERICANS EVERY DAY
Implementing Major New Laws
We are partners with Congress in implementing the policies in three
major new laws and several smaller ones that add to FDA's
responsibilities in advancing the health of Americans.
The Food and Drug Administration Safety and Innovation Act
(FDASIA).--With the passage of FDASIA last year, Congress granted us
important new authorities, reauthorized human drug and device user
fees, and authorized new user fees for generic human drugs and
biosimilars. These authorities and fees are intended to increase the
speed and predictability of medical product reviews, better protect the
drug supply chain, reduce drug shortages, and speed the review of more
affordable versions of drugs that are essential in holding down
healthcare costs. We are working hard to implement FDASIA and achieve
these important goals.
--Drug Approvals.--We continue to run a state-of-the-art drug
approval process that brings important new drugs to Americans
quickly and safely. In 2012, FDA approved 39 novel medicines,
and the great majority were approved in the United States
before any other country in the world. The drugs included 13
treatments for cancer patients, 13 orphan drugs, and the first
brain imaging agent to help rule out Alzheimer's disease.
Recognizing the need to bring safe, lifesaving drugs to
Americans as quickly as possible, FDA approved some of them in
as little as 3\1/2\ months.
--Medical Device Approvals.--Over the past decade, important
indicators of the efficiency of the FDA's medical device review
program, including the average length of review and the size of
the backlog of overdue applications, had steadily worsened.
Since 2011, FDA has worked intensively to turn this around.
Almost every major indicator has now reversed: review times are
getting shorter and backlogs are shrinking. This important
turnaround will allow the industry to bring safe and effective
devices to market more quickly and at lower cost.
--Drug Safety.--FDA has also used your investments to improve our
oversight of the safety of marketed drugs. The new Mini-
Sentinel system allows us to quickly assess potential drug
safety problems using data from over 130 million patients. FDA
used Mini-Sentinel to assess reports that a new blood thinner,
Pradaxa, was causing more bleeding than similar drugs. The
results gave reassurance that bleeding rates were not higher
with Pradaxa than with the other drugs.
--Drug Shortages.--FDA prevented 282 drug shortages in 2012--87 more
than in 2011. Early notification to FDA of potential shortages
has made a huge difference in our efforts. In 2012, we cut the
number of new shortages by more than half (117 v. 251).
--Affordable Drugs.--FDA is working to provide Americans with better,
quicker access to affordable generic drugs and is also
implementing an abbreviated pathway for approval of biological
products shown to be ``biosimilar to'' or ``interchangeable''
with an FDA-approved biological product. Biosimilars are
products that are similar to approved biologics, and while
biologics are among the most important drugs Americans use
today, they are also the most complex and expensive. We are
developing a science-based process for bringing safe and
effective biosimilar and interchangeable products to market,
which should increase competition and create substantial
savings for patients, healthcare providers, and insurers.
The FDA Food Safety Modernization Act (FSMA).--Even though the U.S.
food supply for humans and animals is among the safest in the world,
the current rate of foodborne illness remains too high--according to
CDC estimates, roughly one in six Americans (or 48 million people) get
sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases
each year, leading researchers to estimate a cost of more than $75
billion due to medical expenses and lost productivity. This does not
include costs to the food industry or public health agencies. These are
preventable human and economic costs, and they reflect an outdated food
safety system. FSMA, the most sweeping reform of our food safety laws
in more than 70 years, creates a modern food safety system that shifts
our traditional focus--responding to contamination after it occurs--to
preventing it before it happens. This new prevention strategy involves
all participants in the food system, domestic and foreign, government,
industry, and consumers, doing their part to minimize the likelihood of
harmful contamination.
FDA is working on regulations on the kinds of risk-based measures
food producers and importers should put in place to reduce the risk of
contamination. We take pride in our release earlier this year of two
proposed rules that set science-based standards for the prevention of
foodborne illnesses--one on safe growing and handling practices for
produce and another on prevention practices in facilities that process,
handle, and store food. Before drafting the proposed rules, FDA
conducted extensive outreach with farmers, manufacturers, consumer
groups, State and local officials, and the research community. We have
just completed three public meetings across the country to get
additional input from stakeholders.
The proposed rules are built on existing voluntary industry
guidelines and recognized best practices for food safety. Many
producers already follow these guidelines, so compliance will be less
of a burden. For those who need to add new food safety practices to
their operations, FDA, in collaboration with USDA, will offer technical
assistance and guidance.
FDA is committed to working with industry members to provide the
support they need, especially the smallest businesses. We know that our
rules and oversight practices must be responsive to the diversity of
operations covered by FSMA, be risk-based and flexible, and address
small business concerns. That's why we've included a number of
exemptions for small businesses, including one for farms. The produce
rule would also exempt low-risk products, like potatoes that are rarely
consumed raw, or that will be further processed with a step that kills
bacteria--like vegetables that will be canned. We've also proposed that
small farms and other small business be given extra time to come into
compliance with both rules.
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act).--The Tobacco Control Act gives FDA responsibility to
reduce death and disease caused by tobacco and to lessen tobacco use,
especially the initiation of smoking, by children and teens. This
program is entirely supported by tobacco industry user fees. Since
enactment, FDA has worked to enforce a ban on cigarettes with candy and
fruit flavors, to make them less appealing to kids; prohibit claims
like ``light'' or ``mild'' that misleadingly imply products are safer;
and enforce new smokeless tobacco warnings. FDA has also joined with
States and Territories to enforce laws against under-age sales. We have
conducted over 131,000 retail inspections and sent over 6,800 warning
letters and 420 civil money penalty complaints to retailers.
Other New Authorities.--FDA is also implementing other recently
enacted laws. Last month Congress passed the Pandemic and All-Hazards
Preparedness Reauthorization Act, strengthening FDA's authority to
prepare for chemical, biological, radiological, and nuclear threats, as
well as infectious disease emergencies like pandemic flu, and to
support rapid deployment of medical countermeasures. FDA is also
carrying out new requirements in the Affordable Care Act, including
provisions on biosimilars and nutrition information on menus.
Safeguarding the Global Supply Chain
Using the public's investments, the agency is working to transform
itself into a public health agency capable of preserving the safety of
our food and medical products in a complex global marketplace. We are
developing better enforcement and regulatory tools, encouraging greater
industry responsibility, increasing transparency and accountability in
the supply chain, and increasing collaboration with international
regulatory counterparts and other third parties.
Foreign Posts.--To enhance our ability to oversee import safety, we
now have 12 permanent FDA overseas posts in key locations around the
world: three in China, two in India, three in Latin America, two in
Europe, one in the Middle East, and one in South Africa.
Foreign Inspections.--FDA conducted over 2,700 foreign inspections
in fiscal year 2012, the largest number ever, exceeding last year by 23
percent. We are on track to surpass that record this year.
Border Screening.--To make the most of our limited border
inspection resources, FDA developed PREDICT, a sophisticated computer
screening system that uses intelligence from many sources--such as
intrinsic product risks, past inspection results, and information about
such threats as extreme weather that could spoil a shipment--to flag
the riskiest imports before they arrive. This allows FDA to focus its
border resources on those imports that are most likely to pose a
danger, and at the same time easing entry of low-risk products. PREDICT
has helped stop many contaminated products at the border. Recently,
PREDICT flagged a large shipment of cucumbers from the Dominican
Republic, which were contaminated by salmonella. PREDICT has also
identified products with illegal pesticides, heavy metal contamination,
filth, and decomposition, as well as substandard medical devices and
improperly canned food.
FDA also developed mobile handheld devices that allow our
investigators to immediately identify products that may be counterfeit
or adulterated. The counterfeit detection device uses light waves to
detect irregularities in the chemical composition or labeling of a
drug, while the chemical detection (IMS) device identifies
inappropriate chemical compounds in a product. The IMS recently
identified an unlawful prescription drug--one taken off the market
because it can cause heart attacks and strokes--in a large number of
imported dietary supplements for weight loss. We hope to fund the
development and use of more such mobile handheld devices.
Collaboration With Other Nations.--To address the vast number of
imports successfully, we must build a global public health safety net
by partnering with other nations. FDA has signed over 120 international
arrangements with foreign counterparts to create mechanisms for
information sharing and collaboration. We are actively using
information from, and conducting joint inspections with, trusted
foreign counterparts, and engaging in harmonization efforts on foods
and medical products. For example, we have signed an arrangement with
Brazil, Canada, and Australia to implement a Medical Device Single
Audit pilot program under which a medical device inspection done by one
regulator can be relied on by other regulatory agencies. Such programs
can cut duplicative requirements for industry and allow us to better
allocate our resources.
Supporting Biomedical Innovation
The U.S. food and biomedical industries are among the most
successful and respected in the world and FDA plays a key role in that.
FDA is sometimes viewed as a barrier to the economic success and
innovation of both industries, but that does not take into account the
benefits FDA regulation brings them. Public confidence in a strong FDA
fosters consumer trust in the safety, effectiveness and quality of the
products we regulate. This, in turn, helps producers build their
markets. For example, as FDA became the model for science-based drug
approval around the world, its high standards spurred decades of
medical advances and turned the U.S. pharmaceutical industry into the
world leader in innovative medicines.
As you know, I have made it a priority to help U.S. biomedical
companies maintain their status as world leaders in innovation. It is
well known that advances in biomedical research are not being
translated into real world products as swiftly and surely as we all
would hope. The time and costs of developing new drugs has been
increasing. Yet despite increases in research and development, the
pipeline of new, innovative drugs remains disturbingly limited. Serious
public health needs, such as treatments for autism and Alzheimer's
disease, are not yet being met, despite years of research and
investment. And many drugs are not revealed to be unsafe or ineffective
until the last stages of development, wasting valuable time and
resources. Through its regulatory science programs, FDA is committed to
helping to develop new knowledge and tools that can help translate
basic scientific discoveries and approaches into life-saving medicines,
and reducing the time, complexity and cost of drug and device
development.
Investment in FDA allows our scientists to support innovation
through a range of activities, including:
--the Innovation Pathway, which cuts the time and cost of developing
and reviewing breakthrough device technologies--the first to
benefit from the Pathway was a robotic arm controlled by a
microchip in the brains of patients with spinal cord injuries
or amputations;
--greater use of genetic data to advance personalized medicine,
especially in cancer therapies;
--new scientific tools and partnerships to learn earlier in
development whether a drug or device will work and be safe,
saving time and money now wasted on late-stage product
failures;
--more guidance to industry early in technology development to help
bring important new products, like the artificial pancreas, to
market more quickly; and
--more collaboration with companies earlier in development. When
companies come to us for help early in the process of testing
their products, experience shows that they can shave up to 5
years off their development time. That's a dramatic shortening
of the path to market.
Stretching Budget Dollars
We have also made belt-tightening a priority. We have consolidated
our information technology infrastructure and administrative functions
across FDA, and put in place controls to cut the cost of travel,
training and conferences. We are avoiding additional rent costs by
making better use of existing office space through telework and office-
sharing, and we are reviewing contracts to cut service and product
duplication.
CURRENT BUDGET REQUESTS
The budget includes $4.7 billion, an $821 million increase from
fiscal year 2012. Of this requested increase, user fees account for 94
percent ($770 million). Mindful of the need to reduce spending, we seek
a reduced budget authority in several areas, including a $15.4 million
decrease for human drug, biologic, and medical device programs. We are
also asking for a small number of increases, which are necessary to
meet our growing duties and preserve the safety of our food and medical
products:
--An additional $43 million to carry out our responsibilities under
FSMA and to modernize our food safety system. These resources
will go to building prevention-based food and animal food and
feed safety systems, to reduce the toll of foodborne illnesses.
--An additional $10 million, above fiscal year 2012, for overseeing
the safety of goods from China. This increase will add 16 new
inspectors in China, who can conduct more inspections and train
Chinese counterparts, strengthening our ability to prevent
safety problems before products reach the United States.
--An additional $3.5 million, above fiscal year 2012, to improve the
development timelines and success rates for medical
countermeasures intended to protect against chemical,
biological, radiological, and nuclear threats and new
infectious diseases. The top priorities for these funds include
care for U.S. soldiers suffering from traumatic brain injury,
treatment of acute radiation syndrome, and supporting rapid
deployment of critical medical countermeasures in emergency
situations.
--An additional $17.7 million to permit us to equip and obtain
certification for four already-constructed buildings, including
two labs, on the White Oak campus, so that they may begin
carrying out research to support biomedical advances. Without
these funds, the labs cannot be used and the $300 million cost
of constructing them will have been wasted. Moreover, we will
need to continue to pay rent for the old space occupied by FDA
staff.
Under agreements negotiated with industry, we seek an increase in
current law user fees of $500 million to support our drug, device,
animal drug, animal, food and feed, color additive, export, and tobacco
product programs. We also seek $269 million in proposed user fees,
including $225 million for food facility registration and inspection,
and imports, $31 million for animal drug application fees that are up
for reauthorization this year, $19 million to strengthen our oversight
of cosmetic safety, and $15 million for reinspection of medical product
facilities.
I know that some of you have expressed concern that proposed user
fees for food producers will impose unexpected burdens, especially on
small producers. Please be assured that food-related user fees, if
authorized, will be developed in close cooperation with stakeholders.
CONCLUSION
FDA's oversight of our food and medical products supply is
indispensable to the health and well-being of every American. We carry
out our broad public health responsibilities effectively and with few
taxpayer dollars--even as those responsibilities are expanding as a
result of new legislation, technological advances, and a globalized
marketplace. Our fiscal year 2014 budget targets our spending
efficiently, on programs that are essential to providing Americans with
the safe foods and effective medical products they expect. I look
forward to answering your questions today and to working with you in
the coming year.
Senator Pryor. And I know you have a couple of colleagues
there to help if we get too bogged down in the weeds here. So
we want to welcome them to the subcommittee as well. I know you
introduced them.
BUDGET REQUEST
Let me start here and just jump right in to your budget
generally. As we have talked about a few moments ago, you
prepared this budget before we passed the fiscal year 2013
budget. That puts you at a real disadvantage, and we understand
that. We are sensitive to that.
We are not going to ask you to clarify that today, but I do
hope that you and your team will work with us and our teams
here on the subcommittee to try to update your requests and try
to find the balance we need to find as we go forward. And I
assume you are perfectly willing to do that and would agree to
all work together on that?
Dr. Hamburg. Absolutely. Willing and eager.
Senator Pryor. Well, thank you very much. And again, we
appreciate that. We just understand the circumstances, and I
think everybody understands the circumstances we are in.
SEQUESTRATION
Let me ask about the sequester. This is something obviously
that has been in the news a whole, whole lot. We know how
important it is. We also know that there have been news reports
about the FDA losing the ability to conduct approximately 2,100
domestic and foreign facility inspections for consumer safety.
And now that the sequester is here and now that the cuts
are taking effect, can you please provide us with an update on
how the sequester is affecting your agency?
Dr. Hamburg. Okay. Well, of course, the sequester is of
significant concern to us, and overlaid on the additional issue
of expanding responsibilities, these cuts will come at a cost.
The sequester is about $209 million in terms of cut to FDA,
$126 million in budget authority, and it is important to note
also $83 million in user fees.
We, at the present time, are trying to absorb the impact of
sequester in ways that will have the least impact on the health
of the public and our ability to move forward with critical
programs. We are decreasing travel and conferences, training
programs, cutting back on a range of consulting contracts and
grants.
Sad to say, we are already not at our full-time equivalent
(FTE) caps, and so we won't be able to hire up as much as we
would like. But we won't have to furlough anyone because we are
under where we would like to be, where we think we actually
need to be. But that is another area in which we will absorb
some of the sequester cut.
The issue around the user fees I think is an important one
because we did work carefully with industry and with Congress
to develop a program for the use of user fees in key areas of
our medical product programs. And we will not be able to use
all of those user fees to achieve the performance goals that
were negotiated with industry, and I think that will be
reflected in a slowing of some of our ability to build up key
programs, to advance medical product review programs in
critical ways. And I do think that this is a set of concerns
for all of us.
USER FEES
Senator Pryor. You anticipated my next couple of questions
about the user fee because I think a lot of people would be
surprised to know that you can't use a user fee, something you
negotiated with the industry and everybody understands the
parameters and how they will be used.
Do you think--have you thought about how that is going to
affect your negotiations and discussions with the industry
going forward?
Dr. Hamburg. Why, of course, I am very concerned about
that. The process involves us sitting with industry and also
the engagement of a broader set of stakeholders to really
identify what are the critical issues and concerns, how can we
strengthen programs and activities, and what are our key
performance goals to measure, and then how do we measure
progress toward those goals?
Industry clearly expects that the money that they are
putting forward to the FDA will support these critical goals
and programs and activities, and I think industry has been
surprised, as have been many others, that they would be the
subject of cuts in the same way as budget authority. And I do
think that it is something to think about the next time we sit
down across the table to discuss these fees.
Nonetheless, without these user fees, our programs would be
seriously compromised in our overall resources to do critical
tasks.
FOOD SAFETY USER FEE
Senator Pryor. Yes, and I see that also with food safety
user fees that you are proposing, and I have that concern that
if--we can't act unless it is authorized by other committees
here, and I am not sure those will be authorized.
And I am wondering if you have thought through the
possibility that they not be authorized, therefore not be
appropriated. And how can you do the things you need to do on
the food safety side if those user fees aren't there?
Dr. Hamburg. Well, as we look at the program for food
safety and the implementation of the Food Safety Modernization
Act, clearly the goals of food safety modernization and moving
toward this preventive model is a shared set of goals for
industry and for the benefit of the American people, and I do
think it is appropriate that our budget reflect a combination
of a budget authority commitment and user fees.
We have begun discussions with industry in this arena, and
I think that those will be important discussions as we try to
achieve what has been proposed in the President's budget and as
we work with Congress in shaping the fiscal year 2014 budget.
And the issue of how those user fees are authorized and
appropriated is, of course, an important one, and there will
need to be, of course, a legislative pathway for that.
And I hope we can do it in a way that will maximize the
benefits for everyone and protect those user fee funds for
their intended use.
Senator Pryor. Yes. Well, and I think, just as this
develops over the course of the year, we just need to keep
talking, and it is very important for us to know about your
priorities. And we will work through all the ``what ifs'' as
they come up.
But again, thank you.
I know we have been joined by several colleagues here. So I
am going to turn it over to Senator Blunt and let you ask
questions, and then we will move down the line.
Thank you.
Senator Blunt. Thank you, Mr. Chairman.
BUDGET REQUEST
On maybe the biggest issue that we will need to work
together on regarding the budget is getting the request in
synch with what you need now. Because as the chairman
mentioned, some of your requests were met in the continuing
resolution.
WHITE OAK FACILITY
For example, the move into the White Oak facility, I think
that money is there now. Is that right?
Dr. Hamburg. Well, we, in the continuing resolution--and we
appreciate it greatly--there were monies given to us for the
White Oak consolidation. We do have continuing needs.
Unfortunately, those were not one-time only needs in terms of
the White Oak consolidation.
And as----
Senator Blunt. But the move-in needs were one-time only,
and the completion needs were one-time only, right?
Dr. Hamburg. There are additional needs in order to
complete the buildings.
Senator Blunt. We need to talk about what those are.
Dr. Hamburg. We would be delighted to sit down with you on
that.
[The information follows:]
The additional needs to complete the White Oak Campus are as
follows:
FDA has $17.6 million in additional requirements in fiscal year
2014 over the 2013 appropriation for the Offices and the Life Sciences-
Biodefense Complex, also known as the LSBC. These funds will ensure
final commissioning and certification of specialized laboratories prior
to occupancy. This includes installing and testing specialized
equipment ($1.3 million) for building automation, operation and
monitoring, conducting high-efficiency particulate air filter,
pressurization control, and power tests, installing air sensors,
determining primary bio-containment device effectiveness, and providing
special containment equipment for the Biosafety Level-3 labs, also
known as BSL-3 labs. The BSL-3 labs containment equipment and the
vivarium's pH waste neutralization system are specialized systems that
will also be maintained with this request.
The fiscal year 2014 increase also includes decommissioning ($8
million) the laboratories FDA is vacating at the National Institutes of
Health and at Nicholson Lane, some of which we have occupied since the
1960s. Decommissioning activities include complying with environmental
regulations and mitigating any contamination caused by chemical,
radiological and biological materials.
Funds are also needed for critical operational and logistical
functions on the White Oak Campus, including completion of the
remaining campus security infrastructure. FDA will experience, as part
of the LSBC and office move, a 50-percent growth over the current
campus population as well as a 50-percent increase in building square
footage that must be supported. Specifically, these funds will be used
to develop and implement additional safety programs ($3.1 million) to
support complex laboratories, including high containment specialty
laboratories, expand the Central Utility Plant to support the new LSBC
and Office Complex, and increased operational and logistical functions
($5.2 million), including hazardous materials storage, handling,
processing, and distribution.
FDA must make this investment in early fiscal year 2014 to ensure
that the offices and LSBC are operational and ready for occupancy.
These buildings must be operational and meet safety requirements to
serve critical CBER and CDER programs that help combat emerging
infectious diseases and bioterrorism threats and ensure the safety of
blood, tissues, stem cell therapies, vaccines and drug products.
SEQUESTRATION
Senator Blunt. All right. We need to talk about what those
are. And what amount of money did you say was being sequestered
in fees?
Dr. Hamburg. It is about $83 million.
Senator Blunt. Eighty-three million?
Dr. Hamburg. Million, uh-huh, and that is across a number
of user fee programs in the medical product arena.
Senator Blunt. And your overall shortage in these areas
between now and September 30 would be less than the amount of
money you think you need to complete the year?
Dr. Hamburg. Well, we will have cuts through sequester to
the user fee and the budget authority component of programs----
Senator Blunt. Right.
Dr. Hamburg [continuing]. That support our medical product
review. So, overall, the sequester impact is $209 million.
USER FEES
Senator Blunt. Assuming we went forward with the Budget
Control Act, would you be supportive of the user fee categories
being exempt from sequester?
Dr. Hamburg. I don't know that I am the best person to
speak to the overall policy, but I would be very eager to see
the user fee monies protected in terms of their intended use,
which, as I have mentioned before, were negotiated very, very
carefully with industry in terms of a set of critical programs
and activities and performance goals.
Senator Blunt. And again, for the rest of this year for the
FDA budget, the user fee sequester is $83 million. So this is a
big amount of money.
Dr. Hamburg. It is a big amount of money.
MENU LABELING
Senator Blunt. All right. What about the easy to deal with
topic of menu labeling? Where are you on that? When do you
expect the FDA to issue its final rule?
Dr. Hamburg. Well, we hope to issue that final rule soon.
As you know, it has been an extended process. We have talked
before about how I naively thought that menu labeling would be
one of the easier to implement components of the law, but in
fact, it has been very challenging.
But we have had the opportunity for a process of notice and
comment rulemaking, and we--in response to the proposed rule
that we put forward, we did receive a very large number of
comments. We are currently going through all of those and
trying to finalize a final policy document, and we will be
getting that out certainly by the end of this year, although,
knock on wood, and as soon as we possibly can.
Senator Blunt. By the end of this calendar year or by the
end of this fiscal year?
Dr. Hamburg. I was saying calendar year, but it is a high
priority. We are trying to move forward with it. I can't tell
you exactly when. And whenever I do make those kinds of
statements, I always regret it.
But we are moving into the home stretch, and I know that
you have had many concerns about aspects of it. And we have
heard those concerns, and they were reflected in the comments.
But it has been a complex rulemaking process.
Senator Blunt. Well, you and I both have learned a lot more
about this than we would have ever expected to learn.
Dr. Hamburg. Yes, exactly.
Senator Blunt. And things like the small chain grocery
stores, the food they have available in the store, drive-
throughs, locations that are almost exclusively delivery
locations, how much posting do they need to do at the location,
all those are things that obviously people are going to look
very closely at when that rule does come out.
COSMETIC USER FEE
The cosmetics industry, I understand that the FDA has been
involved in some discussions with the industry looking for a
science-based framework that would establish a uniform national
standard. Do you want to comment on that at all?
Dr. Hamburg. Well, we have had a number of discussions with
industry about their desire for greater harmonization of
approaches. There is an international forum for some of those
discussions that meets regularly with other regulatory
authorities engaged as well.
We think it is an important set of activities, although
different countries do have different legal regulatory
frameworks for oversight of this area, which will not enable
total convergence. But we think that these are important
discussions to be having.
We also do believe that there are opportunities for us to
coordinate more closely with the cosmetics industry, and we
expect to be having some more targeted discussions in the
context of the proposed user fees.
Senator Blunt. I think the industry is growing more
concerned that there might be a lot of conflicting State laws,
and some Federal definitions that were overriding would be
helpful there.
I know this is the second year in a row that you have asked
for these cosmetics industry user fees. I think this year you
estimate the fee would cost the industry a little over $19
million. I am glad to continue to talk about that. I was
opposed to that at the end of our discussions last year and
probably will be again this year, but it is a topic that I am
willing to talk to you about.
MEDICAL DEVICES
On the medical device manufacturers, I understand that a
number of countries have a country of origin first step. If you
haven't been approved in the country the device is made, you
just automatically cannot be approved in a number of countries
around the world.
Costa Rica appears to have been a very big beneficiary of
this. I know there are 14,000 medical device jobs in San Jose
now. Most of them are pretty new, and mostly because that
government, more quickly than our Government, will give them
the country of origin approval.
Have you got some thoughts on how we deal with the medical
device process going more quickly than it has been going? And
they have a fee already that they are willing to pay. Is that
right?
Dr. Hamburg. Yes. Well, with respect to the issue of where
manufacturing occurs, it often is a decision of companies in
terms of costs of manufacturing, price of labor, and other
incentives. And as you know, when the country requires that you
be approved in that country in order to sell in that country,
that is an important incentive as well.
Senator Blunt. Yes, but to be sure we are talking about the
same thing. This is where other countries require as their
first step that you had to have approval in the country where
the device was made before you could even apply for approval in
the country you would like to sell it in.
Dr. Hamburg. Well, that is a national policy. I do think
with respect to Costa Rica, it is interesting to note that they
accept the U.S. approval for devices as an approval within
their own country because they do look to us in many ways as a
gold standard for approval of these products.
But we are working very hard with industry and within our
own program processes and procedures to try to find ways to
streamline our device review process as much as possible, to
make it as clear and predictable as possible. We don't want it
to be overly cumbersome, but we want it to provide appropriate
protections to make sure that products are as safe and
effective as possible for their intended use.
We want to find ways to encourage manufacturers to remain
in this country, to do their work in this country. And I think
that we remain as a Nation a leader in medical device science
and technology and continue to have strong exports in this
area. But we want to make sure that our regulatory programs
support that, but also, of course, address what is our core
mission, which is the review of safety and efficacy.
TISSUE BANKS
Senator Blunt. Two quick questions I will ask for the
record unless we have time for a second round. One is, first of
all, to preface a question on tissue banks, I want to thank you
for personally taking time to get involved in that. I think
there were four areas, following up on their meeting with the
agency, that you all were looking at.
One was to reissue the jurisdictional update guidance
document and allow for a formal comment period. Two was to stop
publishing FDA's descriptions of Tissue Reference Group (TRG)
decisions that they felt had in the past sometimes been
misleading. Three, review the FDA's TRG process to ensure that
it is appropriately addressing current challenges. And four,
your very generous commitment to see that they were meeting
with your organization twice a year.
So just your sense of the time on those four issues----
Dr. Hamburg. Yes.
Senator Blunt [continuing]. At some time when you could
tell me that would be helpful.
Dr. Hamburg. Okay. Terrific. I think we have had some good
discussions and very useful to hear their concerns, and I think
we are addressing them in a coordinated way.
[The information follows:]
1. Reissue the Jurisdictional Update guidance document and allow
for a formal comment period.
Answer. We have heard that some stakeholders have questions about
this policy document, and we understand that there is a need for
improved communication regarding regulatory policy in this area. We are
currently considering how best to address this concern. We agree to
look at this issue and report back on how we are addressing stakeholder
communications regarding the policies described in this document.
2. Stop publishing FDA's potentially misleading descriptions of
Tissue Reference Group (TRG) decisions.
Answer. The TRG was established in 1998. Since then, we annually
have been publishing on our Web site summaries of TRG recommendations.
We instituted this practice in recognition of the public interest in a
transparent TRG process, an interest that was reiterated by Congress in
the last appropriations report directing us to now publish these
updates on a twice-yearly basis. Ending this practice would not serve
important interests in transparency. However, we understand that
industry has concerns that some readers generalize inappropriately from
the summaries that we post on the Web site. In order to address that
risk, we have added the following language to the TRG Web page where
the updates are posted:
Please keep in mind that updates to the TRG Annual Reports are
stated in general terms in order to avoid revealing confidential
information protected from disclosure. The TRG's recommendations are
based on specific facts, which may not be provided in the updates. For
these reasons, it may not be appropriate to generalize broadly from the
updates. If you have questions about your specific product, please
contact [email protected].
3. Review the FDA's TRG process to ensure that it is appropriately
addressing current challenges.
Answer. An inter-center working group has analyzed and revised the
TRG procedures, taking stakeholder comments and concerns into
consideration. FDA has posted an updated Standard Operating Policy and
Procedure (SOPP) for the TRG, and it is publicly available on the FDA
Web site.
4. Conduct two liaison meetings per year. (We understand the
Commissioner has agreed to this item.)
Answer. This request was made in 2012, and CBER/Off ice of
Cellular, Tissue and Gene Therapy (OCTGT) agreed then to a twice yearly
schedule for meetings with AATB. The Commissioner confirmed this
arrangement when she met with AATB in early 2013.
FOOD SAFETY MODERNIZATION ACT
Senator Blunt. And on the Food Safety Modernization Act
rules, FDA took 2 years to draft the rules, yet they are
allowing only 120 days for interested parties to comment. A
number of those parties have requested an extension. I am
hoping that you are looking at that extension, and I will be
glad for some follow-up on that as well.
Dr. Hamburg. Well, we appreciate that these are complex
rules, the proposed rules, to go through and analyze, and we do
intend to extend the comment period so that we can hear all of
the concerns and address them fully. And I think it is a
reasonable request.
Senator Blunt. What are you going to extend by, 180 days?
Dr. Hamburg. I think 120 days.
Senator Blunt. So you are going to double the comment
period?
Dr. Hamburg. Yes.
Senator Blunt. Okay. Thank you, Mr. Chairman.
Senator Pryor. Thank you.
Senator Cochran.
MENU LABELING
Senator Cochran. Mr. Chairman, Madam Commissioner, I
understand the Food and Drug Administration is having some
difficulty in complying with or figuring out how to respond to
the requirement that menus be labeled to show various things
for the consuming public. Food retailers in my State of
Mississippi have expressed some concerns, too, about how this
affects them and how they are supposed to comply.
What type of establishments do you foresee will be affected
or governed by these new requirements?
Dr. Hamburg. Well, the law was quite explicit about chains
of 20 or more restaurants or vending machines in terms of the
applicability of FDA regulatory oversight. Defining exactly
what a--restaurant is fairly straightforward. A restaurant-like
establishment is a more complex challenge in our modern world,
with fast food stores and pizza delivery and the different
kinds of models of in-grocery store cafes, et cetera.
And that is really where the greatest challenges have come
and where we have gone through an extended process of putting
out proposals, asking questions, and seeking public comment.
And we are trying now to go through all of that and compile the
issues and concerns and reflect those back in a final rule,
which we hope will be published very soon.
Senator Cochran. Thank you.
One other concern of importance in my State is with the
catfish industry and the fact that labeling and certification
of the wholesomeness of foods that are going to wind up being
sold in stores or restaurants, whether or not these apply to
foreign fish that come in and are imported into our country.
To what extent are you involved in trying to sort through
those challenges? What is the status of that?
Dr. Hamburg. Well, I think that it is the case that in
terms of seafood in particular, as you mentioned, there is a
growing component of seafood in this country that is coming in
from overseas, and we play a critical role in the oversight of
all of that. And the import of seafood is one of the areas that
surprised me in terms of the shifting of more and more imports
coming from overseas.
You mentioned catfish. That is a particular area of some
regulatory complexity because, as I understand it, several
years ago, Congress actually asked to shift the oversight of
catfish to USDA from FDA, and that process is still in
transition.
And until Food Safety and Inspection Service (FSIS) at FDA
fully takes it over, we are continuing to provide oversight in
that area as well. We work with our partners to try to ensure
the safety and quality of the seafood that Americans eat,
wherever it comes from.
Senator Cochran. Well, we hope that that can be resolved at
an early date. I know it may be complex and challenging, but a
lot of producers and those who are in business here in the
United States are worried that it is being unfairly--or it may
be unfairly applied to domestic producers, as compared with
foreign importers.
So, anyway, your personal oversight of that would be
appreciated.
Dr. Hamburg. Thank you.
Senator Cochran. Thank you.
Senator Pryor. Senator Tester.
Senator Tester. Thank you, Mr. Chairman.
And I want to thank Dr. Hamburg for being here and her
service. And I just want you to know that bringing Thad
Cochran's son to the subcommittee is not going to sway this
subcommittee in the questions and answers. I assume that is
correct, right, Thad?
At any rate, welcome.
FOOD SAFETY MODERNIZATION ACT
Look, I want to talk about the Food Safety Modernization
Act a little bit, too. And I appreciate the ability to visit
with you off the grid, too. I thank you very much for that.
During the debate over the Food Safety Modernization Act,
we had a very healthy discussion about where consumer risk
comes from. One key question was whether the smallest
companies, operating locally, selling at the farmer's market or
at a local grocery store, pose the same kind of risk as the big
national companies do.
And while there were strong feelings on both sides of this
debate, and they were strong, one thing that was lacking was
any epidemiological data to support applying the same rules to
small producers in isolated markets as we do to the big guys
whose mistakes could reach every corner of the country in a
very short order.
So Congress, in order to avoid putting small producers out
of business, did not apply those rules to qualified facilities.
Congress did, however, require a study of the food processing
sector, including facilities collocated on farms, and this
report was to be completed before the promulgation of the new
rules, and the rules were intended to be informed by the study.
And correct me, if I am wrong on that.
However, FDA did not release the study until January--
correct?--along with the proposed preventive control rule. Yet
the study was dated November 2011.
Can you please speak to why the agency did not release that
report and seek comment on it before a proposed preventive
control rule was released? It is about 13 months space.
Dr. Hamburg. We are, as I said, trying to go forward with
an open process with input from all stakeholders, and the
opportunity to bring the best possible science to bear and data
to bear and experience to bear on our rulemaking. I will have
to get back to you on the specifics of the review process for
that report.
[The information follows:]
Section 103(a) of the FDA Food Safety Modernization Act (FSMA)
instructed FDA, in consultation with the Secretary of Agriculture, to
conduct a study of the food processing sector. Section 103(a) of FSMA
also instructed FDA to submit to Congress a report describing the
results of the study not later than 18 months after FSMA's date of
enactment. However, FSMA also required us to promulgate regulations to
establish ``science-based minimum standards for conducting a hazard
analysis, documenting hazards, implementing preventive controls, and
documenting the implementation of preventive controls'' and to define
the terms ``small business'' and ``very small business.'' The
regulations were to be promulgated not later than 18 months after
FSMA's enactment. Under contract with FDA, RTI International conducted
the study, consistent with the FSMA requirements. Also consistent with
FSMA, we have consulted with the U.S. Department of Agriculture (USDA)
about the study. We also included the Food Processing Sector Study as a
reference in the recently issued proposed rule for preventive controls
for human food. The study provides information on the number of
establishments and average sales per establishment by industry and size
of operation. We used the study to inform the proposed rule's
definitions of ``small business'' and ``very small business.''
Although section 103(a) of FSMA did not require us to do so, we
released the study for public comment along with the proposed
preventive controls rule and the proposed definitions of ``small
business'' and ``very small business.'' We took this action so that we
could evaluate and address the comments, before we reported to Congress
on the results of the study.
In the preamble to the proposed rule, we described our plan as
follows:
Consistent with section 418(l)(5) of the FD&C Act, FDA has consulted
with USDA during its study of the food processing sector (Ref. 31). The
study is available in the docket established for this proposed rule
(Ref. 32). We request comment on that study. In section X.B.4 of this
document, we discuss our proposed definitions for small business and
very small business. We will consider comments regarding the study, as
well as comments regarding our proposed definitions for small and very
small business, in any final rule based on this proposed rule.
78 FR 3646 at 3658. Thus, because the study is part of the
administrative record for the rulemaking, we will consider comments on
the study in the same manner as we would consider comments on any other
reference in the administrative record.
Senator Tester. I would like to because----
Dr. Hamburg. Yes.
Senator Tester [continuing]. In my review, it appears that
the FDA did not examine any actual epidemiological data, but it
relied on the process of expert elicitation. And essentially,
academics in the field of food safety and research were
surveyed on their experience.
I think it is--well, point well taken. You will get back to
me.
Dr. Hamburg. I think we can have a rich conversation on all
of the data that has gone into the development of these rules.
Senator Tester. Super. And I thank you for that.
FOOD SAFETY MODERNIZATION ACT
One question that arose during the consideration of the
Food Safety Modernization Act was again whether farms that sell
directly to consumers from farm stands on their own farms
should be treated the same as farmers who sell directly to
consumers out of a truck at a farmer's market, and it is
essentially the same thing.
Under the existing rules, this question has never been
clear. A farmer that sells from his or her own property is
considered a retail food establishment and not a food facility.
The Food Safety Modernization Act required FDA to adjust the
definition of a retail food establishment to ensure that a
farmer selling his or her own food at a market would be treated
the same way.
Can you explain why the rules that were proposed last
January do not address this issue, and do you plan on
addressing it in the final rule?
Dr. Hamburg. Well, of course, in the Food Safety
Modernization Act there was what we finally call the ``Tester
exemption,'' which speaks to some of these issues. But we have
also been trying to build in flexibility in terms of the
proposed rules and how they would be applied, depending on the
activities that were being undertaken and the level of risk.
We have really tried to engage in a lot of outreach and
discussion to understand, noting that there is not a one size
fits all. This is a complex and diverse enterprise, the food
enterprise, and the needs of the produce-growing community are
very different, depending on what you are growing, who you are
growing it for, the size of the facility, et cetera. And so, I
think we are really striving to reach the right balance.
And food safety matters to the American public, whether you
are big or small. But I think in terms of our regulatory
oversight role, we do not want to have a one size fits all. We
recognize the differences. We are trying to achieve a risk-
based approach that really does recognize the differences, and
we are not striving to be unnecessarily burdensome. We are
trying to find the right balance to protect health.
Senator Tester. I very much appreciate particularly the
statement the one size does not fit all. Because one size
really doesn't fit all, and it doesn't fit all in most parts of
Government and especially here.
And where you have--and that is the whole thing. We want
our food to be safe, no mistake about that. We are silly if we
don't. But by the same token, we need to, just as we do in the
financial area, fit the regulation to the risk.
And so, I thank you for that. We will continue to follow
up. My staff will continue to follow up with your staff on ways
we can make this thing work because I think we both want it to
work in the end and work well for the consumer without putting
a bunch of folks who don't pose much of a risk at all out of
business.
So thank you for that.
I talked to you a bit ago about a petition that was in
front of the FDA that had over 1 million signatures on it that
dealt with labeling of GMO [genetically modified organism]
foods.
Dr. Hamburg. Mm-hmm.
GENETICALLY MODIFIED FOODS
Senator Tester. I am going to back up a little bit. When we
talk about chemicals that are applied to food, they go through
a rigorous, and I mean a rigorous, bunch of tests. The GMO
issue is fairly new, 15 to 20 years, and in my perspective,
from my opinion as a dry land dirt farmer, I will tell you that
the amount of testing that is done on genetically modified
foods is slim to none, and slim just left town.
And so, my question to you is, is that with this petition
in hand, it was originally submitted about 1\1/2\ years ago,
November 2011, what are your plans? And I know in previous
conversations, you talked about the plant where their corn,
soybean, cotton, whatever, is really not changed much. But I
don't know if there is tests to prove that.
It is certainly a different plant than it was initially
because there are traits in the environment. So what is your
opinion on labeling? Is it something FDA is going to do?
Dr. Hamburg. Well, we certainly understand that there are
concerns about safety and environmental issues related to
genetically modified foods in the public at large, and it has
been the focus of a lot of scientific work and investigation.
We support a consumer's right to know and voluntary labeling of
genetically modified foods.
Senator Tester. The problem is, is that I am not sure
voluntary labeling is ever going to happen, or it would have
already happened. Just a point.
Thank you, Mr. Chairman.
Senator Pryor. Thank you, Senator Tester.
COSMETICS
I have a few follow-ups, if you don't mind, Dr. Hamburg?
And that is on cosmetics. You know, we talked about user fees
in other contexts. I am not sure we mentioned user fees in
cosmetics.
I know that you have been in negotiations with the industry
on these. My understanding is they are concerned about timely
and fairly rapid reviews of things and make sure that we have
safe products to find that right balance we need.
But are you in a position today to talk about your status
of your negotiations with the cosmetics industry?
Dr. Hamburg. You know, I think that we are at a very early
stage in terms of some of the specifics, but we expect now that
the President's budget has come out and there is a target as
well, that we will be sitting down with the cosmetics industry
in a much more focused way. And of course, we will be also
bringing the fruits of our discussion to Congress as we move
forward.
Senator Pryor. Are you talking about setting up a national
standard for regulation of cosmetics?
Dr. Hamburg. Well, that, I think what we would be talking
about with respect to the user fees would be more trying to
define a shared agenda in terms of what are a couple of
critical priorities in terms of our oversight of them in areas
where the cosmetic industries think that they would benefit and
where we think that through additional resources and
identification of some key areas of activity, we could
strengthen our program.
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
Senator Pryor. Let me also just change the focus here for
one moment to the National Center for Toxicological Research. I
know that they do a lot of things in the nanotechnology world,
which is very important. But this is a facility that also is
looking at the safety of some high-profile issues like BPA and
also antibiotics in food processing animals, pediatrics
anesthetics, even something that is very current this week,
ricin, trying to find the best inactivating agent for that.
So, obviously, it does a lot of important work. And they
certainly benefit your mission and are important to your
mission. And I also know that you have a memorandum of
understanding between the State of Arkansas, led by Governor
Beebe, and also yourselves about trying to make sure that this
is just a first-rate facility all the way around with a lot of
collaboration and help going both ways between you and the
University of Arkansas.
VIRTUAL CENTER OF EXCELLENCE--NANOTECHNOLOGY
Could you talk just a little bit about that memorandum of
understanding (MOU) and the virtual Center of Excellence
established by the MOU and just an update on that, please?
Dr. Hamburg. Sure. Well, we are very excited about this
project and the incredible support that we have gotten from the
State of Arkansas and its outstanding academic institutions. It
is an MOU with five academic institutions in the State, as well
as the Government, and really enables us to move forward in a
couple of critical ways.
One is that we have created a training program in
regulatory science, one of the first formal programs in the
country, and we will be graduating our first group of
accredited students in this area. And that really matters today
and for the future, of course, in terms of really making sure
that we have the strongest science-based regulatory programs.
It also enables us to really focus on some critical issues
like nanotechnology and study them at a very basic science
level as well as all the way through the set of issues that
arise, including clinical experience with the assessment of
safety and efficacy of some of these products. So it really is
a very unique resource.
And as you note, the National Center for Toxicology
Research is a unique entity in the country in terms of its
focus, the kind of work it does, and its impact on critical
issues to the American people. So I think this is really an
outstanding program that we expect will yield a lot of benefits
going forward.
NANOTECHNOLOGY
Senator Pryor. Well, and I know that nanotechnology is
really an emerging field, and it is a rapidly developing field.
Do you feel like the FDA has the resources necessary to stay on
top of all the changes that are coming with nano materials and
nanotechnology?
Dr. Hamburg. Well, of course, we could always use more. But
we have a strong program. Nanotechnology is a very challenging
area for us in the sense that nanotechnology is emerging and
nano-based products are emerging across many domains of our
activity--drugs, devices, foods, cosmetics. And in these
different areas, they may raise different concerns.
So I think it is very, very important that as this field is
evolving, we are very engaged from the get-go in terms of
thinking about both some of the safety concerns that are
important to address, but also how best to harness this new
technology and approach to benefit the American people.
BUILDING AND FACILITIES
Senator Pryor. Right. I am not going to ask you to go
through all the details on the answer to this next question.
But I would ask you to provide us the documentation for your
building and infrastructure needs. And I know you have been
doing that, and obviously, it needs to be updated and made
current.
But I see the request that you have made, and I think it is
important for us on the subcommittee to see all of your needs
and look and see if there are ways that we can help with that,
and we would like to really kind of do a top-to-bottom review
of that and work with you on that because that is very
important. And you can just submit that for the record when it
is ready.
Dr. Hamburg. Okay. Terrific.
[The information follows:]
The Building and Facilities (B&F) Program provides funding to
construct, renovate, repair and improve FDA's 86 owned buildings and
the associated infrastructure for at six sites where operations
critical to FDA's public health mission are conducted. A total of
approximately 1,400 staff and contractors are employed at these sites.
FDA's owned assets include numerous laboratory facilities and a
substantial amount of site infrastructure. It is critical to ensure a
safe working environment for FDA employees. Improving the physical
condition and operational reliability of these assets is also vital to
supporting FDA's work to protect the Nation's health, security, and
safety.
FDA currently has an estimated Backlog of Maintenance and Repair
(BMAR) of $120 million, which represents a comprehensive list of
maintenance and repair deficiencies for buildings and site
infrastructure. In addition, B&F funding is also needed to bring owned
buildings into compliance with sustainable building standards and to
accomplish renovations needed by FDA programs to meet regulatory and
mission requirements.
The Jefferson Lab Complex (JLC) site provides an excellent example
of FDA's needs. FDA conducts mission research at its JLC site, which is
occupied by the National Center for Toxicological Research (NCTR) and
the Office of Regulatory Affairs' (ORA) Arkansas Regional Lab (ARL).
This site represents more than 50 percent of FDA's owned square footage
and BMAR. More specifically, there are at least seven laboratory and
animal holding facilities that are in urgent need of attention with
architectural, HVAC, electrical, and plumbing systems that have reached
the end of their useful life. These buildings are in need of repairs
and improvements to meet code and make them safe to meet FDA's mission.
A Master Plan, which will identify required improvements and
renovations to buildings and site infrastructure, and will propose a
strategy to implement them over the next 5 to 20 years, is almost
complete. In addition to addressing some of the above noted needs, the
Master Plan also addresses critical needs for the construction of a
Nanotechnology Core Facility and an addition to an existing Imaging
Core Facility as well as initiating utility infrastructure support for
a proposed Biotechnology Park (a.k.a., Bioplex) being spearheaded by
The Economic Development Alliance of Jefferson County Arkansas of which
FDA is an active member. Such vital improvement, renovation and
construction projects cannot be completed without adequate B&F funding.
Investing in FDA-owned facilities provides space for expansion and
the ability to renovate and retool infrastructure to support the
complex FDA mission while saving funds. By utilizing its owned space to
maximum capacity, FDA can reduce the amount of rented space it
requires. Jefferson Laboratories alone has approximately 40,000 square
feet of space available for renovation and use, and 490 acres of land
that could be made available for future construction.
FDA ensures its mission support capabilities are resourced
adequately to achieve program success and, in the past, has been able
to defer its maintenance, repairs, and facilities improvement needs as
program needs were of higher priority. But the scale has recently
tipped due to the continuous decreased funding for the B&F Program. FDA
has determined that years of underfunding this program has resulted in
a risk to its mission and to the safety of its employees.
The Agency can no longer defer its maintenance needs as we are
experiencing system failures in our buildings and infrastructure which
not only impact reliability and mission-critical research activities
but also the health and safety of our employees. Funding is needed now
for critical buildings and infrastructure projects to ensure mission
accomplishment and a safe working environment for its personnel. FDA
leadership is also weighing these needs heavily in the formulation of
our fiscal year 2015 budget request.
Below is information regarding FDA's six owned sites and the
critical work conducted at these sites in support of FDA's public
health mission:
Jefferson Labs Complex (JLC)--Jefferson, Arkansas.--This site is
occupied by NCTR and ORA's Arkansas Regional Lab. NCTR conducts
critical research at this site that focuses on toxicity and risk
assessment, nanotechnology, biomarker development, non-invasive
imaging, and studying the extrapolation of data from animal studies to
humans. ARL conducts testing and analysis in support of post market
surveillance. ARL also conducts research, collaborative studies,
regulatory inspections, and scientific consultations to support
enforcement activities.
Gulf Coast Seafood Laboratory--Dauphin Island, Alabama.--FDA's Gulf
Coast Seafood Laboratory site is used by the Center for Food Safety and
Applied Nutrition (CFSAN) to conduct research programs related to
seafood safety, especially FDA-regulated seafood harvested from the
Gulf of Mexico.
Muirkirk Road Complex (MRC)--Laurel, Maryland.--This is a campus
shared by CFSAN and the Center for Veterinary Medicine (CVM) to conduct
research programs related to food and animal drug safety, toxicology,
microbiology, and molecular biology. In addition, laboratories at this
site are used as part of the Laboratory and Food Emergency Response
Networks.
Winchester Engineering and Analytical Center (WEAC)--Winchester,
Massachusetts.--WEAC is an ORA specialty laboratory used to test the
safety and performance of medical devices, microwaves, and
radiopharmaceuticals; to conduct radionuclide testing with food
samples; and to ensure seafood freshness.
San Juan District Office and Laboratory--San Juan, Puerto Rico.--
The San Juan District Office is responsible for compliance with FDA
regulations in the Commonwealth of Puerto Rico and the U.S. Virgin
Islands (St. Thomas, St. Croix, and St. John). The San Juan District
Laboratory is a National Servicing Laboratory that specializes in the
testing and analysis of human drugs (pharmaceutical analysis) and
provides support in team inspections as well as conducting independent
inspections of contract laboratories, domestic and foreign.
Los Angeles District Office and Pacific Regional Laboratory SW--
Irvine, California.--This location houses the Los Angeles District
Office, which serves as ORA's inspection and compliance activity in
Southern California and the State of Arizona. The pacific Regional
Laboratory SW is a multi-functional laboratory performing predominantly
import work in the Foods, Drugs, Cosmetics, Veterinary Feeds, and
Medical Devices program areas. The lab also has specialized
capabilities in the areas of Entomological basis of Filth and
Sanitation, Regulatory Mass Spectrometry, and Regulatory Molecular
Microbiology and Virology.
DRUG COMPOUNDING
Senator Pryor. And the last thing I have really is I
understand that you recently made an appearance before the
House of Representatives, and maybe the issue of drug
compounding came up over there?
Dr. Hamburg. This is true.
Senator Pryor. And I, like everyone else in the country,
certainly on this subcommittee is very, very concerned about
the fungal meningitis outbreak that we saw linked to the New
England Compounding Center. And I also notice that in the
budget, you are requesting, what is it, $3 million, if I am not
mistaken?
Dr. Hamburg. In the continuing resolution fiscal year 2013
budget, we intend, with the agreement of this subcommittee and
support of this subcommittee, to spend $3 million for issues
related to expanding activities with respect to oversight of
compounding pharmacies.
We are, as you may know, very deeply involved in
discussions with Congress, particularly on the Senate side,
with respect to legislation that would give us new authorities
that we very strongly feel we need to be able to provide better
protection for some of the highest risk compounding facilities
that are making sterile products that represent a greater risk,
making them in advance of or without a prescription and selling
them across State lines.
We don't know what that legislation will look like. I am
very hopeful that we will get it. But we will need to come back
to you with additional requests over time as we really
determine the nature and scope of our responsibilities in this
area and what we will need to have the kind of strong and
sustainable regulatory regime to address the safety of
compounding pharmacies.
Senator Pryor. Compounding pharmacies are a very important
piece of the puzzle, and certainly we want those drugs to be as
safe as they can be, just like all drugs. And obviously, a
problem like we saw at the New England Compounding Center
raises concern, and we look forward to working with you on
that.
Senator Blunt.
Senator Blunt. Okay. Let us stay with that topic a little
while. The $3 million that you would expect to commit between
now and the end of this fiscal year on drug compounding, under
what authority would you be getting more involved or do you
need legislation to get involved? What would you spend it on?
Dr. Hamburg. No, we have authority with respect to
compounding pharmacies, but it is far more limited than the
authorities. For example, we have over conventional
manufacturers. As you probably know, compounding pharmacies
have historically been regulated on a routine day-to-day basis
by the States.
But we are increasingly concerned that there are many large
compounding pharmacies out there that are making these high-
risk sterile products, and we feel an obligation to be as
aggressive as possible with our existing authorities to know
who is out there making what and to make sure that there are
not serious sterility concerns and other concerns that would
put the American people at risk.
We do not feel we have all of the authorities that we need
to regulate this arena of compounding pharmacies and
particularly these large compounding pharmacies that are
behaving essentially as outsourcers to hospital networks and
providing critical products to the healthcare system and to
patients. And that is why we are seeking legislation.
We don't have the authority, for example, to require that
all of these facilities register with us and tell us what they
are making. We don't have the authority to go in and fully
inspect them, get access to their records and take samples. We
don't have the authority to hold them to a uniform set of
national standards or the authority to require that these
compounding pharmacies report adverse events to us when they
learn about them and about their products.
DRUG COMPOUNDING LEGISLATION
So we think that everyone would benefit by legislation that
would clarify and strengthen the FDA oversight role.
Senator Blunt. Now I would think, and I would be pleased to
have your comments on this, that there is an argument to be
made on the manufacturing side where a compounder is making a
significant quantity of a compounded product to then be sold,
as opposed to the pharmaceutical side where a pharmacist is
compounding one product for one prescription.
That obviously would take a whole lot more oversight than
on specific manufacturing facilities. Am I off base there in
looking at that that way?
Dr. Hamburg. Well, we recognize the role of traditional
compounders, and we do not want to oversee all compounding
pharmacies in this country. But the industry has been evolving,
and the healthcare system needs have been evolving. And there
is this new sort of hybrid of compounding pharmacies that are
making larger volumes and higher risk products, and we do feel
that that is a gap in our current regulatory framework.
If we were, as has been suggested by some, to treat this
group of compounding pharmacists and pharmacy facilities as
manufacturers, because they are doing some things that look
more like manufacturing in many ways in terms of volume and
some of the kinds of products that they are making, that would
have very, very serious implications for the healthcare system
and patient needs.
APPROACH TO DRUG COMPOUNDING REGULATION
You spoke earlier about the need for sort of a thoughtful,
balanced approach to regulation. Our current authorities might
push us to treating a range of compounding pharmacies like
conventional manufacturers, and that would almost certainly put
many of those companies out of business, both the good actors
and the bad actors.
We don't want a system that will unnecessarily compromise
important industry and important manufacture of critical
medical products, but we also want to make sure that those
compounding pharmacies are appropriately regulated. We believe
that we can find a balanced approach that will require those
pharmacies that are making the high-risk sterile products in
advance of or without a prescription and shipping to other
States in a way that fits appropriate safety standards and good
manufacturing practice for the products they make so we can
assure quality.
We want to be able to know who they are and what they are
making and to routinely inspect them and get access to
everything that we need. We want to make sure that these
compounding pharmacies are making safe, high-quality products.
But we also don't want to apply a sledgehammer if that isn't
what is needed.
And that is why we want to work with Congress to achieve
the kind of regulatory authorities that we need to best serve
the American people at the end of the day.
Senator Blunt. Well, I think it is very important how you
define the role you want to play for the FDA in the future so
that this doesn't later become: We have the right to go in and
check on every pharmacist in America and how they filled every
prescription.
Dr. Hamburg. Believe me.
Senator Blunt. You may have some right to do it, but
clearly, the tools to do that would be, in my view, beyond our
reach.
Do you have any idea how many of these kinds of facilities
there might be? Are we talking about hundreds or dozens?
Dr. Hamburg. Well, we don't really know the full landscape
because they aren't required to register with us in terms of
these higher risk compounding pharmacy facilities. We know
there are about 28,000 compounding pharmacies across the
country, or at least these are the estimates that we get from
industry.
Of those, there are probably about 7,500 specialty
compounders, and a subset of those, some 3,000 are making the
higher risk sterile products that I was just talking about.
Senator Blunt. Well, my thought on this would be to let us
draw this line as appropriately and tightly as we can, if you
really want to get this done, as opposed to broaden the scope
to the point that so many people are so concerned that nothing
happens.
DRUG COMPOUNDING ISSUE IN MISSOURI
We had a problem in Missouri with this, as I mentioned to
you, on some cancer drugs. As I recall about 20 years ago a
pharmacist was knowingly not giving the right prescriptions and
saving the cost of those drugs.
We have very tight laws because of that. I think we are one
of only two States that give pharmacists a specific license to
make a specific compounded product and that was a result of
that problem. And still, if a pharmacist wants to violate the
law and eventually run the risk of going to prison, they could
still not do what they are legally obligated to do.
I don't know what is in a pill or what is in a compounded
product, either one. I have to trust somebody in that process,
and I think there may a place that we can define this in a way
that allows us to do that.
DRUG COMPOUNDING FUNDING
I still don't quite know what you are going to do with the
$3 million between now and the end of the year. So why don't
you have somebody prepare that information.
Dr. Hamburg. Okay. Well, we would be happy to. But we are
going to use it to continue some of the inspections that we
have been doing, follow up on the inspections and----
Senator Blunt. Maybe when I see how you are going to spend
that money, I will know what you are able to do now, compared
to the gap that is still out there to be filled. And do you
have an estimated cost of what it would take to regulate these
manufacturers of the kinds of products you have described?
Dr. Hamburg. Well, we are certainly looking at those costs.
What an overall program would cost depends on ultimately how we
move forward with legislation and new authorities and defining
this category of nontraditional compounders that we were just
discussing. Because as I said before, we understand the
importance of traditional compounders, and we have no interest
and clearly don't have the resources to take on the whole
activity, and it has historically been a State responsibility.
But we do have real concerns about the safety of the
American people in light of an evolving industry, and we do
feel that we do need additional legal regulatory tools and
authorities and we will, in order to implement that, need
additional resources as well.
GENETICALLY MODIFIED ORGANISM FOODS
Senator Blunt. Right. And on the topic that Senator Tester
raised, I heard, I thought, two pretty different views of that.
One was on the testing of GMO foods, he said the testing was
somewhere between slim and none, and slim has left town. So I
guess that means none.
You said a lot of scientific work and investigation here.
You do have to decide whether these products can become part of
a consumable food product. Is that right?
Dr. Hamburg. We do provide oversight of the safety and
wholesomeness of foods, whether they are genetically modified
or not, yes.
Senator Blunt. And the scientific basis, the science that
you look at has led you to believe that any of these products
that are in our current food supply are safe, or they wouldn't
be there?
Dr. Hamburg. We do not believe that there are existing
threats to health from these products.
Senator Blunt. As I understand it, the Department of
Agriculture is involved at deciding what products can be
planted and grown, and then you come in at some point and
decide what the potential food uses of those might be, as
opposed to other uses?
Dr. Hamburg. Well, there are many components to this
question.
Senator Blunt. If you want, the one question I will ask
that maybe narrows that. Where does USDA leave off in a GMO
product and you take over?
Dr. Hamburg. Well, we don't proactively review the product
in the way that we review a drug on a routine basis. We are
reviewing now GE salmon, which I am sure you are aware of. And
actually that is being reviewed under our veterinary drug
program, and it is the first in its class in terms of a
genetically modified product that is coming before us.
And that is being reviewed in terms of safety clearly. But
our overall food program, I mean, not every food that goes into
the marketplace is reviewed and approved by the FDA for safety,
but we monitor safety issues, of course.
Senator Blunt. Then this is one of the topics you would be
monitoring, along with lots of others?
Dr. Hamburg. Genetically modified foods? We are responsible
for overall safety, quality, wholesomeness of the food supply.
With respect to those areas in the FDA domain, of course, as
you know, USDA regulates meat, poultry, and processed eggs.
Senator Blunt. Right. One of the few products we don't grow
in our State, and I think Arkansas, is sugar beets. We grow no
sugar beets. But I know there was a sugar beets case a few
years ago. After the product was approved by USDA, within 5
years about 95 percent of the crop was this product. If you
bought sugar beets, you were almost certain to be buying that
sugar beet because it did whatever apparently the sugar beet
growers wanted a sugar beet plant to do, and 95 percent of the
crop was sugar beets.
And there was a court case that was not about food safety,
but whether it had been properly tested by USDA on
environmental standards. A Federal judge said I think they
ought to test it some more. USDA appealed that. The higher
judge said, no, you have done all you needed to do to test it.
But in the interim, there was some question about whether
all the sugar beets in the country, or 95 percent of them,
could be harvested and sold that year. But the question was not
about the food quality or the food safety. It was about whether
there were other environmental impacts, and higher court
decided, no, there weren't.
But I thought that there was a lot of science on this, and
you apparently think so, too.
Dr. Hamburg. I do.
Senator Blunt. I thank you, Chairman.
Senator Pryor. Thank you.
Senator Cochran, do you have anything further?
Senator Cochran. Mr. Chairman, I would like to express our
appreciation to the panel for being here today and for the job
you are doing, heading up this very important agency.
Thank you for cooperating with our subcommittee.
Dr. Hamburg. Thank you.
Senator Pryor. And thank you.
Dr. Hamburg, I would like to thank you again for being here
and bringing your team here. I look forward to working with
you. This was a great hearing.
And Senator Blunt and I and the whole subcommittee here
look forward to working with you on this year's bill as we go
through that process.
ADDITIONAL COMMITTEE QUESTIONS
And for members of the subcommittee, if you have any
additional questions that you would like to ask for the record,
we would ask that you get those within 1 week. So that is
Thursday, April 25.
And Dr. Hamburg, if you could make your responses available
within 4 weeks of that time, that would be very much
appreciated.
[The following questions were not asked at the hearing, but
were submitted to the Department of response subsequent to the
hearing:]
Questions Submitted by Senator Mark L. Pryor
PROPOSED FOOD SAFETY USER FEES
Question. If the new proposed user fees aren't authorized, what
does that mean for FDA's ability to implement the food safety law?
Answer. The proposed user fees are critical to ensure that FDA is
able to fully implement the FDA Food Safety Modernization Act of 2011
(FSMA). The two major food safety user fee proposals, a Food Import Fee
and a Food Facility Registration and Inspection Fee, are estimated to
generate $166 million and $59 million, respectively. Not having this
$225 million in fees authorized and appropriated will severely limit
FDA's ability to implement FSMA and to create a modern food and feed
safety system that is prevention-oriented, science- and risk-based, and
efficient. In particular, FDA would not have the resources necessary to
modernize the import system by improving the accuracy and efficiency of
inspections. Without additional resources, FDA will not have sufficient
capacity to develop the guidance documents necessary to support
implementation of the preventive controls and produce safety
regulations and to conduct outreach and educational activities for
industry and regulatory partners. FDA will not be able to hire and
train investigators for import oversight, nor will it be able to
modernize compliance programs and inspection practices to improve
efficiency and overall effectiveness of FDA's public health activities.
FDA will not be able to develop a network of shared State and Federal
laboratory data and perform planned assessments of States enrolled in
the Manufactured Food Regulatory Program Standards.
We hope to continue to work with Congress and industry on this
important issue.
Question. Assuming we are working under the same budget restraints
as you are, please send us information as quickly as possible on what
the highest priority activities are that would have been funded with
the user fees.
Answer. FDA's highest priorities for the fiscal year 2014 food and
feed safety program are developing and implementing preventive control
and produce safety standards, increasing the frequency and accuracy of
domestic and foreign inspections, training of regulatory partners in
new inspection protocols, building the capacity of FDA State partners,
and implementing FDA's new import authorities. Of these important
priorities, FDA's efforts in import safety would be the most adversely
affected if the new user fee proposals are not authorized and
appropriated.
The fiscal year 2014 resources would support comprehensive,
prevention-focused import food and feed safety programs that will place
greater responsibility on those in the food supply chain--food and feed
manufacturers, processors, packers, distributors, transporters, and
importers--to ensure that imported food and feed are as safe as those
produced domestically. Without these resources, FDA would not able to
develop and implement a variety of approaches to ensure the safety of
imported foods and feeds, including assessments of foreign food safety
systems and capacity building for foreign industry and regulatory
partners. FDA would also not be able to use data generated by these
activities to prioritize FDA food and feed safety monitoring activities
and thereby enhance the safety of the U.S. food and feed supply. Not
having these additional resources would hamper FDA's efforts to improve
consumer protection by allowing FDA to make better informed decisions
about the admissibility of imported food and feed products.
BUILDING INFRASTRUCTURE NEEDS
Question. Please provide the Committee with the funding that would
be required to address the current backlog of essential maintenance and
repairs at all FDA-owned facilities.
Answer. FDA currently has an estimated Backlog of Maintenance and
Repair (BMAR) of $122 million, which represents a comprehensive list of
maintenance and repair deficiencies for buildings and site
infrastructure. In addition, the Building and Facilities (B&F) Program
funding is also needed to bring owned buildings into compliance with
sustainable building standards and to accomplish renovations needed by
FDA programs to meet regulatory and mission requirements.
The B&F Program provides funding to construct, renovate, repair and
improve FDA's 85-owned buildings and the associated infrastructure for
six sites where operations critical to FDA's public health mission are
conducted. Approximately 1,212 staff and contractors are employed at
these sites. FDA's owned assets include numerous laboratory facilities
and a substantial amount of site infrastructure. It is critical to
ensure a safe working environment for FDA scientists. Improving the
physical condition and operational reliability of these assets is also
vital to supporting FDA's work to protect the Nation's health,
security, and economy.
The Agency can no longer defer its maintenance needs as we are
realizing system failures to our buildings and infrastructure, which
not only impact reliability and mission-critical research activities
but also the health and safety of our employees. Funding is needed now
for critical buildings and infrastructure projects to ensure mission
accomplishment and a safe working environment for our personnel.
Question. Please list the amount of maintenance and repairs
necessary, by location, in order of the Facility Condition Index.
Answer. The table below provides a breakdown of the BMAR for each
of the FDA's six owned locations in order of their respective site
Facility Condition Index scores.
FOOD AND DRUG ADMINISTRATION OWNED ASSETS--BACKLOG OF MAINTENANCE AND
REPAIR (BMAR) AND FACILITY CONDITION INDEX (FCI)
------------------------------------------------------------------------
Site Total BMAR Site FCI
------------------------------------------------------------------------
Winchester, MA.......................... 7,168,893 47.86
Jefferson, AR........................... 92,897,341 72.79
San Juan, PR............................ 2,936,248 77.88
Laurel, MD.............................. 17,368,120 80.91
Dauphin Island, AL...................... 775,482 82.96
Irvine,CA............................... 945,339 97.01
-------------------------------
Total............................. 122,091,423 ..............
------------------------------------------------------------------------
HIGHLY COMPLIANT IMPORTERS
Question. The Committee included report language in fiscal year
2012 which strongly encouraged FDA to ``establish a pilot project to
expedite imports for highly compliant importers.'' In addition, section
713 of the FDA Safety and Innovation Act directed FDA to establish a
partnership program for highly compliant importers by January 2014. Can
you update us on FDA's efforts to implement both of those pieces of
guidance? Will you meet the January 2014 deadline and if not, why?
Answer. FDA has implemented the PREDICT program that facilitates
entry of lower risk products while targeting higher risk projects for
additional review. Additionally, FDA is in the process of developing
two programs that should help to facilitate the import entry of
products from highly compliant importers: the Voluntary Qualified
Importer Program (VQIP) for Food and Feed and the Secure Supply Chain
Pilot Program for pharmaceuticals.
VQIP is a voluntary program under which food and feed importers may
submit an application for expedited review of entries, based on the
risk of the food being imported.
FDA continues to work on the operational design of VQIP authorized
under FSMA and is close to completion. Currently, IT requirements are
being addressed and importer user fees are in development.
The Secure Supply Chain Pilot Program will increase the likelihood
of expedited entry for pharmaceuticals that meet the criteria for
selection under the program. The Secure Supply Chain Pilot Program
should allow FDA to assess the various entities and processes involved
in a repetitive-type import chain, and if found acceptable and if all
information is accurately submitted at the time of entry, would allow
for expedited processing of entries.
FDA plans to announce the start of a pilot program in order to
evaluate the Secure Supply Chain Program. FDA also is planning a public
meeting to gather additional input on all the provisions of section 713
which is a much broader authority than the development of partnership
programs. The information provided through the pilot program and the
public meeting will help inform the regulations that need to be
developed. FDA is developing a timeline for full implementation that
ensures we have adequate public input.
Question. How many importers have expressed their intention to
enroll in the Secure Supply Chain Pilot, and has pursuing the pilot
prevented FDA from implementing a partnership program like that
described in section 713 of FDASIA?
Answer. As the pilot program has yet to be announced, we do not
have definite numbers on how many firms would be likely to participate.
FDA intends to limit participation to 100 qualified applicants during
the pilot phase.
Question. Would FDA consider establishing an advisory panel,
similar to the Commercial Operations Advisory Committee at the Customs
and Border Protection, on import operations? The goal would be to help
FDA incorporate or account for best practices of U.S. importers, as
well as help coordinate import operations among its Centers.
Answer. FDA would consider establishing an advisory panel.
SEQUESTER FOR GENERIC DRUGS
Question. Specific to the newly enacted Generic Drug User Fee Act,
how will sequester of the user fee funds affect the progress of FDA's
implementation of the new program?
Answer. Sequestration may threaten FDA's ability to fulfill the 5-
year performance commitments made under the Generic Drug User Fee
Amendments of 2012. Delays in addressing the backlog of generic drug
applications will slow patient access to new, more affordable generic
drugs.
Question. As you know, the program was enacted to address the
previous backlog of more than 2,700 generic drug applications and to
provide parity in domestic and overseas facility inspections. It was
anticipated that approximately 900 new full-time equivalents (FTEs)
would be added to FDA staff to address this backlog, and that 25
percent of these FTEs would be added in fiscal year 2013. Could
sequester of the user fee funds delay hiring of these new FTEs and
further delay addressing the backlog and providing parity in facility
inspections?
Answer. As a result of sequestration, FDA may be unable to fully
implement the new user fee program. The fiscal year 2013 hiring goal of
25 percent is expected to be met, but the Agency's commitments to
improving review timelines for generic drug submissions--including
reviews of the previous backlog of applications--may not be achievable,
including achieving risk-adjusted parity between domestic and foreign
facility inspections. If sequestration continues to impact user fees
after fiscal year 2013, the hiring goals outlined in the 5-year GDUFA
agreement with industry may not be achieved.
SEQUESTER IMPLEMENTATION
Question. With the implementation of sequester, including the user
fees paid by industry, how are you working to continue to meet
performance goals set under the various user fee acts?
Answer. As a result of the sequester, FDA will have fewer resources
than we had assumed when we agreed to the performance goals in our user
fee program commitment letters. Consequently, FDA may not be able to
meet some of these performance goals. FDA continues to look for more
efficient ways to use the resources we receive, and to apply those
resources to the highest priority activities that will protect and
promote public health by providing timely access to safe and effective
medical products. In the short term, we have had to delay some less
urgent yet still important activities, such as some of the new
enhancements to our user fee programs, as well as certain training and
professional development activities that allow our staff to stay
current with emerging science and technology.
Question. Are you prioritizing activities not directly related to
drug and device review in such a manner to ensure that you are making
the best effort to continue to meet those performance standards?
Answer. Yes, FDA is setting priorities, using a risk-based
approach, for both drug and device review goals and goals not related
to review, to help ensure the health, safety, and well-being of the
American people while we manage our programs with fewer resources than
planned. We must balance our efforts to meet drug and device review
performance goals with our responsibility to monitor the safety of the
products that are already available, and our need to respond to
emerging safety problems.
DIETARY GUIDELINES FOR SEAFOOD
Question. FDA has not yet updated its 2004 advice to pregnant women
on seafood consumption, despite new USDA dietary guidelines and
multiple commitments from the Agency to Congress to do so. Can you
commit to issuing this updated advice this summer, and if not, by what
date will this be issued?
Answer. FDA first issued fish consumption advice relating to
methylmercury in 1994. The advice was updated in 2001 and again in
2004. The 2004 advice was issued jointly by the Food and Drug
Administration and the Environmental Protection Agency. Its purpose was
to protect against the possibility of neurodevelopmental harm to the
fetus and to infants from methylmercury as a result of their mother's
consumption of fish and to protect young children from the possibility
of neurodevelopmental harm from methylmercury as a result of their own
consumption of fish. Since then, studies published in the scientific
literature indicate that, under certain circumstances, fish consumption
by pregnant women and young children may actually improve
neurodevelopment. The Dietary Guidelines for Americans 2010, the
Government's nutritional recommendations issued every 5 years by the
Departments of Health and Human Services and Agriculture, have already
taken this development into account by recommending that pregnant and
nursing women eat at least 8 and as much as 12 ounces per week of fish
lower in mercury. The 2004 FDA/EPA advice does not contain this
consumption target nor does it mention a potential neurodevelopmental
benefit from fish since the evidence for it did not exist in 2004. We
are devoting a significant effort to update the fish consumption advice
and to complete a quantitative assessment of the net effects of fish
consumption during pregnancy on neurodevelopment in order to have a
sound analytical underpinning for that advice. These continue to be top
priorities for FDA. FDA will update the Committee when specific
information about the timing of the release is available.
______
Questions Submitted by Senator Tom Udall
SUNLAND PEANUT COMPANY
Question. It is my understanding that Sunland worked very closely
and cooperatively with the FDA to address the issues found at the
peanut butter plant and that they will be coming back on line with the
FDA's stamp of approval.
Could you outline for the Committee how this use of new authority
worked in New Mexico, and your thoughts on where the new authority was
helpful in ensuring a safe product in the end?
Answer. By using our new authority provided by the FDA Food Safety
Modernization Act to suspend facility registrations, FDA was able to
ensure the safety of public health by not allowing Sunland to
distribute its peanut and nut butter products until appropriate action
was taken to remedy the salmonella contamination in its facilities. The
new tool allowed FDA to take swift action to prevent continued
distribution of food that had a reasonable probability of causing
serious adverse health consequences or death.
Question. Has the FDA used this same authority to revoke operating
certificates elsewhere since the process was carried out in New Mexico?
Answer. FDA has not used this authority elsewhere.
Question. Has the experience with Sunland led to any improvements
in how the FDA will carry out this new authority in the future,
especially as it relates to interaction with companies or businesses
who are in violation of food safety standards?
Answer. FDA has continued to refine our internal processes for
utilizing the new suspension of facility registration authority based
on the valuable experience acquired during the Sunland activity. This
acquired knowledge and experience will facilitate further use of this
new authority for companies or businesses that present a significant
risk to public health.
SMALL PRODUCER/PROCESSORS
Question. In writing the Food Safety Modernization Act, Congress
included a number of provisions to ensure that small and very small
farms and food businesses were not unduly burdened by new regulations.
I am pleased to see that the agency has included in its proposed rules
longer compliance periods and modified requirements for certain small
farms and businesses.
Could you tell me what kind of feedback the FDA is getting from
small farms and businesses on the proposed rules?
Answer. FDA has engaged in extensive outreach efforts to inform
farmers and businesses of the provisions of the proposed produce safety
rule and the proposed preventive controls rule for human food. In
addition to three public meetings held across the country, there have
been six State-sponsored meetings (Ohio, Michigan, North Carolina,
California (2), Georgia) about the proposed produce safety rule and
numerous other outreach sessions via meetings and webinars. These
efforts have allowed the FDA to answer questions regarding the proposed
rule and to hear feedback from its various stakeholders. Organizations
and groups whose stakeholders include small farms and businesses have
been included in this outreach plan. Some small farms and businesses
have expressed interest in the agency's compliance and enforcement
plans for the proposed rules as well as the process of a withdrawal of
a qualified exemption. Questions have been raised about the potential
cost of compliance with the rules, particularly certain water testing
requirements in the proposed produce safety rule. Additionally, small
farmers have asked questions about the requirements in the proposed
produce safety rule for application of untreated biological soil
amendments of animal origin. FDA's outreach efforts have provided a
platform to provide information regarding these and other questions.
Generally, this particular stakeholder segment has indicated their
interest and appreciation for the flexibility that was built into the
proposed rules, such as the fact that the proposed rules would not
apply to certain small farms and businesses and the establishment of a
framework for alternatives to certain requirements of the proposed
produce safety rule. Small farmers and businesses have also inquired
about the availability of technical assistance or potential avenues
that can provide such assistance. It is important to note that the
comment period for the proposed rules will remain open until September
16, 2013, and we anticipate receiving further feedback. FDA is
committed to continuing to work with small farms and businesses, to
address their concerns and ensure that the final rules are flexible and
practicable while enhancing public health protection.
Question. I am concerned about the cost of compliance that FDA
estimates for small businesses. I understand that FDA estimates that
the costs to comply with its proposed produce rule for farms with less
than $250,000 in annual revenue will face over $22,000 in compliance
costs. These additional costs could make or break a small business.
Do you expect that these estimates are accurate?
Answer. Based on the data available and FDA's understanding of the
current practices of the produce industry, these estimates represent
the most accurate costs for a farm to comply with the proposed rule.
The $22,000 estimate cited is actually an average cost for farms
between $25,000 and $250,000 in annual revenue. This means that the
cost of compliance may be higher for some farms closer to the high end
of that distribution and lower for those farms closer to the low end.
We recognize that the potential costs of the regulation are not trivial
and that some covered farms, especially those that need to make
significant changes in their practices to comply with the risk-based
provisions of the rule, may find it difficult to comply. Therefore,
when the rule is finalized we intend to offer considerable technical
assistance to small farms, and to help them comply through later
compliance dates for small and very small farms, guidance documents,
and the efforts of the Produce Safety Alliance, a public-private
partnership dedicated to the development and dissemination of science-
and risk-based training and education programs.
Question. Could you discuss what the agency plans to do to assist
small businesses, including businesses operated by limited resource
producers and beginning producers, in complying with the proposed rules
and in easing this cost burden?
In updating our Nation's food safety laws, Congress also recognized
that training is an important part of a modern food safety system.
Unfortunately, the current budget environment has made it difficult to
provide additional funding for much-needed training for farmers and
food processors on food safety practices.
Answer. Regarding the proposed produce safety rule, FDA is
committed to working with the produce community and with partners in
the U.S. Department of Agriculture (USDA), State agencies, and foreign
governments to facilitate compliance through education, technical
assistance and regulatory guidance. The agency recognizes that the time
needed to comply will vary and as such, the rule proposes to phase in
compliance dates based on farm size. FDA has, together with USDA's
Agricultural Marketing Service, established a jointly funded Produce
Safety Alliance (PSA), a public-private partnership, housed at Cornell
University, that will develop and disseminate science- and risk-based
training and education programs to provide produce growers and packers
with fundamental food safety knowledge. A first phase of PSA's work is
intended to assist farms, especially small and very small farms, in
establishing food safety programs consistent with the Good Agricultural
Practices Guide and other existing guidances so that they will be
better positioned to comply when we issue a final produce safety rule
under section 419 of the Federal Food Drug and Cosmetic Act.
In addition, FDA has also entered into a memorandum of
understanding with USDA's National Institute of Food and Agriculture to
establish a competitive grant program to provide food safety training,
education, extension, outreach, and technical assistance to: (1) owners
and operators of farms; (2) small food processors; and (3) small fruit
and vegetable merchant wholesalers. FDA is currently working with USDA
to execute the competitive grant program, which will prioritize
projects that target small and medium-sized farms.
Regarding the proposed preventive controls rule for human food, FDA
is committed to working with the food industry, especially small and
medium-sized businesses, to facilitate compliance. The rule proposes to
have later compliance dates for small and very small facilities. In
addition, FDA, in cooperation with the Institute for Food Safety and
Health, has created the Food Safety Preventive Controls Alliance to
develop training courses and materials to help industry, particularly
small- and medium-sized companies, when the rule is finalized.
Question. Could you discuss how FDA is addressing this need and
what resources FDA would need to work with other agencies and
organizations to address the need for training of processors and
producers?
Answer. FDA is committed to working with the food industry and with
partners in the U.S. Department of Agriculture, State agencies, and
foreign governments to facilitate compliance through education,
technical assistance and regulatory guidance.
We plan to work with our stakeholders to develop a network of
institutions that can provide technical assistance to the food industry
(including the farming community), especially small and very small
businesses, as they endeavor to comply with the provisions of the final
rules.
FDA intends to further facilitate compliance with the final rules
through the development and dissemination of guidance, in multiple
languages.
Additionally, FDA staff will continue engaging in various outreach
efforts including listening sessions, webinars, teleconferences, and
presentations as these provide the agency with an immeasurable
opportunity to hear feedback from its various stakeholders.
FDA has requested $27 million and 21 FTEs in the fiscal year 2014
President's budget for the development of science-based standards and
guidance documents that support industry adoption of preventive
controls for food processing and produce safety standards, as well as
to provide training and outreach to regulatory partners and industry on
these new FSMA standards.
______
Questions Submitted by Senator Roy Blunt
Question. Commissioner Hamburg, in addition to providing incentives
for innovation, the Biologics Price Competition and Innovation Act was
intended to expand access and lower the cost of life-saving and life-
improving medicines.
How is the FDA progressing on implementing the pathway?
Answer. FDA continues to develop rigorous scientific standards to
ensure that all biosimilar and interchangeable products meet these
statutory requirements, and thus will be safe and effective. Some of
this effort is reflected in three draft guidances FDA issued in 2012
that provide FDA's scientific recommendations on demonstrating
biosimilarity, and we have begun developing guidance on additional key
scientific issues as well. FDA is actively engaging with sponsors
interested in developing biosimilar products to ensure that the
development programs will provide the necessary scientific evidence to
meet the statutory requirements for biosimilarity. Healthcare
professionals and consumers can be assured that FDA will require
licensed biosimilar biological products to meet the Agency's exacting
standards of safety and efficacy.
Question. Have applications been filed or other significant actions
taken by potential applicants?
Answer. To date, FDA has not received an application for a proposed
biosimilar product. The Center for Drug Evaluation and Research (CDER)
continues to meet with sponsors interested in developing biosimilar
products. As of May 21, 2013, CDER has received 56 requests for initial
meetings to discuss development programs involving 12 different
reference products and has held 38 initial meetings with sponsors. Many
biosimilar development programs that have had an initial advisory
meeting with CDER have moved into the development phase and are
requesting biosimilar product development (BPD) meetings. CDER is
actively engaging with these sponsors, including holding BPD meetings
and providing written advice, for ongoing development programs for
proposed biosimilar products. To date, CDER has received 17
Investigational New Drugs (INDs) for biosimilar development programs,
but several additional development programs are proceeding under a pre-
IND.
Question. As to the naming of biosimilars, it is my understanding
that the FDA in 2006 issued a statement in support of the international
naming regime. Is that still the policy position of the FDA? If not,
please explain what has changed and why?
Answer. FDA is currently considering the appropriate naming
convention for biosimilar and interchangeable products licensed under
the pathway established by the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) enacted as part of the Affordable
Care Act. FDA is carefully reviewing and considering the comments
submitted to FDA's biosimilar guidance and public hearing dockets. We
will take into consideration all received comments as we move forward
in finalizing the guidance documents and developing future policies
regarding biosimilar products and interchangeable products.
______
Questions Submitted by Senator Mitch McConnell
Question. In my home State of Kentucky, prescription drug abuse is
responsible for about 100 drug overdose deaths a month. I have received
letters from law enforcement and public health officials expressing
their concern with the effects this epidemic is having throughout my
State. In light of these grave statistics, I would appreciate answers
to my questions regarding FDA's recent activity to prevent further
misuse and abuse of prescription drugs. FDA has informed Members of
Congress that it has the authority under the Federal Food, Drug, and
Cosmetic Act to require that generic versions of an innovator drug with
abuse-deterrent features also include similar features as a condition
of approval. In addition, FDA has stated it has the authority ``to
initiate procedures to withdraw non-abuse-deterrent versions already on
the market.'' When and how will FDA act on this acknowledged authority
to require non-abuse-deterrent drugs to be withdrawn from market?
Answer. If FDA concludes that an extended-release opioid drug
product has abuse-deterrent properties, it has authority under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) to require generic
versions of that product to also have abuse-deterrent properties. FDA
recently approved labeling regarding the abuse-deterrent properties of
one product, OxyContin (oxycodone hydrochloride) controlled-release
tablets, and determined that a previous formulation of OxyContin was
withdrawn for safety and effectiveness reasons, thus precluding
approval of a generic version of the previous formulation. Because
there were no approved generic versions of the previous formulation,
there was no need for a withdrawal. FDA will continue to review other
purportedly abuse-deterrent opioid drug products on a case-by-case
basis and will take regulatory action regarding each product as
appropriate.
Question. FDA's new drug product exclusivity regulations (21 U.S.C.
355(c)(3)(E)(iii)) prohibit the approval of an abbreviated new drug
application (ANDA) for 3 years if certain criteria are met. While
abuse-deterrent products are an important piece of prescription drug
abuse prevention, providing access to lower cost, generic abuse-
deterrent drugs is important for legitimate users. Does a new drug
product applicant need to apply for additional exclusivity, or does FDA
make the exclusivity determination regardless of the applicant's
request?
Answer. FDA determines whether any of the available exclusivity
periods under the FD&C Act applies to a given drug product at or after
the time of approval of a new drug application (NDA). An NDA applicant
is not required to specifically request exclusivity.
Question. Beyond Fast Track and Priority Review status, how does
FDA plan to incentivize the development of generic and innovator abuse-
deterrent formulations?
Answer. FDA is working in variety of ways to incentivize the
development of abuse-deterrent formulations of drugs with the potential
for abuse, with a focus on opioids. First, as called for in FDASIA
section 1139 and in the Office of the National Drug Control Policy
National Plan on Prescription Drug Abuse, we published a draft guidance
entitled Abuse-Deterrent Opioids: Evaluation and Labeling, in January
2013. In it, in addition to laying out the studies and analysis the FDA
is looking at when we consider new formulations for their effects to
reduce abuse, we also included FDA's current thinking on how we will
reflect those data in labeling. The goal of this last activity is to
incentivize the development of new formulations of opioids that we
determine to be abuse-deterrent, by including a clear description of
their effects on abuse in labeling. To further this work, we are
participating in a public meeting in the Fall to discuss the draft
Guidance and solicit scientific input on improving it. We know that
there is broad interest in the development of generic drugs with abuse-
deterrent properties, and we are working internally on the science
needed to give guidance on how we will evaluate those products. We also
intend to discuss generics at the meeting in the fall. Finally, the
FD&C Act also provides for certain periods of marketing exclusivity if
the applicable criteria are met.
Question. What process and timeline will FDA use to make
determinations on other innovator products on the market as to whether
or not they meet the definition of abuse-deterrent and warrant a label
change?
Answer. FDA plans to make determinations regarding other
potentially abuse-deterrent opioid drug products as promptly as
possible using our standard review processes. For a labeling change,
for instance, a sponsor will normally submit an application to request
approval of labeling describing a product's abuse-deterrent properties
and FDA would notify them in a letter whether their proposed labeling
language is approved once our review and decisionmaking is completed.
Question. How will these guidelines apply to generics seeking to
come to market with abuse-deterrent features?
Answer. FDA has not published any guidelines regarding generic
versions of opioid products with abuse-deterrent features. As stated
previously, if FDA determines that an extended-release opioid drug
product has abuse-deterrent properties, it has authority under the FD&C
Act to require generic versions of that product to also have abuse-
deterrent properties.
Question. How does FDA plan on monitoring the marketing of new
abuse-deterrent products to ensure that unintended consequences of
aggressive marketing tactics do not occur due to a label change?
Answer. FDA will monitor drug marketing practices with that concern
in mind. FDA will apply the standards applicable to promotional claims
concerning any prescription drug; that is, among other things, all such
claims must be truthful and not misleading. 21 U.S.C. 352(a) and (n).
______
Questions Submitted by Senator Susan M. Collins
Question. Dr. Hamburg, I am pleased that the FDA issued the final
guidance in November 2012 for the development of artificial pancreas
systems. As you know, many of my colleagues and I are very interested
in seeing that these potentially life-changing systems are made
available to patients as soon as possible, with proper consideration
given to safety and effectiveness. In development across the country
but not yet approved by the FDA, these systems have the potential to
address the serious problem of blood glucose control that exists for
many people with type 1 diabetes using current treatments. Artificial
pancreas systems could also save taxpayer dollars--a recent study found
that Medicare could save almost $1 billion over 25 years with the use
of this technology in adults. The FDA's official guidance is an
important stepping stone in accelerating the development of the
technology, as it provides the FDA's general expectations for
conducting human outpatient clinical trials and for marketing approval
of the devices. Dr. Hamburg, could you tell me how the FDA plans to
support this momentum when new submissions for clinical trials or
product approval are brought to you so that these innovative systems
can be tested without delay and made available to those with type 1
diabetes in the near future?
Answer. We believe that the development of an Artificial Pancreas
(AP) is within technological reach and have assigned significant
resources to facilitate such development. At the beginning of 2012, we
streamlined the AP application review structure. This has resulted in
quicker reviews of investigational protocols and premarket submissions.
Among those, we have approved several outpatient studies in adults and
a diabetes camp study in children.
We co-sponsored a public workshop with the National Institutes of
Health (NIH) and Juvenile Diabetes Research Foundation (JDRF) in March
2013. The workshop initiated a multidisciplinary discussion which will
help to accelerate the development and delivery of an AP. We continue
to pursue outreach efforts with researchers, clinicians, policymakers,
manufacturers and patient advocates to help clarify expectations, and
to help solve challenges as they arise. This collaborative effort is
helping the FDA to make more rapid decisions on studies and will help
to ensure that patients will receive these technologies as soon as
possible. We look forward to working together with the diabetes
community to advance quickly towards an approved AP.
Question. I also would like to inquire about the rules recently
published for public comment by the FDA under the Food Safety
Modernization Act. The proposed rule governing standards for produce
safety includes most fruits or vegetables while they are in their raw
or natural (unprocessed) state. Apple growers in Maine are concerned
that some of the new requirements might be overly burdensome and
expensive to implement. They also question the inclusion of apples in
the rule since apples are not a fruit which has been responsible for
any significant food-borne disease outbreaks in our country. I realize
that the comment period for the rule has been extended, Dr. Hamburg,
and I am interested to hear your comments on this issue.
Answer. The proposed rule's regulatory approach is aligned with the
FDA Food Safety Modernization Act, which directs the Secretary to set
forth procedures, processes, and practices that the Secretary
determines are reasonably necessary to prevent the introduction of
known or reasonably foreseeable hazards into produce and to provide
reasonable assurances that the produce is not adulterated. As explained
in the proposed rule, we tentatively concluded that an approach that
considers both the risk associated with the commodity and that
associated with the agricultural practices applied to the crop under
the conditions in which it is grown would provide the most appropriate
balance between public health protection, flexibility, and appropriate
management of different levels of risk.
The Produce Safety rule, as proposed, does not cover produce that
is documented to receive commercial processing that adequately reduces
the presence of microorganisms of public health significance. An
example of commercial processing that meets this requirement is
processing apples into juice in accordance with the Juice HACCP
regulation (21 C.F.R. Part 120). In addition, the types of produce the
Agency proposed to cover have one or more pathways through which they
can become contaminated. FDA is proposing that farmers control only
pathways that are relevant to their crop. For example, generally, water
used for drip or furrow irrigation in apple orchards would not be
subject to the proposed rule's requirements for agricultural water
because the water is unlikely to contact the harvestable portion of the
crop.
We considered covering only those produce commodities or commodity
groups that had been associated with foodborne illness outbreaks.
Because only a small percentage of outbreaks are both reported and
assigned to a food vehicle, outbreak data may not provide a complete
picture of the commodities upon which we need to focus to minimize
current and future risk of illness.
Our data show that the patterns of outbreaks associated with
produce commodities change over time. Occasionally a produce commodity
that has not previously been linked to foodborne illness is associated
with an outbreak. For these and other reasons discussed in detail in
the proposed rule, our regulatory approach does not rely solely on a
static list of commodities prepared solely from a history of outbreaks.
In the Produce Safety proposed rule, we explicitly seek comment on our
tentative conclusions related to our proposed regulatory approach. FDA
will reach its final conclusions on this issue after considering
comments received. The comment period for the proposed rule closes on
September 16, 2013.
Question. I would like to ask for your thoughts on a topic that has
received a great deal of news coverage in recent years and one that is
of much interest to many of my constituents, which is the issue of
antimicrobial resistance. I have been working with Senator Gillibrand
on legislation that, among other things, would call for the FDA to
conduct a pilot study to better determine relationships between sales
and use data of food animal drugs, and trends in antimicrobial
resistance. As you know, each year the FDA's Center for Veterinary
Medicine publishes sales data on the total volume of antibiotics used
in the United States in food animals. Section 105 of the Animal Drug
User Fee Act of 2008 requires antimicrobial drug sponsors to annually
report not only the amount of antimicrobial active ingredient in the
drugs they sold or distributed for use in food-producing animals, but
also requires animal drug sponsors to list the target animal and
production class specified on the approved labels of the products. The
summary data that the FDA publishes each year, however, reports only
total sales volume. Is FDA able to provide more specificity in this
summary data in future reports, to include target animal species and
production class, since this data is already required to be reported?
Answer. On July 27, 2012, FDA published an Advance Notice of
Proposed Rulemaking (ANPRM) to solicit comments from the public on
possible enhancements to the existing requirements related to the
collection of antimicrobial drug sales and distribution data. The ANPRM
also solicited input on alternative methods for monitoring
antimicrobial use in food-producing animals.
Based on comments received, FDA is currently developing
enhancements to the content and format of its annual summary report on
the sale and distribution of antimicrobial drugs intended for use in
food-producing animals. These enhancements would be consistent with
current requirements. For example, FDA is exploring alternative
approaches for reporting the data it currently receives. This includes
approaches suggested in comments submitted in response to the July 2012
ANPRM, including presenting the data by dosage form, medical
importance, and marketing status (i.e., over-the-counter drugs,
prescription drugs, or the Veterinary Feed Directive Guidance). FDA
expects to use such an enhanced format when it summarizes the data
reported for 2012.
FDA also expects to utilize the rulemaking process to enhance
existing requirements related to the collection of drug sales and
distribution data. For example, FDA is examining the feasibility of
establishing requirements for obtaining estimates of sales broken down
by animal species. Currently, sales data is not required to be reported
by target animal species.
To supplement the sales/distribution data that it already receives,
FDA is also exploring possible mechanisms for collecting additional
information that would be more reflective of what antimicrobial drugs
are actually being used in food-producing animals, including
information that could be used to correlate drug use practices with
trends in antimicrobial resistance.
Question. Are you able to provide the Committee an idea of when the
final version of Guidance for Industry No. 213 might be published?
Answer. A final version of Guidance for Industry No. 213 is
currently undergoing review and clearance. Although FDA does not have a
specific timeline, publication of final Guidance for Industry No. 213
remains a top Agency priority for 2013.
______
Questions Submitted by Senator Lamar Alexander
Question. The budget for FDA includes an unprecedented amount of
funds from industry user fees. Just last year, we established a new
generic drug user fee program to help get more of these products to
patients more quickly. However, I have heard from a constituent that
the generic drug establishment fee would put them out of business, and
they had no time or idea they needed to plan for the over $170,000 bill
they received in March.
How can we work together to make sure that all parties that will be
affected are involved in the user fee negotiations, and how can we
ensure that in the first year of new user fee programs that adjustments
can be made as necessary to protect small businesses from unintended
consequences?
Answer. FDA engaged in significant public outreach, including
convening a number of public meetings with industry and other
stakeholders, to discuss GDUFA and the progress of negotiations.
A fee waiver was considered during negotiations and rejected
because it would have diminished the number of companies required to
pay the fees which, in turn, would have raised the fees for the fee-
paying companies. Unlike brand manufacturers, the majority of generic
companies are small businesses.
Furthermore, an exemption would have added to the administrative
cost of the program by requiring additional staff to determine which
companies met the exemption and handle disputes. This would have
diverted user fee funds away from activities in support of meeting the
goals contained in the user fee agreement, or would have required
higher fees to accommodate the increased administrative complexity.
Small and large generic companies alike are expected to benefit
significantly from reductions in the review time needed to
commercialize their products and from the certainty associated with
GDUFA performance review metrics and program efficiencies.
FDA does not have the current authority to create a fee waiver or
reduction provision for small businesses.
During the next round of generic drug user fee negotiations, FDA
will again invite industry trade associations to participate in
negotiations and hold open public meetings to provide a forum for
industry, and other stakeholder input. All interested parties are
encouraged to provide input.
Question. In 2009, Congress passed the President enacted the Family
Smoking Prevention and Tobacco Control Act, providing FDA broad
authority to regulate tobacco products. I have a few questions on the
implementation of this law.
How did your department adjust and align FDA's new authority with
the authority of other HHS agencies to reduce duplicative programs and
target resources?
Answer. FDA's responsibility with respect to tobacco control
activities is to protect the public health by regulating the
manufacture, distribution, and marketing of tobacco products, and
educating Americans, especially young people, about tobacco products
and their dangers. FDA works closely with other Federal public health
agencies to ensure the various tobacco programs are coordinated and are
not duplicative.
The Tobacco Control Act authorizes FDA to collect quarterly fees
from the tobacco industry. These fees are to be available only for the
purposes of paying the costs of activities that support the regulatory
mission of FDA-related to tobacco products. Furthermore, the Tobacco
Control Act specifies that these tobacco user fees are the only funds
authorized to be made available for FDA's tobacco regulation including
research, compliance and enforcement, and science-based public
education campaigns addressing the dangers of tobacco use.
FDA has put a comprehensive financial stewardship plan in place to
ensure that tobacco user fees only support its regulatory activities.
Although many agencies and offices in HHS, including FDA, are working
together to address the significant public health concerns created by
the use of tobacco products, FDA does not, for example, provide direct
cessation services or engage in community-based tobacco prevention
activities, as some other HHS agencies do.
Question. It is my understanding that there hasn't been a single
product approved under this new law. Innovation will be necessary to
reduce harm and give people who can't quit less risky alternatives. FDA
focuses a lot on innovation, and how does that focus relate to the
concept of tobacco-related harm reduction?
Answer. To date, FDA has not received any new tobacco product
applications and none of the modified risk tobacco product applications
it has received have been accepted for filing. However, FDA has
received over 3,000 ``provisional'' substantial equivalence (SE)
reports for tobacco products introduced into interstate commerce
between February 15, 2007, and March 22, 2011, for which a report was
submitted prior to March 23, 2011. These provisional products can
remain on the market unless FDA finds that they are ``not substantially
equivalent.'' FDA has also received more than 500 ``regular'' SE
reports for new products that manufacturers intend to introduce to
market.
FDA reviews all SE reports as expeditiously as possible and will
continue to do so; however, FDA has observed deficiencies in nearly all
initial SE reports reviewed to date from different tobacco product
manufacturers. As the quality of reports improves and FDA gains more
experience reviewing them, FDA expects both the review times and the
backlog to decrease.
With respect to innovation, tobacco companies have recently
introduced newer forms of tobacco products. FDA is funding research to
better understand these newer products with regard to their relative
risks compared to other tobacco products. It is critically important to
evaluate these products not only in terms of the relative health risks
to individuals, but also to consider the likelihood that nonusers will
start using the product, users who would otherwise stop using tobacco
products will switch to the new product, tobacco users may use the new
tobacco products in combination with other products, and former users
will begin using the new product.
The Modified Risk Tobacco Product provisions of the Tobacco Control
Act may be valuable tools in the effort to protect public health by
reducing the morbidity and mortality associated with tobacco use,
particularly if tobacco product manufacturers can adequately
demonstrate that product changes will substantially reduce, or even
eliminate altogether, either the toxicity or addictiveness of tobacco
products, or both.
FDA is also funding research on reduced nicotine cigarettes,
smokeless tobacco products, and the diversity of tobacco products
including new and emerging tobacco products to inform the advancement
of harm reduction at both the individual and population level.
______
Questions Submitted by Senator Daniel Coats
Question. Medical device manufactures, while supportive of unique
device identifiers (UDIs), remain concerned regarding implementation of
the Proposed UDI Rule. These concerns include the FDA requirement that
UDIs be applied to products in their existing inventory, as well as the
requirement that UDIs be applied directly onto each implantable
product, otherwise known as Direct Part Marking (DPM). Many medical
devices have a significant shelf life allowing for products to remain
in inventory for longer periods of time. Additionally, some segments of
the medical device industry utilize the consignment model, meaning that
devices remain under company control and are not sold to the customer
until they are used or implanted. This method is used to ensure
patients have the most appropriate options. Should the Proposed UDI
Rule apply to these products, device manufacturers would be forced to
recall each device to apply a UDI, potentially interrupting patient
care. Additionally, because the UDI should already be in the patient
record at the time of implantation, there doesn't seem to be any
additional utility to place it directly on an implantable device.
Please describe what steps the FDA is taking to consider the
effects this UDI rule may have on patient quality and choice, as well
as the burden placed upon medical device manufacturers and customers.
Answer. FDA has reviewed the comments submitted to the UDI proposed
rule--including a significant number that addressed the existing
inventory issue and the direct marking requirement for implants.
Although FDA cannot discuss how it will address these comments while
the rule remains in clearance, we wish to assure you that we take these
concerns very seriously and note that FDA's goal is not to require
device manufacturers to recall or re-label already finished medical
devices. Requiring manufacturers to mark medical devices with unique
identifiers will improve postmarket surveillance and patient safety.
Device tracking will ensure more efficient device recalls by assisting
manufacturers, providers, hospitals and patients with quicker
identification and remediation of faulty devices. We believe that the
final rule appropriately strikes a balance between the needs of
patients, clinicians, the healthcare system, and FDA--and the concerns
of the medical device industry.
In addition, FDA is taking a number of steps to ensure that the UDI
will support patient safety, quality and choice. FDA's Global Unique
Device Identification Database (GUDID), which will contain a robust set
of data for every device marked with a UDI, will be publicly available
and will allow patients and clinicians to search for the appropriate
device. In addition to our work with the medical device industry FDA is
also working with numerous stakeholders, including the Brookings
Institution, National Coordinator for Health Information Technology
(ONC), Centers for Medicare and Medicaid Services (CMS), private
payers, solution providers, hospitals and Integrated Delivery Networks
(IDNS) on the adoption and implementation of UDI throughout the
healthcare system and the lifecycle of medical devices.
SUBCOMMITTEE RECESS
Senator Pryor. This subcommittee will meet again on
Thursday, May 9 at 10 a.m. in this room, where we will have
testimony from Secretary Vilsack regarding USDA fiscal year
2014 budget.
Again, I want to thank everyone for being here, and this
hearing is recessed.
Dr. Hamburg. Thank you.
[Whereupon, at 11:46 a.m., Thursday, April 18, the
subcommittee was recessed, to reconvene at 10 a.m., Thursday,
May 9.]