[Senate Hearing 114-]
[From the U.S. Government Publishing Office]


 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2016

                              ----------                              


                        THURSDAY, MARCH 12, 2015

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10 a.m. in room SD-138, Dirksen 
Senate Office Building, Hon. Jerry Moran (chairman) presiding.
    Present: Senators Moran, Blunt, Hoeven, Daines, Merkley, 
Tester, and Leahy.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF HON. DR. MARGARET A. HAMBURG, 
            COMMISSIONER, FOOD AND DRUG ADMINISTRATION
ACCOMPANIED BY:
        JAY TYLER, CHIEF FINANCIAL OFFICER, FOOD AND DRUG 
            ADMINISTRATION
        NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES


                opening statement of senator jerry moran


    Senator Moran. Good morning, everyone. We are delighted to 
have you with us. My first faux pas as new subcommittee 
chairman was to fail to turn on the mike. Senator Blunt is here 
to correct any of those mistakes, and I look forward to working 
with Senator Merkley to see that our subcommittee does its 
oversight work and its appropriations process oversight in a 
very significant and meaningful way.
    We are delighted to be here this morning. Today's hearing 
is going to focus on one of the important aspects of our 
subcommittee, the Food and Drug Administration (FDA), its 
fiscal year 2016 budget request. We thank the Commissioner, as 
I indicated, for being here, along with Mr. Tyler and Mr. 
Cochran.
    We look forward to questioning you, Dr. Hamburg, with this 
being your last appearance before the subcommittee, and let me 
take a moment to thank you for your public service and wish you 
well. We look forward to your testimony today and we look 
forward to your success and enjoyment in the future.
    The agency you head has authority over approximately 20 
cents of every $1 spent in America. Americans expect that the 
food they eat and the drugs they take will be safe and 
effective, and the FDA has vast reach.
    The agency has authority over more than 300,000 foreign 
establishments and 185,000 domestic establishments, ranging 
from food processing plants to facilities that manufacture 
life-saving medications.
    In addition to the facilities themselves, FDA is tasked 
with the regulatory responsibility of individual products. Just 
last week, FDA approved the first biosimilar product in the 
United States, enabling access to important therapies for 
patients in chemotherapy and other cancer treatments.
    In delivering these regulatory responsibilities, your 
private sector partners expect transparency and certainty from 
the FDA, and when I speak to small businesses, agriculture 
producers in Kansas and across the country, their great concern 
is the limits of Government and how it limits their ability to 
create jobs and stifles innovation through unnecessary and 
burdensome regulations.
    In part, we are here to try to eliminate where possible 
that unnecessary burden.
    Over the past 4 years, the FDA has been given significant 
new responsibilities, including the Food Safety Modernization 
Act (FSMA), menu labeling legislation, and drug compounding 
legislation. When implementing these laws, FDA must avoid the 
trappings of one size solution fits all problems. Small 
business and consumers suffer under the practices that limit 
the ability to respond to new requirements and little time to 
implement those changes.
    The agency's final rule on menu labeling in my view is 
overly broad and inflexible and lacks a great deal of 
practicality, and I was disappointed to see the inclusion of 
grocery stores, convenience stores, and other entities that do 
not sell restaurant style food as their primary business 
included in that regulation.
    Under the Food Safety Modernization Act, FDA is tasked with 
implementing the most sweeping changes to food safety laws in 
over 70 years. I was pleased to see that the agency took many 
of the concerns within the agriculture community into account 
by re-proposing significant portions of the rules because they 
were unworkable for farmers.
    With the court mandated deadline for finalization 
approaching, I encourage FDA to consider deliberate and 
thoughtful implementation of this law.
    I look forward to discussing with you these and other 
topics this morning. We have a lot to cover. I will now turn to 
Senator Merkley.
    [The statement follows:]
               Prepared Statement of Senator Jerry Moran
    This hearing will come to order. Good morning. Today's hearing will 
focus on the Food and Drug Administration's (FDA) fiscal year 2016 
budget request, and thank you Commissioner Hamburg, Mr. Tootle, and Mr. 
Cochran for being here today to discuss FDA's priorities for the 
upcoming year. Dr. Hamburg, with this being your last appearance before 
the subcommittee as FDA Commissioner, I want to thank you for your 
public service and your efforts to promote the health and safety of 
American consumers.
    The agency you head has authority over approximately 20 cents of 
every $1 spent in America. Americans expect that the food they eat and 
the drugs they take will be safe and effective. FDA's reach is vast; 
the agency has authority over more than 300,000 foreign establishments 
and 185,000 domestic establishments, ranging from food processing 
plants to facilities that manufacture lifesaving medications. In 
addition to facilities themselves, FDA is tasked with the regulatory 
responsibility of individual products. Just last week, FDA approved the 
first biosimilar product in the United States, enabling access to 
important therapies for patients in chemotherapy and other cancer 
treatments.
    In delivering these regulatory responsibilities, your private 
sector partners expect transparency and certainty from FDA. When I 
speak to small businesses and agricultural producers in Kansas, their 
overwhelming concern is a government that limits their ability to 
create jobs and stifles innovation through unnecessary and burdensome 
regulations. We must always be mindful of these concerns.
    Over the past 4 years, FDA has been given significant new 
responsibilities through the Food Safety Modernization Act, menu 
labeling legislation, and drug compounding legislation.
    When implementing these laws, FDA must avoid the trappings of 
``one-size-fits-all'' solutions. Small businesses suffer under this 
practice all too frequently because they have limited capital to 
respond to significant new requirements and little time to implement 
these changes.
    The agency's final rule on menu labeling is overly broad and 
inflexible and lacks a great deal of business practicality. I was 
disappointed to see the inclusion of grocery stores, convenience 
stores, and other entities that do not sell restaurant style food as 
their primary business.
    Under the Food Safety Modernization Act, FDA is tasked with 
implementing the most sweeping changes to food safety laws in over 70 
years. I was pleased that the Agency took many of the concerns within 
the agricultural community into account by re-proposing significant 
portions of the rules because they were unworkable for farmers. With 
the court-mandated deadlines for finalization approaching, I encourage 
FDA to consider deliberate and thoughtful implementation of the law.
    I look forward to discussing this and other topics with our 
witnesses today. We have a lot to cover this morning, so I will turn it 
over to Senator Merkley for his opening remarks.

                   STATEMENT OF SENATOR JEFF MERKLEY

    Senator Merkley. Thank you very much, Mr. Chairman. I am 
delighted to be here in the role of ranking member, and I am 
certainly looking forward to working with you as we examine the 
budgets for the Department of Agriculture and the FDA.
    Commissioner Hamburg, welcome to what is your last 
appearance before this subcommittee.
    Senator Moran. She is smiling.
    Senator Merkley. You look a little too happy. You have had 
the longest tenure of any FDA Commissioner in recent history, 
so thank you for your service over the last 6 years. You have 
steered the FDA through a period of enormous growth in both 
funding levels and responsibilities.
    In 2009, FDA's budget was just over $2 billion in 
appropriated funds. In 2015, $2.6 billion. If you throw in user 
fees on top of that, the numbers are even higher.
    Since you took the helm, Congress has passed several major 
pieces of legislation including the Family Smoking Prevention 
and Tobacco Control Act, the Food Safety Modernization Act, 
Drug Quality and Security Act, and the FDA Safety and 
Innovation Act, each of which has placed significant new 
responsibilities on the agency, and each of which you are 
currently implementing.
    At the end of the fiscal year, multiple new food safety 
rules will be finalized. I am hopeful that we will see the long 
awaited tobacco deeming regulations from FDA in the next couple 
of months. There is a lot going on, and your leadership will be 
missed.
    I am going to try to wrap this up fairly quickly so we can 
get to questions. I do want to point out this is a very robust 
budget request. The budget for FDA includes an increase of $147 
million in appropriated funding, with much but not all directed 
to food safety activities.
    I know that this subcommittee has been critical of FDA 
budgets in recent years that have simply proposed new user fees 
to fund food safety activities, and the likelihood of approval 
of those fees was minimal.
    This budget does have some additional proposed user fees, 
but also a significant budget authority increase of $109 
million for FSMA implementation, and an increase of $15 million 
for the administration's larger combating antibiotic resistance 
initiative or CARB initiative regarding antimicrobial 
resistance.
    While the FDA's piece of this is small, the role that FDA 
plays in ensuring there are new antibacterial drugs is vital. 
It is a significant issue, and I am pleased to see that you are 
addressing it in the budget, and look forward to your 
testimony. Thank you, Senator.
    Senator Moran. Senator Merkley, thank you. I, too, look 
forward to working with you, and Dr. Hamburg, we are now ready 
for your testimony.
    Dr. Hamburg. Thank you very much, and good morning, 
Chairman Moran--I have the same problem. Six years and I still 
have not learned----
    Senator Moran. Thank you for making me comfortable.

           SUMMARY STATEMENT OF HON. DR. MARGARET A. HAMBURG

    Dr. Hamburg. Thank you, Chairman Moran, Ranking Member 
Merkley, and members of the subcommittee. I am pleased to be 
here today to discuss the President's fiscal year 2016 budget 
request for FDA. It is an important budget request, as Senator 
Merkley noted.
    This will be my final appearance before the subcommittee 
before stepping down as Commissioner, and I want to begin by 
thanking this subcommittee for your past investments in FDA.
    This support has helped us address many of the demands of 
our broad and ever more complex mission. I have appreciated the 
constructive dialogue that we have been able to have over the 
years.
    During my tenure at FDA, Congress has recognized the vital 
and unique role that we play in promoting and protecting public 
health. Landmark new legislation has expanded FDA's authority 
as was just noted.
    We now regulate tobacco products, implement legislation to 
dramatically transform our food safety system, and to expand 
our medical product mandates, and a host of other new programs 
as well, not to mention new requirements to ensure the safety 
and integrity of complex global supply chains for both medical 
products and for food.
    Our accomplishments really demonstrate our ability to 
respond to evolving public health needs and responsibilities 
across the very broad spectrum of products that we regulate.
    However, resources in fact have not kept pace with our new 
authorities and mandates, as well as the demands of dramatic 
advances in the science and technology that underpins the 
products that we regulate, and the rapidly changing global 
marketplace, which has enormous ramifications on the work that 
we do and the people we work to protect.
    Moreover, most of our growth in funding has been in user 
fees provided by regulated industries, resources that can be 
spent only on a limited range of FDA programs.
    We certainly recognize the duty that you have to wisely 
distribute taxpayer dollars among many competing priorities, 
but FDA has had a great return on investment.
    Last year, in terms of budget authority, FDA cost every 
American only about $8 to ensure the safety of their food, 
their access to safe, effective, and even life-saving medical 
products, a safe blood supply, and so much more.
    FDA is committed to finding efficiencies wherever they 
exist. In fact, in the budget before you, we are proposing $16 
million in reductions to our base resources, nonetheless, 
tackling such critical challenges as food safety modernization, 
antibiotic resistance, and precision medicine requires 
additional investments at this time.

                             BUDGET REQUEST

    To help meet our public health mission for fiscal year 
2016, FDA is requesting $4.9 billion, $2.7 billion in budget 
authority, and $2.2 billion in user fees. The increase above 
fiscal year 2015 is $425 million, $148 million of which is 
budget authority. Again, recognizing the larger pressures on 
the Federal budget, we focused the budget request on essential 
functions and urgent needs of our agency.
    I would like first to address FDA's efforts to improve and 
protect America's food supply. The fiscal year 2016 budget 
request includes a total of $1.5 billion for food safety and 
nutrition, including $109.5 million budget authority increase. 
This increase will be largely dedicated to implementation of 
the Food Safety Modernization Act or FSMA.
    Since FSMA was passed in 2011, FDA has made extraordinary 
progress, including the issuance of seven major proposed 
regulations which will be finalized later this year.
    Significant funding gaps still loom. The actual on the 
ground implementation of these regulations will require us to 
modernize inspections and retrain staff to apply the new rules 
effectively and consistently, provide guidance and technical 
assistance to industry to support their compliance efforts, and 
invest in the capacity of our State partners to leverage their 
local knowledge and capacity.
    We also must address concerns about the safety of the large 
and growing volume of food imported from other countries. FSMA 
empowers the agency to hold foreign food producers to the same 
standards we expect of food producers in the United States. We 
must do so to ensure a level playing field for American firms, 
and most importantly, to protect our citizens.
    I cannot overstate the importance of our request to fund 
continued successful implementation of FSMA. A shortfall in 
funding will undermine Congress' intent to transform our 
Nation's food safety program, and will harm all stakeholders.
    If we invest now, I am confident that we can fulfill FSMA's 
vision of a modern prevention oriented food safety system that 
works collaboratively across our global food system to reduce 
foodborne illness, bolstering public confidence in the food 
supply, and maintaining U.S. leadership on food safety.
    In the vital area of medical product safety and innovation, 
the fiscal year 2016 budget request provides a program level of 
$2.7 billion, including a budget authority increase of $33.2 
million above fiscal year 2015.
    Part of the proposed budget increase will support FDA 
implementation of key initiatives of FDASIA, the Food and Drug 
Administration Safety and Innovation Act, and to continue 
important work on the national strategy for combating 
antibiotic resistant bacteria, where we have made important 
strides on both the human and the animal front, although this 
remains a pressing public health challenge.
    An additional $10 million is to support FDA's essential 
role in personalized or precision medicine, and enable us to 
continue to speed the development of promising new diagnostics 
and treatments for patients with serious illnesses.
    Our exciting work in medical product innovation and safety 
is a testament both to the new opportunities that have been 
presented by scientific knowledge and technology, as well as 
our innovative approaches to expedite development and review of 
medical products to address unmet medical needs while adhering 
to established standards for safety and efficacy.
    In fact, in 2014, FDA approved the most new drugs and 
biologics in almost 20 years, and brought life-saving drugs to 
market more quickly than ever. We have also made real progress 
in reducing times for medical devices to reach the market.
    Enhanced funding will help us to maintain our Nation's 
preeminence in biomedical product innovation and safety, and 
will benefit us all.
    Let me close by underscoring that FDA's public health 
mission is indispensable to the health and well being of every 
American. We carry out our mission effectively and with 
relatively few taxpayer dollars, despite tremendous expansions 
in our responsibilities as a result of new legislation, 
scientific and technological advances, and a globalized 
marketplace.
    Our budget request plans for efficient spending on programs 
that are essential to providing Americans with safe foods and 
safe and effective medical products that they expect and count 
on.
    I know that with your ongoing support, FDA will continue to 
move forward in fulfilling its critical responsibilities to the 
American public.
    Thank you.
    [The statement follows:]
           Prepared Statement of Hon. Dr. Margaret A. Hamburg
                              introduction
    Good morning Chairman Moran, Ranking Member Merkley, 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 the President's fiscal year 2016 budget 
request for FDA. 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 2016, FDA is 
requesting $4.9 billion to support our essential functions and priority 
needs.
    On a personal note, I'd like to thank the Committee for its 
continuing commitment to these issues during my 6 years as 
Commissioner. As you know, I will be stepping down at the end of this 
month, so this will be my final appearance before this subcommittee. I 
will miss the constructive dialogue we have enjoyed over the years to 
address matters of mutual concern. My decision to leave FDA was not an 
easy one, as there is always more to be done, and I remain dedicated to 
the vital work and mission of the agency. But, I am confident that I 
leave the agency stronger and more effective than when I began, and 
better positioned to meet the challenges of the 21st century. And, I 
know that with your commitment, FDA will continue to move forward in 
fulfilling its critical responsibilities to the American public.
        fda plays a vital role in america's public health system
    FDA is a science-based regulatory agency charged with an enormous 
and significant public health mission: to promote and protect the 
health of the American people. Our goal in carrying out our mission is 
to ensure the safety, effectiveness, and quality of medical products, 
as well as the safety and security of the vast majority of our Nation's 
food supply. The agency also regulates the manufacturing, marketing, 
and distribution of tobacco products and seeks to reduce the use of 
tobacco products by minors. FDA plays a unique and vital role in 
facilitating the availability of safe and effective products, while 
also protecting citizens from products that may cause harm.
    FDA's important work promotes innovation in the industries it 
regulates, creates jobs, and positions domestic industries to compete 
in the global marketplace. History shows that when there is public 
trust in FDA's oversight, the industries we regulate flourish. 
Conversely, when food and medical products cause serious harm, the 
result is often severe economic damage across the industry involved.
    Congress has recognized the dynamic role that FDA plays and the 
increasingly complex and global environment in which we operate. As a 
result, FDA has been tasked with a multitude of new responsibilities 
and authorities in the public health arena, including the Drug Quality 
and Security Act (DQSA); the FDA Safety and Innovation Act (FDASIA); 
the FDA Food Safety Modernization Act (FSMA); and the Family Smoking 
Prevention and Tobacco Control Act. While FDA has stepped up to meet 
these essential public health challenges under current funding levels, 
successful implementation of these new authorities requires significant 
additional resources.
                fda has a proven track record of success
    FDA's accomplishments over the past year have been as substantial 
as any in the agency's recent history. Across the areas of food safety 
and nutrition, medical product safety and innovation, tobacco control, 
and other areas of our work, our accomplishments demonstrate our 
ability to respond to evolving needs and opportunities--including the 
embrace of new approval pathways, innovative technologies, and cutting-
edge science.
    Moreover, especially given the importance of our work, FDA is a 
bargain. The products regulated by FDA account for more than 20 percent 
of every consumer dollar spent on products in the United States but 
individual Americans only pay about 2 cents per day to ensure that 
those products are safe and effective. This is a small price 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 innovations improve and protect america's food supply
    Food Safety Modernization.--FDA published seven major proposed 
rules and, based on stakeholder input, four supplemental proposals to 
implement FSMA. The agency also completed 8,607 high-risk food 
establishment inspections in fiscal year 2014, exceeding the target of 
6,507 inspections by 32 percent. FDA also released a FSMA Operational 
Strategy Document that focuses on how we can implement FSMA by 
prioritizing prevention, voluntary compliance, risk-based oversight, 
and expanded collaboration across the food safety community.
    Genome-Based Food Pathogen Detection.--FDA established GenomeTrakr, 
the first national pilot network of whole genome sequencers (WGS) for 
pathogen identification to trace where outbreaks start--even at the 
level of a single farm or food facility--based on whole bacterial 
genomes. FDA is already utilizing this innovative technology, such as 
in the identification and closure of a cheese facility connected to a 
Listeria monocytogenes outbreak, to take quicker, yet more targeted, 
action and likely prevent a larger number of illnesses.
    Nutrition Labeling.--On December 1, 2014, FDA published two final 
rules requiring that calorie information be listed on menus and menu 
boards in chain restaurants and similar retail food establishments, and 
on signs for vending machines. Americans eat and drink about one-third 
of their calories away from home, and this is an important public 
health step to help consumers make informed choices for themselves and 
their families. FDA also proposed important updates to the nutrition 
facts label, such as more prominent calorie declarations, to bring it 
up to date with current diet and health concerns.
            promoting innovative medical product development
    Medical Product Application Review.--FDA's rapid drug reviews and 
use of expedited programs has helped provide meaningful new products to 
U.S. patients. In 2014, FDA approved 51 new molecular entities and 
biological products, more than in any single year in almost 20 years. 
Among the 2014 approvals are treatments for cancer, hepatitis C and 
type-2 diabetes, as well as the most new drugs for ``orphan'' diseases 
since Congress approved the Orphan Drug Act more than three decades 
ago. Seventeen of the new approvals are ``first in class'' therapies, 
which represent new approaches in the treatment of disease, and almost 
two-thirds were approved first in the United States. In addition, 
important biological products approved in 2014 include a number of 
groundbreaking vaccines for meningitis B, the flu, and certain types of 
human papillomavirus.
    From 2011 to 2014, the median number of days for FDA to approve 
investigational device exemption (IDE) submissions decreased from 442 
to only 101, cutting the time it takes to bring a new medical device to 
market by nearly a full year. In addition, improvements to the de novo 
program have resulted in a 70-percent reduction in the average total 
time to decision for these submissions.
    These developments are a testament not just to expanding 
understanding of human biology and the molecular mechanisms that drive 
the disease process, but also to FDA's innovative approaches to help 
expedite development and review of medical products that target unmet 
medical needs, while adhering to the established standards for safety 
and efficacy.
    Abuse-Deterrent Opioid Medications.--FDA continues to make progress 
in its efforts to help reduce prescription drug abuse, while remaining 
committed to ensuring that patients with pain have appropriate access 
to medicines they need. In 2014, FDA approved three new opioids with 
abuse deterrent features to give physicians effective new treatment 
options with less risk of abuse. To help encourage the development of 
more abuse-deterrent formulations of opioids, the agency hosted a 
public meeting to discuss scientific and technical issues related to 
development and assessment of abuse-deterrent opioid products and is 
working diligently to finalize its guidance on this topic this spring. 
We also approved a new dosage form of naloxone with an autoinjector to 
allow for the emergency treatment of opioid overdoses in community 
settings.
    Drug Quality and Security Act.--During fiscal year 2014, FDA 
conducted over 90 inspections of compounding facilities, issued warning 
letters, and worked with DOJ to bring criminal and civil enforcement 
actions. The agency also continued to develop a framework to implement 
the new law. FDA has issued numerous policy documents to implement 
Federal Food, Drug, and Cosmetic Act section 503A, as amended by the 
DQSA, as well as section 503B, as added by DQSA, concerning outsourcing 
facilities. In addition, on February 23-24, 2015, FDA held the first 
meeting of the Pharmacy Compounding Advisory Committee to provide 
advice on scientific, technical, and medical issues concerning drug 
compounding.
     fda works to reduce the impact of tobacco on the public health
    Family Smoking Prevention and Tobacco Control Act.--FDA published 
the proposed ``deeming rule'' to extend FDA's tobacco authority to 
additional tobacco products, including e-cigarettes, and is reviewing 
over 135,000 comments the agency received in preparation of the final 
rule. Public health-based regulation of these products can help reduce 
the death and disease toll from tobacco use. FDA also closely monitors 
retailers' compliance with restrictions on tobacco product marketing 
and sales to youth--and takes strong corrective action when violations 
occur. In addition, the agency launched a major public education 
campaign targeting youth about the dangers of tobacco products, with 
the goal of reducing or preventing use in future generations.
          fda tackles emerging, unique, and complex challenges
    Combating Antimicrobial Resistance.--FDA has made important strides 
in confronting the growing resistance of some bacteria to antimicrobial 
drugs. In 2014, FDA approved four novel systemic antibiotics to expand 
the pipeline of new medical products available for identification, 
prevention, treatment, and/or cure of bacterial infections. In 
contrast, only five new antibiotics had been approved in the previous 
10-year period. In addition to working on the human medical product 
side, FDA has made great progress on its initiative to fight 
antimicrobial resistance by restricting the use of medically important 
antimicrobials in food animal production to legitimate animal health 
purposes. All 26 drug companies with affected products have committed 
in writing to remove animal production uses from their FDA-approved 
labels and bring the remaining medical uses under veterinary 
supervision by the end of 2016. FDA is working closely with USDA, 
producers and drug companies to support implementation of these 
important changes and gather data to verify their effectiveness in 
reducing antimicrobial resistance.
    Ebola Outbreak Response.--In response to the Ebola epidemic in West 
Africa, FDA has acted aggressively to help expedite the development and 
availability of investigational medical products for Ebola, including 
by: providing regulatory advice and guidance to commercial developers 
and U.S. agencies; helping to facilitate access to investigational 
medical products for patients with Ebola when requested by clinicians; 
and authorizing the use of eight investigational diagnostic tests for 
Ebola under FDA's Emergency Use Authorization authority. We have 
collaborated extensively with the World Health Organization, NGOs and 
several international regulatory counterparts to support international 
response efforts. FDA has also monitored for fraudulent products that 
claim to prevent, treat, or diagnose Ebola and took action, as 
warranted, to protect public health.
           fda's fiscal year 2016 president's budget request
    The fiscal year 2016 President's budget request for FDA is $4.9 
billion for the total program level, which is $425 million above the 
fiscal year 2015 enacted level. Of the total funding, $2.7 billion is 
budget authority and $2.2 billion is user fees. The fiscal year 2016 
increase consists of $148 million in budget authority and $277 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. Mindful of the larger pressures on the Federal 
budget, we have focused our request on the most urgent needs for fiscal 
year 2016.
                              food safety
    The fiscal year 2016 budget provides a total program level of $1.5 
billion for food safety, which is $301 million above the fiscal year 
2015 enacted level. This total includes a $109.5 million increase in 
budget authority and a $191.8 million increase in user fees. The 
proposed budget authority increase will be almost exclusively dedicated 
to implementation of FSMA.
    FDA's successful implementation of FSMA is essential to reducing 
foodborne illness, bolstering public confidence in the food supply, and 
maintaining U.S. leadership on food safety internationally. With FDA 
under court order to issue many key FSMA regulations in 2015, fiscal 
year 2016 is an absolutely crucial year for the investments needed to 
ensure timely, effective, and non-disruptive implementation. FDA's 
collaborative implementation strategy requires a modernized approach to 
inspection and enforcement, focusing on food safety outcomes and 
encouraging voluntary compliance. To be successful, this strategy 
requires retraining and retooling of FDA and State inspectors. In 
keeping with FSMA's theme of collaboration and partnerships, the 
largest single portion of the budget authority will go to the States to 
better integrate, coordinate, and leverage Federal and State food 
safety efforts.
    FDA's FSMA philosophy of ``educate before and while we regulate'' 
also requires investing in guidance, education, and technical 
assistance for industry to support their compliance efforts, especially 
among smaller scale farmers and manufacturers. FDA will deliver this 
assistance through collaborative alliances and training partnerships.
    Finally, FDA must make crucial investments in fiscal year 2016 to 
implement the new import safety system mandated by Congress. This 
includes FSMA's Foreign Supplier Verification Program requirements, 
which are the foundation for FSMA's new import safety system and key to 
helping assure a level playing field of food safety standards and 
oversight for U.S. consumers and industry.
    The investments FDA can make with the fiscal year 2016 budget 
authority request will enable the agency to maintain momentum toward 
timely and successful implementation of FSMA. Without these 
investments, implementation will be disrupted and delayed.
                 medical product safety and innovation
    The fiscal year 2016 budget provides a program level of $2.7 
billion, which is $84.8 million above the fiscal year 2015 enacted 
level, to continue core medical product safety activities across FDA 
programs.
    With part of this increase, FDA will support implementation of 
three initiatives of FDASIA: the Unique Facility Identifier; Unique 
Device Identifier; and Electronic Biological Product Application 
Submission programs. FDA will also continue contributing to the 
National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) to 
help ensure the judicious use of medically important antimicrobials in 
food-producing animals; to evaluate new antibacterial drugs for patient 
treatments; to streamline clinical trials; and to develop better 
vaccines for antibiotic resistant organisms. An increase of 
approximately $1 million will support continued implementation of new 
compounding oversight authorities and the evaluation of sunscreen 
ingredients. Finally, $10 million of the increase will help FDA adapt 
its regulatory process to developments in ``precision medicine.'' 
Funding this initiative will permit FDA to keep pace with scientific 
advancements and help speed the development of promising new 
diagnostics and treatments that will enable precision medicine to be 
successful.
                          rent and facilities
    Within the budget request, FDA requests a program level increase of 
$38.9 million for infrastructure. FDA has a growing workforce of 16,000 
full-time equivalents (FTEs), resulting in rising operational rent 
costs. Without the requested funding, FDA cannot simultaneously support 
this expanded workforce, critical facility needs, and its increasing 
programmatic responsibilities. The request also includes funding for a 
feasibility study to address FDA's expanded workforce and facility 
needs on the White Oak campus.
                         current law user fees
    A $78.5 million increase is requested for current law user fees, 
which will help FDA fulfill its mission of protecting the public health 
by assuring the safety and efficacy of human and veterinary drugs, 
biological products, and medical devices, assuring the safety of our 
Nation's food supply, and advancing the public health by helping to 
speed innovations that will offer safer, more effective and higher 
quality medical products.
                               conclusion
    FDA's public-health mission is indispensable to the health and 
well-being of every American. We carry out our broad public health 
responsibilities effectively and with relatively few taxpayer dollars, 
despite dramatic expansions in our responsibilities as a result of new 
legislation, scientific and technological advances, and a globalized 
marketplace. Our budget request plans for efficient spending on 
programs that are essential to providing Americans with the safe foods 
and safe and effective medical products they expect. We look forward to 
answering your questions today and to working with you in the coming 
year.

    Senator Moran. Commissioner, thank you very much. In the 
hopes that the human trafficking legislation can proceed, we 
are going to allow Senator Leahy the opportunity first to ask 
questions so he can get to the Floor.

                          DRUG SAFETY LABELING

    Senator Leahy. Mr. Chairman, I appreciate especially as the 
newest member of this subcommittee the courtesy of the 
chairman.
    A couple of questions. Commissioner, as I told you 
privately before, I hate to see you leave. I understand it 
reaches a point, but thank you for what you have done.
    In 2013, FDA issued a proposed rule that ensures generic 
drug companies can update their safety labels when they learn 
new safety information. Brand-name manufacturers have that 
ability now, and it is tremendously important. I have a 
constituent, Diana Levine, who was able to seek justice when 
she got a mislabeled brand-name drug and lost her hand as a 
result of it.
    The FDA's proposed rule for generics has been sitting there 
for over a year, and the FDA recently reopened its rulemaking 
which would allow an industry backed alternative that actually 
turns the existing labeling rules on its head. Their proposal 
is that no brand-name drug company nor generic drug company 
could update its label immediately upon learning of adverse 
side effects, and there would be no liability if something 
happened.
    That does not seem the way it should be. I would hope FDA 
would commit to complete the rulemaking in a way that if there 
are problems with a drug, that consumers would know about it 
immediately, not have it delayed.
    Dr. Hamburg. Thank you for those observations. Certainly, 
our goal as we are working through this process is to ensure 
that patients and their healthcare providers can get access to 
the most recent safety information, wherever it emerges from, 
whether it is from experience with an innovator drug or generic 
drug, and that the systems really enable rapid and responsive 
communication of information.
    We have received a lot of comments on the proposed 
guidelines, lots of different stakeholder perspectives. We have 
tried to listen very carefully and have held a number of 
meetings and are holding another public meeting on March 27.
    We do plan, of course, to proceed with finalizing, but we 
want to make sure the process is inclusive, but the goal is to 
provide the best possible information for patients.
    Senator Leahy. Best possible and the most timely.
    Dr. Hamburg. And the most timely. Realistically, one of the 
concerns that you may be aware of is if only the innovator can 
make the change, the sponsor of the original product, then what 
happens in a world where there is increasing reliance on 
generics and some of the original innovator drugs are no longer 
in the marketplace.
    Senator Leahy. Also the warnings can be done immediately, 
perhaps not the changes immediately, but the warnings could. I 
will follow up with further questions on that.

                       MAPLE INGREDIENT LABELING

    Let me go to what may sound like a parochial thing. In 
Vermont, winter will end; I have been assured after having 
lived there for 75 years, it does end. Then we go into maple 
season. It is very, very hard work on the 30-so gallons of sap 
for every 1 gallon of maple syrup, but we are able to do this 
and we can sell it because people rely on it being pure maple 
syrup.
    Here is what is happening. More and more things are being 
sold. For example, this is pure Vermont maple syrup. I would 
hasten to add that it is very, very good. We go through a lot 
at home. Then people have things like this that are sold, maple 
and brown sugar. You go into the ingredient list, and there is 
no maple whatsoever. There is caramel color and things like 
that.
    Are you able in your funding to go after people who are 
actually mislabeling these things, because the people who have 
done the work for this pure Vermont maple syrup are being badly 
hurt.
    Dr. Hamburg. Well, certainly the kinds of responsibilities 
that FDA pursues involves ensuring the accuracy of labeling in 
key areas.
    This issue about the maple syrup is not unknown to us, and 
in fact, we did recently pursue a criminal case where someone 
took cane syrup with a little bit of maple syrup flavoring, I 
guess, and labeled it as a product of Vermont when in fact it 
was not, and as maple syrup. In fact, those individuals pled 
guilty. That was back in 2012, I think.
    We hope that actions like that send a message, but it is 
the case that we have such a broad range of responsibilities, 
we do have to prioritize. Certainly, the issues around being 
able to pursue all of the misleading and false claims has been 
one that has been challenging for us in areas that range from 
food products to drugs to dietary supplements to cosmetics, and 
it is one where working with industry and working with 
consumers so we get reports where there are actions that we can 
aggressively take are very helpful to us.
    Senator Leahy. I realize you have to be selective. I can 
tell you right now, unless there is really strong action 
against some of these people, you are going to destroy 
something that is not only part of the culture of our State, 
but it is a very important industry in our State, and one in 
which there are some very, very hard working people who through 
no part of their own are wiped out.
    Dr. Hamburg. It is very important. The more we can get 
information about where problems occur, we monitor the 
marketplaces well. We do inspections to enhance our enforcement 
activities.
    We were pleased we were able to take that action swiftly 
and aggressively to protect true and authentic maple syrup from 
Vermont.
    Senator Leahy. Thank you, Mr. Chairman.
    Senator Moran. You are certainly welcome. It is nice to see 
the Senator from Vermont parochially protecting----
    Senator Leahy. First time a parochial interest has ever 
come up in my 40 years on this Committee.
    Senator Moran. All the rest of us are certainly reluctant 
to criticize that circumstance.

           STATUTORY ROLE OF THE FOOD AND DRUG ADMINISTRATION

    Commissioner, let me ask first, one of the areas that I 
have focused some attention on in my time on the Appropriations 
Committee, and Senator Blunt is now the chairman of the Labor, 
Health, and Education Appropriations Subcommittee, but what is 
the formal statutory as well as informal relationship between 
the Centers for Disease Control (CDC), the National Institutes 
of Health (NIH), the Department of Health and Human Services 
(HHS), how does FDA statutorily and otherwise relate to the 
healthcare issues, the health issues, associated with those 
other agencies?
    Dr. Hamburg. We are one of the agencies of the Public 
Health Service, and we are part of the Department of Health and 
Human Services. I report to the Secretary of Health and Human 
Services. Many of the authorities that I have as FDA 
Commissioner derive through authorities given to the Secretary.
    Certainly, we work very closely with our partners in the 
Public Health Service. There are many issues of overlapping 
concern, whether it is food safety and the infectious disease 
work that NIH does, the outbreak investigation work that CDC 
does, and the product oversight that we do. We work together as 
a team or in response to an emerging public health crisis like 
Ebola, where we all have important roles to play in order to 
support an effective and meaningful public health response.

                           DIETARY GUIDELINES

    Senator Moran. Let me ask about one or two of those arenas. 
In regard to dietary guidelines, what role will FDA have in 
advising the Department of Health and Human Services?
    Dr. Hamburg. For the dietary guidelines, at least as I 
understand it, it is a process that ultimately involves 
decisionmaking that is coordinated between the Secretary of 
Health and Human Services and the Secretary of the Department 
of Agriculture, USDA.
    FDA does play a role in reviewing reports and information 
that goes into the final determinations, and we of course bring 
our science based approaches to our recommendations in terms of 
nutrition science and health.
    Senator Moran. What is the status of that process now at 
the Department of Health and Human Services and your role?
    Dr. Hamburg. I believe there is a report that is currently 
under review that was developed by a group of outside 
scientific experts, and we like other components of HHS have 
been asked to review that report and make comments for the 
Secretary.

                     EBOLA EMERGENCY APPROPRIATIONS

    Senator Moran. You mentioned Ebola, one that the Centers 
for Disease Control as well as NIH was actively engaged in. 
Congress appropriated additional money to the FDA to expedite 
and develop the availability of medical products related to 
Ebola.
    Can you bring us up to date on the status? What approval 
process success have we had in the effort to combat Ebola?
    Dr. Hamburg. The FDA has been very actively involved in 
responding to Ebola. We are not quite as visible. We are not 
the front page news on the response to the Ebola crisis, but we 
have played a very meaningful role in terms of both trying to 
make unapproved medical products available as needed for 
diagnosis or treatment of individuals at risk for disease or 
with disease.
    Importantly, also working with our scientific colleagues to 
really put in place the systems for scientific evaluation and 
research so that we can actually learn what works and what does 
not in terms of new treatments and vaccines that may have a 
very important role in this continuing outbreak, but will be 
absolutely crucial to have when there is a future epidemic.
    Sadly, by the nature of this disease, there almost 
certainly will be future problems with Ebola in Africa, and 
perhaps in other places.
    We also have a role in monitoring for fraudulent products 
and fraudulent claims. Sadly, in the Ebola situation as we have 
seen in other public health crises, there are people that 
readily jumped to the opportunity to try to sell products that 
offer hope but no proven value, so we also are taking action 
against some fraudulent products in the marketplace.
    Senator Moran. Commissioner, can you point to changes in 
process, in other words, expediting the process to get medical 
approval accomplished? What has happened since Congress gave 
the supplemental appropriations to FDA that is different today 
than it would have otherwise been?
    Dr. Hamburg. Congress has been beneficial in our ability to 
respond in a number of ways, certainly the supplemental funds 
that were given for Ebola will make a significant difference. 
As yet, those funds have not been expended. We have responded 
pulling from other resources, but those dollars are going to be 
very meaningful in our overall program.
    Authorities that Congress has given us at earlier points 
have also made a difference. The emergency use authorization 
(EUA), for example, that was part of the Pandemic and All 
Hazards Preparedness Act (PAHPA) legislation, has enabled us in 
this context and in other settings to be able to make as yet 
unapproved diagnostics available so that better assessments of 
patients and their needs can be made.
    In response to Ebola, we have done a significant number of 
EUAs, making those products available, and certainly some of 
the flexibility in terms of regulatory pathways that Congress 
has given us has enabled us to move more swiftly.
    Senator Moran. Thank you. Let me now turn to the ranking 
member, Senator Merkley.

                       TOBACCO DEEMING REGULATION

    Senator Merkley. Thank you very much, Mr. Chair. Thank you 
for your testimony, Dr. Hamburg. It will not surprise you that 
I want to start by addressing the rules controlling the 
regulation of tobacco products.
    It was 2009 when the United States, Congress, and the 
President passed legislation giving FDA the power to regulate 
these products. We are now in 2015, 6 years later. We do have a 
draft deeming rule out, and comments have been turned in. At 
last count, I understand the goal is to have a final deeming 
rule out by June.
    Can you give us assurances that we are going to have this 
rule by June, 6 years since the legislation was passed?
    Dr. Hamburg. I can tell you that it is my strong commitment 
and that of the team at the FDA--we are shooting very hard for 
that June timeframe. We feel this is an absolutely essential 
regulation that is foundational for many other aspects of our 
ability to meaningfully regulate tobacco products that are in 
the marketplace and may be in the marketplace in the future.
    I share your deep interest in this and can assure you of 
the commitment of our agency. We did, as I think you know, get 
an enormous number of comments on the deeming rule when we did 
the proposed reg. I think it was more than 135,000. Some of 
them were duplicative, I will say. Serious comments.
    We are systematically going through. We knew we would get a 
lot of comments. We geared up for that, and we do not feel that 
will be an impediment to meeting our tentative, and publicly 
indicated the goal in terms of what was put forward in the 
unified agenda of June 2015.
    Senator Merkley. Can you give us some sense as to whether 
the final rules will prevent the tobacco industry from selling 
candy-flavored products?
    Dr. Hamburg. You know, I cannot comment on what is in a 
rule that is still in formulation.
    Senator Merkley. Do you think it would be a good idea for 
the final rule to include----
    Dr. Hamburg. Let me say this is an area of intense focus 
and concern. One of the things that I would like to highlight 
in terms of FDA activities that I think are really a 
contribution has to do with the research that we are actually 
supporting through our tobacco program to better understand 
some of these issues about the influence of different aspects 
of tobacco products on behavior and use, initiation and 
succession, and also looking at subpopulations who may be using 
tobacco products differently.
    We are investing in some very targeted research activities 
in different key areas, and also a first of its kind major 
longitudinal study that we are doing in collaboration with NIH 
that will give us very important insights, and the data for 
regulatory decisionmaking that will be so crucial, so that when 
we make regulations in key areas, they will be based on good 
strong science that will meet the public health needs and also 
be able to survive potential litigation, which we know in this 
arena can often come.

                              E-CIGARETTES

    Senator Merkley. Thank you for all that work. During this 
timeframe, these years that have been passing, many, many new 
products targeted at children have come forward. New 
technologies have come forward with the E-cigarettes.
    We are finding that children are finding easy access to E-
cigarettes. Just to give you an example, I know we anticipate 
the deeming regulations will require minimum age and i.d. 
restrictions to limit access to children, but a study funded by 
the National Cancer Institute published at the beginning of 
this month showed that getting E-cigarettes online by children 
is quite easy, specifically found that only 5 of 98 attempts by 
teens to buy E-cigarettes online were blocked by online vendor 
attempts to verify customer age.
    CDC has also reported the rate of teens who reported using 
E-cigarettes has doubled just between 2011 and 2012. My 
understanding is that is continuing to grow very rapidly 
between 2012 and now.
    What this means is while this vacuum exists, and I must say 
when products are labeled after things like flavored gummy 
bears and double dutch chocolate, so on and so forth, the 
targeting for children is quite obvious, and certainly it is 
well understood that addiction to nicotine occurs in your 
teenage years, that addiction rarely occurs after the age of 
21.
    It is obvious why this is being done. This has tremendous, 
huge health implications for our youth. This is why we are 
expecting FDA to act as if every person in the agency has a 
child who might be affected by the ulterious effects of 
nicotine addiction.
    It has been a little bit of a sense by many of us here in 
Congress, and you know the phrase, ``While Nero fiddled, Rome 
burned.'' While the FDA is fiddling around with trying to get 
everything perfect, a tremendous number of our children become 
addicted to products deliberately targeted at them.
    It is in your power to act. If there is any way to convey a 
sense of urgency that just seems to be missing over the last 
now 6 years on your way out, as you wrap up, it would be so 
important to the health of this Nation.
    Dr. Hamburg. I can tell you we do have a sense of urgency. 
We do understand this is a historic opportunity to transform 
the oversight of these products and to really bring science 
based public health regulation to bear.
    We feel the same sense of urgency you do to get the deeming 
rule completed because that is the foundation for some of the 
other important actions that you are talking about. We do feel 
that while deeming is one key aspect of what we are doing, we 
also are making enormous strides forward in other key ways, 
including limiting access of cigarettes and the other products 
specified in the Family Smoking Prevention and Tobacco Control 
Act to children, targeting also an educational campaign at 
youth.
    As you know, much of life-long smoking begins in young 
people. I think sadly you can get addicted to nicotine at any 
age, but it is certainly the pattern with smoking that if you 
start smoking young, you are more likely to continue into 
adulthood with all of the attendant and preventable health 
consequences.
    I can assure you that terrific important work is going to 
continue to come out of our Center for Tobacco Products. It is 
a commitment that extends across the whole agency in terms of 
its priority. We certainly hear your concerns and want to work 
with you going forward.
    Senator Merkley. Thank you very much, Doctor.
    Senator Moran. The Senator from Missouri, Senator Blunt.

                             MENU LABELING

    Senator Blunt. Thank you, Chairman. I look forward to 
working with you and your leadership on this subcommittee. I 
have been on this subcommittee as you have, since we came to 
the Senate. I find it a very encouraging subcommittee to be 
part of. Certainly, Senator Pryor did a great job of leading 
the subcommittee the last 2 years, and I would hope that you 
and Senator Merkley have the same positive relationship that 
Senator Pryor and I had as we sat in the two seats that you are 
in now.
    Commissioner Hamburg, while we have not agreed on 
everything you have done, I think the country has benefited 
from the great capacity, energy, and judgment you have brought 
to this job. I am glad you have been willing to stay as long as 
you have. I am sure there are lots of other opportunities out 
there, and you will soon find out just how good they are, and I 
hope they are good.
    One of the things I have often said in your leadership 
here, one of the great things you have been able to do is be so 
knowledgeable in so many areas, that when there was something 
you did not know, you did not hesitate to say I really do not 
know and I will find out, which only verified the many things 
that you did know.
    Thanks for the work you have done. Good luck in what you 
will do next.
    Senator Moran has already brought up menu labeling, a topic 
that you and I have spent a lot of time and energy talking 
about over the last several years. I know it is an assignment 
that took a lot more time than anybody would have ever 
imagined.
    I am not going to give you time to respond to it today 
because we could quickly lose the 3 minutes and 29 seconds I 
have left.
    I do have a series of questions for the record that I am 
hearing and Senator Moran is hearing, others. What is 
restaurant type food, what is food on display, what is a 
standard menu item. There are a number of questions and I have 
about 15 of them here in front of me that we will ask you and 
your staff to deal with, not only for the benefit of the 
committee, but for all the people that currently believe 
without those questions being answered quickly, they cannot 
comply by the end of this year with what the Department is 
asking them to comply with.

                      MOBILE MEDICAL APPLICATIONS

    Senator Blunt. In terms of the new technology out there, I 
think one of the challenges for the Acting Commissioner and 
then the full-time Commissioner will be how to deal with 
everything that is happening and Smartphone technology as a 
shorthand way to discuss the many things that are going to be 
out there that will be quickly improved and improvable, and 
more and more affordable, unless we needlessly stand in the way 
of that.
    I think you are leaving a discussion in place that is a 
helpful one about at what point does FDA need to be involved 
and at what point does FDA not need to be involved.
    I would hope that discussion goes on where we really try to 
figure out what kinds of things have life threatening impact 
and what kinds of things are just simply helpful for you and 
others to know about your daily health that can be monitored 
quickly in ways that it has not been before. That is certainly 
something as a member of this subcommittee I continue to be 
looking at.

                             GENERIC DRUGS

    A couple of quick questions. One, on generic drugs, while I 
think under your leadership, the approval of new drugs has 
gotten quicker. The approval of generic drugs has gotten 
slower. I think we are up to the point now where we have gone 
from 30 months in 2011 to 42 months in 2014.
    I want to talk a little about what we can do to make that 
move from the more expensive drug to the generic drug happen 
more quickly than it is happening now, or at least as quickly 
as it used to happen.
    Dr. Hamburg. I am not aware of those numbers you are 
citing. I will have to go back. As you say, if I do not know, I 
will say so. In fact, we have been making a major push in the 
generic drug area. It is true we have had unacceptable backlogs 
in approval times.
    As part of FDASIA and the user fee negotiations, for the 
first time in that process, we actually worked with the generic 
drug industry to develop a user fee program so we could get 
more adequate resources to do the job both in reviewing drug 
applications and in addressing the backlog.
    We have expanded the program. We have made great progress 
in addressing the backlog. One of the challenges with generic 
drugs, which as you note are so important in terms of people 
having access to important medical care, and they now represent 
a very, very large proportion of spending on prescription 
drugs, but many of the generic drugs that are used in this 
country are actually manufactured overseas.
    There is also additional complexity in our approval process 
of the need to do inspections of the facilities before 
approval, and the additional time and costs of the 
international component.
    The fact that we have now this user fee program in place, 
which has measurable goals and performance measures that are 
transparent and monitored by industry and other stakeholders, I 
think you are going to see enormous progress. I think we have 
made enormous progress.
    We have addressed 72 percent of the existing backlog that 
was in place at the time that the Prescription Drug User Fee 
Act (PDUFA) and FDASIA went into effect.
    I think you will be pleased by the progress that has been 
made and will continue to be made.
    Senator Blunt. Just one follow up on that, Mr. Chairman. I 
am told there are 4,000 applications pending.
    Dr. Hamburg. That was the backlog at the time that FDASIA 
was----
    Senator Blunt. What do you think the pending number today 
is?
    Dr. Hamburg. As I said, I understand we have cleared/
addressed 72 percent of that backlog.
    Senator Blunt. I assume other people are applying. What has 
been added to that number?
    Dr. Hamburg. Our commitment in the PDUFA process, the 
generic drug user fee process, was that by 2017, we would have 
eliminated all backlog, existing and from incoming.
    Senator Blunt. You believe you will?
    Dr. Hamburg. I do believe that we will.
    [The information follows:]

    Answer. Based on the volume of generic applications received in 
previous years, the Generic Drug User Fee Act (GDUFA) [program] assumed 
that the Food and Drug Administration (FDA) would receive approximately 
750 original abbreviated new drug applications (ANDAs) per fiscal year. 
In fact, we received significantly more in the first 2 years of GDUFA: 
almost a third more applications in fiscal year 2013; and double the 
expected number in fiscal year 2014.
    Approximately 3,300 original ANDAs are currently pending with the 
agency while 700 are pending with industry.
    We are determined to make significant progress in reducing these 
numbers over the next few years and achieving GDUFA performance goals.

    Senator Blunt. Thank you, Chairman, for letting me follow 
up.
    Senator Moran. To the Senator from Montana, I do not think 
I ever served on a committee in the Senate that we have not 
been together on, and here you are again. I just want you to 
know that this subcommittee is going to be very actively 
engaged, and you are going to have plenty of opportunities to 
spend your time fulfilling the senatorial responsibilities as 
compared to anything outside of the United States Senate.

                              FOOD SAFETY

    Senator Tester. I appreciate that because as you and I both 
know, you coming from Kansas and myself coming from Montana, 
and especially the way I look, food is pretty damn important, 
okay.
    We thank you for your leadership, Mr. Chairman, and Ranking 
Member Merkley.
    Just out of curiosity, do you know where you are going to 
land when you leave?
    Dr. Hamburg. No, I made my decision to step down 
independent of future opportunities. I am going to rest, relax, 
regroup, and then decide. I suspect that I will still be 
involved in many of the kinds of issues that I have dealt with 
at FDA.
    Senator Tester. We wish you the best. I have a question 
here that deals with food safety research. The Center for Food 
Safety and Applied Nutrition is within your purview; correct?
    Dr. Hamburg. Correct.
    Senator Tester. I have a list. I think this came from you 
guys. It shows about $4.5 million in risk analysts and 
evaluation. I would assume you are talking about the budget 
partially for the Center for Food Safety?
    Dr. Hamburg. Which number are you referring to?
    Senator Tester. I was just wondering how much money, just 
to cut to the chase, how much money is dedicated towards the 
Center for Food Safety and Applied Nutrition out of this 
budget?
    Dr. Hamburg. I am going to look to one of my helpers here.
    Senator Tester. That is perfectly all right.
    Dr. Hamburg. You want the Center for Food Safety and 
Nutrition?
    Senator Tester. Yes, I want to know how much money they 
have to work with.
    Dr. Hamburg. $1.2 billion.
    Senator Tester. $1.2 billion?
    Dr. Hamburg. You are interested in research specifically?
    Senator Tester. Yes. My understanding is in research, you 
are doing your research to find out what will kill you and what 
will keep you healthy.
    Dr. Hamburg. Yes. We cut up the budget in so many different 
ways.
    Senator Tester. Can you get back to me on that?
    Dr. Hamburg. Yes.
    [The information follows:]

    Answer. $1.2 billion is the total fiscal year 2015 food safety 
funding amount. In fiscal year 2016 the total food safety request is 
$1.5 billion. Of the total fiscal year 2016 request, $355 million in 
budget authority and user fees is for the Center for Food Safety and 
Applied Nutrition (CFSAN). This is an increase of $74.5 million over 
fiscal year 2015 enacted. CFSAN provides services to consumers, 
domestic and foreign industry and other outside groups regarding field 
programs; scientific analysis and support; and policy, planning and 
handling of critical issues related to food and cosmetics.
    The $4.5 million for risk analytics and evaluation in the fiscal 
year 2016 President's budget request would support the development of 
new tools for ranking risks, prioritizing program activities across the 
FDA Foods and Veterinary Medicine Program based on opportunities to 
reduce risk, and linking risk-based priorities more clearly with budget 
formulation and execution. These tools, for example, will better inform 
FDA about which foods, including animal foods, are most vulnerable to 
which bacterial contaminants, and where it should invest its research 
efforts to most effectively identify how to reduce contamination of 
food.

    Senator Tester. That is a very critical component to the 
FDA's job. I do not know that you can tell somebody that they 
can or cannot put an ingredient into food or into cosmetics or 
into medicine unless you know what it is going to do.
    I am curious to know how much that line item is.
    Dr. Hamburg. Can I also add that I am really delighted that 
we have a new Director for the Center for Food Safety and 
Nutrition who brings a strong science and research background, 
Dr. Susan Mayne, who is here somewhere. There she is.
    One of my goals before I step down was to make sure that we 
had the right leadership. That research activity is so 
essential to what we do.

                            FOOD INSPECTIONS

    Senator Tester. Very important. I want to touch on one 
thing, if you want to talk parochial, we will talk really 
parochial. That is how do you train your inspectors that are in 
the field? Do you hire them and then just send them out or do 
they go through training on how to interpret the rules that 
they have to apply to the individuals on the ground?
    Dr. Hamburg. No, they are hired, looking for certain 
fundamental credentials, and then they are trained, and 
training, of course, is an ongoing process, and certainly in a 
world where there is greater specialization, that training is 
increasingly important.
    Senator Tester. The point I am going to get to is you have 
a set of rules. Most people in business can read. Then if an 
inspector comes out and interprets those rules different than 
what they are, it really ping pongs that--call them 
``producer'' or whatever you might want to call them.
    The question is what is done to hold the inspectors 
accountable? I am all about inspectors doing their job, but I 
want to make sure they do their job correctly, as the rule 
applies.
    Dr. Hamburg. Absolutely. The work of the inspectors is then 
overseen by a management structure, and there are many decision 
makers before enforcement actions are actually taken. There is 
considerable oversight of the inspection activities, but one 
thing----
    Senator Tester. Just a second, and sorry for cutting you 
off, we only have about 5 minutes. If an inspector comes out 
and the producer feels that those rules are being interpreted 
in a way different than what they are printed, what is their 
recourse?
    Say a manufacturer is manufacturing widgets, and the 
inspector comes out and says no, you cannot do this because the 
rules say you cannot do it, and you read the rules, and the 
rules do not say you cannot do it. What is that widget 
producer's recourse?
    Dr. Hamburg. To engage with us in a discussion. After the 
inspection is done, there is a report, and that report is gone 
over with the product sponsor and can be questioned.
    Senator Tester. But the question is how do you notify, how 
does that producer of those widgets know who to get a hold of? 
They are dealing with the inspector. There is a conflict of the 
way the rule was implemented. Is there somebody--are they told 
of somebody within the agency that if there is a conflict here, 
you get a hold of so and so and they can help remedy it? Do you 
see what I am saying?
    Dr. Hamburg. Yes. There is a system and people do know how 
to get in touch with us, believe me.
    Senator Tester. The people who are regulated know how to 
get in touch with you?
    Dr. Hamburg. I think one of our goals over the course of 
the last few years has been to try to increase transparency and 
communication to make it easier and to clarify our rules and 
expectations.
    One of the reasons we are asking for money in this budget 
for FSMA is to be able to train our inspectors to new systems 
and provide the proper oversight, and----
    Senator Tester. Right. Excuse me for going over time a 
little bit, Mr. Chairman. One of the reasons I want to give you 
money is to make sure that those inspectors are trained and 
make sure there is the kind of outreach that is going on.
    What I do not want to do is give you money if that outreach 
does not happen and if that inspector training does not happen.
    My question to you is when it comes to outreach to folks 
who are on the ground, you need to regulate them, the people 
you are regulating, how do you do that outreach? You have some 
additional dollars for outreach in this budget. How do you do 
that outreach and where is it focused?
    Dr. Hamburg. The outreach, particularly as we have been 
working on FSMA, has been really very extensive. We do it by 
working with both the larger organizations that represent the 
different food producers and farmers, and also doing regional 
meetings and on farm visits, et cetera.
    I think while there is a huge need to continue those 
efforts and extend them, I think we have laid a groundwork as 
we have worked on the FSMA rules for what is a real 
partnership.
    We want to extend the work with State and local partners, 
and that is part of what is in this budget request, to actually 
give money to counterparts at the State and local level to help 
do some of that on the ground work.
    Senator Tester. Appreciate it. Thank you, Mr. Chairman. I 
would just say I want you to be able to do your job, but I also 
want you to be able to do it in a way that meets the needs of 
the consumer and meets the needs of the business community out 
there, too. Thank you very much, and I do appreciate your work 
very, very much.
    Dr. Hamburg. Thank you.
    Senator Tester. Thank you, Mr. Chairman.
    Senator Moran. Senator Daines. Welcome.

                           DIETARY GUIDELINES

    Senator Daines. Thank you, Mr. Chairman. You are surrounded 
by Montanans here this morning. You have John Tester, myself, 
from both corners of Montana.
    I spent 12 years working for Procter & Gamble, and I used 
to work a lot with the FDA. I really appreciate all the work 
that you do, and I think I have an understanding of the heavy 
lift that is entailed in your job every day.
    Thank you for coming to this subcommittee hearing today. As 
you know, Montana is a large producer in ag, it is our number 
one industry, $5 billion a year. Maintaining a high-quality 
food supply is of paramount importance for our producers.
    In Montana, agriculture plays an important role in the 
diets of Montanans, for Americans across the country, and even 
around the world.
    The question I had really relates to some of the dietary 
guidelines, and specifically in the fiscal year 2015 omnibus, 
there was a congressional directive that expressed concern that 
the advisory committee was ``Showing an interest in 
incorporating environmental factors into their criteria,'' and 
directed the Secretary to include ``Only nutrition and dietary 
information, not extraneous factors'' in the final guidelines.
    As you know, the scientific report of the 2015 Dietary 
Guidelines Advisory Committee was just released last month. It 
included, and I quote, ``Environmental approaches are needed to 
compliment individual based efforts to improve diet and reduce 
obesity and other diet related diseases.''
    The question I have is do you think the advisory committee 
report is compliant with the congressional directive?
    Dr. Hamburg. Well, as I think you probably know, our role 
in this is not a direct one, but it is advisory to the 
Secretary of Health and Human Services in terms of reviewing 
materials, including the report you mentioned, that then become 
the basis for decisionmaking by the Secretary of HHS and the 
Secretary of the Department of Agriculture.
    Our role is really to provide feedback in terms of the 
science of nutrition and health. The broader issues that you 
were referring to, I think, were reflected in a report that was 
done by an outside group of scientists, but in terms of what we 
will be commenting on to the Secretary of Health and Human 
Services will be on nutrition science and health.
    My understanding is at the end of the day, the decisions 
that are made will really focus on the dietary guidelines that 
are science based.
    Senator Daines. Doctor, do you believe the environmental 
issues are within the purview of developing those dietary 
guidelines?
    Dr. Hamburg. Well, from the FDA's perspective, as I said, 
that is not something that we are looking at. My understanding 
is that the Secretary of Agriculture and the Secretary of 
Health and Human Services understand their role in terms of 
establishing the dietary guidelines.

                     FOOD SAFETY MODERNIZATION ACT

    Senator Daines. Okay. FSMA was brought up here a minute 
ago, I would like to talk about that for a moment. You 
highlighted the fact that the successful implementation of FSMA 
is essential to improving food safety.
    I have been hearing concerns from Montana ranchers and 
farmers across our State about the President's budget that is 
proposing to consolidate these food safety programs currently 
split between the USDA and HHS into a new agency entirely 
within HHS.
    They are concerned that an inevitable result of such a 
significant consolidation could negatively impact FSMA, and 
result in inspection delays and some logistical challenges.
    Why are you removing the USDA from the food inspection 
process?
    Dr. Hamburg. You know, I think what was in the President's 
proposed budget was really laying out the concept of trying to 
find more integrated ways of addressing a very important 
problem of food safety. It is fragmented, not just across USDA 
and FDA, but also many other agencies of Government.
    As you probably know, for a long time there have been 
discussions about should there be a consolidated approach that 
would really bring together different components and different 
agencies.
    For us, the need to implement FSMA takes a very high 
priority, and as we implement FSMA, we are trying to do it in 
coordination with USDA and other important players at the State 
and Federal level, and we think it is a process that is working 
very well, even though we are in different agencies or 
departments with different legal regulatory frameworks for our 
work.
    The on the ground ability to coordinate has been, I think, 
very successful, and we expect to build on that.
    Senator Daines. One of the concerns I am hearing from the 
ag community is the loss of expertise by removing the USDA from 
the food safety process. Do you have concerns? The USDA has 
some expertise unique to agriculture.
    Dr. Hamburg. Well, I think these two programs have 
historically worked quite well together, but they do have very 
different approaches and different legal regulatory frameworks 
and different targeted commodities in terms of the work that we 
do, and certainly different areas of expertise.
    As I noted, there are other components of Government that 
also bear on food safety. I think that it makes sense to look 
at how we can better coordinate, whether that requires creating 
a new single agency or whether there are more effective ways 
for coordination is, of course, a debate.
    Senator Daines. Yes, I think our ag folks are concerned 
about the subject matter expertise the USDA has brought to the 
ag portion of that, I guess that would be the voice coming from 
the ag community.
    Thank you. I am out of time, Mr. Chairman.

                             MENU LABELING

    Senator Moran. Thank you, Senator. We are going to have 
another round of questions, Commissioner. Thank you very much.
    I want to address menu labeling a bit more. My 
understanding is that the FDA has announced something they are 
calling guidance as of this morning in regard to this issue 
that Senator Blunt raised about the inability of many who may 
be or are regulated by FDA in menu labeling, their ability to 
actually know what to do between now and December.
    In cursory review of what FDA has said this morning in what 
they call guidance, it appears to us that it is simply 
restating things that have already been put before the public 
and before this subcommittee previously, and that no real 
benefit, no additional certainty or knowledge of what behavior 
needs to occur, what actions need to be taken, could be 
garnered by reading what you are calling guidance.
    Again, I would reiterate this issue about the scope of what 
you are asking many to do in menu labeling, and the significant 
costs it will take to comply with those requirements, and yet 
the uncertainty about if the business expends that money, 
whether they will really have met the regulations.
    Let me ask a couple of questions about individual or sector 
of the food industry concerns. One that comes to mind, and 
Kansas is a place, so I can be provincial this morning, Kansas 
is a place that originates Pizza Huts, pizza delivery.
    It is our understanding that the regulations do not allow 
the regulations to be satisfied by posting caloric values on 
the Internet despite the fact that is where most people 
apparently today order a pizza.
    In fact, the requirement is that the information be 
provided on the box that the pizza is delivered in, and that 
there are--I do not know what the number is--hundreds of 
different ingredients that you could order for your pizza, and 
the ability to label the caloric values on that pizza box for 
that specific pizza is an impracticality.
    Are those issues that you are aware of, addressing and 
understand the need for common sense, if anybody is going to be 
able to comply with the direction you are going, particularly 
in this setting in which it is not a restaurant?
    Dr. Hamburg. Well, the restaurant like establishments is 
clearly the hardest part of this equation. It was hard as we 
worked through what should be in the proposed rules, and as we 
went to finalizing, and now as we move towards implementation, 
and in particular, some of the foods on display as opposed to 
the more traditional preset menu kinds of situations.
    I think first we have to clarify just misinformation. The 
requirement you just mentioned for calories on the pizza box is 
not something that I have ever heard of, and I agree, it does 
not make sense. We have tried to be quite flexible, recognizing 
these new ways that foods get sold in our country, and the 
complexities.
    We have tried to address that, and a lot of time was spent 
on pizzas and the fact that you can have different toppings and 
arranging for ranges of calories and also recognizing that, at 
certain places, people order it over the Internet and not where 
there is a posted menu.
    Grocery stores is another area that I know Senator Blunt 
has been concerned about as well. We are working closely with 
that industry, with the broad FMI that represents many of the 
supermarkets, but also individual companies, to try to 
understand what the questions are.
    We have not put out guidance but we plan to propose some 
guidance or put out a framework to address some of these areas 
that are more confusing, particularly the food on display.
    Our goal in doing this is to not disrupt practices or add 
unnecessary burden. We want to be able to have a smooth and 
efficient implementation of this and work with the components 
of industry as needed to make that possible.
    To clarify as explicitly as we can where the problems are 
and what needs to be done is our goal, and we are underway 
trying to achieve that, but there is more work to be done.
    Senator Moran. My understanding about something called 
guidance being issued by the FDA today on this topic, is that 
inaccurate?
    Dr. Hamburg. I am not sure what that would be referring to. 
It was a plain language summary of the rule for small 
businesses, so an effort to try to clarify what is in the rule 
and what is not.
    Senator Moran. More guidance to come, more actual guidance.
    Dr. Hamburg. Yes.
    Senator Moran. The rule does not require the labeling of a 
box of pizza for the number of calories based upon the 
ingredients included in the pizza?
    Dr. Hamburg. Not to the best of my knowledge and belief, 
no.
    Senator Moran. Well, obviously there is uncertainty about 
the direction that a business must go to comply with the 
regulations, and what you described to me as your goal is a 
good thing.
    What it brings to my mind is that getting us from this 
point to the certainty by December seems pretty far stretched 
to me, and a delay in the final implementation or the final 
effect of the rule is something you should consider.
    Dr. Hamburg. There clearly is more work to be done. The 
discussion we have just had, I think, underscores that there is 
still considerable confusion about what is actually in the rule 
and need to spell that out more explicitly, addressing the 
individual concerns of companies and the industry more broadly, 
and really narrowing in on some of these areas that are just 
harder to address and more confusing as we go from the issuance 
of the final rule to the actual implementation.
    Senator Moran. Do you believe that FDA has the discretion 
whether to include food delivery services, the pizza delivery 
and the grocery stores, the salad bar at the grocery store--
that was a FDA decision to include, not a legislative 
requirement?
    Dr. Hamburg. I believe the salad bar issue was actually 
explicitly in the law, but we were asked to look at restaurants 
and restaurant like establishments, because the fact is that 
the world we live in no longer revolves around traditional 
restaurants, but there are many, many settings where you can 
get prepared food intended for individual consumption at that 
site or immediately thereafter, and the law did ask us to look 
at that broader range.
    Senator Moran. Let me now turn to Senator Merkley.

                       IRRIGATION WATER STANDARDS

    Senator Merkley. Thank you very much. There is a camp song 
that has a stanza of ``I lika pizza, I lika pie, I don't like 
onion in my eye.'' I will use that as a transition to talk 
about onions.
    We have a lot of onions growing in Oregon, and in the 
effort to provide guidelines for the Food Safety Modernization 
Act, part of that is related to the water that is used in 
irrigation. My onion growers have been very concerned about 
this. The initial standard was that the water had to meet 
recreational water standards.
    Would it be fair to summarize that is roughly equivalent to 
whether a lake is safe to swim in? Is that a fair 
representation of that?
    Dr. Hamburg. Yes.
    Senator Merkley. It is largely expected that irrigation 
water for onions would never meet that standard. The water is 
precious. It is used to irrigate. It is recollected. It is 
reused. It goes from irrigation ditch to the field, back to the 
irrigation ditch.
    The feedback, there has now been an exemption granted or at 
least I think this is in the next version of the rule, that if 
irrigation water has not been put on a crop for 7 days before 
it is harvested, then they are exempted from having to meet 
that standard. Is that a fair way to represent it?
    Dr. Hamburg. Well, I think what I can say is that we heard 
very clearly that some of what was put forward in the original 
proposed rule would impose a lot of restrictions that would not 
meaningfully improve public health and safety, and would 
produce burdens.
    We listened to that. We rethought. We looked at what did 
the data tell us. We did a supplemental to that proposed 
rulemaking in order to put forward a new model and approach, 
and we are confident that as these proposed rules move to 
final, that the concerns that you and the onion growers have 
had will be addressed.
    I would say there have been other areas where we have 
learned about concerns, have looked at it in terms of what does 
the data tell us, where is the evidence, what is the impact on 
health, and we have tried to learn from what we have heard, to 
accommodate, to try to achieve the least burdensome approach to 
meaningful rulemaking that will address the goals of FSMA, 
which is to improve food safety and actually support a vibrant 
successful food industry.
    Senator Merkley. Great. I think that is the least 
burdensome approach, and certainly appropriate. If you look at 
this often, I hold a town hall in every county every year and I 
get a lot of feedback. The onion growers have come out to talk 
about this issue. They have been very concerned.
    Here is where they start the conversation, there is not a 
single known case of E. coli contamination linked to an onion 
bulb product in America. I believe that is correct. Is it, to 
the best of your knowledge as well?
    Dr. Hamburg. To the best of my knowledge.
    Senator Merkley. The reason is because of the way these 
onion bulbs are harvested, whatever E. coli might be there 
dies. The product has a continual drying period before it gets 
to the grocery store shelf. Outer layers of the onion are 
peeled.
    For all these reasons, that is why it has not occurred. 
There has been an impact from green onions from Mexico that are 
harvested in a completely different way.
    I think they appreciate very much that they have been 
heard, and I appreciate very much they have been heard, because 
having something that creates a substantial burden without 
having any public safety is the sort of thing that just drives 
people nuts.
    When people complain about regulations, I say well, give me 
specific examples, and this is a very specific example. I 
believe it is anticipated that they are still going to be asked 
to test their irrigation water every week and report.
    I will continue the conversation with the FDA, but if you 
know in advance the irrigation water is never going to meet 
that test, and if you know in advance you are going to be 
exempted from having to meet that test, maybe that is also an 
unnecessary burden on the industry, and maybe there is another 
way to approach it that does not require the expense and 
complexity of testing and reporting, especially when at the end 
of the process, they are going to be exempted.
    Can I just encourage the FDA to continue to take a look at 
that?
    Dr. Hamburg. Yes. I think that we have tried to make this a 
process where we can learn from the real world experience, look 
at the data and the evidence, and look at the impact on public 
health. That is, I think, the goals we all share, to ensure 
that we have a safe, high quality food supply, and that we do 
not overly burden farmers and producers in the process.
    Senator Merkley. Just to close with this specific question 
because my time has run out, can you encourage me as you are 
leaving the FDA to continue to look at whether the testing 
requirement under this set of circumstances is still overly 
burdensome?
    Dr. Hamburg. Yes. In the case of the onion growers, there 
is the issue of being able to demonstrate bacterial die off. 
When it sits, as you said, baking in the sun. Those are 
important factors in terms of what would be required.
    It is challenging because number one, there are lots and 
lots of different food commodities and they all have very 
specialized issues and concerns as we have learned in the 
process of doing this. I can tell you I have learned a whole 
lot more about food, farming production, and consumer 
preferences as well.
    This will be a dynamic process also as we learn more and 
unexpected things happen as well. We do not see when we 
complete this rulemaking and implementation of FSMA that we are 
done with food safety forever because we have to continue to 
bring new, better science and technology to the process, but 
our process is that new and better science and technology will 
actually improve and modernize and streamline some of what 
needs to be done and provide better monitoring and oversight of 
our Nation's food supply.
    Senator Merkley. Thank you.
    Senator Moran. The Senator from North Dakota.

                        EXPANDED ACCESS REQUEST

    Senator Hoeven. Thank you, Mr. Chairman. I would like to 
thank all of you for being here today.
    Dr. Hamburg, I would like to address my question to you. As 
you are aware, we have a family in North Dakota that is 
struggling with pantothenate kinase-associated 
neurodegeneration (PKAN). They have youngsters in the family 
that are struggling with PKAN. They made a compassionate use 
application to FDA for use of the drug, RE024. You and I have 
spoken about this before. The family continues to try to gain 
compassionate use access to this drug.
    I am wondering what you can tell me in terms of helping 
make that happen.
    Dr. Hamburg. You know, I have not received an update on the 
status of that. I know you and I have talked, and certainly I 
can go back and look at the specifics of that instance.
    As you know, in terms of requests for expanded access, when 
requests come to us, we generally, I think 99 percent of the 
time, actually support the applications of the healthcare 
provider working with families.
    There were some specific issues in this case, the fact that 
we generally are very supportive, and in this case, there were 
some concerns. I cannot really speak to the status or the 
specifics.
    Senator Hoeven. As of our last meeting, at least one of the 
issues was FDA wanting the manufacturer to do some additional 
work, make an additional investment in some of the research on 
the drug, and we were asking if you would work with the company 
to do that, and also we were appealing to the company directly 
to do it as well, so they could reach an agreement with you in 
order to allow the compassionate use for the family.
    I would ask that you check on that.
    Dr. Hamburg. I do remember that discussion and we needed 
the company's permission to be able to share more information 
with the family and healthcare provider, and with you.
    Senator Hoeven. Right.
    Dr. Hamburg. I do not know--I know our lawyers spoke with 
the company. Perhaps the company decided that they did not want 
that information shared. I will go back and learn more.
    Senator Hoeven. I would ask that you update us on that 
status and anything else you can do. Would you be willing to do 
that?
    Dr. Hamburg. I would be.
    [The information follows:]

    Answer. I will be happy to follow up with you in a letter, so as to 
avoid disclosure and privacy issues.

                           RIGHT TO TRY LAWS

    Senator Hoeven. The second thing is in our State, our 
legislative session is underway. They are considering passing a 
``right to try'' law. I think you are familiar with ``right to 
try'' laws that a number of States have now passed, which would 
perhaps afford an opportunity for this family to go directly to 
the manufacturer under a contractual arrangement and gain 
access to the drug.
    I just want your reaction to how you would handle that if 
in fact North Dakota is able to pass that ``right to try'' 
legislation, and then how would you approach that, how would 
you be able to facilitate that option for the family?
    Dr. Hamburg. Well, we do feel that we play a valuable role 
in the process. At the end of the day, it is the company that 
has to make the decision to make the product available through 
an expanded access process.
    In many instances, I can tell you that the FDA has played a 
very constructive role in encouraging the company to in fact 
make the decision to do so, and in some instances, we may have 
additional information that can help inform the decisionmaking 
about whether this is the right action to be taken.
    We feel that we play an important role in the system that 
enables patients to get access to unapproved drugs outside of a 
clinical trial process when they have a serious or life-
threatening condition, but we know many States have been 
looking at the notion of expanded access, and I do not know the 
specifics of what is happening in your State.
    From my perspective, I would say that the FDA actually is 
an important partner and makes many contributions to what 
ultimately will serve the patient best.
    Senator Hoeven. If the State proceeds with the ``right to 
try'' law, you would be willing to help with that process?
    Dr. Hamburg. As I said, I do not know anything about the 
specifics in your State. We certainly would be happy to provide 
technical assistance or input on aspects, but what I wanted to 
really emphasize is that we do believe that if you look at 
experience, FDA is not the barrier to access in the vast, vast 
majority of cases, and that in fact we do play a valuable role 
and can provide important information, and often support and 
almost a form of advocacy for the expanded access program.
    Senator Hoeven. I am asking for your help on both of those 
options. You are willing to do that?
    Dr. Hamburg. Yes.
    Senator Hoeven. You are willing to provide help for both of 
those options if we can make one of them work? That is what I 
am asking.
    Dr. Hamburg. I am willing to work with you to try to better 
clarify the expanded access program to provide expert input in 
terms of what might be under consideration, and certainly FDA 
is very eager to be helpful in expanded access cases.
    We actually just recently re-did the paperwork for expanded 
access requests to come to us, and it was actually described in 
one newspaper article as a ``breathtaking effort to diminish 
bureaucratic red tape.''
    We have been very hard to make this program clearer and 
more accessible and to help get patients and their healthcare 
providers access when it is appropriate.
    Senator Hoeven. Thank you.
    Senator Moran. Just a couple more questions, Commissioner. 
We will do one more round, although I will submit most of my 
questions for you to answer for the record.

                      MOBILE MEDICAL APPLICATIONS

    Senator Moran. Let me just ask quickly about digital health 
devices. The FDA has issued guidance that it does not intend to 
enforce compliance with the standard regulatory controls for 
medical devices. Let me make sure that my premise is true, 
unlike my last question. That is true?
    Dr. Hamburg. We have stated, I think, very clearly and put 
forth a number of documents and reports indicating that we want 
to take a risk-based approach. We have no need to be involved 
in the regulatory oversight of the full range of mobile medical 
apps that are coming into the marketplace, many of which can 
provide a great deal of important information to individuals 
about their health status.
    We really want to focus on the mobile medical apps where 
there is a very important diagnostic or medical device activity 
that really bears on medical decisions, medical interventions, 
and can have serious implications for health.
    It is not the platform, but it is the function, and we want 
to focus on the high risk.
    Senator Moran. Is there any more certainty that can be 
provided so that we do not stifle innovation in this arena? Can 
FDA make more clear what can be created, what can be innovated, 
without the threat of the regulatory burden?
    Dr. Hamburg. I think as you know this is sort of an area of 
a great deal of new activity really exploding in many ways, and 
a lot of companies that previously had not been working with 
the FDA in terms of regulatory oversight as well.
    We are trying very hard in a timely way to put out 
information in terms of our regulatory role and how we will 
undertake the oversight of these mobile medical apps.
    In addition, we have had a lot of public meetings, and will 
continue to do that, meetings with individual companies and 
stakeholders. I think it is going to be an ongoing process 
because there are misperceptions. People are very worried that 
we are going to be regulating products that we have no 
intention of providing that kind of regulatory oversight.
    We do want to focus on those higher risk products where 
important medical decisions may be made, and if it does not 
work, it is going to put the patient at risk, and if it was an 
EKG device in your doctor's office, it would be regulated by 
the FDA, and you would want it to be accurate so you would not 
have the wrong treatment. If it is an iPhone that is doing the 
same thing, you still want it to be accurate.
    I think there are a lot of good examples where it really 
matters. There are a lot of examples where we do not feel a 
need to step in and provide regulatory oversight because the 
implications of the procedure being undertaken, the function of 
that mobile medical app does not carry with it the same risks 
for patients and does not form the basis for the same kind of 
medical decisionmaking and action.

                  FOOD SAFETY MODERNIZATION ACT RULES

    Senator Moran. Will FDA be able to meet the court-ordered 
deadline on FSMA and its regulations?
    Dr. Hamburg. We are committed to that; yes.
    Senator Moran. Will the FDA be able to meet its deadline as 
ordered?
    Dr. Hamburg. Yes. This is something that is just enormously 
important, and we have been working very hard. The process took 
a little bit longer than we hoped in part because of the level 
of outreach that we have done, and we felt the responsibility 
to go back with the supplementals to get more feedback and 
clarify some of the areas that had been raised as concerns.
    Yes, we are on track to meet those goals, and we have been 
working closely with all of the components of the system that 
have to be part of that in terms of HHS and the White House 
review. We are all committed and determined to be successful.
    Senator Moran. Your budget, the administration's budget 
proposes substantial funding increases to modernize the food 
inspection system. We talked a little bit about that in other 
questions. Yet, this is considered transformational. FSMA is 
considered transformational.
    If it is transformational, is there something that we will 
spend less money on because we are doing things in a new way? 
If it is transformational, it seems to me it ought not always 
be that we need more money to transform. It ought to be we are 
spending less money over here doing things better and 
transforming to a better system that costs less.
    Dr. Hamburg. I think FSMA will be transformational in the 
sense of saving money and saving lives. We are shifting from a 
system that was reactive, waiting for problems to occur, and 
then trying to fix them after the fact, to one that will be 
preventive.
    It means we will prevent foodborne outbreaks. One in six 
Americans get ill from foodborne illness every year. There are 
$78 billion worth of preventable costs to the healthcare system 
because of foodborne illness, 3,000 deaths a year as well.
    The cost to industry, every time there is a recall, even if 
it is not your product, if it relates to your product, like 
there was a spinach and E. coli outbreak in California a number 
of years ago, it was one company, but the whole spinach 
industry was affected, and not just affected during the period 
of concern about the outbreak, but I am told it took years. It 
may not have even occurred that spinach purchasing went back up 
to the pre-outbreak levels.
    To be able to have a preventive approach, to be able to 
really enhance trust and confidence in the food supply, to 
prevent illness, to enhance the ability of industry to be able 
to excel in terms of food safety, the confidence of buyers and 
consumers in this country, and frankly, for trade and exports, 
all of that are going to be benefits of FSMA.
    We certainly appreciate what Congress did in giving us 
these new responsibilities and authorities, and I think it is 
going to make a lasting difference to the benefit of all.
    Senator Moran. Thank you.
    Senator Merkley.

                       FOOD SAFETY MODERNIZATION

    Senator Merkley. Thank you very much. I know it takes a lot 
of work to address the seven different categories and rules 
that are coming out in FSMA. There is a lot going on there in 
each one of those rules.
    I appreciate the enormous work that has gone in to 
realizing this vision for food safety.
    Back in 2009, there was a Salmonella outbreak in peanut 
butter, and 700 people became significantly ill, nine people 
died. Someone who almost died was a little 3-year-old boy named 
Jacob Hurley. This compelled his father, Peter, to become a 
major advocate of trying to tackle this challenge. I have had a 
number of conversations with Peter and his family in the course 
of the time we were considering this act.
    Now we are down the road to having this, as you put it, 
preventive approach rather than the reactive approach, which is 
exactly the right framing.
    What can I tell Peter and Jacob today about what will 
happen, using peanut butter as an example, making it much less 
likely for peanut butter to have a contamination that could 
cause an illness?
    Dr. Hamburg. Well, I think you can say that advocacy work 
has made a difference because FSMA was passed and it is now 
being implemented. We do need these additional resources now to 
actually go from what is being spelled out in a set of, I 
think, very thoughtful and responsible regs that have been 
developed, and actually seeing the difference on the ground.
    We need the money to make that happen, and I do not think 
while our budget authority request is bigger than you have seen 
before, that it is excessive in terms of what is needed.
    You may be aware at the time the law was passed, the 
Congressional Budget Office (CBO) estimated that it would take 
about $580 million over 5 years to implement FSMA 
appropriately. If we get the $109 million, we will be about 
halfway to what they thought we needed. We are trying to 
implement as efficiently as possible.
    We need to do a number of things. We need to modernize our 
inspections with training and education to reflect the needs of 
a preventive approach. We need to work with industry to really 
make sure they understand what is expected of us, the 
discussion I was having with Senator Tester and some of the 
others about the importance of the open communication and 
understanding and technical assistance.
    We need to work with our counterparts at the State level, 
and actually a significant amount of our ask, I think it is $32 
million, will be going to the States because they need to be 
working on the ground level to make sure this new approach is 
in place and working.
    We have to also address the international component, which 
is enormous and growing in terms of the foods that are coming 
in from other countries and countries with much less stringent 
oversight in terms of safety and quality, so we need to get the 
resources to implement the foreign supplier verification 
process, to be able to ensure an adequate number of foreign 
inspections, and to really make sure that both for consumer 
protection and to have a level playing field for domestic 
producers that the same standards and quality approach----
    Senator Merkley. I might just interrupt you here so I can 
follow up a little bit before I run out of time. Would it be 
appropriate for me to characterize it this way, going back to 
the peanut butter example, the way the ingredients are grown, 
the way they are harvested, the way they are processed, 
additional testing along the way, we are changing the systems, 
we are enhancing the testing all to create a system where the 
potential for contamination is absolutely minimized.
    Dr. Hamburg. Where the potential for contamination will be 
minimized and any problems we identify as swiftly as possible 
are addressed.
    Senator Merkley. Thank you.
    Senator Moran. Senator Merkley, thank you very much. 
Commissioner, thank you very much. Doctor, we wish you well. 
Thank you for your testimony. Thank you for your team's 
presence with us this morning.

                     ADDITIONAL COMMITTEE QUESTIONS

    For members of the subcommittee, any questions that you 
would like to submit for the record, and I will have several 
myself, should be turned in to subcommittee staff within 1 
week, which is Thursday, March 19, and we would appreciate if 
the FDA could respond to those questions within 4 weeks from 
that.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
               Questions Submitted by Senator Jerry Moran
    Question. Where is the FDA in the process of approving the 
backlogged applications for new sunscreen products?
    Answer. As required by the Sunscreen Innovation Act (SIA), FDA has 
completed several important steps in the review process for sunscreen 
active ingredient applications marketed for a material time and extent 
in other countries and determined eligible for review prior to 
enactment of the SIA. We have reviewed all eight pending sunscreen 
active ingredient applications, evaluated submitted data, and 
identified the missing information we need to determine that sunscreens 
containing each ingredient would be generally recognized as safe and 
effective. We have issued proposed orders outlining additional data 
needed in order to make a determination that each ingredient meets this 
standard.
    As outlined in the SIA, the data requested must be gathered and 
submitted to the FDA for evaluation before the agency can proceed to a 
final sunscreen order. We look forward to receiving and reviewing the 
data. The agency is committed to doing its best to continue to meet 
future deadlines under the SIA--and to provide American consumers with 
additional options for safe and effective sunscreen ingredients.
    Question. Shouldn't more focus and priority be placed on preventive 
care for skin cancer? Why are Americans having to wait so long for new 
sunscreen products?
    Answer. Americans currently have access to numerous sunscreen 
products. These include broad-spectrum products with an SPF value of 15 
or higher, which, if used as directed with other sun protection 
measures, decrease the risk of skin cancer and premature skin aging 
caused by the sun. As described in the preceding response, FDA is 
actively working to assure that sunscreens, including sunscreens that 
would contain the ingredients being evaluated under the SIA, provide 
safe and effective protection.
    Heightened concerns about the risk of skin cancer and premature 
aging have fundamentally altered consumers' use of sunscreen products 
over the past few decades. Americans once applied the products in 
modest amounts while at the beach or exercising during peak hours of 
summer sun exposure. In contrast today, Americans--young and old, fair-
skinned and not--now routinely spread on sunscreens all year round. A 
large increase in the amount and frequency of sunscreen exposure 
combined with advances in scientific understanding that some sunscreen 
ingredients may be absorbed into the bloodstream have raised safety 
concerns. Commercial marketing experience alone is inadequate to 
evaluate these concerns.
    The SIA does not relax the FDA's scientific standards for 
evaluating safety and effectiveness or the requirement that the agency 
have adequate data on which to base a generally recognized as safe and 
effective (GRAS/E) determination. FDA has proposed data requirements, 
unanimously supported by an Advisory Committee panel of independent 
scientific experts, to meet this standard. We look forward to receiving 
and reviewing industry data--and helping American consumers make 
informed decisions about these products.
    Question. The agency's tentative determination on partially 
hydrogenated oils represents a substantial shift from the current 
framework. Why did the FDA not undergo the customary rulemaking process 
and instead issue a determination?
    Answer. Our action conforms to FDA regulations which set forth a 
process by which the agency, on its own initiative or in response to a 
petition from an interested person, may determine that a substance is 
not GRAS. Specifically, title 21 of the CFR, section 170.38(b)(1), 
provides that FDA may initiate this process by issuing a notice in the 
Federal Register proposing to determine that a substance is not GRAS 
and is a food additive subject to section 409 of the FD&C Act. Section 
170.38(b)(2) requires the notice to include a period of 60 days for 
comment.
    Question. If the health concern is over trans fat, why focus on 
PHOs and not trans fat specifically?
    Answer. Partially hydrogenated oils (PHOs) are ingredients added to 
food to achieve specific technical effects, and are the primary dietary 
source of artificial trans fat in the United States.
    Question. Given that PHOs are used globally, the agency's 
determination could potentially impact trade compliance. Did the FDA 
consult Federal agencies with trade oversight before issuing this 
determination?
    Answer. FDA is charged with protecting the U.S. food supply, and 
applies its regulatory authorities to ensure that food, including all 
substances added to food, is safe. We believe our tentative 
determination complies with all relevant legal requirements. We further 
note that a number of other countries have already placed restrictions 
on the use of trans fat-containing ingredients, including Denmark, 
Austria, Hungary, and Switzerland. In addition, the European Commission 
is currently considering action on industrially produced trans fat in 
food.
    Question. This past December, Congress enacted legislation that 
gives the FDA authority to expediently add diseases to the Tropical 
Disease Priority Review Voucher Program to spur development of 
vaccinations for neglected diseases. Are you considering adding 
diseases to the program, and has FDA begun the work to make the 
additions?
    Answer. FDA is considering adding diseases to the list of tropical 
diseases in the Priority Review Voucher program. The legislation 
enacted last year expanded the voucher program to Ebola and streamlined 
the process for the agency to add other qualifying diseases, if it 
determines such additions are appropriate. We are working on these 
issues now.
    Question. Is Chagas disease under consideration?
    Answer. Yes, FDA is considering adding Chagas to the list of 
tropical diseases. Adding Chagas to the list was recommended by members 
of Congress and stakeholders attending a public meeting on tropical 
diseases that qualify for tropical disease vouchers.
    Question. How long will it take FDA to complete the process to add 
a new disease?
    Answer. While FDA cannot specify a particular timeframe for the 
designation process, the agency will follow this new, expedited process 
to make any changes as quickly as possible.
    Question. FDASIA was enacted by Congress 3 years ago and required 
FDA to issue new regulations for medical gases. Not only has there been 
no proposed rule, Congress has yet to receive the report that was due 
over a year ago. What is the status of the agency issuing these 
regulations?
    Answer. FDASIA requires FDA to:
  --Review current regulations regarding medical gases, obtain input 
        from medical gas manufacturers and other interested parties, 
        and determine if any changes are necessary.
  --Provide a report to the Senate Committee on Health, Education, 
        Labor and Pensions and the House Committee on Energy and 
        Commerce on its findings.
  --If changes are determined to be necessary, finalize such changes by 
        July 2016.
    As you note, the report to Congress is past due. We apologize for 
the delay and are working to complete and submit the report as soon as 
possible. We have sought and received comments from medical gas 
manufacturers and other interested stakeholders, and we have conducted 
an extensive review of the Federal drug regulations with regard to 
medical gases. We held a public meeting on this topic in December 2013. 
In addition, Dr. Janet Woodcock, the Director of FDA's Center for Drug 
Evaluation and Research, met with representatives of the medical gas 
industry in February 2014. Following this meeting, the Compressed Gas 
Association and the Gas and Welding Distributors Association submitted 
a joint revised set of proposed regulatory changes for FDA's 
consideration. We have completed our review of these proposed changes 
and are working to finalize and submit the Report to Congress.
    Question. Will the FDA have the final regulations in place by the 
January 9, 2016, deadline?
    Answer. FDASIA does not require regulation changes unless they are 
deemed necessary as a result of the regulation review. If changes are 
deemed necessary, section 1112 of FDASIA requires final regulations by 
July 9, 2016, 48 months after enactment of the act. We will do our best 
to meet the deadline.
    Question. As you know, CFSAN has for a number of years supported 
several Food Safety Centers of Excellence that help to support the food 
safety research needs of the FDA through basic research and various 
other tasks. The Committee has long been supportive of the work of 
these Centers. Can you please provide some background on Food Safety 
Center of Excellence funding for fiscal year 2015 and fiscal year 2016, 
and whether or not you can provide an increase in basic research 
support levels in fiscal year 2016?
    Answer. The FDA Food Safety Centers of Excellence (COEs) support 
critical collaboration between FDA and academic institutions to advance 
regulatory science through innovative research, education, and 
scientific exchanges.
    In fiscal year 2014 CFSAN awarded $11.025 million in funding to the 
COEs. While FDA intends to maintain strong support for these Centers, 
final decisions on precise funding amounts for fiscal years 2015 and 
2016 are still pending.
    Question. It is my understanding that the FDA requested authority 
from the Office of Management and Budget to conduct a study on the 
proposed changes to the Nutrition Facts Panel (NFP) related to consumer 
comprehension of an ``added sugars'' disclosure on the NFP in addition 
to ``sugars.'' Additionally, FDA published in the Federal Register on 
March 3, 2014, its plan to conduct a consumer study to better 
understand ``how consumers would comprehend and use this new 
information.'' Can you please provide me with the status of this study, 
the data produced to date, including the questions and responses 
specific to the declaration of added sugars on the Nutrition Facts 
label, and the FDA's plans and timing for making these results 
available to the public for comment?
    Answer. FDA has completed the study of consumer comprehension of an 
``added sugars'' disclosure on the NFP in addition to ``sugars.'' We 
are in the process of preparing a report summarizing the data from this 
study. We will make the report available to you and the public when it 
is complete.
    Question. About a month ago, the New York State Attorney General 
claimed that GNC and three other retailers were selling herbal products 
that did not contain the labeled ingredients. This caused and continues 
to cause quite a stir inasmuch as half of all Americans take 
supplements. The New York Attorney General's allegations were based on 
a series of tests known as DNA barcoding. DNA barcoding, I am told, is 
an inappropriate test for herbal extracts because the extraction 
process tends to destroy the DNA markers. I am also told that the U.S. 
Pharmacopeia and the FDA do not use this type of test to determine 
whether or not certain herbal extracts are present in a product. Can 
you confirm that, in fact, the FDA agrees that DNA barcoding is not an 
appropriate test for herbal extracts?
    Answer. Speaking generically, FDA does not use DNA sequencing for 
botanical authentication. The FDA's current research and development 
for DNA sequencing based methods for plants is focused on the 
development of a plant species DNA library and development of validated 
methods for identification of botanical materials.
    We are not privy to the details of methods employed during the NY 
Attorney General's investigation and, because of this, FDA has not 
stated whether DNA barcode testing is an appropriate test or 
examination for this investigation. Currently, if FDA were to use DNA 
methods on herbal extracts, we would use them in combination with 
established chemical or other acceptable methods historically used to 
verify the identity of these products. At this time, FDA does not use 
DNA sequencing by itself to analyze an herbal extract.
                                 ______
                                 
                Questions Submitted by Senator Roy Blunt
                              biosimilars
    Question. I want to state up front that I support the development 
and marketing of biosimilars. That is why I have been incredibly 
frustrated at the lack of transparency in the implementation process. 
The first approval should have been well understood and considered a 
real accomplishment. Instead, it has highlighted that all the policy 
and implementation questions we have been asking you to answer remain 
unanswered due to the lack of published guidance.
    Commissioner Hamburg, you stated at a hearing just last week before 
the House Appropriations Subcommittee that guidance on naming was 
coming soon. Two days after that hearing FDA approved the first 
biosimilar product, but we still don't have any guidance. Can you 
please share your exact timeline for publishing guidance?
    Answer. While the agency cannot provide a specific timeline for the 
release of any guidance, FDA continues to clarify our approach to 
implementation of the Biologics Price Competition and Innovation (BPCI) 
Act and provide guidance and information to assist biological product 
developers--sponsors/companies--with bringing biosimilar and 
interchangeable products to market.
    FDA has recently issued three final guidances:
  --Scientific Considerations in Demonstrating Biosimilarity to a 
        Reference Product
  --Quality Considerations in Demonstrating Biosimilarity of a 
        Therapeutic Protein Product to a Reference Product
  --Biosimilars: Questions and Answers Regarding Implementation of the 
        Biologics Price Competition and Innovation Act of 2009
    FDA has published the following draft guidances since 2012:
  --Clinical Pharmacology Data to Support a Demonstration of 
        Biosimilarity to a Reference Product
  --Reference Product Exclusivity for Biological Products Filed Under 
        Section 351(a) of the PHS Act
  --Formal Meetings Between the FDA and Biosimilar Biological Product 
        Sponsors or Applicants
  --Biosimilars: Additional Questions and Answers Regarding 
        Implementation of the BPCI Act of 2009
    The agency is continuing to review the comments received as we move 
forward in finalizing these draft guidances. In addition, FDA expects 
to issue draft guidance in 2015 on the following topics identified in 
CDER's Guidance Agenda:
  --Considerations in Demonstrating Interchangeability to a Reference 
        Product
  --Statistical Approaches to Evaluation of Analytical Similarity Data 
        to Support a Demonstration of Biosimilarity
  --Labeling for Biosimilar Biological Products
  --Nonproprietary Naming for Biological Products
    Question. Will the guidance document on naming address the 
confusion raised about labeling of biosimilars? Specifically, the label 
for the biosimilar product FDA approved on March 6 appears to 
contradict the agency's current draft labeling guidance. Does FDA still 
believe that health professionals should have a label that includes all 
the information necessary to make prescribing decisions, including a 
statement that a product is a biosimilar and whether a product has been 
determined to be interchangeable? The label for the product you just 
approved does neither.
    Answer. FDA believes that healthcare professionals should have 
product labeling that includes the essential scientific information 
necessary to make informed prescribing decisions for their patients. 
FDA expects to issue draft guidance on labeling for biosimilar products 
in 2015. The public will be provided with an opportunity to comment on 
this draft guidance when it is published.
    Question. Further, given the lack of clarity on the question of 
extrapolation in the product's label, when exactly is the guidance on 
that topic expected? How will physicians know which indications were 
actually researched and validated for the biosimilar?
    Answer. FDA undertakes a rigorous and thorough evaluation to ensure 
that a biosimilar product meets the statutory and regulatory standards 
for approval and has been determined to be safe and effective under the 
conditions of use described in approved product labeling. Approval of a 
biosimilar product is based on review of evidence that may include 
structural and functional characterization, animal study data, human 
pharmacokinetic and pharmacodynamics data, clinical immunogenicity 
data, and other clinical safety and effectiveness data that 
demonstrates that the product is highly similar to the reference 
product (notwithstanding minor differences in clinically inactive 
components) and that there are no clinically meaningful differences 
between the biosimilar product and the reference product in terms of 
safety, purity, and potency.
    Additionally, a biosimilar application must include information 
demonstrating, among other things, that the proposed biosimilar has the 
same route(s) of administration, dosage form(s) and strength(s) as the 
reference product, and that the condition(s) of use for the proposed 
biosimilar have been previously approved for the reference product. To 
determine which indications have been approved for a biosimilar 
product, healthcare professionals are advised to review the labeling--
prescribing information--of the biosimilar product.
    FDA has issued final guidances, ``Scientific Considerations in 
Demonstrating Biosimilarity to a Reference Product,'' and 
``Biosimilars: Questions and Answers [Q&A] Regarding Implementation of 
the Biologics Price Competition and Innovation Act of 2009'' (Q&A 
I.11), describing the potential for a biosimilar applicant to 
extrapolate data derived from a clinical study sufficient to 
demonstrate safety, purity, and potency in an appropriate condition of 
use to one or more additional conditions of use for which licensure is 
requested and for which the reference product is licensed, if 
sufficient scientific justification is provided. FDA expects to issue 
draft guidance on labeling for biosimilar products in 2015. The public 
will be provided with an opportunity to comment on this draft guidance 
when it is published.
    Question. How does FDA intend to update the label for the product 
with respect to the name? I understand that it was approved with a 
``placeholder'' for the name. What does this mean and why did FDA 
proceed this way?
    Answer. The agency had an application for a biosimilar product that 
was ready for approval and designated a proper name with a 
distinguishing suffix for this product (filgrastim-sndz) on a product-
specific basis while continuing to consider broader policy issues 
regarding the nonproprietary names of biological products. Some Agency 
communications used the term ``placeholder'' to describe this 
nonproprietary name. That term was intended to indicate that FDA's 
designation of a nonproprietary name for this product should not be 
viewed as reflective of the agency's decision on a comprehensive naming 
policy for biosimilar and other biological products. FDA intends to 
issue draft guidance on how current and future biological products 
marketed in the United States should be named in the near future. If 
the filgrastim-sndz name is inconsistent with the naming policy FDA 
adopts for biological products, however, FDA would work with the 
applicant to minimize the impact that labeling changes would have on 
the manufacture and distribution of this product.
                            untitled letters
    Question. I understand that the FDA uses untitled letters to 
increase public accountability of firms, which may deter future 
violations and increase compliance with the law. However, it has come 
to my attention that the Center for Biologics Evaluation and Research 
(CBER) may be systematically using untitled letters as a means to 
reclassify tissue products instead of following protocol established in 
the Administrative Procedure Act.
    Prior to issuing each of the untitled letters, does FDA issue 
guidance or regulations which provided clarity regarding the 
classification of the product(s)? If so, please provide the key 
citations.
    Answer. CBER does not systematically use untitled letters as a 
means to reclassify tissue products instead of following the 
regulations that have been established under the Administrative 
Procedures Act.
    The requirements for FDA's regulation of human cells, tissues, and 
cellular and tissue-based products--HCT/Ps--are found in 21 CFR part 
1271. Subpart A contains general provisions, including the criteria 
that must be met in order for an HCT/P to be regulated solely under 
section 361 of the Public Health Service Act (PHS Act) (21 CFR 
1271.10). In accordance with 21 CFR 1271.20, if an HCT/P does not meet 
the criteria under 21 CFR 1271.10, it will be regulated as a drug, 
device, and/or biological product under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) and/or section 351 of the PHS Act. These 
regulations were finalized after a period of public notice and comment, 
consistent with the Administrative Procedures Act.
    As required by law, FDA publishes regulations in the Federal 
Register. FDA usually uses ``notice and comment rulemaking'' to issue 
regulations. The first public step in the notice and comment rulemaking 
process is for FDA to issue a proposed rule, which explains what we 
intend to require, and asks for public comment. Based on the comments, 
FDA will then decide to end the rulemaking process, issue a another 
proposed rule, or issue a final rule. The final rule preamble responds 
to comments on the proposed rule and explains the new regulatory 
requirements.
    FDA issues guidance documents, which describe the agency's 
interpretation of or policy on a specific regulatory issue. They do 
this by providing recommendations for meeting the criteria or 
requirements in regulations. 21 CFR 10.115(b). Guidance documents may 
relate to the processing, content, and evaluation of submissions as 
well as inspection and enforcement policies. In the context of HCT/Ps, 
it is anticipated that guidance documents will improve stakeholders' 
understanding of the definitions in part 1271.3 and how to apply the 
regulatory criterion in 21 CFR 1271.10.
    An untitled letter is an advisory action that cites violations that 
do not meet the threshold of regulatory significance for a warning 
letter. The format and content of an untitled letter should clearly 
distinguish it from a warning letter. For example, as discussed in the 
FDA's Regulatory Procedures Manual, untitled letters are not titled; do 
not include a warning statement that failure to take prompt correction 
may result in enforcement action; do not evoke a mandated district 
follow-up; and request (rather than require) a written response from 
the firm within a reasonable amount of time. They are issued to address 
inspectional findings or compliance issues at a specific firm.
    Here is a link to FDA's Regulatory Procedures Manual for the 
record: http://www.fda.gov/ICECI/ComplianceManuals/
RegulatoryProceduresManual/ucm176871.htm.
    Question. Do you currently have any policies and procedures related 
to how soon after you issue an untitled letter to a company you 
subsequently post it on your Web site? If not, are you considering such 
a policy?
    Answer. CBER's policy is to post all untitled letters on its Web 
site as soon as practicable after confirmation of receipt by recipient 
and a review of the letter prior to disclosure to include redaction of 
any trade secrets or confidential commercial information. CBER started 
posting these letters in 2002; this complies with the commitment made 
by the agency in the Transparency Initiative.
    Question. Do you currently have any policies or procedures related 
to the issuance of an untitled letter related to the appearance of the 
letter? For instance, do you require that all untitled letters issued 
to a company have the header ``Untitled Letter?''
    Answer. As described in the FDA's Regulatory Procedures Manual, 
chapter 4-2, untitled letters are not titled, and therefore do not have 
the header ``Untitled Letter'' on the letter. Here is the link to FDA's 
Regulatory Procedures Manual for the Record: http://www.fda.gov/ICECI/
ComplianceManuals/RegulatoryProceduresManual/ucm176871.htm.
    Question. For the untitled letters in question, were any issued to 
the company without the header ``Untitled Letter''? If so, when the 
letter was subsequently posted on your Web site, did it include such a 
header?
    Answer. Untitled letters are not titled, and therefore do not 
include the header, ``Untitled Letter.'' For clarity, and to 
distinguish them from warning letters, untitled letters are identified 
as such on CBER's Web site.
    Question. Prior to issuing each of the untitled letters, did you 
have any communications (formally or informally) with the company 
regarding the issue that was the subject of the untitled letter?
    Answer. If the untitled letter was issued subsequent to an 
establishment inspection, the FDA investigator may have informally 
discussed the situation, although they are not required to do so. An 
untitled letter can often be the initial communication with regulated 
industry concerning regulatory violations.
    Question. Prior to issuing each of the untitled letters, did you 
use alternative regulatory options to resolve questions related to 
product classification, which may include formal inquiries (whether via 
official correspondence or via telephone) or directed inspections with 
appropriately qualified inspectors?
    Answer. In determining whether to issue an untitled letter, FDA 
officials generally consider whether evidence shows that a firm, 
product, and/or individual is in violation of the law or regulations. 
Such evidence may have been obtained during a routine or directed 
inspection, or other means of surveillance, such as Internet Web site 
surveillance. Untitled letters are often used as an initial 
correspondence and can be an alternative to other regulatory options, 
such as a warning letter.
    Regarding jurisdictional questions, FDA's Tissue Reference Group--
also known as the TRG--was created as specified in the ``Proposed 
Approach to the Regulation of Cellular and Tissue-based Products'' 
published by FDA in February 1997. The purpose of the TRG is to provide 
a single reference point for product specific questions received by FDA 
--either through the Centers, or from the Office of Combination 
Products (OCP)--concerning jurisdiction and applicable regulation of 
Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). 
FDA has publically posted information on how manufacturers can submit 
inquiries to the TRG, as well as publically disclosing TRG 
recommendations regarding HCT/P classification, on its Web site.
    Here is a link to FDA's Tissue Reference Group's Web site: http://
www.fda.gov/biologicsbloodvaccines/tissuetissueproducts/
regulationoftissues/ucm152857.htm.
    OCP issues classification and jurisdiction assignments for medical 
products. Classification and jurisdiction assignments can be made 
informally or formally. Informal assignment requests should be made by 
directly contacting OCP. Formal assignment requests can be made by 
submission of a Request for Designation Document, also known as RFD, to 
OCP.
    Here are links to the Office of Combination Products' 
Jurisdictional and RFD Information: http://www.fda.gov/
CombinationProducts/JurisdictionalInformation/default.htm and http://
www.fda.gov/CombinationProducts/RFDProcess/default.htm.
    Question. Subsequent to receiving an untitled letter, did any 
company request that you post a response to such letter? If so, did you 
post the response to the letter?
    Answer. FDA policies and procedures do not currently include the 
posting on the Internet of manufacturers' responses to FDA's untitled 
letters. CBER has only rarely received a request to post the response 
to an untitled letter and declined to do so. However, a company is 
always able to post information on its own Web site, including its 
response to the untitled letter and any other information in regards to 
addressing FDA's concerns.
    Question. Have you considered issuing formal ``close out'' letters, 
similar to what is done for warning letters?
    Answer. FDA policies and procedures do not currently call for 
issuing untitled letter close-out letters.
                       fda food safety activities
    Question. I have heard from many organizations that are requesting 
appropriate funding for FDA's food safety activities in fiscal year 
2016 and continue to oppose the proposed industry user fees, which have 
been repeatedly rejected by Congress, to pay for food safety 
activities. Commissioner Hamburg, do you still believe the user fees 
are necessary and do the user fees have industry and political support?
    Answer. In fiscal year 2016, FDA has requested an increase of 
$301.2 million to support its FSMA implementation efforts. The request 
includes a net increase of $109.5 million in Budget Authority and 
$191.8 million in User Fees. The total request is critical to ensure 
full implementation of FSMA. FDA continues to work with its 
stakeholders to build support for the proposed food safety User Fees. 
However, FDA is most concerned with having an appropriate level of 
funding for successful implementation, not the funding source.
                                 ______
                                 
             Questions Submitted by Senator Mitch McConnell
    Question. I submitted five questions for the record last year, but 
never received a response from your agency on a single question. Why 
has nearly a year gone by without a response from your agency?
    Answer. FDA did not receive questions for the record from 
Appropriations subcommittee staff last year. While we were not aware of 
your questions, we are happy to answer them this year or in a briefing 
or letter.
    Question. Prescription drug abuse remains a serious problem in my 
home State of Kentucky where more than 80 Kentuckians die each month as 
a result of this epidemic. In fact, the demand for opiates has led to a 
heroin epidemic in Northern Kentucky, and heroin overdoses caused 61 
deaths in this part of the State in 2012. Approving drugs with abuse-
deterrent features is one tool among many available to FDA to help 
prevent prescription drug abuse. While much attention has been given to 
abuse-deterrent formulations for extended-release, long-acting opioids, 
what steps has FDA taken to encourage the development of these 
formulations in immediate release opiates? Furthermore, what is the 
rationale behind FDA's decision not to require a Risk Evaluation and 
Mitigation Strategy (REMS) for immediate release opioids?
    Answer. The FDA looks forward to a future in which most or all 
opioid analgesic medications--not just extended-release/long-acting 
(ER/LA) opioids products--are available in formulations that are less 
susceptible to abuse than the formulations that are on the market 
today. While ER/LA opioid analgesics typically contain larger amounts 
of drug and therefore carry a higher risk for overdose and death, abuse 
of immediate-release (IR) products is also a significant concern.
    FDA plans to finalize guidance on the evaluation and labeling of 
all abuse deterrent opioid formulations, both IR and ER/LA, in the near 
future. The guidance--based, in part, on comments received during a 
public meeting held to discuss the development, assessment, and 
regulation of such products--will suggest the types of studies that 
should be conducted to demonstrate that a given opioid formulation has 
abuse-deterrent properties. The guidance will also discuss the 
evaluation of those studies and the labeling that may be approved based 
on the results.
    FDA's focus on incentivizing development and use of all opioid drug 
products with abuse-deterrent features has significantly increased 
interest in producing these products. Some 30 investigational new drug 
applications (INDs) have been submitted by manufacturers seeking to 
conduct clinical trials on potentially abuse-deterrent products. FDA is 
working with drug makers to advance the science of abuse deterrence and 
navigate the regulatory path to market as quickly as possible. 
Companies are exploring promising alternatives to currently marketed 
abuse-deterrent formulations in an innovative array of scientific 
techniques and approaches.
    Additionally, abuse-deterrent opioid products, both IR and ER, may 
be eligible for one or more of FDA's expedited review and approval 
programs, including fast track designation and priority review 
timelines, if they meet applicable criteria.
    ER/LA opioid analgesics typically contain higher doses of opioids 
than IR opioids or opioid/non-opioid combinations products because they 
are intended to release the drug over a longer period of time. As a 
result, ER/LA opioid analgesics may be more desirable to individuals 
who misuse or abuse opioids--and pose a greater risk of fatality in the 
event of an overdose. These concerns informed the FDA's decision to 
require the ER/LA Opioid Analgesics REMS.
    FDA has received a citizen petition asking the agency to require IR 
opioids to include labeling changes that parallel those required of ER/
LA opioid analgesics. The agency is in the process of reviewing and 
responding to that petition. If the agency determines that a REMS is 
necessary to ensure that the benefits of IR opioid analgesics outweigh 
the risks, we will take appropriate action.
    Question. In a statement you released last year, strengthening 
surveillance efforts at FDA to actively monitor the prescription drug 
abuse epidemic and emerging trends was identified as a priority action 
item for the agency. It is my understanding that FDA has various 
surveillance methods either in place or in the pilot phase to monitor 
post-marketing safety issues. Will you please explain all of the post-
marketing surveillance efforts underway at FDA related to prescription 
drug abuse, including if and how the Sentinel program will be used to 
support surveillance efforts related to prescription drug abuse trends? 
What other agencies is FDA coordinating with on surveillance efforts, 
and how is that coordination being implemented?
    Answer. FDA actively monitors adverse event and medication error 
reports submitted by pharmaceutical manufacturers and the general 
public (e.g., doctors, nurses, patients, and family members of 
patients) through the FDA Adverse Event Reporting System (FAERS). 
FAERS, a key component of postmarketing surveillance, helps to identify 
new drug safety issues that were not observed during the clinical 
trials that served as the basis for drug approval. FDA safety 
evaluators regularly screen FAERS reports.
    To supplement surveillance efforts, FDA has required new 
postmarketing studies for all ER/LA opioids. These studies will help to 
better assess the risks of misuse, abuse, addiction, overdose and death 
associated with long-term use of ER/LA opioids.
    The Sentinel Program is a vital tool in FDA's surveillance efforts. 
Sentinel utilizes administrative healthcare claims data from healthcare 
providers and facilities and may at some point help us to understand 
issues brought to medical attention by patients prescribed opioids, 
once the claims for events such as overdoses are appropriately 
validated. As part of the required safety studies, FDA is requiring 
manufacturers to validate administrative claims that may be indicative 
of opioid overdoses. We are hopeful that this effort will yield 
reliable algorithms that can be used more broadly in administrative 
claims data, like Sentinel, to study these types of outcomes of 
prescription opioid abuse.
    The agency is also collaborating in several efforts to collect more 
robust and comprehensive data on opioid abuse, including ER/LA opioid 
abuse. FDA is working with the National Center for Health Statistics at 
the Centers for Disease Control and Prevention (CDC) to obtain detailed 
national data on emergency department visits relating to drug abuse 
from hospitals participating in the new National Hospital Care Survey. 
FDA is also working with the National Electronic Injury Surveillance 
System--Cooperative Adverse Drug Event Surveillance Project (NEISS-
CADES) to expand the data collection and abstraction process to include 
abuse-related clinical encounters. In addition, the agency is leading 
an ongoing collaborative project with CDC to identify and quantify 
deaths related to specific drugs, including those due to overdoses 
caused by prescription opioid products. Finally, FDA is exploring ways 
to use data from State-based Prescription Drug Monitoring Programs to 
better understand prescribing and dispensing behaviors of controlled 
substances that play a role in the evaluation of prescription drug 
abuse.
    FDA is committed to making a difference in this epidemic. We 
continue to actively partner with others to implement the 
Administration's National Drug Control Strategy and Prescription Drug 
Abuse Prevention Plan--and reduce prescription drug misuse, abuse and 
addiction. FDA is also continuing its close participation in 
surveillance efforts through the Prescription Drug Abuse Subcommittee 
of the HHS Behavioral Health Coordinating Council.
    Question. As you know, FDA approval of innovator drugs that lack 
abuse-deterrent features is a major concern in my home State of 
Kentucky. Why has FDA refrained from granting an abuse-deterrent label 
to products that meet the requirements of abuse-deterrence under any 
one of tiers 1, 2 and 3 of the FDA Draft Guidance for Industry on 
Abuse-Deterrent Opioids? How does FDA recognize and communicate, or 
plan to recognize and communicate, that although a product may not have 
the ability to meet the requirements outlined under all the tiers 
listed in the FDA Draft Guidance for Industry on Abuse-Deterrent 
Opioids, it may still offer technology that makes the product more 
difficult to abuse than others?
    Answer. FDA has approved four ER/LA opioid analgesics with labeling 
describing the product's abuse-deterrent properties consistent with the 
draft guidance. They include: OxyContin; Targiniq ER; Embeda ER; and 
Hysingla ER.
    We have rejected abuse-deterrent claims for products when the data 
were insufficient to support such claims. FDA will approve labeling 
describing a product's abuse-deterrent properties when the data show 
that a product's abuse-deterrent properties can be expected to result, 
or actually have resulted, in a meaningful reduction in that product's 
abuse.
    We are still in the early stages of abuse-deterrent product 
development--the market has a small number of products using abuse-
deterrent technologies, and the agency is assessing each opioid drug 
product's safety and efficacy on a case-by-case basis. FDA expects 
these technologies to improve and expects products containing them 
(both innovator and generic) to become more widely used. FDA looks 
forward to a time, hopefully not so far in the future, when the 
majority of opioids are in effective, abuse-deterrent forms; forms that 
substantially reduce abuse, including by oral, intranasal, and 
intravenous routes.
    FDA hopes that the final guidance, to be released soon, will 
clarify abuse-deterrent labeling claims. Abuse-deterrent labeling will 
be approved for products. All abuse-deterrent labeled products can be 
expected to result, or will have actually resulted, in a meaningful 
reduction in that product's abuse.
    Question. The incidence of newborns suffering withdrawal has 
tripled throughout the country since 2000. To put this in perspective, 
in 2009, approximately one infant was born each hour showing signs of 
drug withdrawal. In Kentucky, this condition increased more than 2,400 
percent from 2000 to 2012. Babies suffering from drug dependence are 
more likely than other newborns to have complications such as low birth 
weight and respiratory complications, placing additional hurdles in 
place to becoming healthy and adding costs to the healthcare system. 
What activities is FDA involved in to address the rising number of 
babies being born dependent on opioids?
    Answer. The agency is also alarmed by the dramatic increase in the 
number of babies born with Neonatal Opioid Withdrawal Syndrome (NOWS) 
and recently augmented the labeling warnings about this risk for ER/LA 
opioid analgesics. Product labeling is FDA's primary tool to inform 
prescribers about approved uses of medications and to assist them in 
making the best decisions for their patients.
    For women with chronic pain, there are no analgesics that come 
without some risk to a developing fetus. Nonsteroidal anti-inflammatory 
drugs (NSAIDs) cannot be used during the third trimester. Other non-
opioid medications used for the treatment of pain also have risks.
    Given the risks associated with alternative products, opioid 
analgesics may be an appropriate treatment option during pregnancy. We 
are committed to providing the necessary information to prescribers and 
patients so that they may make informed decisions regarding appropriate 
use of these drugs during pregnancy.
    As noted above, FDA is also continuing its close participation in 
surveillance efforts through the Prescription Drug Abuse Subcommittee 
of the HHS Behavioral Health Coordinating Council.
    Question. Incidence of skin cancer continues to rise in the United 
States. One American dies every hour from melanoma, the deadliest form 
of skin cancer. We know that sun exposure is a high risk factor for 
melanoma and we know that using sunscreen effectively can reduce that 
risk. Yet, Americans still do not have access to sunscreen ingredients 
that have been on the market all over the world. To encourage the FDA 
to review the backlog of sunscreen applications that had been pending 
for more than a decade, Congress passed and I supported the Sunscreen 
Innovation Act, which was signed into law by President Obama last 
November. What steps are being taken by FDA to see that sunscreen 
ingredients that have been on the market and used safely all over the 
world are accessible to Americans?
    Answer. It is very important that consumers have access to safe and 
effective preventive skin care drug products. FDA is actively working 
to assure that sunscreens containing the ingredients being evaluated 
under the Sunscreen Innovation Act (SIA) provide such protection.
    As required by the SIA, FDA has completed several important steps 
in the review process for sunscreen active ingredient applications 
marketed for a material time and extent in other countries and 
determined eligible for review prior to enactment of the SIA. We have 
reviewed all eight pending sunscreen active ingredient applications, 
evaluated submitted data, and identified the missing information we 
need to determine that sunscreens containing each ingredient would be 
generally recognized as safe and effective. We have issued proposed 
orders outlining additional data needed in order to make a 
determination that each ingredient meets this standard.
    As outlined in the SIA, the data requested must be gathered and 
submitted to the FDA for evaluation before the agency can proceed to a 
Final Sunscreen Order. We look forward to receiving and reviewing the 
data. The agency is committed to doing its best to continue to meet 
future deadlines under the SIA--and to provide American consumers with 
additional options for safe and effective sunscreen ingredients.
    Heightened concerns about the risk of skin cancer and premature 
aging have fundamentally altered consumers' use of sunscreen products 
over the past few decades. Americans once applied the products in 
modest amounts while at the beach or exercising during peak hours of 
summer sun exposure. In contrast today, Americans--young and old, fair-
skinned and not--now routinely spread on sunscreens all year round.
    A significant increase in the amount and frequency of sunscreen 
exposure combined with advances in scientific understanding that some 
sunscreen ingredients may be absorbed into the bloodstream have raised 
safety concerns.
    The SIA does not relax FDA's scientific standards for evaluating 
safety and effectiveness or the requirement that the agency have 
adequate data on which to base a generally recognized as safe and 
effective (GRAS/E) determination. FDA has proposed data requirements, 
unanimously supported by an Advisory Committee panel of independent 
scientific experts, to meet this standard. We look forward to receiving 
and reviewing industry data--and helping American consumers make 
informed decisions about these products.
                                 ______
                                 
              Questions Submitted by Senator Steve Daines
    Question. Earlier this month, FDA took the significant step of 
approving the first biosimilar drug. It is disappointing, however, that 
important guidance is still not forthcoming from the agency on issues 
such as naming, interchangeability, and others. In fact, in the almost 
exactly 5 years since enactment of the biosimilars law, no final 
guidance on any biosimilars topic has come from FDA.
    What is the anticipated timeline for these important guidance 
documents, which are essential to encouraging and assisting companies 
to develop biosimilars that will benefit patients?
    Answer. While the agency cannot provide a specific timeline for the 
release of any guidance, FDA continues to clarify our approach to 
implementation of the BPCI Act and provide guidance and information to 
assist biological product developers--sponsors/companies--with bringing 
biosimilar and interchangeable products to market.
    FDA has recently issued three final guidances:
  --Scientific Considerations in Demonstrating Biosimilarity to a 
        Reference Product
  --Quality Considerations in Demonstrating Biosimilarity of a 
        Therapeutic Protein Product to a Reference Product
  --Biosimilars: Questions and Answers Regarding Implementation of the 
        Biologics Price Competition and Innovation Act of 2009
    FDA has published the following draft guidances since 2012:
  --Clinical Pharmacology Data to Support a Demonstration of 
        Biosimilarity to a Reference Product
  --Reference Product Exclusivity for Biological Products Filed Under 
        Section 351(a) of the PHS Act
  --Formal Meetings Between the FDA and Biosimilar Biological Product 
        Sponsors or Applicants
  --Biosimilars: Additional Questions and Answers Regarding 
        Implementation of the BPCI Act of 2009
    The agency is continuing to review the comments received as we move 
forward in finalizing these draft guidances. In addition, FDA expects 
to issue draft guidance in 2015 on the following topics identified in 
CDER's Guidance Agenda:
  --Considerations in Demonstrating Interchangeability to a Reference 
        Product
  --Statistical Approaches to Evaluation of Analytical Similarity Data 
        to Support a Demonstration of Biosimilarity
  --Labeling for Biosimilar Biological Products
  --Nonproprietary Naming for Biological Products
    Question. Within 30 days, please provide the subcommittee with a 
list of biosimilars guidance documents you expect to publish this 
calendar year. With respect to any draft biosimilars guidance, please 
indicate when you expect to make that guidance final.
    Answer. Please see the previous response.
                                 ______
                                 
              Questions Submitted by Senator Jeff Merkley
                  state inspection standards for fsma
    Question. The budget includes $32 million to train approximately 
1,000 State food safety inspectors, and to help the States implement 
real-time information sharing capacity with FDA. That comes out to 
training about 20 inspectors in each State, which isn't that many.
    What oversight will FDA provide to make certain that State 
inspections are up to FDA standards, and how will they monitor the 
States?
    Answer. For State inspections performed under FDA food inspection 
contracts, FDA will evaluate the contracted State agencies' overall 
performance throughout the contract period. Inspectional performance 
evaluation will include review of inspection reports, audit assessments 
and joint Federal/State inspections. State inspections will be 
collaboratively scheduled by the FDA district offices and each 
contracted State agency. In addition, there are 40 State-manufactured 
food regulatory programs enrolled in the Manufactured Food Regulatory 
Program Standards (MFRPS), which represents 89 percent of contracted 
inspections, which are used by the States as a guide for consistent, 
continuous improvement for State food manufacturing programs. MFRPS 
standards promote development of a high-quality State-manufactured food 
regulatory program and include a process for continuous improvement. 
The MFRPS are updated, when applicable, to facilitate compliance with 
new legislation, regulations, guidance, inspection programs, and agency 
rules as they are developed.
    Finally, FDA recognizes the need to establish training programs for 
Federal and State inspectors who will conduct inspections on behalf of 
FDA for the new FSMA regulations. The expected outcome of the 
evaluation is to ensure competency in the performance and quality of 
inspections regardless of the regulatory entity that performs such 
inspections.
                        imported food inspection
    Question. GAO recently published a report regarding FDA's foreign 
offices and made a couple of significant findings. The first was that 
FDA is not conducting nearly the number of foreign inspections as FSMA 
mandated. They conducted approximately 1,300 inspections in 2012, and 
plan to conduct only 1,200 in fiscal year 2015. FSMA mandated 600 
inspections in 2011, with a doubling of the previous years' inspection 
level for the following 5 years. The second finding was that 44 percent 
of foreign office positions were vacant as of October 2014.
    I understand that the FDA has indicated that they don't intend to 
fulfill the FSMA mandate, and don't necessarily believe that would be 
useful.
    However, how is FDA determining what the appropriate level of 
physical foreign inspections should be?
    Answer. Under the FDA Food Safety Modernization Act (FSMA), FDA was 
directed to inspect at least 600 foreign food facilities in 2011 and, 
for each of the next 5 years, to inspect twice the number of facilities 
inspected during the previous year. FSMA provides FDA a multi-faceted 
toolkit to better ensure the safety of imported food. This toolkit 
includes increased foreign inspections, as foreign inspections provide 
direct accountability for inspected firms, incentives for all foreign 
firms exporting to the United States to comply with U.S. requirements, 
and critical intelligence for FDA concerning foreign food safety 
practices. The toolkit also includes sharpening private sector 
accountability for import safety, leveraging private sector resources, 
and taking advantage of any resources and services the foreign 
governments can provide to elevate assurances that food imported into 
the United States meets FSMA's prevention-oriented standards and 
requirements.
    Foreign inspections are an important part of the new import safety 
system mandated by FSMA, but they cannot alone ensure comparable safety 
of imported and domestic food. FDA has been clear in its Report to 
Congress under section 110(a)(1) of FSMA that the agency does not 
anticipate going significantly beyond 1,200 foreign food facility 
inspections per year in the foreseeable future until after other parts 
of the new import safety system have been implemented. FDA's position 
is based on the enormity of the additional funding that would be needed 
to meet FSMA's foreign inspection goals, coupled with FDA's view that 
additional resources would be more effectively spent first on 
implementing tools in the FSMA import safety toolkit that leverage both 
FDA and private sector resources to ensure the safety of foods exported 
to the United States by foreign firms.
    FDA is committed to allocating its resources using a risk-based 
inspection model for the selection of firms and the number of firms per 
country. This risk-informed approach is based on the strategic 
allocation of programmatic resources by integrating in a systematic 
manner the relevant quantitative, qualitative, and deterministic public 
health safety factors to obtain a decision to select firms and 
countries. This approach better protects the safety of the U.S. food 
supply and gives the agency flexibility to adjust FDA resources 
effectively and efficiently as emerging issues arise.
    FDA Centers and Offices work collaboratively on an inspection work 
plan each year. For example, the FDA India Office works with ORA and 
CFSAN to develop a work plan for food facilities inspections in India. 
The FDA India Office provides information to FDA headquarters regarding 
high-risk facilities and high volume facilities that have not been 
inspected. The FDA India Office requests other food facilities 
inspections based on local intelligence, e.g. complaints, informants, 
local news, and other sources. In March 2015, FDA signed a memorandum 
of understanding with the Indian competent authority that has oversight 
of some food exports. The FDA India Office hopes to be able to leverage 
information from this authority to further target high-risk food 
facilities that export to the United States.
    Another example is from the FDA China Office. The FDA China Office 
develops a list of recommended firms for inspection to share with ORA 
and the Centers. Similar to the FDA India Office, the FDA China Office 
uses local intelligence to help select which firms should be included 
on the list in addition to those higher risk food facilities that have 
not had a previous inspection and are known to be active suppliers to 
the United States.
    FDA also is working diligently to fill vacancies within our foreign 
offices. In fact, since the time of the GAO report, FDA has already 
reduced the vacancy rate from 44 percent to 40 percent.
    Question. Since you aren't planning to fulfill the FSMA mandate, 
what is your plan?
    Answer. As discussed, FSMA provides FDA a multi-faceted toolkit to 
better ensure the safety of imported food. For example, the foreign 
supplier verification programs mandated by FSMA will be the foundation 
of a new system under which importers will take greater responsibility 
for ensuring that foreign manufacturers produce food in compliance with 
U.S. safety requirements. Another import-related program, the Voluntary 
Qualified Importer Program (VQIP), will make it easier for participants 
in the program to import items into the United States, based on 
demonstrated high-performance in food safety, and enable FDA to better 
focus its resources on potentially higher risk imports. FSMA also 
directs FDA to establish an accredited third-party audit program, under 
which third-party auditors can assure importers and FDA that foreign 
producers are using effective preventive controls. Final rules 
requiring foreign supplier verification programs and establishing the 
accredited third-party audit program are scheduled to publish this 
year.
    The agency is expanding its collaborations with foreign governments 
so that FDA can rely as appropriate on foreign government food safety 
programs and gain knowledge about the safety of foreign exports. This 
allows FDA to focus its own resources more efficiently.
    FDA's current focus with respect to foreign facility inspections is 
targeting them to achieve the greatest public health benefit. FDA's 
selection of foreign food facilities for inspection is based on an 
overall, cross-cutting risk profile. The primary factors contributing 
to a facility's risk profile include: (1) the food safety risk 
associated with the commodity (the type of food), (2) the manufacturing 
process, and (3) the compliance history of the facility, such as 
refusal rates for products that were denied entry into the United 
States. In addition, section 201 of FSMA requires FDA to identify high-
risk facilities and allocate resources to inspect facilities according 
to the known safety risks of the facilities, and includes several 
factors to consider when making that assessment.
    FDA is committed to reconfiguring import screening and field exam 
activities to complement oversight of FSMA's foreign supplier 
verification requirement and ensure that FDA is making strategic, risk-
based use of its import oversight resources. This initiative is 
documented in FDA's Operational Strategy for the Implementation of FSMA 
(http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm). FDA is 
also committed to building data integration and analysis systems to 
strengthen risk-based targeting of resources. As FDA moves forward with 
implementing the new FSMA toolkit for imports, FDA intends to monitor, 
analyze, and reconsider a host of factors, including the number of 
foreign inspections we conduct and how we target establishments. FDA 
will adjust its plan as necessary, and as funding permits, to further 
our public health mission. All of these activities will contribute to 
FDA's ability to ensure comparable safety of imported and domestic food 
and also rely on FDA receiving sufficient resources.
    Question. How has a vacancy rate that high affected the ability of 
the foreign offices to do their jobs, and how are you addressing this 
issue?
    Answer. As noted in the GAO report, FDA has undertaken efforts to 
improve staffing in its foreign posts but has experienced some 
challenges. For example, following expanded funding under the China 
Safety Initiative, FDA's China Office has been working extensively and 
over an extended period of time with Chinese counterparts to obtain 
visas for an increased number of FDA staff to be based in China. In a 
positive development, the FDA signed two Implementing Arrangements 
(IAs) with its Chinese counterparts in November and December 2014. The 
documents, signed with China's General Administration of Quality 
Supervision, Inspection and Quarantine (AQSIQ) and China's Food and 
Drug Administration (CFDA), frame the work of regulatory personnel 
posted in each country, outline the expectations of FDA and AQSIQ 
regarding inspections of food facilities, and detail the expectations 
of FDA and CFDA regarding inspections of drug facilities.
    As of May 2015, there are now 11 FDA FTEs in the FDA's Beijing, 
China Office. This includes an additional seven staff who have recently 
been issued visas and deployed to the China Office. We have one foods 
investigator who is preparing to deploy, but has not yet applied for 
her visa. We currently also have two drug investigators on short-term 
detail. The FDA China Office is actively recruiting staff to reduce the 
current vacancies and is working closely with FDA's Office of Human 
Resources (OHR). FDA continues to augment the staff in China with 
temporary duty details and foreign cadre inspections to complete its 
inspectional work plans in China.
    The FDA India Office also has faced recruitment challenges but is 
working to hire additional staff. At present, the FDA India Office has 
five positions filled, including two food investigators. The FDA India 
Office has set an inspection target for in-country investigators to 
ensure inspection performance expectations are met. For fiscal year 
2014, FDA India Office food inspections met work plan goals. Fiscal 
year 2015 inspectional targets are currently on track to meet 
expectations. FDA will conduct inspections with temporary duty details 
and foreign cadre inspectors until full staffing is achieved.
    More generally, to address some of the recruitment challenges for a 
foreign assignment, FDA's Office of International Programs has:
  --Developed continuous vacancy announcements for multiple geographic 
        sites to maximize the pool of applicants.
  --Developed an SOP for foreign post renewals and extensions to remove 
        obstacles to retaining staff.
  --Created interview panels that include relevant Center involvement 
        to promote the selection of subject matter experts 
        knowledgeable about Centers' programs.
  --Strengthened the OIP deployment process(es).
  --Created temporary details.
  --Made more strategic utilization of locally employed staff (LES) in 
        foreign posts.
  --Leveraged other U.S. Government agencies field deployment 
        processes/programs.
    Despite some challenges to recruit highly qualified investigators 
to our foreign offices, OIP has been successful in strengthening 
inspection capabilities in FDA's offices overseas. In the past year 
alone, FDA's foreign offices have increased the total number of 
inspections and expanded the countries in which foreign inspections are 
being conducted by in-country investigators and investigators on 60-120 
day detail assignments to foreign offices.
     fda office of regulatory affairs (field staff) reorganization
    Question. You started an initiative last year to reorganize your 
field staff in order to make them more specialized. The goal appears to 
be to have inspectors who are very focused on one type of inspection--
drug facility inspections, for example, instead of having inspectors 
who have to play many different roles. With the increasing complexity 
of drug and food manufacturing, as well as FSMA implementation, this 
seems like a good idea.
    Will this reorganization require additional funding and training? 
If so, how much?
    Answer. FDA is working to realign inspection and compliance staff 
and managers by program (e.g. food, pharmaceutical, etc.). Training is 
a critical component of enhancing specialization of FDA's inspectorate 
and ensuring the staff has the expertise and tools needed to keep pace 
with changing and advancing technology in the industries FDA regulates.
    As part of FDA's program alignment efforts, ORA is working with FDA 
Centers to evaluate current training programs, develop new and novel 
approaches for training staff, and work toward more collaborative 
training leveraging both Center and Field experts. FDA will train our 
staff, State partners, and educate industry on new regulations 
resulting from FSMA, FDASIA, and other recently enacted laws. At this 
time, however, it is unclear whether or not the agency will require any 
additional resources or training related to the realignment effort.
    Question. Do you anticipate hiring additional staff as part of this 
effort?
    Answer. It is too early to precisely predict the Office of 
Regulatory Affairs' (ORA's) future staff requirements, transitioning 
from a geographically based management model to a program-based 
management model, where investigations, compliance, and operational 
managers are aligned by program. ORA is comparing its current staffing 
level with the staffing needs for each program area. This information, 
along with data from each program's inventory, will be used to 
determine the gaps in staffing by program area. Once this gap analysis 
is complete, ORA will begin aligning staff to the new program 
management model and employ specific hiring requirements by program.
    Question. How will you make sure the inspection staff is properly 
allocated across the country?
    Answer. As FDA works to align inspection and compliance staff and 
managers, FDA is evaluating the current inventory of regulated firms 
across the country and across the globe. In the past decade, FDA has 
seen unparalleled growth of imported products which necessitates FDA to 
allocate staff across the United States based on domestic industry and 
at ports of entry and in foreign countries to ensure protection of the 
American public. FDA will align current staff not only by program but 
also by operational needs ensuring staff will be best positioned to 
inspect, examine, and collect samples of both domestic and imported 
products. In addition, FDA will target any inspectional hiring in those 
specialties and locations where there is a need.
                        electronic drug inserts
    Question. FDA recently published a rule requiring electronic-based 
labeling for healthcare providers, but there have been many concerns 
raised about them. The ag report last year actually included language 
directing FDA not to publish a rule that would require electronic 
labeling in lieu of paper inserts. Concerns raised include 
cybersecurity issues, a lack of access to the Internet in parts of 
rural America, and the loss of Internet access everywhere during a time 
of disaster. I understand that this rule only applies to healthcare 
providers and not packages provided directly to patients, but I believe 
these concerns are still valid.
    Why did FDA move forward on this rule, and will these issues be 
addressed in the final rule?
    Answer. On December 18, 2014, FDA issued a proposed rule entitled 
``Electronic Distribution of Prescribing Information for Human 
Prescription Drugs, Including Biological Products.'' We believe that 
this proposed rule addresses the Committee's concerns about the use of 
electronic labeling, while at the same time ensuring that the most up-
to-date prescribing information is available for use by healthcare 
providers.
    If finalized as proposed, this rule would generally require that 
prescribing information intended for healthcare professionals be 
distributed electronically, but also provide for continued access to 
prescribing information in paper format in a number of circumstances. 
For example, the proposed rule allows for drugs to be exempted from 
electronic-only distribution if electronic-only distribution could 
adversely affect the safety, effectiveness, purity, or potency of the 
drug; is not technologically feasible; or is otherwise inappropriate. 
Also, the proposed rule requires manufacturers to provide a toll-free 
telephone number that healthcare providers can call 24 hours a day, 7 
days a week to request a paper copy of the label.
    FDA would like to emphasize that this is a proposed rule, subject 
to notice-and-comment procedures. We granted a request to extend the 
comment period for 60 days, until May 18, 2015. FDA will consider all 
comments submitted in response to the proposal as we work to finalize 
the rule. We fully expect that the concerns you have raised will be 
addressed through that process.
                   food safety centers of excellence
    Question. As you know, CFSAN has for a number of years supported 
several Food Safety Centers of Excellence that help to support the food 
safety research needs of the FDA through basic research and various 
other tasks. The Committee has long been supportive of the work of 
these Centers.
    Can you please provide some background on Food Safety Center of 
Excellence funding for fiscal year 2015 and fiscal year 2016, and 
whether or not there will be an increase in basic research support 
levels in fiscal year 2016?
    Answer. The FDA Food Safety Centers of Excellence (COEs) support 
critical collaboration between FDA and academic institutions to advance 
regulatory science through innovative research, education, and 
scientific exchanges.
    In fiscal year 2014 CFSAN awarded $11.025 million in funding to the 
COEs. While FDA intends to maintain strong support for these Centers, 
final decisions on precise funding amounts for fiscal years 2015 and 
2016 are still pending.
                                 ______
                                 
            Questions Submitted by Senator Dianne Feinstein
             fda oversight of antibiotic use and resistance
    Question. Commissioner Hamburg, I am pleased to know that your 
agency expects drug companies to fully participate in the agency's 
policy for withdrawing growth-promoting uses of medically important 
antibiotics in food animals. To what extent does the agency expect this 
policy to reduce antibiotic use in agriculture? Does the agency have 
specific performance goals for this policy?
    Answer. FDA is confident that the changes outlined in Guidance for 
Industry (GFI) #213 will be fully implemented by the December 2016 
target date. These measures will significantly change how these drugs 
have been used for decades. Production uses of medically important 
antimicrobials will be eliminated as will over-the-counter access to 
the remaining therapeutic uses of these products in the feed or water 
of food-producing animals. In addition to tracking completion of these 
changes, FDA is enhancing data sources in a number of ways to help 
monitor the effects of GFI #213 over time. For example, FDA intends to 
publish a proposed regulation that would enhance the quality and 
utility of antimicrobial drug sales and distribution data it receives 
on antimicrobial drugs intended for use in food-producing animals by 
requiring reporting of such data by animal species. FDA is also working 
with State partners to perform whole genome sequencing on samples 
collected under the National Antimicrobial Resistance Monitoring System 
(NARMS), which will provide unprecedented data on the traits of 
resistant strains of foodborne bacteria from animals and animal-derived 
foods. Further, FDA is working with the Centers for Disease Control and 
Prevention (CDC) and the United States Department of Agriculture (USDA) 
to develop a plan for collecting additional data on antibiotic use and 
resistance to help provide a comprehensive, objective, and balanced 
summary assessment of antibiotic drug use and resistance in animal 
agriculture. FDA is continuing to work with USDA and CDC in developing 
this plan and expects to hold a public meeting in the summer of 2015 to 
obtain input from the public.
    Question. Commissioner Hamburg, I am concerned that some 
antibiotics approved for disease prevention or control do not have an 
explicitly defined duration or use or may be approved for use at a sub-
therapeutic dose. What steps is the agency going to take to ensure 
these antibiotics are not used inappropriately in agriculture?
    Answer. As FDA moves forward with implementing the changes outlined 
in Guidance for Industry (GFI) #213, FDA is also focusing on the 
remaining therapeutic uses of those products and evaluating whether 
additional improvements can be made to better align those uses with 
current antibiotic stewardship principles. For example, concerns have 
been raised about the use of medically important antibiotics for 
prevention purposes. FDA considers uses that are associated with the 
treatment, control, and prevention of specific diseases to be 
therapeutic uses that are important for assuring the health of food-
producing animals, but would not consider the administration of a drug 
to apparently healthy animals in the absence of any information that 
such animals were at risk of a specific disease to be judicious. In 
addition, when such uses of medically important antibiotics are deemed 
necessary, it is important that the duration of administration be 
appropriately limited. Therefore, as part of FDA's overall effort to 
ensure the judicious use of medically important antibiotics, FDA is 
currently developing a process and timeframe for evaluating and 
addressing that issue.
    Question. Commissioner Hamburg, I strongly support your agency's 
move to bring antibiotics under veterinary oversight. In your policy on 
judicious antibiotic use, you establish guidelines for veterinarians to 
consider when directing that an antibiotic be used for disease 
prevention, such as using antibiotics only for animals at risk of 
developing an infection and when no other reasonable alternatives 
exist. What steps is the agency going to take to ensure these 
guidelines are followed?
    Answer. In highlighting the importance of veterinary oversight of 
medically important antibiotics, FDA noted in Guidance for Industry 
(GFI) #213 that veterinarians in the course of their professional 
practice take into consideration a number of relevant factors for 
determining the risk of a specific bacterial disease and for 
determining whether the use of medically important antimicrobials for 
prevention purposes is appropriate in a particular situation. These 
factors include whether: (1) there is evidence of effectiveness; (2) 
such a preventive use is consistent with accepted veterinary practice; 
(3) the use is linked to a specific etiologic agent; (4) the use is 
appropriately targeted to animals at risk of developing a specific 
disease; and (5) no reasonable alternatives for intervention exist.
    A critical step that is being taken through implementation of GFI 
#213 is to change the over-the-counter (OTC) status of these products 
so that licensed veterinarians have an oversight responsibility and are 
in a position to ensure that factors such as those described above are 
taken into consideration. Once the feed use products are changed from 
OTC to Veterinary Feed Directive (VFD) status, veterinary authorization 
of these products must be done in compliance with the procedures 
described in the VFD regulation. In conjunction with implementing the 
updated VFD regulation, FDA intends to enhance its inspectional 
activities to ensure compliance with the VFD requirements. FDA is also 
directing resources towards education and training on the VFD process 
and on judicious use. FDA is also engaging veterinary and producer 
organizations in this issue, as they play a key role in veterinarians' 
practical application of judicious use principles at the farm level. 
FDA is very encouraged by the strong commitments organizations like the 
American Veterinary Medical Association have made to this effort.
    Question. Commissioner Hamburg, Congress provided an additional $3 
million for the National Antimicrobial Resistance Monitoring System 
(NARMS) in fiscal year 2015, and this increased funding level was 
requested in the fiscal year 2016 budget. Can you describe how your 
agency will use these increased funds to make critical improvements to 
NARMS, and how these improvements will allow it to collect 
statistically valid data on antibiotic resistance trends in foodborne 
pathogens and to identify more outbreaks involving antibiotic-resistant 
pathogens?
    Answer. FDA is using the extra funds to collect additional retail 
meat samples for the analysis of antimicrobial resistance and to 
implement advanced technologies in molecular characterization to 
improve microbial analysis.
    Prior to its receipt of the additional monies, NARMS was only able 
to sample approximately 6500 retail meats, resulting in the recovery of 
300-500 Salmonella isolates. This did not provide enough data for 
statistically valid analysis of antimicrobial resistance trends for 
most products. With the additional monies NARMS is working to increase 
the number of samples tested by the current participating laboratories 
and expand testing to include additional geographic areas not currently 
under surveillance. With these changes FDA will be able to collect 
enough Salmonella isolates to improve the statistical confidence around 
NARMS resistance trends, thereby making NARMS data more useful for 
regulatory decisionmaking. This enhancement also meets Sub-Objective 
2.4.1 of the White House's National Action Plan for Combating 
Antibiotic Resistant Bacteria, ``Enhance surveillance of antibiotic 
resistance in animal and zoonotic pathogens and commensal organisms by 
strengthening NARMS and leveraging other field- and laboratory-based 
surveillance systems.''
    The advent of whole genome sequencing (WGS) is poised to vastly 
improve the microbiology and epidemiology of infectious diseases. At 
relatively low costs, comprehensive genetic information can be gleaned 
in a short time. With the enhanced funding, NARMS has been able to 
continue efforts to implement WGS, as well as the information 
technology and bioinformatics infrastructure needed to sustain it, 
through the purchase of additional equipment, software, and reagents. 
Furthermore, NARMS now has the capacity to sequence all Salmonella 
isolates collected from retail meats from 2002 (the inception of the 
retail meat program) to present. By expanding the whole genome sequence 
database with retail meat isolates collected through NARMS, FDA will 
greatly improve the detection of foodborne outbreaks, the attribution 
of resistant infections, and research on the evolution and spread of 
resistant bacteria in the food supply, among other things. By the end 
of the year, NARMS will publish the sequence information and 
accompanying metadata for all retail Salmonella isolates tested through 
2014.
                                 ______
                                 
            Questions Submitted by Senator Patrick J. Leahy
                     food safety modernization act
    Question. The premium Vermont brand depends on adhering to the 
highest standards of quality and food safety. However, Vermont's 
diversified farms are very concerned that implementation of the Food 
Safety Modernization Act may crush them under a burden of fees, paper 
work, and poorly targeted and confusing rules. I appreciate that your 
food safety team, led by Mike Taylor, has visited Vermont several times 
and has listened many of my constituent's concerns, resulting in better 
rules, yet many questions still remain for our farmers and our State 
agencies.
    The budget request includes an increase of $109.5 million for a 
total of a total of $1.3 billion in budget authority for FSMA 
implementation. By your own estimate this leaves a gap of $166 million. 
I am worried that your budget falls short on the needs for your State 
partnerships, staff training, and education and technical assistance 
for producers and value added agriculture.
    With this gap and your current funding request, please explain to 
me how you are going to educate before you regulate?
    Answer. In addition to the increase of $109.5 million in Budget 
Authority, FDA has also proposed an additional $191.8 million in User 
Fees. Taken together, FDA believes this additional $301.2 million will 
allow FDA to fully implement FSMA.
    FDA intends to continue partnering with other Federal, State, and 
foreign government agencies and organizations; land grant universities 
and other academic institutions; produce farm and food industry 
associations; and food safety professional organizations during the 
implementation phase. We remain committed to increasing education and 
accessibility to technical assistance to foster and facilitate 
compliance. At our recent public meeting on the implementation strategy 
for the FSMA rules, we received additional input from the public on the 
best ways for us to help educate industry to assist in compliance and 
improve public health. However, FDA's ability to complete the 
activities described depends on receiving the proposed funding in the 
fiscal year 2016 President's budget. Without this funding, these 
activities would need to be scaled back.
                           dietary guidelines
    Question. The FDA's Dietary Guidelines Advisory Committee (DGAC) 
recommended on February 19, 2015, an update to the Dietary Guidelines 
and urged the FDA to re-consider its advice that pregnant women or 
those that may become pregnant eat no more than 6 ounces of albacore 
tuna per week, concluding that ``for the majority of commercial wild 
and farmed species, neither the risks of mercury nor organic pollutants 
outweigh the health benefits of seafood consumption, such as decreased 
cardiovascular disease risk and improved infant neurodevelopment,''. A 
number of consumer and public health stakeholders have raised 
significant concerns with the reliability of the risk/benefit risk 
analysis on which the recommendation is based as compared to the 
volumes of peer reviewed literature on which the current tuna 
consumption advisory is based.
    How will the FDA have reconcile the new risk benefit approach 
recommended by the Dietary Guidelines Advisory Committee with the 
established scientific literature to publish final guidelines that best 
promote public health?
    Answer. In developing the draft updated fish consumption advice 
released in June 2014, FDA and EPA reviewed the totality of the 
scientific evidence, including the research that influenced the 
recommendation in the Dietary Guidelines for Americans 2010. That 
totality of science included evidence on the harmful effects of 
methylmercury and beneficial effects from eating fish. In addition, an 
FDA analysis of seafood consumption data from over 1,000 pregnant women 
in the United States found that 21 percent of them ate no fish in the 
previous month. Those who ate fish ate far less than the Dietary 
Guidelines for Americans recommends, with 50 percent eating fewer than 
2 ounces a week.
    Before issuing final advice, FDA and EPA committed to accepting and 
considering public comment as well as seeking the advice of the FDA's 
Risk Communication Advisory Committee (RCAC). RCAC held a public 
meeting on the draft updated advice on November 3-4, 2014, which 
provided a forum for open discussion of the issues. The public comment 
period closed on March 26, 2015.
    The agencies are now considering the public comments and whether 
any modifications to the advice are needed. We expect this process to 
be completed in 2015. Please be assured that completing the updated 
advice remains a priority.

                          SUBCOMMITTEE RECESS

    Senator Moran. This subcommittee will meet again at 10 a.m. 
on Tuesday, March 17. Our witness will be the Secretary of 
Agriculture, Secretary Vilsack.
    We thank you all for your presence. Wish you well, 
Commissioner, in your future endeavors.
    Dr. Hamburg. Thank you.
    Senator Moran. I thank everyone for their attendance. This 
meeting is adjourned.
    [Whereupon, at 11:34 a.m., Thursday, March 12, the 
subcommittee was recessed, to reconvene at 10 a.m., Tuesday, 
March 17.]