[Senate Hearing 113-877]
[From the U.S. Government Publishing Office]






 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2015

                              ----------                              


                        THURSDAY, APRIL 3, 2014

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:01 a.m. in room SD-138, Dirksen 
Senate Office Building, Hon. Mark Pryor (chairman) presiding.
    Present: Senators Pryor, Merkley, Blunt, Cochran, and 
Collins.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF HON. DR. MARGARET HAMBURG, COMMISSIONER
ACCOMPANIED BY:
        WILLIAM TOOTLE, DIRECTOR, OFFICE OF BUDGET
        NORRIS W. COCHRAN, DEPUTY ASSISTANT SECRETARY, OFFICE OF BUDGET


               opening statement of senator mark l. pryor


    Senator Pryor. I`ll go ahead and call our hearing to order 
here. And let me just say welcome everyone to the subcommittee 
on Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies. And today, we are talking 
about the Food and Drug Administration (FDA).
    So I'd like to thank everyone for being here today, 
especially Commissioner Hamburg who has done great work over 
there, as well as Mr. Tootle and Mr. Cochran. Thank you for 
your time and your preparation. And I know that you have to 
deal with a set of very complex issues not just in what you do 
normally, but also in the budget environment this year, one 
that we're all living in right now. And you're working hard to 
honor the responsibilities of the FDA and we appreciate your 
efforts on that.


                                 budget


    I'm not going to take up a lot of time with an opening 
statement, but I would like to say that this budget is quite a 
change from the budgets we've seen from FDA over the past few 
years. For an agency that regulates products, representing more 
than 20 cents of every $1 that Americans spend, with a budget 
of over $2.5 billion,

[[Page 2]]

(2the increase you're requesting is minimal; less than 1 
percent. And on the one hand, I think people appreciate that, 
but on the other hand, we recognize the challenges that that 
presents, as well.
    And I know that you will talk about a larger request, but 
it is important to note that that's beyond the jurisdiction of 
our subcommittee because it's based on user fees. And we'll 
focus mostly on what the subcommittee has control over. But, 
certainly, if you want to talk about user fees, you're 
certainly welcome to do that.


                     food safety modernization act


    It's often pointed out that FDA's responsibilities are 
incredibly vast; certainly they continue to grow and to evolve. 
Currently, you're in the middle of the implementation of the 
Food Safety Modernization Act (FSMA) which, I'm sure, we'll 
hear more about this morning. You're also continuing to respond 
to issues about compounded drugs and implementing the Drug 
Quality and Security Act (DQSA) which was signed into law last 
November.
    So here, again, you have your plate full. We appreciate the 
challenges you face. Look forward to hearing about your budget.
    And also, one thing I think that we need to recognize is 
the world continues to become smaller. And you really are in 
charge of regulating a global marketplace; it's not just the 
U.S. market but really the, because the United States is such 
an important part of the global economy, in your areas of 
jurisdiction, you really are, in some ways, managing or 
overseeing a global marketplace. And that brings its own set of 
responsibilities and challenges.
    New medical treatments are coming onboard. We're going 
from, kind of, a one-size-fits-all in the world of medicine to 
finding drugs and treatments and cures that are very, very 
personalized. And, even though this is exciting, once again, it 
creates a whole new set of challenges for you to have the right 
science and the right methodology and the right approach to get 
the best results we can possibly get while always being safe, 
of course.
    And so that's obviously a big picture overview. Your agency 
has a lot of supporters not just around the country and around 
the world, but also in the Senate. But we also know that 
there's a lot of expectations on this agency because the FDA 
has, really, a long track record of getting it right and we 
appreciate that.


               national center for toxicological research


    So we can talk about the funding for the National Center 
for Toxicological Research (NCTR). In Arkansas, I know that 
there's a cut there. We'll talk about that. They continue to do 
groundbreaking research in nanotechnology and a number of other 
places. So, we'll talk about that during the question period.
    And you also have a very small increase in your budget 
proposed for implementing the FSMA and with a much larger sum 
proposed in new user fees. And, again, we'll talk about that, 
too.
    So, with all that said, what I'd like to do is turn it over 
to my ranking member, a great leader on these issues, Senator 
Blunt.

[[Page 3]]

(3


                     statement of senator roy blunt


    Senator Blunt. Well, thank you, Chairman Pryor. And thank 
you for your extraordinary leadership of this committee and 
your partnership in the issues we deal with.
    Dr. Hamburg, we're pleased you're here. Mr. Cochran and Mr. 
Tootle, thank you for everything you do. I have a statement for 
the record, but let me mention a couple of things in that 
statement.
    First of all, the impact of the agency is significant. 
Twenty cents out of every spending $1 goes to things that FDA 
one way or another is involved in. Americans expect that the 
food they eat to be safe and the drugs they take to be safe and 
effective. Your private sector partners also expect you to be 
that; a partner in trying to make those things work and, to 
those conclusions, in the best way for everybody involved, and, 
ultimately, the best way for the consumer. And, of course, part 
of that means getting products to the consumer as quickly as we 
can but no more quickly than we can.
    It's like somebody once said, ``Everything should be as 
simple as possible but no simpler.'' And, that's sort of what 
we want to see happen at the FDA. We want this done as quickly 
as we can get it done, but obviously it's important that it be 
done in the right way.
    In the last 3 years, the FDA has been given significant new 
responsibilities: The Food Safety Modernization Act; the, what 
sounded easy but turned out not to be so easy, menu labeling 
legislation; the drug compounding legislation that just gave 
you new responsibilities in the last year. And in all of those, 
and everything else you do, I think we need to be careful.
    And our job is to be insistent that we don't get into a 
one-size-fits-all mentality because one size almost never fits 
anybody. And small businesses really suffer from procedures 
that are designed for businesses that are much bigger than the 
job that they're trying to do.


                     food safety modernization act


    Under the Food Safety Modernization Act, the FDA is tasked 
with implementing the most sweeping changes in food safety in 
over 70 years. There's a lot of anxiety in the agricultural 
community about the implementation of this act. And, back to 
the one-size-fits-all concept of how this act would work, and 
something that Senator Shaheen and I in a letter signed by 
others brought to your attention and you've responded to in the 
last few weeks. And we see that there's a handful of setbacks 
already in addressing this law as people say, ``Well, this 
really doesn't work for us. And here's why we want you to 
understand better that this doesn't work in all of the 
environments that now the Food Safety Modernization Act would 
take today's FDA.''
    But we're glad you're here. I look forward to the chance to 
ask questions about this budget and about the ongoing work of 
the agency.
    And, Mr. Chairman, again thank you for your leadership and 
for calling this hearing today.

[[Page (1)]]

    Senator Pryor. Well, thank you.

[[Page 4]]

(4
    And we really only have one witness today, although, she 
has, can I say, two wingmen up there with her. Is that fair to 
say? The wingmen are Bill Tootle, who is the Director of Office 
and Budget at the FDA; and also we have Norris Cochran, he is 
at Department of Health and Human Services (HHS), Office of 
Budget; and of course, the star of the show today is going to 
be Dr. Margaret H. Hamburg.
    Welcome. And I don't think we're necessarily going to put a 
timer on yours. We'd love for you to--you understand you can 
submit your full statement for the record. If you want to 
summarize it, that's up to you.
    And, what we're going to try to do here is probably 7-
minute rounds, is probably what we're going to do here.
    So, go ahead, Dr. Hamburg. Thank you for being here.


             summary statement of hon. dr. margaret hamburg


    Dr. Hamburg. Great.
    Thank you so much. And I, of course, would like to submit 
my full statement for the record.
    But, Chairman Pryor and members of the subcommittee, I do 
appreciate the opportunity to come before you today and to 
discuss our fiscal year 2015 budget. I also want to thank you 
for the subcommittee's past investments in FDA. Really, your 
unflagging support for FDA's work to promote and protect public 
health, even in these challenging budgetary times, is deeply 
appreciated. And the recent work you've done to help us around 
some of the sequester issues also has been very meaningful.
    As you know, FDA's mission is far-reaching. We're tasked 
with ensuring the safety, effectiveness, and quality of human 
and animal drugs, biologics, medical devices, and other medical 
products; as well as the safety of our blood supply, safety and 
quality of some 80 percent of our Nation's food supply, and, 
most 0recently, the responsibility to regulate the 
manufacturing, marketing, and distribution of tobacco products.
    Today, FDA must respond to ever more complex challenges. We 
must stay at pace or ahead of the rapid advances in science and 
technology that are driving product developments and 
innovation. And globalization is dramatically increasing the 
volume of imported goods, as well as the complexity of their 
supply chains.
    I'm happy to report that last year FDA moved forward on 
many fronts to address these and other significant challenges. 
We took major steps towards implementing the Food Safety 
Modernization Act, or FSMA, which will enable FDA to build a 
modern prevention-focused food safety system, protecting 
Americans against foodborne illness from both domestic and 
foreign sources. We approved novel medical products in cutting-
edge areas of science to

[[Page 2]]

address critical medical needs. We've made progress in reducing 
drug shortages. And working with members of Congress and 
industry, we reached agreement on an approach to pharmacy 
compounding and set a timeline for a National Track and Trace 
System for prescription drugs that, when fully implemented, 
will further bolster the safety of the drug supply chain.

[[Page 5]]

(5


                                 budget


    Looking ahead to next year, FDA is requesting a budget of 
$4.74 billion for fiscal year 2015. This represents a modest 
increase of 8 percent overall, or $358 million, to help fund 
our highest priorities.
    In 2015, as noted, proposed and current user fees account 
for a significant proportion of our total budget request, 46 
percent, with budget authority dollars comprising the rest. We 
recognize the larger pressures on the Federal budgets. So our 
budget request focuses on our most urgent needs; the safety of 
medical products including compounded drugs and the safety of 
our food supply. We're also asking for a small increase for 
infrastructure.
    More specifically, the 2015 budget provides a program level 
of $2.6 billion to continue core medical product activities 
across FDA programs, which is $61 million above the fiscal year 
2014 enacted level. And, importantly, this budget includes $25 
million in budget authority to enhance pharmacy compounding 
oversight activities.


                         compounding pharmacies


    The 2012 fungal meningitis outbreak that killed 64 people 
and sickened some 750 others across 20 States in this country, 
demonstrated the critical need for improved oversight of 
compounding pharmacies. To better protect the American people, 
FDA quickly stepped up activities within available resources, 
and then Congress passed the Drug Quality and Security Act, in 
November 2013, giving us new responsibilities and authorities; 
though without commensurate resources.


                              food safety


    FDA's 2015 budget also requests an increase of $263 million 
for food safety including resources to continue implementing 
FSMA. Implementation will reduce foodborne outbreaks which 
continue to cause preventable illness, hospitalization, and 
deaths. Implementation will also minimalize the market 
disruptions and economic costs inflicted by these outbreaks and 
significant contamination incidents.
    This is a crucial time if we're to realize the vision and 
mandate of FSMA. While we'll still be able to issue the FSMA 
rules without increased funding, it will be impossible to 
effectively implement these important rules and to reduce or 
prevent serious and costly foodborne disease.
    New resources are required in fundamental areas: Training; 
the provision of guidance and technical assistance to industry 
especially small growers and producers; support to build and 
strengthen partnerships with States; and the creation of a 
modern import safety system.

[[Page 3]]

    In conclusion, I want to underscore that FDA is a unique 
and essential agency. What we do matters for health and quality 
of life of individuals, families, and communities across our 
Nation. And it matters to the health and vibrancy of our 
economy, jobs, and our global economic competitiveness, as 
well. Yet the FDA budget is, in fact, a remarkable bargain.
    As has been noted, the products we regulate account for 
more than 20 cents of every consumer dollar spent on products 
in the

[[Page 6]]

(6United States. Yet, individual Americans pay a scant 2 cents 
a day to support our work; a small price to pay for life-saving 
medicines approved as fast, or faster, than anywhere in the 
world; a food supply that is among the safest in the world; and 
confidence in a vast array of important products that Americans 
rely on each and every day.
    So I thank you for your past support and I look forward to 
our ability to discuss these important issues this morning.
    Thank you.
    [The statement follows:]
           Prepared Statement of Hon. Dr. Margaret A. Hamburg
    Good morning Chairman Pryor and Members of the Subcommittee, I am 
Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration 
(FDA). Thank you for the opportunity to appear before you today to 
discuss FDA's fiscal year 2015 budget request. I would like to thank 
the subcommittee for its past investments in FDA, which have helped us 
meet the demands of our broad and increasingly complex mission. For 
fiscal year 2015 FDA is requesting $4.74 billion, which represents a 
modest increase to address our highest priorities.
     fda plays a vital role in an increasingly complex environment
    FDA is a science-based, regulatory Agency with a public health 
mission. Our Agency is charged with an enormous and significant task: 
to promote and protect the health of the American people, and 
increasingly, people all over the world. This includes efforts to 
ensure the safety, effectiveness, and quality of human and animal 
drugs, biologics, medical devices, and other medical products, as well 
as the safety and wholesomeness of four-fifths of our Nation's food 
supply. It also includes working to foster the scientific innovation 
that will lead to tomorrow's products, and more recently, regulating 
the manufacturing, marketing, and distribution of tobacco products 
while seeking to reduce the use of tobacco products by minors.
    The medical and food products we regulate have the potential to 
sustain life, reduce suffering, treat previously untreatable diseases, 
and extend lives. They are products that range from those used daily, 
such as fruits and vegetables or medicines to treat other chronic 
conditions, to products that may be needed once in a lifetime, such as 
an automated external defibrillator, to save someone's life. FDA has a 
duty to make safe and effective products available as quickly as 
possible, while at the same time protecting citizens from products that 
may cause harm. It is this dual responsibility to public health that 
highlights the critical nature of the Agency. The ability to prevent 
the outbreak of a foodborne illness is very different but just as 
important as fast approval of a life-changing medical product. The 
health of the citizens of the United States depends on both.
    Many of the products we regulate are more complex than ever. Gone 
are the days when treating patients was based on signs and symptoms 
alone. Rapid developments in science and technology are making it 
possible for physicians to truly personalize diagnosis and treatment. 
For example, just last May, FDA approved two drugs for melanoma along 
with companion diagnostic tests that use the genetic characteristics of 
the patient's tumor to help determine whether a patient will respond. 
The ability to evaluate remarkable products like these requires FDA to 
stay ahead of the curve.
    Scientific innovation is also driving remarkable advances in 
medical device development. For example, we are working hard to support 
the development of an artificial pancreas which would represent a huge 
advance in the management of diabetes. Products such as these offer 
great promise in reducing the burden of disease by tailoring 
interventions more effectively.
    In addition to becoming more complex, the environment in which FDA 
protects and promotes the health and well-being of the American people 
is becoming increasingly global. Over the last 10 years, the number of 
imported shipments of FDA-regulated products has skyrocketed--in 2013, 
approximately 29 million shipments of imported food and medical 
products entered the United States. Imports account for 50 percent of 
fresh fruits and 20 percent of fresh vegetables, 80 percent of seafood, 
and 40 percent of the drugs on our shelves. Most of this increase in 
imports is coming from countries with limited regulatory oversight.
    A strong FDA is critical not only to the domestic and global public 
health, but also to the U.S. economy, the balance of trade, and 
homeland security. The imple

[[Page 7]]

(7mentation of FDA's mission promotes innovation in the industries it 
regulates and affects costs in the broader economic and healthcare 
systems. Innovations not only create jobs, they position the domestic 
industries to compete in the global marketplace. 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.
               we moved forward on many fronts this year
    This past year's accomplishments on behalf of public health have 
been as substantial as any in FDA's recent history. There were too many 
significant actions to list here; below are just a few of the 
highlights of fiscal year 2013.
    Food Safety.--FDA published seven major proposed rules that form 
FSMA's central framework for moving to a comprehensive 21st Century 
food safety system. These science-based standards are designed to keep 
produce safe, implement modern preventive controls in human and animal 
food/feed facilities, modernize oversight of imported foods, guard 
against intentional contamination, and help ensure the safe transport 
of food and feed. In August, FDA issued a final rule defining ``gluten-
free'' for food labeling, to help the estimated 3 million Americans who 
have celiac disease make food choices with confidence to better manage 
their health. In November, we took further steps to reduce the amount 
of artificial trans fat in processed foods.
    Nutrition.--FDA recently proposed updating the Nutrition Facts 
label on food packages to reflect new public health and scientific 
evidence about nutrition, obesity, and chronic disease. Serving size 
requirements would be updated to reflect the amounts of food people are 
actually eating and drinking, and the format of the label would be 
refreshed, with key parts of the label such as calories, serving sizes, 
and percent daily value displayed more prominently.
    Breakthrough Therapies.--In 2012, FDASIA created a powerful new 
tool to facilitate the development and review of ``breakthrough 
therapies.'' In 2013, FDA's Center for Drug Evaluation and Research 
(CDER) received 121 requests for breakthrough therapy designation, and 
has already granted the designation to 36 potentially innovative new 
drugs that target both rare (epidermolysis bullosa, and Waldenstrom's 
macroglobuilnemia) and common (cystic fibrosis, breast cancer, and 
hepatitis C) conditions.
    Drug Shortages.--In 2013, FDA helped to prevent 170 drug shortages. 
In October, the Agency issued a ``Strategic Plan for Preventing and 
Mitigating Drug Shortages,'' outlining the Agency's strategy for 
improving its response to early notifications of a potential shortage, 
as well as identifying long-term initiatives that the Agency is 
considering or that stakeholders could take to address the underlying 
causes of shortages, such as opportunities for drug manufacturers to 
promote and sustain quality manufacturing.
    FDA also issued a proposed rule that, if finalized, will expand the 
early notification requirements.
    Unique Device Identification.--On September 20, 2013, FDA announced 
the final rule requiring that most medical devices distributed in the 
United States carry a unique device identifier (UDI). The system will 
be phased in over several years, focusing first on the highest risk 
medical devices. Once fully implemented, the UDI system will enhance 
the ability to quickly identify devices when recalled, improve the 
accuracy of adverse event reports, and help prevent counterfeiting and 
diversion. It will also offer a clear way of documenting device use in 
electronic health records and clinical information systems.
    Drug Quality and Security Act.--On November 27, 2013, the Drug 
Quality and Security Act (DQSA) was enacted. Within days of enactment, 
issued three draft guidances for industry related to how the Agency 
intended to implement the new requirements.
    As of March 6, 2014, 32 firms had registered as outsourcing 
facilities--and inspections have begun, focusing first on facilities 
that have not had a recent FDA inspection. A list of the facilities and 
information about what it means to register as an outsourcing facility 
is publicly available on FDA's website and is updated weekly.
    New Molecular Entities.--Last year marked another strong year for 
FDA approvals of novel new drugs (NMEs). In 2013, FDA approved 27 
NMEs--about the same as the 26 average annual approvals since the 
beginning of this decade. Some of these medications offer new hope to 
patients who previously had few or no treatment options. Examples of 
NMEs approved this year include a ``game- changing'' virtual cure for 
Hepatitis C, a drug that attacks breast cancer cells like a ``smart 
bomb'' reducing damage to normal tissues, and four new drugs to treat 
diabetes. Of

[[Page 8]]

(8the NMEs approved in 2013, one-third were identified by FDA as 
``first-in-class,'' and one-third were approved to treat rare or 
``orphan'' diseases. Almost three-quarters (74 percent) of the NMEs 
approved by FDA in 2013 were approved first in the United States before 
any other country.
    Public Health Preparedness.--We continued our efforts in 2013 to 
work with U.S. Government partners and product developers to facilitate 
the development and availability of medical countermeasures for 
responding to potential public health emergencies. This has resulted in 
the recent approval of several medical countermeasures to help protect 
the Nation from chemical, biological, radiological and nuclear threats, 
including an inhalational anthrax therapeutic, a botulism antitoxin, a 
next-generation portable ventilator, and several influenza diagnostic 
tests. For emerging infectious disease threats, such as the avian 
influenza A (H7N9) virus and the Middle East Respiratory Syndrome 
coronavirus (MERS-CoV), FDA issued Emergency Use Authorizations for 
diagnostic tests using new authorities created under the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013. In addition, FDA 
recently approved several seasonal influenza vaccines--including a 
vaccine manufactured using modern cell culture techniques and a vaccine 
made through recombinant DNA technology.
    Family Smoking Prevention and Tobacco Control Act.--In 2013 we made 
significant progress in implementing the Family Smoking Prevention and 
Tobacco Control Act. We signed contracts with state and local 
authorities to enforce the ban on the sale of regulated tobacco 
products to children and teens. By January 31, 2014, approximately 
258,300 inspections were conducted resulting in about 13,400 Warning 
Letters being issued, and over 1,200 Civil Monetary Penalties were 
imposed. We launched a significant research initiative, and issued the 
first-ever determinations on whether certain new tobacco products were 
or were not ``substantially equivalent'' to products already on the 
market. Just last month we launched a national public education 
campaign aimed at reducing the number of young people who use tobacco 
products.
    In addition we took important steps towards fighting the 
development of antibiotic-resistant bacteria, decreased the backlog in 
medical device applications, and exceeded our new ADUFA and AGDUFA 
performance goals. Our emphasis on product quality is accelerating, 
with the Center for Devices and Radiological Health (CDRH)'s Voluntary 
Compliance Improvement Program pilot, and CDER's new Office of 
Pharmaceutical Quality.
    FDA accomplished all this and more while costing Americans only 
about $8 per person a year. FDA is a bargain--the products regulated by 
FDA account for more than 20 percent of every consumer dollar spent on 
products in the U.S., but individual Americans only pay about 2 cents a 
day to ensure that those products are safe and effective. This is a 
small price to pay for life-saving medicines approved as fast or faster 
than anywhere in the world, confidence in medical products that are 
relied on daily, and a food supply that is among the safest in the 
world.
           fda's fiscal year 2015 president's budget request
    The fiscal year 2015 President's budget request for FDA is $4.74 
billion for the total Program Level, which is $358 million above the 
fiscal year 2014 enacted level. Of the total funding, $2.58 billion is 
budget authority and $2.16 billion is user fees. The fiscal year 2015 
increase consists of $23 million in budget authority and $335 million 
in user fees. The growth in user fee funding stems from several new 
programs, along with increased collection authority for many of FDA's 
existing programs.
    We are mindful of the larger pressures on the Federal budget, and 
have focused our request on the most urgent needs for fiscal year 2015. 
Serious product safety and quality lapses in recent years have caused 
serious public health situations, most notably those involving 
foodborne illness and the compounding of unsafe drugs, so FDA is 
seeking increases in order to strengthen oversight of the pharmacy 
compounding industry and to support food safety and implementation of 
FSMA.
    In addition, FDA must continue to advance medical countermeasures 
and maintain the integrity of operations and infrastructure, and is 
asking for small increases to support these activities as well.
                         medical product safety
    The fiscal year 2015 budget provides a program level of 2.6 
billion, which is $61 million above the fiscal year 2014 enacted level, 
to continue core medical product safety activities across FDA programs. 
Within this amount, FDA will invest $25 million in budget authority to 
enhance pharmacy compounding oversight activities in

[[Page 9]]

(9fiscal year 2015, which will significantly benefit public health and 
safety. It also includes $4.6 million for proposed International 
Courier user fees.
    In 2012, a fungal meningitis outbreak associated with a compounded 
sterile drug resulted in 64 deaths and over 750 cases of infections 
across 20 States. Since September 26, 2012, 28 firms ceased sterile 
operations. Since that time, FDA has learned of at least 20 compounders 
that may have shipped contaminated drug products, and has received at 
least 125 reports of adverse events, including serious infections, 
associated with drugs produced by compounders. As of March 6, 2014, FDA 
is aware of 40 recalls by compounding pharmacies, including some 
recalls overseen by FDA, and others overseen by a State.
    These statistics demonstrate the magnitude of the problems with 
compounders' sterile operations.
    FDA intends to continue risk-based, follow-up, and for-cause 
inspections of compounding pharmacies to identify pharmacies with 
deficient sterile compounding practices.FDA is also encouraging 
purchasers of compounded products to buy from registered outsourcers, a 
new category of compounder created by the DQSA and that will be subject 
to enhanced FDA oversight and Federal quality standards.
                              food safety
    The fiscal year 2015 budget provides a total program level of $1.48 
billion for food safety, which is $263 million above the fiscal year 
2014 enacted level. Within this amount, FDA will invest $24 million in 
budget authority to further advance recent gains in food safety 
modernization through implementation of FSMA. A majority of the 
increase is the result of new user fees, including $60 million in Food 
Facility Registration and Inspection fees, and $169 million in Food 
Import fees.
    With the requested increase in budget authority, FDA will be able 
to develop guidance and provide technical assistance for industry, 
provide technical support for FDA inspectors, and begin to implement 
training for FDA and state inspectors. If the proposed user fee revenue 
is authorized and appropriated, FDA will be able to undertake the wider 
array of activities needed to fulfill the food safety modernization 
goals of FSMA, including retraining of the Federal and state inspection 
force, training and technical assistance for small and mid-size growers 
and processors, and building the modern import oversight system 
mandated by FSMA. The implementation of the broad preventive controls 
framework mandated in FSMA will reduce instances of foodborne illness 
seen recently as a result of E. coli O157 contamination of pre-packaged 
salads, Salmonella and Listeria contamination of cheese products, and 
Listeria contamination in cantaloupe, and minimize the market 
disruptions and economic costs inflicted by illness outbreaks and 
significant contamination incidents.
                             infrastructure
    Within the funding for medical product and food safety, and medical 
countermeasures, FDA requests a program level increase of $5.8 million 
for infrastructure. Infrastructure includes GSA Rental Payments, Other 
Rent and Rent Related costs, and White Oak Consolidation.
                         current law user fees
    Within the funding requested is a $75.4 million increase for 
current law user fees, which will allow FDA to fulfill its mission of 
protecting the public health and accelerating innovation in the 
industry. The user fees collected will support the review and 
surveillance of human and animal drugs, medical and mammography 
devices, food and feed, color additives, export certification, and 
tobacco products. The request includes statutorily mandated increases 
for many existing programs, which will expand the available options for 
treating and curing diseases and will fund strategies to prevent and 
reduce the use of tobacco products by young people and reduce the 
burden of illness and death caused by tobacco products. Some of the 
amount requested supports infrastructure costs associated with current 
law user fee programs.
                               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 2015 budget targets our spending 
efficiently, on programs that are essential to providing Americans with 
the safe foods and effective medical products they expect. We look 
forward to answering your questions today and to working with you in 
the coming year.


[[Page 10]]

(10
    Senator Pryor. Thank you. And thank you for your testimony.
    Let me go ahead and jump in with the first question. Again, 
we'll do 7-minute rounds.

                              E-CIGARETTES

    Dr. Hamburg, on Monday of this week, I sent you a letter 
about e-cigarettes, e-liquids, or some people call them liquid 
nicotine. There was a recent New York Times article that stated 
that nationwide poisoning linked to e-liquids jumped to 1,351 
in 2013, and that's a 300 percent increase over 2012. And it 
looks like, based on the current numbers, that the 2014 number 
will probably be double what 2013 was. So obviously this is an 
exploding problem. And I think one of the reasons it is 
exploding is because of these little bottles right here.
    This is a product called ``J Juice.'' And this one is, 
believe it or not, the flavor is ``Scooby snacks;'' okay? This 
one over here, the flavor is ``sour apple.'' And this one over 
here, the flavor is ``moon pie.'' And so, the thing that 
concerns me is really the packaging and the attractiveness to 
children. They're actually--you can go to the candy aisle at a 
convenience store or a grocery store and you will see something 
very similar to this except it's candy.
    And I see the numbers and I, obviously, one of the first 
things that concerns me about this is the marketing to 
children, when you have a little friendly, colorful packets 
like this, and then, the packaging itself, it's not childproof. 
Childproofing probably helps the toddlers and the small 
children; it really doesn't help teenagers.
    And we can talk about some of that in just a moment, but I 
do think that at least there's probably a whole range of issues 
to talk about with these, legal and others, but also I do think 
that probably the first priority should be to try to keep these 
out of the hands of children.
    And when I look at Arkansas and I look at our statistics in 
our State, there've been almost 80 cases of poisoning. And, of 
those, about one-fourth were kids age 5 and under. So, again, 
it's not lim

[[Page 4]]

ited to them but you see this really strong tendency to kids 
age 5 and under. And of the more than 1,300 exposures 
nationwide in 2013, about 90 percent of them were pediatric 
cases.
    So I know that you're concerned about this, I've talked to 
you and your staff has told us some of the things you're doing. 
So if you don't mind, if you could just walk through with the 
subcommittee some of the things you're doing. I know you're in 
a process and some things you really can't talk about it in 
great detail but the subcommittee would like to hear what 
you're doing with this liquid nicotine.
    Dr. Hamburg. Well, we share your concern about the 
potential risks of these e-cigarettes and liquid nicotine 
exposure and do feel that this is an area that requires greater 
attention, action, and concern.
    At the present time, we do not have the authority to 
regulate e-cigarettes and some of these other products you're 
describing unless they make a therapeutic claim, in which case 
then they can be regulated as a drug.

[[Page 11]]

(11

                              DEEMING RULE

    But in the absence of that, we do need to pursue what we 
call the ``deeming rule,'' which is something that was laid out 
in the 2009 Family Smoking Prevention and Tobacco Control Act. 
That really gave us authority to go beyond what was explicitly 
in the law, which was the oversight of tobacco, roll-your-own, 
and smokeless tobacco--cigarette tobacco, roll-your-own, and 
smokeless tobacco, to other products that are increasingly in 
the marketplace. And we've been working hard on that. And we 
hope, some of you have heard me say this before, but we really 
are making progress and hope that that proposed deeming rule 
will be put forward very soon so that we can have broader 
comment in the input. And that is a critical building block for 
our ability to address what you were describing and other 
products in the marketplace, as well.
    I would also say, though, that while we have been working 
hard on that, we have also been investing in an important 
scientific research that will give us new information so that 
we can most responsibly regulate these products. And we've been 
doing that within our agency and with partners in the Federal 
Government, including the National Institutes of Health (NIH) 
and the Centers for Disease Control and Prevention (CDC); as 
well as providing grants to academic institutions to help us 
build the knowledge base about both the behaviors associated 
with these products and their health impacts, and also to 
better understand some of the constituents of these products 
and the public health implications and medical implications of 
those, as well.
    Senator Pryor. Yes. I know part of what you're striving to 
do is to be very science-based and understand that. But I also 
do think that when you look at the numbers, especially if you 
take one issue here that, to me, would seem fairly easily to 
tackle, at least in the beginning, would be just the packaging 
of this.
    I'm curious, like you mentioned a deeming rule, do you have 
to go through that process on a deeming rule just to work on 
packaging? And then, how long does that typically take? I know 
you

[[Page 5]]

said very soon you'd allow for comment but how long does that 
process typically take?
    Dr. Hamburg. Well, we do need to have authority over these 
products in order to regulate them and take certain actions. So 
that is why the deeming rule is so important. It's foundational 
to so many other things that we need to undertake.
    I will be honest with you that I think it has taken too 
long to move the deeming rule forward and we are pushing very 
hard to get it out as a proposed rule for broader discussion 
and then for finalization so that we can take these actions and 
provide the regulatory oversight; always science-based, that is 
crucial. But we need to be able to address these other 
important products that weren't directly covered in the 
original legislation.
    Senator Pryor. Yes. And I'm not trying to just single out J 
Juice because the truth is there are dozens of these different 
companies and labels. And I think, right now, this is such a 
new development, I'm not sure that we really know where all 
this is being made, and what all is in here, and who would 
regulate it and things like that.

[[Page 12]]

(12
    It's a little bit of a Wild West out there but I am seeing 
what we call ``vapor shops.'' Those are starting to spring up 
in Arkansas. And I didn't know this until the other day. I was 
talking to our Alcohol Beverage Control guy in the State that 
does that and he was saying that this is a real challenge, is 
these vapor shops.
    But also online. That's a whole new thing. Again, I had 
some of my staff look at this online. And literally, you say, 
``Oh, yeah, I'm 18,'' or ``I'm 21.'' Click. And then you can 
get just unlimited stuff. And some of the flavors, again: 
``tutti fruity,'' ``fruit punch,'' ``grape,'' ``cherry,'' lots 
of other choices; lots of brands.
    So I'm not really trying to single out just one brand. And 
I'm not even saying that this is all completely horrible, but 
it's a challenge especially with young people that I think 
it's, again, it's a complicated set of issues that I know 
you're focused on. I'd like to continue to work with you on 
that.
    I've exhausted my time for the first round. So, Senator 
Blunt.
    Senator Blunt. Thank you, Mr. Chairman.
    We'll have more than one round, too; won't we? So we'll 
have time to ask questions we want to ask today.
    And again, Dr. Hamburg, thank you for being here.

                        PREVENTIVE CONTROL RULE

    As I may have mentioned in my opening statement, Senator 
Shaheen and I sent a letter in November of last year about the 
Food Safety Modernization Act and certain sections in Produce 
Safety and Preventive Controls for Human Food Rules. You're re-
proposing part of those rules. Why aren't you just re-proposing 
all of the rules so that people can see the new changes in the 
context of the rest of the rule that's out there?
    Dr. Hamburg. Well, this has been a very open process where 
we have tried to reach out and really get input on all of the 
different rules. There are seven foundational rules for 
implementation of this important new law. Congress gave us some 
very rigorous deadlines for implementation and the courts have 
also weighed in as well. So we are really pressed to move 
forward. At the same time, we want to get it right.

[[Page 6]]

    And so, what we have been trying to do is to listen 
carefully, including going out to farms and food producers 
across the country for meetings, visits, and listening sessions 
to understand where the concerns are. And there are a set of 
clear, targeted concerns in the area of preventive controls for 
human and animal feed as well as in the produce area. And 
that's where we think that by re-proposing, we can make a real 
difference.
    We agree with your earlier comment about this is not an 
arena where the one-size-fits-all model can work. We want to 
find practical, workable, solutions that will matter to make it 
feasible for industry to implement these important new rules 
and the spirit of the Food Safety Modernization Act. But that 
will also make a difference for improving public health in 
reducing preventable foodborne outbreaks.
    So I think we're moving forward on the path that makes 
sense that enables us to reach our common goals but in a timely 
way that will matter for both consumers and for industry.

[[Page 13]]

(13

                     ADMINISTRATIVE PROCEDURES RULE

    Senator Blunt. Well, I do think there's some significant 
merit to, when you re-proposed certain rules, other rules that 
were in that package may be impacted by that as well. But I 
know in the Health Committee, in the last month or so, a number 
of our colleagues were concerned that you might not be totally 
adhering to the Administrative Procedures Rule. And you 
addressed that to some length.
    What I'd really like to know today is, as you re-propose 
the Preventive Controls Rule, that you intend to adhere to the 
Administrative Procedures Rule and ensure that any new testing 
requirements would be subject to economic analysis and full 
notice.
    Dr. Hamburg. Well, we certainly are committed to adhering 
to the Administrative Procedures Rule. And we're committed to 
really listening to the various stakeholders as they raise 
issues and concerns. So, I take your comments to heart. And we 
will take them back to the agency to review what we're doing 
and also as we shape the re-proposal.
    Senator Blunt. And that will include an economic analysis?
    Dr. Hamburg. Yes. I----
    Senator Blunt. I think that's----
    Dr. Hamburg. Probably multiple economic analyses.

                            ANIMAL FEED RULE

    Senator Blunt. All right. You just mentioned the part of 
the rule that related to what, I believe, the rule may have 
referred to as ``waste.'' ``Byproducts'' would be another term 
that I would have more traditionally, I think, seen used 
because the waste could wind up in places it doesn't need to 
wind up in if you really, truly, decide that this is just 
material that is to be discarded as opposed to material that 
can be re-purposed, I guess, as we re-propose these rules.
    Last night, FDA announced that brewers' grains would be 
addressed in the re-proposal of the animal feed rule. You and I 
talked about that part of the rule the other day. And, since 
then, I thought about this with some greater thought to what 
we're really

[[Page 7]]

doing here. And, I think the issue is larger than brewer's 
grains. I think there are lots of products that, from burnt 
potato chips to orange peels that are re-purposed to animal 
feed and other things, and under all of the restrictions that 
we would want to have there, I'm a little concerned that the 
only thing that FDA appears to be revisiting right now is the 
brewer's grains part of the so-called waste. I think it's a 
bigger issue than that. And any response you'd like to have, 
I'd be glad to hear.
    Dr. Hamburg. Well, I think, I mean, I'll be honest with 
you, that this was an issue that was only recently brought to 
my attention in terms of the agricultural practices. And, in 
discussing it with the team at the FDA, there was a strong 
sense that this is an area of importance that we want to 
support sustainable agriculture practices. And it makes 
enormous sense. We do believe that it can be addressed in a 
practical, sensible way. After our conversation about 
distillers' grains, I took that back and we're looking at that. 
So I think we will be looking at it more broadly.

[[Page 14]]

(14
    Senator Blunt. I think you really need to because the place 
that these things will wind up if we don't make the most out of 
products we can make the most out of, it's going to be in a 
landfill somewhere; nobody benefits from that until you truly 
are at the point that there's no economic or societal purpose 
to be served by getting more out of what we have. World food 
needs are going to increase dramatically. That means that not 
only do we need to think about how we produce more food but how 
we more effectively use the food and food products we have. And 
I think this is a big issue and I'm glad that you're going to 
go back and look at it again.
    This is everything from leftover seeds that aren't used 
that are then mixed into animal feed. I think one of the major, 
maybe all of the companies that have orange peels and citrus 
peels, pelletize those, and then they have found good and 
productive purposes for those. And again, they go somewhere 
that nobody benefits from more things in the landfill, 
particularly if there's real value left in these products. And 
I'm hopeful that you're going to look much more in-depth at 
what all that really means industry-wide.
    Chairman, I'm out of my time, too.
    Senator Pryor. Thank you.
    Senator Merkley.

                              DEEMING RULE

    Senator Merkley. Thank you very much, Mr. Chairman.
    And thank you for all of your testimony.
    And I want to continue the conversation that the chair 
began regarding the deeming regulation. We passed this act in 
June 2009. And it took 4 years and 4 months for the FDA to send 
it to OMB which, to me, is an egregious amount of time.
    At the beginning of that period, we had products being test 
marketed in Oregon and elsewhere in the country that were 
dissolvable tobacco products. We had dissolvable tobacco formed 
into toothpicks like this. We had it being formed into mint-
tobacco candy with caramel and mint flavorings. We had 
dissolvable tobacco being formed into breath strips, as ironic 
as that might seem. Here is some mint breath strips that you 
might want to try made out of tobacco. And we had an explosion 
in the flavors of cigars and

[[Page 8]]

cigarillos and so forth. Just a little sampling here; we've got 
``sweet cherry,'' ``Captain Black.'' We've got the ``grape'' 
cigar; we've got the ``strawberry'' cigar. Make sure we get 
some ``apple'' cigars. And the list would go on and on.
    The whole point being that the tobacco industry understands 
that you have to addict children because adults don't pick up 
tobacco products and start using them. Essentially, it has to 
happen before the age of 21.
    And all of this, I am told, and have been told repeatedly 
by the FDA, would be covered through the deeming regulation. 
But as you point out yourself, you have to get the deeming 
regulation done to get that authority. And all we're talking 
about now is the draft regulation. It's only the draft 
regulation that's been sent to OMB. And then, OMB has been 
sitting on it the last 4 months. I find this really 
embarrassing, disgraceful, and it's harmful to the children of 
America that the FDA has been sitting by for years with this

[[Page 15]]

(15power, enacted in 2009, and not even getting the first step 
in the regulatory process completed which is to get out of 
draft regulation.
    I would like for you and your team to wake up every 
morning, visit the OMB, and get that thing out there, because 
people's lives are being impacted. We've had a huge 
conversation about healthcare in our Nation. Well, this is 
healthcare. This is about the addiction to products that cause 
all kinds of disease over the course of one's life. And it's 
not just the quality of life. It is also the cost to the 
healthcare system treating all of these diseases.
    Now the chair beat me to the punch in talking about the 
next phase of this and you may have started seeing the 
emergence of vape shops. This is a picture of a vape shop. It's 
called ``DC Vape Joint,'' and it has a little underground 
entrance to it here just a few blocks from our Capitol. Inside 
of that ``vape joint'' shop, you find various displays of 
liquid nicotine of all kinds. You find a rack of dozens and 
dozens of different flavors.
    And I brought two of these today because I think they 
demonstrate an insidious strategy to addict our children to 
nicotine. This one, and the chair had a similar bottle, called 
``Scooby Snacks.'' Now, if that's not designed to appeal to a 
child, I don't know what is. And, if you look at it closely, it 
says, ``Zero milligrams of nicotine.'' Oh, there's no nicotine 
in this. Is this a bottle of juice? We're not sure. There are 
no ingredients listed on this. It's designed to go into an 
electronic cigarette, but this is one of those many vials of 
products that are out there being displayed. And the other 
bottles look the same. And, here, we have ``gummy bear.'' Now, 
``gummy bear,'' if you look closely, doesn't have zero 
milligrams of nicotine. It has 10 milligrams.
    And so here you have the starter kit, called ``gummy 
snacks,'' to get kids using this stuff in electronic cigarettes 
that look like this. They sell these little starter kits in 
that vape shop. They're hoping kids will start with this zero 
milligrams, but they'll soon be using the other. And if this 
one with 10 milligrams, is flavored ``gummy bears?'' That's 
obviously marketing to children.
    The ``gummy bear'' one, actually, you can read the 
ingredients on it. And it notes it contains nicotine, so on and 
so forth, keep out of reach of children. This one, it's printed 
in white on black. It's virtually impossible to read so I had 
the expert eyes of my staff tell

[[Page 9]]

me what this actually said. And, let's see. Where do I have 
that? Right here. This fine print that is in the block that 
normally would have the ingredients says, ``Stay weird, 
challenge the status quo, everybody love everybody and, above 
all, enjoy yourself.'' That's the starter bottle for this line 
of nicotine products.
    You all have got to get this deeming regulation done. You 
have a responsibility to the health of American citizens, our 
children, and 4 years and 4 months to get the first draft over 
to OMB is unacceptable. And for OMB to be sitting on this now 
over the last few months is unacceptable.
    I had a timeline done of all the times I've contacted the 
FDA about this. It was signed into law in June 2009 and, about 
8 to 10 different times I've either sent letters, met with you, 
or met with Lawrence Deyton who was Director of the Center for 
Tobacco Products, and time and time again it was said, ``We're 
working on it,

[[Page 16]]

(16we're working on it, we're working on it. We want to make 
it, kind of, iron-solid.''
    Well, there's no making anything that can't resist a 
lawsuit. Of course there are going to be lawsuits. There are 
teams of lawyers that've been preparing their cases over the 
last 4 years. I'm sure they'll attack every angle once it's 
done. But, to never get through the gates and get that process 
started of getting a draft regulation, it's completely 
absolutely unacceptable. And I have no idea--we've done 
letters, we've done meetings, with you, we've done meetings 
with folks that work for you.
    How do we possibly convey the importance of this to the 
future of America, to healthcare, and actually get some action?
    Dr. Hamburg. Well, as I said, it has taken far too long. We 
have been working very hard on this. It has been a complex 
challenge for many reasons.
    I do believe that very soon I will be able to call you and 
say that the deeming rule is out. It will just be the first 
step in a process, though. As you noted, it's a proposed rule. 
But it is essential we get it out. I could not agree with you 
more that this is a vital issue that these products represent 
very real threats to health and to the future of our children. 
We have to get it done and we have to get it done soon.
    Senator Merkley. Well, I'm just asking you to make your 
agency as visible as possible with OMB for their review to be 
completed. If you can advise on how we can be helpful. It's 
just, let's not let another month pass with this thing 
gathering dust in some bureaucrat's closet.
    Dr. Hamburg. I think we're almost to the point of the 
proposed rule. And I promise you, you will be among the very 
first calls that I make. But we have to respond, and your 
criticisms are fair. This is one of the most important public 
health challenges before us. And we have this unique 
responsibility in terms of oversight of these products. And we 
are committed to moving forward on this.
    Senator Merkley. Thank you very much.
    Senator Pryor. Thank you.
    Senator Cochran.
    Senator Cochran. Mr. Chairman, I may have not appreciated 
the practical part of the question that we just heard and the 
answer to it.

[[Page 10]]

    I was going to ask about the Modernization Act public 
comment period and whether or not that was going to be 
extended. There's some concern as I understand it that because 
of overlapping and maybe other factors among the new rules that 
the Food and Drug Administration intends to implement, whether 
or not there isn't sufficient comment period.

                             PRODUCE SAFETY

    According to one piece of information I have in front of 
me, it says there was less than a month between publication of 
the Feed Safety Rule and the comment deadline for the draft 
rules on produce safety and preventive controls for human food. 
Is that something we need to worry about or provide advice and 
counsel to how do you do this and still recognize the fairness 
to your consumers that this contemplates?

[[Page 17]]

(17
    Dr. Hamburg. Well, thank you for your questions. And it 
follows nicely on an early question.
    As was noted, this is a sweeping transformation of the food 
safety system in our country recognizing both domestic and 
global needs. The law that was passed by Congress really laid 
out a very ambitious agenda for us including a schedule for a 
set of important rules.
    The comment period is still open on two of the seven 
foundational rules. But on the other ones we have tried to 
extend comment periods to have a broad outreach and opportunity 
for comment and input through, various mechanisms; an open 
docket, public meetings, a range of discussions, etc.
    We are currently continuing our interactions with the range 
of stakeholders. And we are anticipating that we will re-
propose certain aspects of some of the critical rules; the 
preventive controls for animal and human feed and produce where 
there have been areas where the concerns have been very clear 
and where we feel that we do need more opportunity to find the 
right regulatory pathways to really develop the right 
approaches that will make a difference. Make it a law that is 
feasible for industry to implement, but achieve the goals of 
reducing foodborne outbreaks for American consumers.
    Senator Cochran. One of the joys of the community where I 
lived back in Mississippi are the farmers' market outlets where 
produce farmers bring in their wares and provide opportunities 
for the general public to come look and buy fresh fruits and 
vegetables, particularly.
    And this is a very popular avenue for good diet habits. 
Families go to the farmers' market on Saturdays and get up 
early. And I can remember as a young boy my grandparents who 
had truck farming interests in Mississippi, taking items from 
the farm that had been grown there or the farm for display and 
for sale. It was a very exciting thing. And, thinking back on 
it, it was a real tradition that has carried forward even to 
the present day. People really enjoy the opportunities that 
this provides even if you're living in the city and not on a 
farm like my family was when I was small.
    What exemptions, if any, or differences, if any, should be 
recognized and made available for small family farms to provide 
their vegetables and fruits that's grown on their places, to be 
seen and

[[Page 11]]

sold without fear of running afoul of some Federal official 
coming and saying, ``You violated some rules and you shut down 
this operation.''
    And, to what extent do you think that the Federal 
Government should be involved in that? Or should we let State 
and local governments manage the Saturday morning visits to the 
farmers' markets?

                            TESTER AMENDMENT

    Dr. Hamburg. Well, we all enjoy, I think, those local 
farmers' markets and they play an important role in the 
community and for health. The law does include some explicit 
recognition of that; the so-called tester amendment gets at 
some of those issues about small growers and producers.

[[Page 18]]

(18
    We also feel that the implementation of this new law has to 
be done in partnership, importantly, including with State and 
local agencies and organizations so that really it will reflect 
and build on what is already being done and what works for 
promoting and protecting the safety of the food supply. Whether 
you're a big grower or a small grower, I think everyone wants 
to produce great, high-quality food. But in terms of the 
application of aspects to the Food Safety Modernization Act, 
there is a recognition of the special needs of small farmers 
and producers. And that is certainly reflected in how we are 
addressing it and will be implementing it.
    Senator Cochran. Does this mean there'll be exemptions for 
State and local governments to regulate and monitor and 
inspect, rather than having the Federal Government?
    Dr. Hamburg. That there will be extensions; did you say?
    Well, we're working closely with USDA and the agricultural 
extension service as we try to implement this.
    And part of what we are seeking in our budget request is 
moneys that will enable us to actually give seed money to State 
agencies as well as technical assistance and training so that 
they can be full partners in implementation.
    Senator Cochran. Thank you.
    Senator Pryor. Thank you.
    Let me just, one last comment on what Senator Merkley and I 
asked you about earlier. And that is, I'll just say we can't 
wait for another tragedy to act. And I know that you're trying 
to act. But just count me in to work with you and industry to 
try to facilitate moving this through as quickly as possible. 
And, to me, it seems like the childproof packaging is a 
commonsense first step. I think there's a lot of other things 
we need to do but I would love to work with you on that and 
continue to move that down the tracks as quickly as possible.
    Dr. Hamburg. Thank you.

                         COMPOUNDING PHARMACIES

    Senator Pryor. Let me change gears, if I can.
    You mentioned compounding pharmacy in your opening 
statement. And I guess what I heard you say is that the status 
report on that is you're making progress. Kind of moving 
through the various things you need to do there. But are there 
any particular challenges? I mean is there a problem with the 
law that was passed?

[[Page 12]]

Or is there something going on that you didn't anticipate that 
the subcommittee needs to know about?
    Dr. Hamburg. Well, I think that the passage of the DQSA is 
a very important step. It clarifies one component of the prior 
existing law that related to compounding pharmacies for the 
FDA's so-called 503(a) which had been interpreted differently 
in different courts. And so, we had sort of a patchwork in 
terms of its application. So that is now clarified and it will 
be uniformly applied across the Nation.
    It also created a new category under 503(b), which allows 
compounding pharmacies that are making certain high-risk 
products, sterile injectables, to register with the FDA and be 
subject to our oversight. And I think, to promote safer, better 
quality products for patients, our challenge there is that this 
is a voluntary pro

[[Page 19]]

(19gram and some compounding pharmacies will appropriately 
register with us. And actually, I think about 35 have to begin 
that process of coming under our regulatory oversight for these 
very important, medically important products, but high-risk 
products.
    But there may be many other compounding pharmacies that 
are, in fact, making these high-risk products that don't choose 
to register with us, don't choose to become part of this new 
regulatory framework. And we are concerned that some of those 
manufacturers and the products they produce may not be 
adequately safe for patients and medical care in our 
communities.
    So we need to maintain a very proactive posture here. We 
need to continue to monitor who's out there doing what, which 
is hard if they don't have to register with us. We need to work 
closely with States who have the primary responsibility for 
traditional compounding pharmacy regulation. So there are a lot 
of challenges. And we think it's very, very important to 
protecting public health that we maintain a very strong 
presence in this arena and continue to build a strong program.
    Senator Pryor. And, back to your budget, and looking at the 
cost to you of implementing this and rolling this out and doing 
all the things you need to do, as I understand the budget, in 
order to find the resources you need, you're paying for that 
with some unspecified cuts to other medical products' safety 
activities. And do you know what those are yet? And do you know 
how it's going to work?

                               WHITE OAK

    Dr. Hamburg. Well, it is the case that the $25 million for 
this new initiative is not new money but it is coming from 
elsewhere within the agency. We have the opportunity to 
reallocate $15 million that would have been used for White Oak, 
our Washington headquarters' consolidation activities, that 
will go unutilized because, sadly, the General Services 
Administration (GSA) is not funded to do the construction 
necessary to continue to build out our master plan for that 
campus. And the rest of the moneys will be taken from other 
efficiencies that we can find within the agency and really 
trying to leverage resources as best we can.
    This is so important to the health and safety of the 
American public that we feel we need to have resources to build 
a program that will make a difference. And, over time, I think 
we're going to have to find other budget mechanisms to support 
these crucial ac

[[Page 13]]

tivities. And it is my guess, based on what I see as the need 
out there and the demands on FDA that likely we will have 
activities and responsibilities that outstrip the available 
resources.

                     FOOD SAFETY MODERNIZATION ACT

    Senator Pryor. And let me change gears here, again, on the 
Food Safety Modernization Act.
    Mr. Tootle here, at some point, wrote on his blog, an FDA 
blog, that ``With current resources, we will still be able to 
issue the FSMA rules but we won't be able to effectively 
implement them.'' And, obviously, I have that concern. I think 
a lot of people have that concern just about resources and how 
we're doing here. But are you requesting enough money to issue 
these rules and to implement them?

[[Page 20]]

(20
    Dr. Hamburg. This is a crucial time in terms of 
implementing the program itself. We can complete the process of 
finalizing the rules as we've been discussing, but what really 
matters to the public and to safety is that we put these 
programs in place in fiscal year 2015 and subsequent years are 
going to be crucial to that effort.
    And we need the moneys that we have requested in order to 
fully implement and realize the potential of this program to 
undertake certain critical activities that are vital to success 
including building the modern Import Food Safety Program that 
we need; including building the important partnership with the 
States, that Senator Cochran and I were just discussing, in 
terms of the seed money States need to build capacity and the 
training and technical assistance that are necessary to be able 
to ensure that they can be full partners in this effort. And we 
need resources so that we can work as effectively as possible 
with industry in terms of training and technical assistance as 
they move to implement this important new law.
    So, it is essential that we have these resources. And I 
think that with those resources, we can really make this law 
work and achieve the vision that Congress had when they passed 
it.
    Senator Pryor. But are you requesting enough for fiscal 
year 2015 to get done what you need to get done in fiscal year 
2015?

                               USER FEES

    Dr. Hamburg. Well, the amount of money that is in the 
budget request reflects our thoughtful and serious assessment 
of what we would need and, I think, mirrors other assessments 
that have been undertaken.
    The Congressional Budget Office (CBO) came out with a 
somewhat higher budget number for the overall implementation 
needs of the Food Safety Modernization Act. We took another 
look and tried to be a little bit more conservative. But, we do 
need money to implement this.
    We also realize that the user fee request is a challenge 
that the user fee option is one that has been utilized in other 
arenas of the FDA but not so much in the food space. And so, as 
we look at fiscal year 2015, we see a budget need and the 
pathway to get there is a complicated one. And we look forward 
to working with you on that because, I think, we all share a 
recognition that being able to

[[Page 14]]

really implement this law matters to the health and safety of 
the American public and it really matters to the food industry 
that plays such a crucial role in our food safety system.
    Senator Pryor. Senator Blunt.
    Senator Blunt. Commissioner, I think this is the fourth 
year in a row that the budget has requested these fees. And I 
think now they're around $220 million in new and repetitive 
registration and import fees. I think it's unlikely that those 
fees are approved.
    Given the choice, would you rather just have appropriated 
money from general revenue or have this financed on a fee 
basis?
    Dr. Hamburg. Well, what matters to me as Commissioner of 
the FDA and to the team that's been working so hard on food 
safety and what ultimately matters, I think, to our country, is 
that we get the job done; that we successfully implement this 
important law.

[[Page 21]]

(21And from my perspective, we need the dollars and we need the 
money if fiscal year 2015 is a critical year for 
implementation.
    And we need a sustainable funding stream as well. Too 
often, we have been in a position where there's a focus on an 
issue and we get some resources and then they get cut back when 
the attention shifts somewhere else. So we need a level of 
funding that is both adequate and sustainable. And if it comes 
from budget authority, that would be terrific.
    Senator Blunt. Do you know anything that we don't know that 
would make this request for fee increases more likely this time 
than the precious three times you asked for it?
    Dr. Hamburg. Well, I think that it is true that you've seen 
this request before. We have had discussions with industry and 
components of industry are more supportive than others in terms 
of user fees. It will be a discussion that we'll continue. 
Meanwhile, we are trying hard as an agency to implement this 
important law and I think we have to be realistic about the 
need for resources.
    Senator Blunt. On the compounding resources, the CBO's 
score, the Congressional Budget Office score was about half 
what--was $12 million and declined pretty dramatically after 
the first 3 years of getting you up to where, I guess, to 
initiating the program.
    I have two questions, really. One is why is this amount 
twice as big as what the Congress anticipated it to be? And 
two, the budget proposes reductions of $3.685 million in money 
that previously would have gone to looking at human drugs, 
$1.628 million reductions in biologics, a $2.88 million 
reduction in medical device programs without any real 
understanding on, any explanation on how those amounts of money 
that previously we thought we needed in these areas could be 
shifted now to compounding?
    So why the bigger number? And is there any explanation for 
the several millions of dollars shifted around internally; why 
you don't need it there now and did need it there before?
    Dr. Hamburg. Well, first, with respect to the CBO question. 
We are really trying to better understand their estimates 
because we don't think that they actually match what the needs 
are. And this has been an evolving area of focus, but we also 
think that there are some timing issues in terms of how and 
when they did their assessment. And so we're going to be 
working with them to better understand.

[[Page 15]]

    As far as the moving money around, the reductions that you 
note are not because they're being redirected towards the 
pharmacy compounding issue, we're going to be really looking 
across the agency and looking to find efficiencies rather than 
taking from other programs. But we are operating in a very 
constrained budget environment. And, if you ask me, do we have 
what we need in each of these critical program areas to do the 
job that we've been asked to do and I think we must do, in most 
cases, I do believe that the demands outstrip the resources.
    So it's a very challenging time. And we are trying to 
really look at programs in as clear-eyed a way as possible; 
focus on the critical needs and priorities; and to try to build 
strength in other ways. In certain instances, through 
partnerships and collaborative activities, through economies of 
scale and other efficiencies, and by really focusing on what 
are the most critical and urgent needs.

[[Page 22]]

(22

                            SEQUESTERED FEES

    Senator Blunt. In the fee area, one, our committee tried to 
do all we could to be sure you had access to the fees that you 
were able to collect, some of which were set aside by the 
sequester process. And, from an authorizing point of view, Mr. 
Pryor and I both have been very interested to see that happens 
again. But did happen. We got those fees back. But I think 
you've got another $79 million worth of fees that were 
collected prior to 2010 that the Office of Management and 
Budget says can't be spent.
    Do you have any advice here, Mr. Cochran or Mr. Tootle, on 
what we could do about that so that that money could actually 
be used to advance the purposes it was collected for?
    Dr. Hamburg. Well, first, let me thank you for the work 
that you did to help address the problem of the sequestered 
fees, the user fees, which was very worrisome and we're 
grateful for the leadership that you brought to that.
    With respect to the outstanding user fees, in terms of past 
collection, you are right. I think the number is $79 million 
and I think you've created a framework in terms of language 
that enables us to engage in discussions with the Office of 
Management and Budget (OMB) and we're actively in that process 
because we would--as I was saying, in answer to your last 
question, we do have critical needs and those resources could 
make a difference.
    Senator Blunt. Right. Well you do have critical needs and 
you do have this money that's been collected for the purposes 
of some of these needs specifically.
    And I'd certainly be willing to, and have been willing to 
be as helpful as I could be to convince the Office of 
Management and Budget, or whoever needs to be convinced. Maybe 
we need to do that with some further language again this year, 
but we want to work with you on that. There's no reason to have 
that money collected as fees for a purpose not to be somehow 
fenced off from ever serving that purpose. So----
    Dr. Hamburg. Thank you.
    Senator Blunt. Thank you, Mr. Chairman.
    Senator Pryor. Thank you.
    Senator Cochran.
    Senator Cochran. I've already----

[[Page 16]]

    Senator Pryor. Senator Collins.
    Senator Collins. Thank you very much.
    I thank the Senator from Mississippi and the chairman and 
ranking member.

         OFFICE OF FOODS AND VETERINARY MEDICINE--SPENT GRAINS

    Commissioner, I understand that Senator Blunt has brought 
up already the issue of spent grains. Grains that have been 
used to make beer and serve no further purpose to the brewer 
and are now being used for animal feed. I have to tell you, but 
I think the FDA's approach is a perfect example of a solution 
in search of a problem. This practice has been going on for 
literally centuries where brewers have donated or sold, often 
for little money, their spent grains to farmers.

[[Page 23]]

(23
    In Maine, we have an emerging craft beer industry that now 
employs over 1,000 people and 90 percent of spent grains 
produced by craft brewers are disposed of as animal feed. To 
me, this makes great sense. It recycles the remainder of the 
spent grains. And there simply is not evidence of problems.
    I understand, and agree, that it's essential that we ensure 
the safety of our Nation's food supply. But this is an example 
of regulatory overreach that will hurt both the small 
employers, that our craft brewers are, and the farmers that are 
working so cooperatively with them. So I want to just second 
the concerns that Senator Blunt has raised and urge you to take 
a really hard look at what the impact of that rule is and 
whether you're really solving a problem or creating one.
    Dr. Hamburg. Well, thank you.
    And you were not present when we had the early discussion.
    Senator Collins. Correct.
    Dr. Hamburg. I'll just reiterate that we have heard these 
concerns. Senator Blunt actually raised some additional ones 
around this notion of sustainable agriculture and recycling of 
product. We actually do think that this is an arena where there 
are sensible, reasonable solutions and we're committed to 
working towards those. And we think that this issue can be 
effectively addressed when we put forward a re-proposal this 
summer of some of the components of the human and animal feed 
preventive controls rule and the produce rule.

                          ARTIFICIAL PANCREAS

    Senator Collins. Good. I hope we will see a significant 
change.
    I know that you're also aware, well aware, of my strong 
interest in the development and approval of an artificial 
pancreas, which would help people living with type 1 or 
juvenile diabetes to achieve dramatically better control over 
their blood glucose levels until a biological cure is found.
    And I want to start by commending you and your team for all 
your work to advance these critically important technologies by 
streamlining the review structure in improving outpatient 
studies in a timely manner. An extremely important step was 
taken last year when your agency approved a Low Glucose Suspend 
system which is considered, in many ways, to be the first 
generation of an artificial pancreas technology.

[[Page 17]]

    I can tell you from the long years of work that I've done 
with families with children with type 1 that they are so eager 
for a breakthrough in this area. I know you're collaborating 
closely with the families and with stakeholders like the 
Juvenile Diabetes Research Foundation and with medical 
researchers outside the agency. But could you give me an update 
on your timeline, your strategy, for ensuring that these very 
promising new technologies reach patients as soon as possible?
    Dr. Hamburg. Well, thank you for the question and your 
appreciation of how hard we've been working in this area. I do 
think it's really a model for the importance of FDA working in 
full partnership with the scientific search community, medical 
care community, and importantly patients and families.

[[Page 24]]

(24
    The development of an artificial pancreas would transform 
the health and the quality of life of individuals living with 
type 1 diabetes and of course to their families as well. And 
it's not yet available anywhere in the world but we are really 
working hard to make it a reality.
    We put forward final guidance several years ago to really 
lay out what would be the regulatory pathway to try to 
encourage manufacturers to move in this direction and ensure 
the right research and study. We now also have, I think, 12 
clinical studies, some community-based studies, including one 
at a summer camp, to try to really understand how the current 
prototypes would work and, we want to move this as swiftly and 
surely as possible.
    We want to make sure that the product is safe and effective 
because if you are relying on this for the assessment of your 
glucose levels, in a continuing way and the delivering of 
insulin, it needs to do it right. But we think the science and 
technology is coming together with an acute and currently unmet 
medical need. And it's a very exciting and promising 
undertaking.
    And I would just add that it also, I think, is a model for 
other areas of medical product development as well; the 
partnership with key stakeholders and really trying to leverage 
the opportunities in science and technology today with critical 
unmet medical needs.
    Senator Collins. Thank you.
    Mr. Chairman, could I do one more? Or--thank you very much.

                    SEIZURE MEDICATION--CANNABIDIOL

    Commissioner, I recently had a very poignant meeting with a 
family in my office in Maine whose daughter had suffered for 
years, since she was age 11, from uncontrolled seizures. And 
she had been unable to control her convulsions with regular 
seizure medications and her family finally decided to have her 
try a tincture extracted from marijuana with a high cannabidiol 
(CBD) value, which does not cause the psychogenic effects of 
smoking marijuana. And, just so my colleagues don't 
misunderstand, I'm opposed to the legalization of marijuana the 
way that Colorado has done.
    But, for this young girl, the results have truly been 
remarkable and life changing. She's now a college freshman. She 
has not had seizures in many, many months whereas before she 
was having them all the time. And she's not, obviously, 
experiencing any kind

[[Page 18]]

of high because of the tincture that she is taking; so it's not 
interfering with her in that way.
    I know that a drug containing highly purified CBD, similar 
to the tincture being used by my constituent, is currently 
under investigation by the FDA under its expanded access 
Investigational New Drug program to help treat a few children 
with intractable epilepsy or other kinds of seizures.
    Could you tell me where you are in this process? Has 
consideration been given to expanding the number of young 
people who could participate in the program? And, as a 
physician, do you have any preliminary thoughts on whether this 
may, in fact, be a promising treatment for children who have 
uncontrollable seizures?
    Dr. Hamburg. Well, you raise many important issues.

[[Page 25]]

(25
    With respect to a specific product that might be under 
review by the FDA, without permission from the sponsor I can't 
speak to that. But what I certainly can say is that, number 
one, I think it's very important that we really study potential 
medical applications of marijuana and marijuana components. The 
active ingredients in a controlled way so that we can really 
understand what works, how, and for what conditions. So I think 
that is a very important undertaking. And certainly, this issue 
of that class of product for epilepsy has been brought to my 
attention as an area where there are scientists and medical 
providers who believe it holds great promise.
    With respect to expanded access while a drug is under 
study, we are very responsive to applications or requests that 
come. At the end of the day, it's the company that has to 
decide with affirmation from us to make the product available. 
But that is something where, over a period of many years now, 
we have had an active program. And, the majority of requests 
for expanded access that come before us are supported by the 
FDA.
    Senator Collins. Thank you very much.
    Thank you, Mr. Chairman.
    Senator Pryor. Thank you.

                               FEED RULE

    I have about four or five questions left. I'm just going to 
try to run through these very quickly.
    One is to follow-up on a question by Senator Blunt and 
Senator Collins, on the feed rule, the feed rule. And actually, 
mine is a little different take on that. I know that under the 
current rule, as I understand it, feed mills are exempted in 
situations where the owners of the mill are feeding animals it 
owns, on land it owns. Animals it owns on land it owns. And 
that's probably a sensible exemption or exception. But the 
question is should it be extended because in the poultry world 
and in the pork or swine industry world, oftentimes they own 
the animals and they own the mill but they contract out to 
independent farmers to do that. Or do you know are all 
considering extending that exemption?
    Dr. Hamburg. What I would like to do, with your permission, 
is take this back to the experts within the FDA because this is 
an important question, but it's at a level of detail that I 
really can't answer.
    [The information follows:]

    Section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) requires the registration of facilities engaged in manufacturing, 
processing, packing, or holding food for consumption in the U.S. These 
requirements are implemented in Title 21 of the Code of Federal 
Regulations, part 1, subpart H, Registration of Food Facilities. Some 
facilities, e.g., farms, are not required to register as a food 
facility under this subpart. The definition of furm is found in 21 CPR 
1.227(b)(3):
    Farm means a facility in one general physical location devoted to 
the growing and harvesting of crops, the raising of animals (including 
seafood), or both. Washing, trimming of outer leaves of, and cooling 
produce are considered part of harvesting. [The preceding sentence 
would be deleted under the proposed rule ``Current Good Manufacturing 
Practice and Hazard Analysis and RiskBased Preventive Controls for 
Human Food,'' 78 Fed. Reg. 3646, 3795 (Jan. 16, 2103).] The term 
``farm'' includes:
    (i) Facilities that pack or hold food, provided that all food used 
in such activities is grown, raised, or consumed on that farm or 
another farm under the same ownership; and

[[Page 26]]

(26
    (ii) Facilities that manufacture/process food, provided that all 
food used in such activities is consumed on that farm or another farm 
under the same ownership.
    Section 103 of the FDA Food Safety Modernization Act applies only 
to facilities that are required to register under section 415 of the 
FD&C Act and its implementing regulations. At this time, FDA is not 
intending to extend/change the definition of ``farm'' to include farms 
providing animal food to other farms. The feed mill in the scenario 
presented would probably be required to register as a food facility as 
the feed is not being consumed on a farm under the same ownership as 
the feed mill.

    Senator Pryor. Sure. Okay. That's great.

                             DRUG SHORTAGES

    And another one, I'm totally changing gears here as well, 
is on drug shortages. And I think we kind of barely touched on 
that in testimony or in questions. But, I know that there are 
drug shortages and there have been some Government 
Accountability Office (GAO) recommendations. And I'm just 
curious about the status of that and if you're working with 
industry to try to make those drug shortages less frequent and 
less severe?
    Dr. Hamburg. Yes.
    Well, it's a really important area. And, as you know, over 
the years there have been shortages in medicines that are 
really critical to the practice of medicine and the care of 
patients. We have seen some very significant progress. We went 
from, I think it was 251 shortages a couple of years ago, to 44 
this past year. But we're seeing another trend that we're 
paying attention to which is we're seeing some of the shortages 
sustained for a longer period of time.
    A number of things are making a difference as we respond to 
shortages and helping us really grapple working with industry, 
of course, who on the frontlines of this to address the 
problem. One is that through the Food and Drug Administration 
Safety and Innovation Act (FDASIA) we got new authorities to 
require companies to report to us not just if they were going 
to discontinue a medically important product within a 6-month 
timeframe, I think it was, but if there was reason to believe 
that there was an imminent threat to a product, a supply chain 
disruption, et cetera. So that's given us an opportunity to 
engage much earlier with companies that might have emerging or 
real shortages.
    We work closely with companies to try to address the cause 
of the shortages whether it's quality or lack of availability 
of a product so that we can keep that product in the 
marketplace. If it's a quality issue that requires them to 
actually stop manufacturing for a while, we work with them to 
try to fix the problem as quickly as possible.
    We also try to identify other manufacturers making that 
same kind of product and encourage them and work with them to 
actually ramp up the manufacturer. Or sometimes identify a 
manufacturer who might not be making that specific product but 
could make that product and, again, we would work with them to 
quickly move them towards an ability to make that product.
    And when necessary, we also will look oversees to see if 
there's an equivalent product that's available and approved in 
another country but not here and then we will move to make that 
drug available through importation to address a shortage need.

[[Page 27]]

(27
    So we have a range of tools. We have tried to be very 
proactive and responsive and flexible working with companies. 
There are

[[Page 2]]

some fundamental problems in that the majority of these 
shortages are in the arena of generic sterile injectables which 
are drugs that have a low return on investment but high 
requirements in terms of manufacturing capability and upkeep to 
keep the manufacturing at the appropriate quality level. There 
are, in many of these areas, limited manufacturers who are 
still making these products. So if one has a problem either in 
quality or supply chain, it puts at risk the national supply.
    So, it is something that we need to continue to work on. We 
do believe we have made progress. We do believe that working 
with companies around a broader quality agenda and really 
modernizing manufacturing as part of that will make a long-term 
difference.

               DRUG APPROVAL DUCHENNE MUSCULAR DYSTROPHY

    Senator Pryor. Okay.
    And we talked about before the wide range of topics that 
you have to deal with. Here's another topic: Duchenne muscular 
dystrophy. My understanding is there's a new therapy that's in 
the pipeline that shows some promise. And, apparently, it's not 
a cure but it just maybe will delay the onset of some of the 
symptoms of the disease. And my question really is, is this 
going to be a good candidate for accelerated approval or is 
that not a consideration right now?
    Dr. Hamburg. Well, again, I can't really speak to the 
specifics of a product that's under review. But what I can say 
here is that we all know that Duchenne muscular dystrophy is a 
devastating disease for patients and their families.
    We also recognize that advances in science and technology 
are really opening up huge new opportunities to find meaningful 
treatments. Maybe even someday a preventive or a cure. And we 
are working hard with the scientific research community, as 
well as the patient community, to try to find a pathway to 
realize the promise of science for these patients.
    There has been a huge effort around this disease and the 
products that are in development. I would say that it's an area 
where some of the top scientists and leaders in FDA have 
committed a huge amount of time and effort. And I think we are 
making progress. And, I really hope so because it's such a 
devastating disease. But the science and product development is 
very promising.
    Senator Pryor. Senator Blunt.
    Senator Blunt. Well, on that topic, I know we've had a 
number of Missouri families and clearly the individuals 
involved want to find the best help they can find and they want 
to find it as quickly as they can. And I'm glad you're pursuing 
that and hope we can find the answer to some of these possible 
cures, this one particularly, as quickly as it's possible to do 
and to safely do.

                             MENU LABELING

    On menu labeling, when do you expect the final rule to come 
out?
    Dr. Hamburg. Well, sadly, this is a conversation that we've 
had before.
    Senator Blunt. We have.

[[Page 28]]

(28
    Dr. Hamburg. It has been a long undertaking. And as you, I 
think, noted in your opening remarks, what had initially seemed

[[Page 3]]

like a relatively straightforward undertaking, menu labeling 
the nutritional content, especially calories, has been much 
more challenging than expected. But we are moving towards a 
final rule. And I do believe that I will not have to come to 
another budget hearing and have this discussion with you. But, 
no, I take very seriously----
    Senator Blunt. Well, depending on the ruling, you might. 
You might have to have this discussion.
    Dr. Hamburg. But you have raised a number of important 
issues over time and issues that have also been reflected in 
other comments on the proposed rule. And, you know, we have 
received lots of comments and undertaken a thoughtful, 
considerate analysis. And I think many of your concerns will be 
reflected back in the final rule.
    Senator Blunt. Some of those, as you know, would include, 
like, prepared food is a very small part of what a grocery 
store might do, a drive-through location, a delivery location 
where very few of the customers would ever see what was posted 
on the wall no matter how many things you posted on the wall.
    Do you have any anticipation, once you propose the rule, 
how long the compliance period would be?
    Dr. Hamburg. You know, I actually don't know the answer to 
that.
    My colleague Mike proposed a year.
    But the other thing I might just mention, I think you're 
probably aware, is that the menu labeling requirement applies 
to restaurant or restaurant-like establishments that are chains 
of 20 or more and have consistent menus. So that helps to 
narrow the focus. Not all restaurants will be asked to 
implement this menu labeling.
    Senator Blunt. Okay, good.

                         MITOCHONOLNAL DISEASES

    As the chairman has prefaced many of his questions on a 
very different topic, the FDA recently held a public meeting on 
reproductive technology. The purpose of the meeting and quotes 
was for the prevention of transmission of mitochondrial 
diseases ended those quotes, which involves cryoembryo using 
DNA from three parents.
    The advisory committee, the FDA briefing for the committee, 
said ``that the FDA recognizes that there are ethical and 
social policy issues related to genetic modification of eggs 
and embryos and that these issues have the potential to affect 
regulatory decisions; however, such issues are outside the 
scope of this meeting.''
    My view of that would be that the ethical questions 
associated with the procedures should be considered before we 
have a lot of discussion about how you do this. I'm just 
wondering if the ethical bridge is outside the scope of FDA. 
When do you think we should have that ethical discussion?
    Dr. Hamburg. We think those discussions should be ongoing 
and we are working to make sure that those discussions are 
engaged. We don't believe that we are the right agency to lead 
those discussions and it needs to be a broader societal 
discussion as well as

[[Page 29]]

(29bringing important expertise to bear. But research is going 
on in

[[Page 4]]

this area of what's called ``oocyte modification'' in assisted 
reproduction to address mitochondrial disease.
    And we undertook this public meeting in order to begin to 
understand what is the nature of the science and what is being 
done. I would add that research is being done in this country 
and in other countries and is being looked at as a policy 
matter in other countries of the world as well. But it's a very 
preliminary discussion and we do feel strongly that the broader 
social and ethical context has to be addressed.
    And, as I said, we are working to make sure that that 
happens as we also make an effort to understand what's really 
happening in terms of the scientific research. And, of course, 
mitochondrial disease is a serious problem. It affects a 
limited number of people in this country, but for those who it 
affects it is a very serious concern. And so, there's an 
eagerness to understand what kinds of scientific opportunities 
might exist to address it. But we are not unaware of all of the 
other issues that are raised and feel that those need to be 
addressed as a high priority.
    Senator Blunt. And I think you said you were working to 
ensure that the ethical questions are being addressed, though, 
not by you.
    Dr. Hamburg. Well, we would take part just because I think 
this is an issue that needs broad engagement. And, you know, 
certainly we would not move forward. We don't think that the 
science is ready to move forward based on that public meeting 
in terms of moving to clinical studies. But I think that we 
understand the importance of these issues and the broader 
context for this kind of scientific research. And so, as I 
said, we want to make sure that all of the issues; scientific, 
social and ethical, are examined fully.
    Senator Blunt. Well, I would hope so. And I hope you 
continue to use some of you efforts and the ongoing discussions 
with groups who should be talking about this to do so. You 
know, if the purpose of looking at this in the very narrow way 
you did was to see if it was just so dangerous that nobody 
should even being talking about it, I might understand that. 
But when you begin to talk about things that are this different 
from the way humans have always procreated and the potential of 
what might happen unknown, there is an ethical bridge here that 
we all understand that we're crossing that somebody should be 
in charge of that discussion or ensuring that that discussion 
happens before agencies of Government decide, well, this is the 
only thing we really have to do with this, so we should step 
forward and do our part of this before society has had the kind 
of discussion they need to have about the ethics of this kind 
of science and this kind of activity.
    But, Dr. Hamburg, I'm always really impressed by both your 
broad understanding of what you do and your willingness to look 
at things that you realize you don't understand yet because 
this is a huge portfolio. And the worse person we could have 
doing this job is somebody who thought they had all the answers 
on every topic. And I think today, again, you've expressed your 
interest and willingness to look at things that have broader 
context than maybe the agency initially thought they had. And I 
appreciate you and your responses to the questions today.
    Dr. Hamburg. Thank you.

[[Page 30]]

(30
    Senator Blunt. Thank you, Chairman.

[[Page 5]]

    Senator Pryor. Thank you.

                        ELECTRONIC DRUG LABELING

    I have two final questions for you and they're going to be 
quick. One is something I didn't know about until recently and 
that is the electronic distribution of prescribing information 
that goes along with drugs.
    My understanding is that this is the paper insert that you 
kind of get in there and unfold and look at it if you ever want 
to. By the way, I probably throw mine away more often than I 
read it. But every now and then, I want to see it and I want to 
have it. But I can think of lots of examples where that 
information could be and should be included to the end user. 
But anyway, we can talk about those if you want to. But 
regardless of my personal feelings about it, my understanding 
is that there's a possible rule change on that ending with the 
Office of Information and Regulatory Affairs (OIRA), and so I 
was wondering if you have an update on that or a status report 
on that?
    Dr. Hamburg. Well, I think we are looking towards making 
information more available on the Web. Some of us are slower to 
fully adapt. But, you know, there is a sense that that is, in 
fact, how many people get their information and if it's on the 
Web it's there. As you pointed out, many people just throw away 
their labels, their insert information, and I think that is a 
concern.
    In addition, I think one of our critical goals is 
manifested across various aspects of what we do is how can we 
communicate the important information in a way that's more 
understandable, accessible, and useful to consumers. And so, I 
think the move towards the electronic here is really an effort 
to try to make the information, in fact, more available to 
consumers.
    Senator Pryor. I think, again from my standpoint, I think 
of maybe seniors don't, typically don't always have the 
technology other people do. Rural people sometimes have 
challenges connecting to the Internet. You know, you think of 
scenarios: People traveling; people with kids and the kids are 
having a sleepover somewhere. I mean, I can just sort of see 
where that paper, from my standpoint, should continue to follow 
the--we'll see what comes out there.
    And the last thing, of course, I want to do, I've heard you 
sing the praises and you've heard me sing the praise of the 
NCTR many times. And I know that we were able to get them some 
additional money. And you obviously care about NCTR. And could 
you just give me a little update on what you're seeing down 
there and how things are going at the National Center for 
Toxicological Research?
    Dr. Hamburg. Yes.

                             NANOTECHNOLOGY

    Well, we do have a shared interest in NCTR and it really 
does represent a unique resource for FDA and for the Nation as 
a research organization that is really solely based on studying 
really important issues about toxicology, safety, and risk of a 
range of products that we regulate. And we have been able, I 
think, to accomplish some remarkable things there and have been 
very grate

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ful for the interest and support that you have provided over 
the years.
    Most recently, I think we've really done some 
groundbreaking work in the area of nanotechnology, including in 
partnership with the research universities in Arkansas and the 
State of Arkansas. Through a research alliance and 
collaboration we've been able to really build important 
programs to deepen our understanding of the toxicology of 
various components of products to develop new tools; to assess 
potential toxic effects more effectively and swiftly and 
earlier in a product development process, which is important in 
terms of saving time and saving costs; and developing new 
models that whether it's biomarkers or bioimaging that enable 
us to have new models rather than relying on what our 
increasingly outdated approaches as well, where you just try to 
study something in an animal model which isn't really adequate 
for a human model, and then when you try to make the 
translation it may not work.
    So really trying to apply cutting-edge science and 
technology to better and improve toxicology assessment 
technologies. They've also been a leader for us and more 
broadly in terms of the area of bioinformatics and how do we 
really harness the tools of computers and information 
technology to deepen our understanding of existing data, our 
collection of new data, and our analysis of critical problems 
for health. So they really are a very, very important resource.
    And, we have been able to, in recent years, undertake some 
important new projects. And we appreciated the one-time money 
that we were provided with last year that went to support some 
of the important activities I just mentioned.
    Senator Pryor. Well, thank you for that.
    And also, let me say, thank you for this hearing. We've 
kept you here for 95 minutes. You've been on the hot seat for 
that entire time. But thank you for being here and doing this.
    What we're going to do is we're going to leave the record 
open here for the subcommittee members to submit additional 
questions if they have them for another week, which is 
Thursday, April 10, and then we'll allow you all three or four 
weeks to respond to those.

                         CONCLUSION OF HEARINGS

    But anyway, thank you again for your leadership and for the 
FDA and all the things FDA does. And, with that, we'll conclude 
this hearing.
    Thank you.
    Dr. Hamburg. Thank you.
    [Whereupon, at 11:36 a.m., Thursday, April 3, the hearings 
were concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]