[Senate Hearing 116-]
[From the U.S. Government Publishing Office]




 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2020

                              ----------                              


                        THURSDAY, MARCH 28, 2019

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:42 a.m. in room SD-138, Dirksen 
Senate Office Building, Hon. John Hoeven (chairman) presiding.
    Present: Senators Hoeven, Merkley, Tester, Udall, Leahy, 
and Baldwin.

                 DEPARTMENT OF HEALTH & HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF HON. SCOTT GOTTLIEB, M.D., COMMISSION

                OPENING STATEMENT OF SENATOR JOHN HOEVEN

    Senator Hoeven. Good morning. We will call this hearing to 
order.
    Today, we are going to focus on the Food and Drug 
Administration's fiscal year 2020 budget request. I would like 
to thank the Ranking Member and other members for being present 
today and certainly thank you, Dr. Gottlieb, for being here 
today to discuss FDA's priorities for the upcoming year. Thank 
you for your public service and your commitment to promote the 
health and safety of American consumers.
    I wish you well in your next endeavor. Although I am 
certainly disappointed that you are leaving, and I appreciate 
your service very much.
    I look forward to working with Dr. Sharpless when he 
officially takes over as Acting Commissioner.
    In every budget cycle, there are winners and losers, and I 
think it is fair to say that, once again, FDA is one of the 
winners this time around.
    For fiscal year 2020, the FDA's budget request for 
appropriated funds is a 5.5 increase over fiscal year 2019. 
This is one of the highest percentage increases in all of the 
Department of Health and Human Services, especially when you 
factor in that for 2019, the Congress provided the FDA with a 
$268.6 million, or 9.6 percent, increase.
    So this is an important conversation to have because your 
agency impacts the lives of Americans every single day.
    The FDA has authority over approximately 20 cents of every 
dollar spent in America. Americans expect that the food they 
eat and the drugs they take will be safe and effective.
    The FDA's vast research covers 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 the facilities 
themselves, FDA is tasked with the regulatory responsibility 
for individual products.
    In delivering these regulatory responsibilities, your 
private sector partners expect transparency and certainty from 
the FDA.
    When I speak to small business owners and AG producers in 
North Dakota, their overwhelming concern is that overly 
burdensome regulations coming out of Washington, D.C. often 
stifle innovation and hinder their ability to create jobs. 
While we all support the FDA's mission, we must also be mindful 
of these types of concerns.
    I believe that the FDA must avoid the trappings of a one-
size-fits-all approach, and I urge you and your staff to take a 
commonsense approach that supports our Nation's innovators.
    That being said, Doctor, I look forward to your testimony 
today, as well as my colleagues' questions. I will now turn to 
the Ranking Member, Senator Merkley, for any opening remarks 
that he may have.

               OPENING STATEMENT OF SENATOR JEFF MERKLEY

    Senator Merkley. Thank you very much, Mr. Chairman, and, 
Dr. Gottlieb, thank you for your 2 years of service.
    And I join the Chairman in wishing you very well in the 
next chapter. I am hoping you will be able to help coach the 
FDA to continue on some of the initiatives that you have been 
working on, particularly the challenges on food safety, on 
taking on the importation of opioids.
    I really appreciate the work that you have initiated in 
regard to vaping. I would like to see our Government go further 
faster in order to take on the epidemic of vaping use among 
teenagers and the resulting challenges of nicotine addiction, 
and I hope you will be able to help that from afar.
    I do have significant concerns about the approval of 
genetically engineered salmon. Salmon are such an amazing vital 
part of Northwest ecosystem and Northwest culture, and those of 
us from salmon States are concerned about any possibility of 
genetically engineered fish making it into the wild. And while 
always there are assurances things will not happen, crazy 
things happen, and then we go, ``Why did we let that happen?'' 
It cannot be the case on putting this genetically altered fish 
in a place where it could in fact enter the wild.
    I look forward to your comments, and thank you.
    Senator Hoeven. Are there other members who wish to make 
opening statements?
    [No response.]
    Senator Hoeven. All right. Hearing none, Dr. Gottlieb, 
begin. Thank you for being here, and please proceed with your 
opening statement.

              SUMMARY STATEMENT HON. SCOTT GOTTLIEB, M.D.

    Dr. Gottlieb. Mr. Chairman, Mr. Ranking Member, and Members 
of the Subcommittee, thank you for the opportunity to appear 
before you today to discuss the President's fiscal year 2020 
Budget request for the FDA.
    This is the last time I will appear before this 
Subcommittee in my current role, and I am grateful for the 
opportunity to work with you. I am proud of what we 
accomplished together to advance the public health mission of 
the FDA over the past 2 years, and I am thankful for your 
willingness to support us in moments of challenge and moments 
of opportunity.
    We are especially grateful for the funding increases this 
Subcommittee provided for FDA in fiscal year 2019. The funding 
requested in the President's 2020 budget will allow the FDA to 
build on these efforts to promote competition and bring better 
and more affordable products to the market, to modernize a food 
safety system, and strengthen our response to outbreaks and 
foodborne illness and many other priorities.

                             OPIOID CRISIS

    Today, I want to focus on one of my highest priorities 
since taking my role 2 years ago, the FDA's work to combat the 
opioid crisis. This remains the biggest public health crisis 
facing the FDA. The 2020 Budget request requests $55 million to 
continue supporting the four main areas of the FDA's work. 
These funds will continue to build on the significant financial 
investments this Subcommittee has provided to the FDA for our 
opioids work over the last 2 fiscal years.
    During those last 2 years, the FDA worked to change our 
approach to this crisis. We committed to act more quickly as we 
confront new risks and to take a more aggressive approach to 
regulatory action.
    One of the most important new steps we could now take is to 
consider a comparative advantage of new opioids seeking 
approval relative to other opioids already on the market. The 
supply of drugs does not create demand, and it is wrong to 
assume that just because the agency approves a new drug and it 
is introduced to the market, it is going to somehow lead to 
greater levels of abuse.
    But, nonetheless, the underlying question is a fair one to 
ask. In the setting of an opioid crisis, if a novel drug may be 
eligible for a monopoly, should we demand that a new drug prove 
it has some benefit over existing drugs in terms of how it 
treats pain and preferably how it can help reduce the 
propensity for diversion and abuse?
    We want to ask these same questions in other therapeutic 
settings for a lot of practical reasons, but we know opioids 
are different. And today, I come before you to say that after 
careful deliberation, we believe the FDA needs a new 
comparative standard for future approvals of new opioid drugs.
    Given the public health crisis we face and that American 
families are still being destroyed by the epidemic, I believe 
that FDA should treat opioids as a class differently from other 
drugs.
    We want to incentivize drug developers to focus on 
developing new opioids that offer material therapeutic 
advantages over already approved opioids. Safety advantages 
might mean a new drug has reduced abuse liability or reduced 
incidence or severity of serious adverse events. An 
effectiveness advantage might be to improve pain control for 
particular subpopulations that could help doctors more narrowly 
tailor their prescribing of opioids to carefully selected 
settings.
    We hope this new approach would also incentivize developers 
to increasingly focus their efforts on non-opioid alternatives 
that could eventually begin to replace opioids as the drugs of 
choice when it comes to products used to treat pain that 
address risks of addiction.
    For this to work, the FDA believes that there should be a 
premarket demonstration that a new opioid is superior to an 
already approved opioid or opioid-containing drug for the same 
general indication. The standard should be that a new opioid 
provides significant advantage relative to an already approved 
opioid drug for the same general indication in terms of greater 
efficacy and safety.
    This type of approval framework could operate in 
conjunction with our existing program for breakthrough drugs, 
or it could be paired with new designations for all pain 
therapies that have preliminary evidence of safer, more 
effective performance.
    We want to find ways to prioritize and make more efficient 
the development of novel treatments for pain that have the 
potential to offer significant advantages over our existing 
options.
    Congress could also consider how other incentives, 
including exclusivity, might help drive development of drugs 
with safer attributes.
    At the FDA, we have considered all the options to address 
this crisis, and we have already embarked on many novel 
efforts. We have concluded that we need to change our approval 
approach as well and continue to treat opioids differently in 
order to fight one of the largest public health tragedies that 
our Nation has ever faced.
    Thank you.
    [The statement follows:]

            Prepared Statement of Hon. Scott Gottlieb, M.D.
    Good morning Chairman Hoeven, Ranking Member Merkley, and Members 
of the Subcommittee. Thank you for the opportunity to appear before you 
today to discuss the President's fiscal year 2020 Budget request for 
FDA.
    First, I would like to thank the Subcommittee for your continued 
support of the Agency. FDA has received strong bipartisan support 
throughout the appropriations process in recent years and fiscal year 
2019 was no different. I believe this support reflects our shared 
commitment to the vital role FDA has protecting and promoting the 
public health. The funding this Subcommittee provides is essential to 
the Agency fulfilling its mission. The professional staff of FDA is 
grateful for your support of their work and the funding increases the 
Subcommittee provided FDA in fiscal year 2019.
    Last year, FDA accomplished a broad array of scientific advances 
and regulatory actions across our broad portfolio. Our work included 
promoting generic drug entry as a way to foster drug competition and 
lower drug prices through the implementation of the Drug Competition 
Action Plan, a record-setting year for approvals of novel medical 
devices and advanced several meaningful initiatives to continue 
enhancing the safety of medical devices. The Agency also continued 
advancing food safety and nutrition, launching our Nutrition Innovation 
Strategy to leverage nutrition as a tool to reduce the burden of 
chronic disease, and we took steps to empower consumers with nutrition 
information by supporting retail food establishments in meeting menu 
labeling requirements. We also furthered implementation of the Food 
Safety Modernization Act (FSMA) which builds proactive safety 
approaches into the production of human and animal foods. With your 
continued support, we have more opportunity to deliver on the promises 
of promoting the health of the public we serve.
    The funding requested in the President's fiscal year 2020 Budget 
will allow the Agency to sustain its current work--protecting the 
safety of the food and medical products consumers use every day--and 
build on these efforts by requesting additional resources to make 
significant
    progress on several important fronts; including fostering 
innovation and competition to bring better and more affordable products 
to market, promoting the development of innovative medical products, 
combatting the opioid epidemic, modernizing food safety and 
strengthening foodborne illness response, and implementing the 21st 
Century Cures Act (Cures).
    Overall, the Budget requests $6.1 billion in total resources for 
FDA--which is an increase of $643 million or 12 percent above the 
fiscal year 2019 Annualized Continuing Resolution (CR). At this total 
level, the Budget includes an increase of $362 million in budget 
authority and an increase of $281 million in user fees. The Budget 
requests considerable new resources for FDA and makes significant new 
investments in advancing critical areas of science, technology, and 
public health.
    As the regulatory Agency responsible for ensuring the safety and 
effectiveness of more than $2.5 trillion worth of products used by 
consumers, I remain steadfast that these funds are critical investments 
in our public health agency.
         efforts to advance safe and effective medical products
    The fiscal year 2020 Budget request for medical product safety is 
$3.8 billion, an increase of $428 million above the fiscal year 2019 
Annualized CR, which includes increases of $316 million in budget 
authority and $112 million in user fees. A few examples of the new 
medical product initiatives this Budget request supports are described 
below.
Transform Medical Device Safety, Cybersecurity, Review, and Innovation

    FDA has been improving policies and processes to address scientific 
advances and enhance the safety of medical devices. These improvements 
are critical to protect patients and foster innovation. FDA's 
fragmented information technology systems are not well-suited to 
support these activities. The Budget requests $55 million for an 
initiative to build an integrated knowledge management system and 
portal for medical devices to enable safety issues to be monitored, and 
effectiveness to be evaluated, across the total life cycle of the 
device and to build out our digital health program. These capabilities 
will better leverage pre-existing and new data in near real time. This 
modernization effort is essential for implementing FDA's new approaches 
for digital health technologies, breakthrough devices, use of real-
world evidence and medical device cybersecurity.
Medical Countermeasures

    FDA works with partners at all levels of government--local, state, 
territorial, tribal, Federal, and international--to support medical-
countermeasure-related public health preparedness and response efforts. 
This includes working closely with Federal partners through the Public 
Health Emergency Medical Countermeasures Enterprise to build and 
sustain the medical countermeasures programs necessary to respond 
effectively to chemical, biological, radiological, and nuclear (CBRN) 
threats and emerging public health threats, such as pandemic influenza, 
as well as with the Department of Defense to support the development of 
medical products needed to protect American military personnel. In 
fiscal year 2018, FDA approved 28 medical countermeasures, including 
the first drug with an indication for treatment of smallpox.
    The Budget includes $128 million for medical countermeasure 
activities, of which $31.5 million is for the Medical Countermeasure 
Initiative, an increase of $7 million above the fiscal year 2019 
Annualized CR level. This investment will increase FDA capacity to 
facilitate the development and availability of medical countermeasures 
to respond to CBRN and emerging infectious disease threats by 
furthering the establishment of clear, scientifically supported 
regulatory pathways for medical countermeasures, filling critical 
scientific gaps, and advancing platform and manufacturing technologies 
for medical countermeasures.
Integrated Pathogen Reduction of the Blood Supply

    Advancing the continued safety of U.S. blood supply through new 
safety innovations is a critical public health priority for FDA. The 
Agency currently works to prevent transmitted infections through a 
combination of blood donor screening and laboratory testing methods. 
Pathogen reduction technologies, however, are a potentially more 
efficient method of decreasing the risks posed by viral and other 
pathogens that may be found in blood. These technologies are currently 
available for platelets and plasma, but with this new funding, FDA 
would work to promote innovation and expand their use to improve the 
protection of our blood supply.
    The Budget requests $20 million to pilot this technology as a tool 
that could help reduce the risk of transmission of contaminating 
viruses and other microorganisms from Whole Blood and still allow its 
subsequent separation into various blood components. This pathogen 
reduction technology could eventually help protect the blood supply 
from existing and emerging pathogens and, if successful, could 
potentially reduce or eliminate certain existing blood donor screening 
and testing requirements. It is possible that if this technology were 
incorporated broadly, it could enhance national security by enabling a 
blood supply that would be safe in the face of a wide variety of 
emerging pathogens. It may also deliver these protections for a 
potentially lower cost than those associated with current screening and 
testing methods.
Compounding

    FDA's compounding program--including implementation of the Drug 
Quality and Security Act--is a priority for the Agency. We understand 
that compounded products serve a critical role for many patients across 
the country and we are committed to develop new policies for 
outsourcing facilities, including policies to improve the quality of 
outsourcing facilities' compounded products. We are also helping 
address providers' needs for supplies of non-patient- specific 
compounded medications (office stock). For example, with the new 
resources provided by Congress in fiscal year 2019, we plan to 
establish a Compounding Center of Excellence to provide training on 
good manufacturing practices for outsourcing facilities and develop a 
specialized group of investigators who would focus on outsourcing 
facility inspectional activities. By engaging with outsourcing 
facilities and states, we can help the domestic outsourcing facility 
adhere to the quality standards needed to protect patient health and 
support sector growth.
    The Budget builds on our efforts and requests $76 million to 
support compounding activities. Of this total, $14 million will be used 
to catalyze the development of policies and regulations for the 
outsourcing facilities, including advancement of the list of bulk drug 
substances that outsourcing facilities may use in compounding and 
current good manufacturing practice guidance and regulation specific to 
outsourcing facilities. The activities supported by this funding would 
give outsourcing facilities tools to better meet healthcare providers' 
and patients' needs for compounded drugs.
                     efforts to advance food safety
    The fiscal year 2020 Budget request for food safety is $1.4 
billion, an increase of $67 million above the fiscal year 2019 
Annualized CR, which includes an increase of $38 million in budget 
authority and $29 million in user fees. A few highlights of the Budget 
request are described below.
Advancing FSMA

    As part of our ongoing implementation efforts related to FSMA, the 
Budget proposes allocating an increase of $16 million above the fiscal 
year 2019 Annualized CR level to provide inspections through the state 
cooperative agreement programs. These additional resources are 
essential to the successful implementation of FSMA and are key to 
protecting public health by ensuring that manufacturing and processing 
facilities comply with the new FSMA requirements.
Strengthening Response Capabilities for Foodborne Outbreaks

    Efficient global markets for food production and distribution allow 
American families access to a wide range of wholesome and affordable 
food choices that can improve their health. We want to provide 
Americans the benefits from access to a highly diverse food supply, 
while reducing risks from foodborne illnesses.
    In order to strengthen our response capabilities to foodborne 
disease outbreaks by improving our capacity to detect early signals 
associated with foodborne illness and shortening response timelines 
once human or animal food contamination is detected, the Budget 
requests an increase of $16 million above the fiscal year 2019 
Annualized CR level. In fiscal year 2017 and fiscal year 2018, FDA's 
Coordinated Outbreak Response and Evaluation network evaluated nearly 
120 potential human food safety outbreak incidents per year. That is 
nearly double what was reviewed in fiscal year 2015 and fiscal year 
2016. The increase requested in the Budget will allow the Agency to add 
new staff and resources to enhance signal detection, response to 
outbreaks, and post-response evaluations. FDA will also add staff to 
oversee its recall process and make the recall process timelier.
Promoting Innovation and Emerging Technology While Maintaining Product 
        Safety

    Innovations in plant and animal biotechnology offer tremendous 
opportunities for advancing public health. Promising new technologies 
have the potential to improve human and animal health, animal well-
being, food productivity and food security. FDA will continue to 
facilitate the safe development of these emerging technologies by 
investing in continued enhancements to our review capabilities for 
biotechnology products and other novel products, assessing these 
products in a risk-based manner to provide predictable 
commercialization pathways that can foster product innovation and 
market access in a safe and timely way, and improve consumer nutrition. 
To these ends, the Budget proposes a new $28 million user fee for 
Innovative Food Products, which FDA intends to develop in collaboration 
with industry and other stakeholders. The Budget also requests an 
additional $8 million in budget authority to improve review times and 
eliminate unnecessary burdens to industry related to the premarket 
safety reviews of animal food ingredients.
                                tobacco
    The Budget requests $100 million in new tobacco fees, and includes 
manufacturers and importers of deemed tobacco products, including 
electronic nicotine delivery systems, and certain other products within 
the FDA's tobacco user fee assessments. E-cigarettes, in particular, 
represent an increasing share of the tobacco marketplace. The new 
resources will support the FDA in its continued efforts to create a 
modern regulatory framework for the appropriate oversight of e-
cigarettes and in taking continued steps to reduce youth use of all 
tobacco products. One of our most important public health efforts is to 
continue standing up a framework to make sure we can put e-cigarettes 
through an appropriate series of regulatory gates, and aggressively 
confront youth use of these products to make sure children do not 
become addicted to nicotine.
                                opioids
    One of my highest priorities as FDA Commissioner is combatting the 
ongoing crisis of opioid addiction. The FDA has changed its approach to 
the opioids crisis and is taking a much more aggressive approach to 
regulatory action. At the FDA, we've committed to taking more rapid 
action in the face of new threats, like the growing prevalence of 
illicit fentanyl that's contributing to overdose deaths, or the 
continued prevalence of prescriptions being written for durations of 
use that are too long for the clinical circumstances for which they're 
intended. We've changed the way we're tackling these issues and stepped 
up our intervention when it comes to opioids. Going forward, we're 
going to be looking at the potential for evaluating the comparative 
benefits and risks of new opioids relative to other opioids already on 
the market. We've raised the question of whether there should be such a 
standard for new opioid approvals to offer some advantage over the 
existing armamentarium. We plan continue to evaluate this concept as we 
work to modernize the FDA's framework for assessing the risks and 
benefits of opioid drugs. FDA is focusing its efforts in the following 
four priorities:

  --Decreasing exposure and preventing new addiction,

  --Supporting the treatment of those with opioid use disorder,

  --Fostering the development of novel pain treatment therapies, and

  --Increasing enforcement and assessing benefit-risk.

    The Budget requests an additional $55 million above the fiscal year 
2019 Annualized CR level to continue supporting the four main areas of 
the Agency's work. These funds will continue to build on the tremendous 
financial investments this Subcommittee has provided to the Agency for 
our opioids work over the last two fiscal years.
                         21st century cures act
    Implementation of the 21st Century Cures Act (Cures) continues to 
be a top priority for the Agency. Cures includes provisions that have 
the potential to impart far-reaching effects on scientific advancements 
in medical product development. The law complements many efforts 
underway at FDA. All of these efforts are aimed at transforming the way 
we support product development and maintaining FDA's gold standard for 
safety and effectiveness. Toward these efforts, the Budget requests a 
total of $75 million to support our implementation work.
                               conclusion
    The last year was historic for the Agency. We are diligently 
working on a number of fronts and the vital work we do provides 
Americans with better ways to improve their health and welfare, 
empowering consumers to make informed choices about the products they 
use and the foods they feed to their families. This Budget will help 
FDA maintain and complement our current efforts, as well as provide a 
renewed focus and investment in some of the Agency's and the nation's 
top public health priorities. I look forward to answering your 
questions today and the Agency looks forward to working with all of you 
going forward.

    Senator Hoeven. Thank you, Dr. Gottlieb. We will now have 5 
minute rounds of questions.

                  OPIOIDS APPROVAL PROCESS & LABELING

    Let us start on the opioid issue, in terms of labeling--not 
only the approval process, but talk about what needs to be done 
as far as the approval process, the labeling, and how that has 
contributed to the problem and how that can be remedied.
    And then also your effort to work with the drug companies 
to develop drugs that help reduce opioid use and help wean 
somebody off opioids in a way that actually works for them.
    So, if you could, touch on all three of those aspects of 
the problem.
    Dr. Gottlieb. Well, thank you, Mr. Chairman.

                            OPIOID LABELING

    On the labeling specifically, one of the things we have 
committed to, we have taken a number of steps to try to improve 
the labeling and the Risk Evaluation and Mitigation Strategies 
(REMS) system that governs the prescribing of opioids, 
including extending the educational requirements to all 
providers, not just physician providers, but non-physician 
providers, and requiring education around both the immediate-
release formulations and the long-acting formulations of the 
drugs. Previously, it was just on the long-acting formulations.

                            OPIOID APPROVAL

    But one of the more significant recent steps that we have 
taken is to implement the authorities that we were given under 
the Substance Use-Disorder Prevention that Promotes Opioid 
Recovery and Treatment for Patients and Communities (SUPPORT) 
Act to require effectiveness studies looking at the 
effectiveness of drugs with long-term administration.
    One of the questions is whether or not with prolonged 
administration of these drugs, chronic administration of these 
drugs, you have declines in effectiveness that then cause some 
of these safety issues to arise, where you might have increased 
prescribing that might lead to increased addiction as a result 
of the declines in effectiveness, and is declining 
effectiveness itself a potential safety issue? And we will look 
at it that way.
    So we are going to require the sponsors to do long-term 
effectiveness studies for the first time, and we are going to 
be embarking on that in the coming months.

                     MEDICATION-ASSISTED TREATMENT

    With respect to the issue around Medication-Assisted 
Treatment (MAT) options, we have promulgated new guidance to 
try to create additional pathways to get (MAT) therapy for 
opioid addiction, opioid use disorder to the market.
    We know there are approved therapies that all work. They 
work better in conjunction with psychosocial support, and we 
want to both create new options and perhaps longer-acting 
formulations of some of these drugs, as well as try to address 
some of the stigma associated with some of these treatments.
    There is a perception that someone who is on replacement 
therapy for treatment of opioid use disorder is somehow still 
addicted to an opioid because they are still receiving an 
opioid to relieve the physical symptoms of withdrawal, but that 
person who could be living a very productive life does not have 
addiction anymore. They have physical withdrawal, and the 
replacement therapy is treating the physical withdrawal, but 
they are able to rejoin a productive life. And so we are trying 
to address some of the stigma associated with these treatments 
as well.

                         REPLACEMENT THERAPIES

    Senator Hoeven. Are these replacement therapies coming to 
market, and are you able to verify they are safe and effective? 
And, again, back to the labeling issue, are you able to both 
label them appropriately? Are you working not just on going 
forward the new drugs coming on market and addressing the 
labeling issue, but also any existing issues that you have with 
labeling on drugs that have already been approved?
    Dr. Gottlieb. Well, the treatments themselves are on the 
market. There is a number of treatments on the market that are 
approved for this indication. Where we have seen some recent 
innovations is in longer-acting formulations of some of these 
drugs, which can help drive patients to maintain therapy.
    There might be other opportunities for new kinds of 
innovations, new kinds of drugs in addition to the replacement 
therapies, like buprenorphine.

                            OPIOID LABELING

    The labeling issues I think that we have seen come up more 
recently, the questions around the labeling of these drugs, is 
around the labeling for chronic use, and that label and that 
indication has undergone a lot of revisions over time. But the 
questions that we have been asked--and they are appropriate 
questions--is whether or not we have adequate information about 
the long-term safety of these drugs when they are administered 
chronically, and that is where we are going to be using the 
authorities we were given under the SUPPORT Act to require new 
studies, looking at the safety issues associated with chronic 
administration and in particular whether or not efficacy 
declines with respect to long-term administration. And that in 
and of itself creates certain kinds of safety issues.
    Senator Hoeven. How many of these replacement therapies 
have we seen in the market? Do you anticipate them being a 
solution to reduce the opioid use and the problems associated 
with it?
    Dr. Gottlieb. Well, I think it is one solution.
    We see products in development. So there are products in-
house. A number of them are different formulations of some of 
the existing drugs that are on the market. It is one solution.

           HOLISTIC SOLUTION TO ADDRESSING THE OPIOID CRISIS

    Senator Hoeven. What do you think about holistic solutions? 
Give me the steps that you would see as a holistic solution to 
addressing the opioid crisis.
    Dr. Gottlieb. Well, trying to reduce prescribing, trying to 
rationalize prescribing, so you reduce the rate of new 
addiction.
    A lot of the historical addiction was addiction formed in a 
medical setting, people who had appropriate prescription, but 
became addicted as a result of the medical use of these drugs.
    We need to rationalize prescribing, make sure fewer 
prescriptions are written, and when they are written, they are 
for an appropriate duration of use.
    We need to address the illicit drugs that are pouring into 
this country. So interdiction is a cornerstone of our efforts. 
We have taken down a lot of websites. We have stepped up our 
work in the international mail facilities, thanks to resources 
that this Committee provided to the Agency.
    We also need to work on innovation. How do we get products 
to market that are non-addictive alternatives to opioids, non-
opioid alternatives, as well as innovation when it comes to 
treatment?
    So those are the three prongs of what we are trying to do 
to address this at a high level. We are working pretty 
aggressively over all three of those domains.
    I would just say, in sort of summing that up, the nature of 
this crisis is changing. It has gone from one that was a crisis 
formed from medical prescribing to one where, increasingly, 
people who become newly addicted to opioids, their first 
introduction is now an illicit drug, and increasingly, it is a 
super-potent formulation. It might be pressed fentanyl being 
sold as OxyContin or Vicodin inappropriately. That is not what 
it is. It is a counterfeit drug, and so I think that we need to 
recognize that.
    We still look at, for example, flows of illicit drugs 
coming into this country in terms of pounds of drugs seized. 
What we need to be looking at is the potency of the drugs 
coming in, and when you look at drugs on that basis, I think we 
have a monumental challenge in terms of what is coming into 
this country and the changing nature of this addiction crisis.
    Senator Hoeven. Senator Merkley.
    Senator Merkley. Thank you very much, and I am glad you got 
to speak to the fentanyl.
    We approved $140 million to FDA to help tackle opioid 
crisis. I believe the bulk of those funds have been spent 
trying to intercept fentanyl coming in from China and India.
    I just want to check in and see if that is the case, and 
from what we have learned, is that any feasible objective, or 
is it just too simple to mail this incredibly potent opioid to 
multiple destinations in the U.S., or do we have a handle on 
how we can really intercept it?
    Dr. Gottlieb. Well, I do not know that I can tell you that 
we have a handle on it. I cannot even tell you that we have a 
full measure of the scope of the challenge across the 
Government.
    Our interdiction work is primarily at the international 
mail facilities and is primarily focused on non-controlled 
substances. We focus on FDA-approved products.
    When a controlled substance is spotted in the international 
mail facilities, it goes immediately to Customs and Border 
Protection. If it is screened, then United States Postal 
Service (USPS) spots a controlled substance.
    But what we do is we get the packages that are pills but 
presumed not to be controlled substances, but even in examining 
those, we find a high rate of controlled substances. So we are 
basically the last line, but things are still getting through.
    The reason they are getting through is people are getting 
more sophisticated about how they are sending them in. They are 
sending in sort of small shipments. They are disguising them as 
Over-the-Counter (OTC) drugs. They are stripping labels from 
it. So if a dog does not sniff it, it is in a small package, it 
looks like an over-the-counter drug, it might go through the 
first line of screening and then come to us. So we are the last 
line of defense in the international mail facilities, even 
though it is not our primary mission.
    This Committee provided us about $100 million in resources. 
When I got to FDA, there were seven Full-Time Employees (FTEs) 
doing this mission. With the work of Mel Plaisier, the 
Associate Commissioner for Regulatory Affairs (ACRA) at the 
agency, we freed up, internally, resources to put about 25 
people on that mission. With the resources from this Committee, 
we will increase that number to about 135, I believe, and be 
able to screen 100,000 packages a year, a substantial increase, 
but still a small amount of what is coming in.
    Senator Merkley. And just a sense of that, we probably 
receive 100,000 packages or more a day across the Country to 
get a scope of the challenge.
    Dr. Gottlieb. Last year, I believe it was 800--it was going 
to approach, I think last year, 800 million packages. It is 
heading towards a billion packages a year, so this is a 
fraction of a fraction.
    But even though it sounds daunting and it sounds like we 
are screening a trivial amount, the amount that we are 
screening allows us to glean information that allows us to 
dramatically improve our targeting. So we do not need to screen 
a high percentage of packages to be highly effective.
    Senator Merkley. Thank you, and I will look forward to 
continuing to learn from FDA what is working and what is not. 
Things we are trying that are not working, let us move 
resources to things that are.

                    ONLINE ORDERING OF E-CIGARETTES

    I wanted to turn to the e-cigarettes. I am going to miss 
having the ongoing conversation with you about taking on the 
flavors designed for children. I know that you have moved with 
this regulation to have a separate room, but also to allow such 
to be delivered by mail. And I am wondering if one is allowed 
to order over the mail, all these different flavors that are 
appealing to kids and given the sophistication of our children, 
are we going to have any sort of effective barrier to keep 
these many flavors designed to appeal to children out of the 
hands of children?
    Dr. Gottlieb. Senator, in some respects, I believe 
personally the measures that can be implemented when it comes 
to online ordering might be more foolproof. Nothing is 
foolproof. We will accept that, but I think it might be more 
foolproof than the kinds of measures that we can implement at a 
retail setting or point of sale.
    There are other things sold online that are adult-only 
products. You think of wine ordered online where you have 
stringent age verification requirements, adult signature on 
delivery, where you can implement controls that can largely 
keep these products out of the hands of kids.
    Actually, I think from my perspective, based on what I have 
known in my briefings I have received from my experts, I think 
it is maybe more challenging at the point of sale and retail.
    I will also close by saying--and this is not to say that 
things could not shift, but only a small percentage of these 
products are actually sold online, certainly less than 10 
percent when you look across the different manufacturers.
    Senator Merkley. So if we proceed in this fashion and you 
mentioned wine. Many States are allowed to choose whether or 
not they allow deliveries of alcohol being ordered through the 
mail. Will States have the ability to choose as to whether to 
allow these child-appealing flavors to be delivered through the 
mail?
    Dr. Gottlieb. It is an interesting question whether or not 
States can pass statute that supersedes a Federal standard. 
There is no preemption. So, presumably, they could pass laws 
that supersede the Federal allowance.
    Senator Merkley. Okay. Well, that would be an interesting 
thing for the States to take up because, as you have rightly 
acknowledged, it is such an explosion. Just in the time that we 
have been in this conversation in the last 2 years, we have 
seen a huge expansion.
    My impression is you have come to the point of view that 
this is a significant problem we have to keep working to take 
on because while the vaping can help smokers stop smoking, they 
do not need all these candy-flavored flavors to do that, and 
those are primarily targeted at children.
    Dr. Gottlieb. And your words and your warnings to me when I 
talked to you during my confirmation process have sadly proven 
true, Senator.
    Senator Merkley. Thank you.
    Senator Hoeven. Senator Leahy.
    Senator Leahy. Thank you, Mr. Chairman.
    Dr. Gottlieb, I am going to miss having you here. I do 
appreciate your availability when I have called and when we 
have had questions. I suspect there are four people in 
Westport, though, that will be glad to have you back, your wife 
and your three children, and you probably will not mind that 
either. Is that safe to say?

                             CBD REGULATION

    Dr. Gottlieb. I am going to miss this position. This has 
been a wonderful, wonderful journey.
    Senator Leahy. Well, let us go over a couple things. I 
realize everybody has got different questions.
    We did a bipartisan 2018 Farm Bill. I was pretty proud of 
it. Republicans and Democrats did things the way they should 
do. The Chairman is a member of that Committee, and we passed a 
Farm Bill with overwhelming margins, both the House and Senate. 
We had some significant wins for Vermont families and dairy 
farmers, organic producers, but also, what I was mostly 
concerned about, rural communities across the country.
    It also reclassified hemp as an agricultural product rather 
than a controlled substance. We had farmers, processors, 
retailers in my State and most States that want to enter this 
market. They want to leverage the potential, but they have 
significant regulatory and enforcement uncertainty, including 
with the FDA.
    You recently stated the FDA, if I have got this correct, 
could take years to create an informal pathway for hemp-derived 
Cannabidiol CBD products to be sold, despite the fact they are 
widely available in the market.
    How do you think the FDA should use its enforcement 
discretion on the use of CBD as an ingredient?
    Dr. Gottlieb. Well, we are using enforcement discretion 
right now.
    I will take enforcement action against CBD products that 
are on the market if manufacturers are making what I consider 
over-the-line claims. So if you are making CBD and you are 
claiming it can cure cancer or prevent Alzheimer's disease, we 
are going to take action against that because that could 
mislead a patient to foregoing otherwise effective therapy.
    But there are products on the market right now, that given 
our enforcement priorities and our limited resources, we have 
not taken action against. That is not an invitation for people 
to continue marketing these products. We are concerned about 
it.
    But we heard Congress loud and clear here. We know you want 
a pathway. Under our regulatory scheme, it is a challenging 
route because this not only exists as a drug in the 
marketplace, but it is also under substantial clinical 
investigation. So even if there was an approved drug, because 
it was never previously in the food supply, we do not have a 
clear route to allow this to be lawfully marketed, short of 
promulgating new regulations.
    That is why, in closing, one of the things that the working 
group that is headed up by Amy Abernethy, who is here with me 
today, our Principal Deputy Commissioner, is going to be 
looking at is what options we could propose to Congress to 
potentially legislate on this issue in a specific manner.
    Senator Leahy. Well, that is what I am thinking of, a 
legislative fix. I do not envy you trying to figure out a 
regulatory one because you have other agencies with 
jurisdiction. Would you please, as you continue on this, make 
sure my staff and I are kept apprised of what type of a 
legislative fix it might be? And then the various Committees 
that members of this Committee serve on will probably be where 
the legislative fix will go.
    I would just like to get some certainty here. I am not 
diminishing the complexities, but I would like to get some 
certainty.

                        PRESCRIPTION DRUG COSTS

    And another area of certainty, we have the high cost of 
prescription drugs. You and I have discussed expediting generic 
drugs into the market. We have a bipartisan Creating and 
Restoring Equal Access to Equivalent Samples (CREATES) Act. Key 
Republicans, key Democrats have endorsed this. I think it will 
save money. I think it will have a real impact. I wish we would 
hurry up and pass it.
    I look at things like insulin. Insulin prices increased 
from 2006 to 2015 by more than 500 percent. I hear of people 
who ration their insulin medicine. You are a physician. You 
understand this better than I do, but my wife, who is a 
medical-surgical nurse, has talked with some of these people 
and told them that you cannot do that. You got to use it the 
way you are told to use it.
    So how is the FDA working to ensure generic developers do 
not delay their current development of follow-on or generic 
insulin until after March 2020 when they might have a different 
regulatory procedure?
    Dr. Gottlieb. Well, we have recently, as you know, Senator, 
taken steps to implement the legislation that was passed to 
move the biologics that were historically regulated as drugs 
into the biosimilars pathway.
    Historically, it has been very hard to develop a generic 
version of insulin under the drug scheme because it was a 
biologic regulated as a drug. So proving sameness under the 
Abbreviated New Drug Application (ANDA) process, under the 
traditional Hatch-Waxman process was challenging, and a lot of 
the insulins came to the market through a route called 
505(b)(2), which did not allow for automatic substitution.
    We believe under the biosimilars pathway, we are going to 
see much more vigorous competition from truly interchangeable 
insulin products, and we already have a lot of applications in-
house and a lot of activity for products looking to come 
through that pathway. We think it is going to be easier to get 
to the market as a copy and also to claim interchangeability 
under the biosimilars pathway. So we are optimistic that this 
market can continue to evolve in a positive way.
    Senator Leahy. Is it going to be delayed until March 2020?
    Dr. Gottlieb. I do not think there should be any delay. 
This has been telegraphed for a number of years, and so we have 
seen companies make accommodations for the change in the market 
position of these products. And so companies have filed 
applications or are seeking to file applications under the 
biosimilars pathway, anticipating this change.
    Could there be one or two sponsors that sort of get caught 
trying to slip in under the old pathway before the data 
conversion? It is possible. There was always going to be the 
potential for a few outliers, but by and large, we are seeing 
very vigorous activity under this new proposed framework.
    Senator Leahy. Thank you.
    Senator Hoeven. Senator Udall.
    Senator Udall. Thank you, Mr. Chairman.
    I was going to say to Ranking Member Merkley, who I think 
talked earlier about the genetically modified salmon, I share 
his comments and also join him in his remarks.

                         YOUTH E-CIGARETTE USE

    Dr. Gottlieb, thank you for being here today. I am pleased 
that this budget gives additional funding to help evaluate e-
cigarettes. I remain deeply concerned about the skyrocketing 
use of e-cigarettes by our Nation's youth. The CDC survey data 
showed an astounding 78 percent increase in e-cigarette use 
among high school students in 2018.
    In my home State of New Mexico, 51.5 percent of teens have 
used e-cigarettes. This is significantly higher than the 
national average of 42.2 percent.
    The U.S. Surgeon General has said e-cigarette smoking among 
youth has reached epidemic proportions. I fear that these 
products, especially flavored e-cigarettes, are creating a new 
generation of nicotine addicts.
    I applaud you for raising the alarm about this epidemic; 
however, I have been clear with you that I believe FDA must 
take more aggressive steps to effectively address this pressing 
public health concern.
    If new CDC survey data reveal that youth e-cigarette use 
does not decline in 2019, do you agree an appropriate next step 
is to remove flavored e-cigarettes from the market until they 
undergo review by the FDA?
    Dr. Gottlieb. Well, Senator, I share your concerns.
    I will say at the outset we still believe that the e-
cigarettes could be a viable tool for currently addicted adult 
smokers to transition off of combustible tobacco on to 
something that, while not safe, is less harmful than 
combustible tobacco.
    We also believe at a time when we are advancing the rule, 
this year, to regulate nicotine content in combustible 
cigarettes, to render them minimally and not addictive, the e-
cigarettes offer another alternative for adults who still want 
to enjoy satisfying levels of nicotine, but it will no longer 
be available, presumably, in a combustible cigarette.
    But I have said all along that that cannot come at the 
expense of addicting a whole generation of children on these 
products, and what has changed our posture was the data that 
you cited, which I received on August 31st. And a week later, 
we gave a statement that this was an epidemic and we were going 
to have to take new steps.
    I think if the 2019 National Youth Tobacco Survey shows 
another large increase in the rate of use among children, to 
answer your question directly, I think we will have to look at 
the pod-based and cartridge-based e-cigarettes as a category 
and consider additional regulatory steps, including the 
potential that we might need to seek the market withdrawal of 
some of these products until they have approved Premarket 
Tobacco Application (PMTAs) by the agency.
    Senator Udall. Don't you think we have enough evidence 
today to remove them from the market today for youth? For 
youth?
    Dr. Gottlieb. We are trying to engage in a very careful 
public health balancing here, and we put forward a set of 
policies that we want to see if maybe it can work, which is to 
try to put in place significantly heightened age verification 
requirements for the flavored products sold at point of sale. 
That policy is being implemented right now. We are confident 
that it will be implemented. Some companies have already taken 
voluntary steps to comply with that.
    But, again, to your question, if the 2019 National Youth 
Tobacco Survey data reveals another sharp increase, we are 
going to have to significantly reevaluate what we are doing 
here and contemplate potentially taking these off the market.
    Look, all of these policies come with significant 
tradeoffs. We do see adults switching to e-cigarettes as 
anecdotal evidence of that. There is some data to suggest that 
currently addicted adult smokers are transitioning to the e-
cigarettes. So there is a very careful public health balancing 
that we have been trying to engage in here, but we cannot get 
caught behind the curve, to your point.
    Senator Udall. Can we expect anything from you before you 
leave? I mean, this would be a nice way to go out of office.
    Dr. Gottlieb. Well, look, I pushed hard to get out that 
policy on the issues around the flavored products at point of 
sale, and I am very confident. We received broad support from 
the White House within the administration. Secretary Alex Azar 
is very strong on this issue, and we have got strong statements 
of support from the White House. I am very confident that that 
policy will be finalized and implemented.
    We got out a foundational rule today with respect to 
tobacco, and we will continue to make tobacco policy right out 
the door, but I am also very confident that my successor is 
going to pick up the mantle here and will share my concerns 
around the youth use.
    Senator Udall. As you know--and you and I have talked about 
this before--as a State Attorney General, we sued the tobacco 
companies, and our strongest case was that they were addicting 
young people. And they had the studies, and they said if you 
addict young people, then they get a smoker for life. And I 
think that is what they are doing here, and I am glad you are 
on top of it. And I hope you will be as aggressive as you can 
before you leave because I think we are in the middle of an 
epidemic, and I think we really need to do something about it.
    Thank you very much, and we are going to miss you a lot.
    Dr. Gottlieb. Thank you, Senator.
    Senator Hoeven. Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman.
    And I agree we will miss you.

                      DAIRY STANDARDS OF IDENTITY

    Commissioner Gottlieb, last year, you committed to looking 
into concerns that I have raised on behalf of dairy farmers 
across this country who are rightly frustrated that plant-based 
imitation products get away with using dairy's good name for 
their own benefit.
    These products use dairy's good name, and there is no 
consequence, even though it is clearly against FDA rules.
    While I still believe that FDA could begin enforcement 
immediately, I know that you felt it was very important to 
receive public input on the issue before beginning an 
enforcement process, and I want to thank you for keeping your 
commitment to America's dairy farmers and making some forward 
progress on this issue.
    Since our hearing last spring, things have gotten much 
worse for our dairy farmers. In the last year, Wisconsin lost 
633 mostly small- and medium-size family dairy farms, many of 
which had been operating for generations.
    Our trade situation has become less stable. Markets are 
very tough for milk, with retaliatory tariffs on cheese, and 
the trade situation is also less stable for corn and soybeans, 
the commodities that keep our dairy farmers in business.
    Farmers have faced also an extremely cold and snowy winter 
in my State that has caused hundreds of barns to collapse, and 
dangerously cold temperatures have caused livestock losses. It 
is really, really hard out there right now for dairy.
    So, as they face these stressful times, farmers in 
Wisconsin and across the country are looking to the Food and 
Drug Administration to do its job, and they are closely 
following the actions you have taken thus far. It is not just 
farmers who are paying attention. Among the comments that the 
Food and Drug Administration received was a request from the 
American Association of Pediatricians that ``FDA reserve the 
labor of milk solely for traditional dairy products to ensure 
that children receive the optimal nutrition they need to 
thrive.''
    Would you please provide me an update on what you have 
learned from the comments you have received? And please 
describe the next steps that the Food and Drug Administration 
intends to take on this matter.
    Dr. Gottlieb. Thank you, Senator.
    We understand and appreciate the concerns you raise. They 
are not lost on us. It is very important as we work on policy 
here that we go through a deliberative process to build a 
careful administrative record. We will get challenged if we do 
change the standards of identity to confirm with what you are 
advocating.
    One of the reasons the agency has prevailed at promulgating 
very important public health rules and wins in court is because 
we do careful rulemaking, and we have good, good legal teams. 
And we go through a very deliberative process.
    With respect to this Request for Information (RFI), we 
received 13,000 comments. The comment period just closed on 
January 28th. So we have just begun going through those.
    I will say that from a public health standpoint, the 
critical question--or one of the critical questions we are 
going to ask is whether or not consumers perceive a certain 
nutritional value when they see the term ``milk'' used on a 
product and whether or not they are getting that across a 
spectrum of products that are using this.
    And to build on the point that you made about the American 
Academy of Pediatrics, we saw, for example, evidence in the 
literature that children that were fed rice milk, if I recall 
the study accurately, actually faced nutritional deficiencies 
because it did not have the same nutritional content. That is 
one of the places where the agency would seek to address this 
issue through a potential change in the standards of identity 
and kind of public health orientation that we are going to take 
to this question.
    Senator Baldwin. So this year's funding bill for the Food 
and Drug Administration included a sizeable increase in 
funding, $2 million specifically to help the Food and Drug 
Administration address the staff and capacity shortages that 
have been present.
    With that new funding and new staff on the job, when do you 
expect to have conclusion to your review of these comments?
    Dr. Gottlieb. Well, the new funding was greatly appreciated 
by the agency.
    We just received and we are starting to spend it now. To 
give you sort of a sense of the FDA's budget, within CFSAN, the 
Center for Food Safety and Applied Nutrition, 5 percent of the 
overall budget of that center is related to nutrition, infant 
formula reviews, and standards of identity. So it is a small 
proportion of the budget. So $2 million was meaningful, and it 
allowed us to go from two FTEs dedicated to this effort to as 
many as five FTEs, which is going to help. We hope to continue 
to support that program.
    It is hard for me to give you a sense right now at what 
point we will go through those 13,000 comments, but this is a 
priority for the agency. It is a key component of our nutrition 
innovation strategy to try to look at the standards of 
identity. There are 300 out there; 100 deal with dairy. We want 
to update them. We want to update them systematically, perhaps 
as categories of standards of identity that we can update all 
at once. So this is a very high priority for our overall 
nutrition program.
    Senator Baldwin. I appreciate the fact that it is a high 
priority. I just want to stress that at this particular moment 
and for the last couple of years, there have been a confluence 
of challenges facing dairy in the United States. Whether it is 
low price that farmers are being paid for milk, whether it is 
oversupply in some situations, the uncertainty with tariffs and 
retaliatory tariffs against dairy products, the weather, 15 
percent of Wisconsin's dairy farms have gone out of business in 
the last 2 years, 15 percent, mostly the small- and medium-size 
family farms that have been passed down from generation to 
generation. And they work so hard every day to meet the 
standards of identity that exist in Federal law, and they are 
only asking for the Food and Drug Administration to enforce the 
law.
    Dr. Gottlieb. Thank you.
    Senator Hoeven. Let us see. Who is next? Oh, yeah. Senator 
Tester.
    [Laughter.]
    Senator Tester. Thank you, Mr. Chairman. I appreciate it.
    Thank you, Commissioner, for being here. I thank you for 
your good work, and I wish you the best as you go back into the 
private sector. I appreciate your work as Commissioner of the 
FDA.
    And just to kind of dovetail on to Senator Baldwin's 
comments, and I was not going to do this, but I always thought 
milk came from an animal. But what the hell? You know, things 
change.
    [Laughter.]

                              BIOSIMILARS

    Senator Tester. Look, earlier this week, the Department of 
Justice released a statement to the Court of Appeals for the 
Fifth Circuit affirming a ruling in a Texas case that found the 
entire ACA unconstitutional. You know that. That is not 
breaking news.
    I am worried about the impact of the ruling. I am worried 
on a whole bunch of reasons, but I want to touch on something 
that Senator Leahy talked about because the ACA created a 
pathway for FDA approval of biosimilars.
    In your announcement of this plan, you had said enabling a 
path to competition for biologics and biosimilars is the key 
for reducing cost. It is my understanding that the judge rules 
the ACA unconstitutional. There is no longer a statutory 
authority for the FDA to encourage development of biosimilars.
    If the biosimilars approval pathway as a part of the ACA, 
which it was, and it is overturned, would not this thwart the 
FDA's plan to increase access to biosimilars?
    Dr. Gottlieb. Well, certainly, if the statutory framework 
was overturned, it would. I would hope if that came to pass, 
Congress would work to reauthorize it. So it was a very 
important pathway, and we fully support it, obviously. And we 
think it has been profoundly impactful with consumers.
    Senator Tester. I agree, although I do not need to tell 
you. You have been here long enough to know that predicting 
what Congress will do or will not do, whether it requires 
common sense or not, is pretty difficult.

                         NON-OPIOID PAINKILLERS

    There was another thing here that was brought up earlier. 
How close are we to a non-opioid painkiller?
    Dr. Gottlieb. There are products in development that look 
very promising, but they are in early stages of development. It 
is hard to predict how quickly they can move through 
development because a product that was a non-addictive 
alternative for the treatment of pain could presumably qualify 
for breakthrough designation and perhaps did, but I could not 
disclose that. So they could move through efficiently.
    Senator Tester. Well, it looks to me that if we ever get to 
a point where it actually happens, it is effective, we could 
shut some of this garbage, get it off the market.
    Dr. Gottlieb. Right. I share your hopes.
    I would say that, historically, there has been no free 
lunch when it comes to drugs for the treatment of chronic pain. 
Every drug that we have marketed has some concerns associated 
with it, whether it is the opioids that have the addictive 
potential or something like Tylenol. We have never had a 
perfect drug here.

                            CELL-BASED MEAT

    Senator Tester. Okay. I want to talk about something I do 
not think we have talked about today yet, but maybe we have. I 
was not here for the whole thing, and that is cell-based meat, 
lab-grown meat, the product of genuine animal muscle cells that 
are cultured in a lab to produce a meat product. It is very 
similar to meat in taste and appearance and texture, but has no 
bone and no fat.
    Senator Hoeven. Senator, it is not meat.
    Senator Tester. That is absolutely correct. That is the 
point I am going to get to in a second.
    [Laughter.]
    Senator Tester. There was a point in time in my life where 
my wife and I operated a custom butcher shop, and just as I 
figured milk got to be from an animal, meat always came from an 
animal, okay? And if it is done in a lab, I guess you could 
make that connection back, but I wondered.
    So earlier this month, Secretary Perdue announced that the 
FSIS and the FDA reached an agreement to regulate cell-based 
meat. Do you think that cell-based meat should be labeled meat 
or poultry?
    Dr. Gottlieb. Well, you do not make it sound very 
appetizing, but I will let your comment stand. I will not 
comment on it.
    But I believe--we have worked out a framework here where 
the FDA is going to have regulatory purview over the production 
aspects that we know very well, the culturing process, the 
biotechnology process, and we consider that the pre-harvest 
process.
    After the product itself comes out of the culturing process 
and it is no longer in a living system, which we are calling 
the post-harvest process, USDA is going to have full purview 
over that process, and that would include the labeling of it. 
That would include the labeling considerations. It would 
include the packaging, how it gets flavored, spiced, all that.
    So, ultimately, I think it is going to be within USDA's 
purview to make a decision around how these products are 
labeled.
    Senator Tester. So you do not believe FDA will be able to 
play a role.
    Dr. Gottlieb. We would certainly advise on it and provide 
expert input and be part of a collaborative process, but 
ultimately, the authority for the post-harvest process is going 
to be within the purview of USDA.
    Senator Tester. So let me ask you this, as long as my time 
is about up, but I do not see anybody else in line. Whose job 
is it going to be to test this product to find out of it--I 
mean, you talked about--and I do not want to make the parallels 
here because they are a little different, but to find out if it 
has the same nutritional value, the same health benefits, the 
same ability.
    I do not want to become a vegetarian. You can look at me. 
You know I am not a vegetarian, and the truth is that I like 
beef and I like pork and I like lamb. And if it is grown in a 
lab and I do not know that it is growing in a lab and they call 
it meat as meat is meat and there has not been any testing 
done, we got a problem.
    So who is doing the testing?
    Dr. Gottlieb. Well, the primary mission here for the FDA is 
safety, and we are going to be looking hard at these kinds of 
questions through the development process, the sort of pre-
harvest process, the nutritional content of it, whether or not 
it is comparable, whether or not there are risks being 
introduced into the product.
    But, ultimately, we are working on a framework where there 
is going to be joint jurisdiction. That was the direction we 
got from Congress. We appreciate that direction. We have signed 
an Memorandum of Understanding (MOU) to implement that, and 
ultimately, the decisions about how that is implemented are 
going to be determined in guidance that we are working on right 
now.
    So I would say in short, both agencies are going to have a 
role to play here.
    Senator Tester. So let me give you an example, and it is 
fairly controversial. But I believe in testing. I believe in 
testing for everything, whether you are talking prescription 
drugs or food, when it has been altered.
    In the case of genetically modified grain, for example, 
when I asked a predecessor of yours about are you going to do 
testing on grain that has been genetically manipulated to find 
out if it has the same qualities as the original kernel, they 
said a grain is grain is grain.
    That same argument could be used on cell-produced, lab-
produced meat. Is that your view?
    Dr. Gottlieb. I think it is getting to the original 
question that you asked me, which is--and it is a fair 
question, which is how are these going to be positioned in the 
market, and will the consumers have any disclosure around 
whether or not this is derived from a carcass versus a 
culturing process, and I think those issues are yet to be 
worked out. But, ultimately, USDA is going to have purview over 
how this gets graded and how it gets positioned relative to 
meat, so that there is consistency across that USDA process.
    Senator Tester. Okay. Well, I would just say this. First of 
all, thank you for your work, and I mean that. I think that you 
have done an admirable job as Commissioner of the FDA, and 
hopefully, in your exit memo, you will tell the next chap, 
whoever it may be, to make sure they do their due diligence. 
That is all I am asking because once we get something 
introduced into the food system and if it is not what we think 
it is, then you get all sorts of medical costs. And since the 
ACA has been worked on to be done away with, who the hell is 
going to pay for it?
    Anyway, thank you very, very much.
    Dr. Gottlieb. Thanks a lot, Senator.

                            CELL-BASED MEAT

    Senator Hoeven. Thanks to Senator Tester for his questions 
about cell-based meat or product, and I want to associate 
myself with those comments.
    I appreciate you coming in and discussing this at length 
with me and your willingness to work with USDA to better 
understand how important that issue is to our ranchers and to 
our consumers. That is another area where I think you have 
shown leadership and effectiveness that we appreciate, a very 
important issue.
    Most of my remaining questions have been asked by other 
members.

                    REDUCING PRESCRIPTION DRUG COSTS

    The President wants to bring down the price of prescription 
drugs. We all do. Your thoughts on how we can do that?
    Dr. Gottlieb. Well, I see within our purview at the agency 
trying to create more product competition in the market, and it 
is not only with respect to generic drugs, where we have 
advanced a lot of initiatives to try to bring more generics 
into the market, but also with novel drugs, where we see 
second-to-market innovation in novel drug categories coming to 
market more slowly than it has historically.
    I think once you have product competition, we need to have 
the mechanisms in the marketplace to inspire price competition, 
and there are places in the market where that does not happen. 
And then once we have price competition, we need to make sure 
that the price competition results in discounts that actually 
can benefit the consumer, and there are places in the market 
that does not happen, especially through rebating schemes where 
the consumers do not benefit directly from the discounting that 
is happening.
    But those two are outside the scope of my Agency. What is 
within my purview is the ability to create product competition, 
and that is where we focused our efforts.

               REGULATION OF HEMP: HEMP-RELATED PRODUCTS

    Senator Hoeven. Now that the Farm Bill has legalized 
growing and selling hemp and hemp-related products, what is 
FDA's role in regulating those products; for example, the oil 
and those kind of things?
    Dr. Gottlieb. Well, it gets back to the question with 
respect to the CBD, and we are working through a process right 
now on how we could allow CBD to be lawfully marketed as a 
dietary supplement or a food additive or an additive in animal 
food.
    We recognize Congress' desire for there to be a pathway to 
allow for this. We recognize--we heard Congress, through what 
they said in the Farm Bill, but because this exists as a drug 
product and has not previously been in the food supply, there 
is not a straightforward path, currently. We have to go through 
a rulemaking.
    I recognize that could take time, and that is why we have 
put together a very high-level working group, staffed by some 
of our most creative policymakers to try to think through 
alternatives, including potential legislative alternatives.
    There is precedent for Congress legislating in the context 
of a single ingredient, and so you could, for example, 
contemplate a scheme here where Congress gave FDA authority to 
contemplate CBD as a food ingredient at certain concentrations 
and potency and purity and then have it exist separately as a 
drug product at a different concentration, different potency 
and purity. Fish oil, for example, exists that way in the 
marketplace, but fish oil, we did not need to come up with a 
legislative option to do that because it was previously in the 
food supply. CBD obviously was not. It was a scheduled 
substance prior to recent years.
    Senator Hoeven. Well, again, Dr. Gottlieb, we are going to 
miss having you in this role. You have been responsive, 
obviously very knowledgeable on these issues, and very diligent 
in pursuing them, and I think it is a testament that just about 
every Senator here today thanked you for your work and 
complimented you on it.
    So, again, I want to do the same and wish you the best in 
future endeavors. Thank you for your service.
    Dr. Gottlieb. Thank you, Mr. Chairman. Thank you for your 
support of the agency.

                    ADDITIONAL COMMITTEEE QUESTIONS

    Senator Hoeven. With that, the meeting will--let us see. I 
think we have some taking some testimony. For members of the 
Committee, any questions you would like to submit for the 
hearing record should be turned in to the Subcommittee staff 
within 1 week, which is Thursday, April 4th. We would 
appreciate if we could have responses back within 4 weeks of 
that time.
               Questions Submitted by Senator John Hoeven
    Question. The Drug Supply Chain Security Act of 2013 was enacted to 
develop and enhance drug supply chain security and gave the FDA a 
November 2015 deadline to finalize regulations for the licensing of 
third-party logistics providers and wholesale distributors. However, as 
of today, not even the proposed licensure standards have been issued. 
Where is the rulemaking package related to licensure, and when can we 
expect to see the proposed licensure standards?
    Answer. Ensuring the security of the drug supply chain and 
protecting U.S. consumers from suspect and illegitimate prescription 
drugs is a paramount concern for FDA. The Agency has been diligently 
working to implement the supply chain security provisions of the 
Federal Food, Drug, and Cosmetic Act, as amended by the Drug Supply 
Chain Security Act (DSCSA), since DSCSA's enactment in late 2013. FDA 
began implementing the licensure reporting requirements for third party 
logistics providers (3PLs) and wholesale distributors starting in 2014. 
Self-submitted information about 3PLs and wholesale distributers is now 
in one national database. Product tracing and verification requirements 
began in 2015. These efforts increased the oversight of members in the 
drug supply chain. Due to increased oversight, FDA and members of the 
supply chain can better identify and swiftly respond to illegitimate 
product to help ensure that the product is not further distributed. FDA 
has issued 16 guidance for industry for stakeholder clarity on 
implementation of the DSCSA. These include guidance on implementation 
of product identification (serialization) requirements of the DSCSA. In 
addition, FDA launched its pilot project program on February 8, 2019, 
to encourage supply chain stakeholders to pilot processes, systems, or 
innovative technologies to inform the development of an electronic, 
interoperable system for product tracing down to the package level that 
is required by 2023.
    FDA has also been developing the regulations for national standards 
for licensure of 3PLs and wholesale distributors. Currently, the rule 
is in the proposed rulemaking stage and is listed along with other 
anticipated proposed rules on the most recent Unified Agenda (UA). FDA 
anticipates advancing a proposed rule later this year, following its 
approval by the Office of Management and Budget. Sometimes it takes 
longer to issue a proposed or final rule than predicted when the UA was 
issued, but the Agency continues working to move the proposed rule 
forward.
    Question. This Subcommittee's fiscal year 2019 bill directed the 
FDA to finalize the guidance for industry entitled ``Bacterial Risk 
Control Strategies for Blood Collection Establishments'' by September 
30, 2019. Are you on track to finalizing the draft guidance and do you 
anticipate major changes from the draft guidance?
    Answer. FDA intends to meet the September 30, 2019 date in the 
Subcommittee bill to publish the final guidance document on Bacterial 
Risk Control Strategies for Blood Collection Establishments and 
Transfusion Services to Enhance the Safety and Availability of 
Platelets for Transfusion. FDA issued a revised draft guidance in 
December 2018 and the Agency is working expeditiously to finalize the 
revised draft guidance after considering all comments received during 
the public comment period that closed on February 4, 2019.
    Question. I understand that the agency has prioritized food safety 
and traceability as key drivers for protecting public health. When 
Congress passed FSMA in 2011 it aimed to increase the capacity to 
detect and respond to food safety problems. Part of that effort was to 
expand the utilization of U.S. based accredited independent 
laboratories to do more food safety testing. FSMA required FDA to 
promulgate a laboratory accreditation rule by 2013 to in part 
facilitate this expansion. I understand that it still has not been 
promulgated. When does FDA intend to promulgate this rule?
    Answer. FDA is pleased to let you know that the Agency has plans to 
issue a proposed rule this year. As you know, FSMA required FDA to 
engage in extensive rulemaking and develop associated supportive 
material needed to establish a modernized regulatory framework. FDA 
prioritized completing the seven foundational rules that implement the 
core of the preventive framework of FSMA. The rulemakings for these 
foundational rules were completed in May 2016 and FDA continues to 
issue accompanying draft guidances and other supportive materials and 
engage in training activities.
    Since the seven foundational rules issued, FDA has been better able 
to focus attention on the remaining FSMA priorities, including the 
laboratory accreditation program.
    Question. Solving for drug shortages, particularly as it relates to 
the availability of robust competition in the generic drug market, is 
something you have prioritized in the context of lowering prescription 
drug costs. It is my understanding that the FDA has established a task 
force to explore what more FDA can suggest to improve competition in 
the marketplace. In our 2019 bill this committee asked for an update on 
how FDA is expediting the review of generic applications in the case of 
a shortage. I understand that FDA has also been working to better 
harmonize regulatory work with other developed nations.
    Can you please provide an update on how FDA is expediting generic 
applications and leveraging efforts to harmonize inspections and 
application requirements with other regulatory bodies in the effort to 
move generics to market more quickly here in the United States?
    Answer. Section 506C(g) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) permits FDA to expedite the review of certain submissions 
and expedite inspections that could help mitigate or prevent drug 
shortages. Review of ANDA submissions related to drug shortages is 
prioritized in accordance with FDA's Manuals of Policies and Procedures 
(MAPPs) Prioritization of the Review of Original ANDAs, Amendments, and 
Supplements and Drug Shortage Management. In calendar year 2017, the 
most recent year for which data are available, FDA expedited the review 
of 132 submissions. These submissions included 43 NDA/NDA supplements, 
71 ANDA/ANDA supplements, and 18 BLA/BLA supplements. FDA also 
prioritized 30 establishment inspections to address drug shortages 
under section 506C (g)(2).
    FDA is also working with international regulatory partners to 
advance policies that will help us continue to accelerate innovator and 
generic product development. For example, FDA recently submitted to the 
International Council for Harmonization of Technical Requirements for 
Pharmaceuticals for Human Use (ICH), a key international body comprised 
of other regulatory authorities and the pharmaceutical industry, a 
proposal to develop internationally harmonized guidelines on scientific 
and technical standards for generic drugs.
    FDA uses ``risk-based'' targeting to prevent, uncover, and combat 
data and manufacturing problems. Risk-based means that the Agency 
strategically directs inspection and oversight efforts toward 
facilities most likely to exhibit quality issues in need of resolution. 
FDA has also leveraged its abilities to oversee a global manufacturing 
market by building relationships with other international regulatory 
agencies. Among many other synergies generated by these partnerships, 
FDA utilizes the results of inspections done by many countries in the 
European Union to avoid inefficient and unnecessary duplication of 
inspections.
    FDA has been implementing the Mutual Recognition Agreement with the 
E.U. since November 2017. Thus far the U.S. has deemed 24 of the 28 
authorities as capable. This allows the U.S. to harmonize with the EU 
on surveillance inspections by sharing inspectional outcomes.
    Question. Modernizing the review process at FDA for new medical 
technologies and software is captured by your ongoing reorganization, 
including a pre-certification pilot program for manufacturers as one 
possible new way to review medical software applications.
    Could you explain to the committee how the more traditional review 
process can run in parallel to these modem approaches and how over time 
the new efficient pathways you are proposing would be scaled up, and, 
if results are not as expected, how FDA might change course in the 
future?
    Answer. The Software Precertification (Pre-Cert) program is 
envisioned as a voluntary pathway that would be available as an 
alternative to the traditional premarket review pathways for 
appropriate software as a medical device (SaMD). The current Pre-Cert 
model, described in three documents issued in January 2019, embodies a 
regulatory model more tailored than the current regulatory framework to 
assess the safety and effectiveness of software technologies without 
inhibiting patient access to these technologies. Software manufacturers 
would continue to have the option to pursue traditional premarket 
review of their software products, instead of participating in the 
Software Pre-Cert program.
    In January 2019, FDA released the 2019 Test Plan, the primary 
purpose of which is to assess whether the Pre-Cert components outlined 
in the Working Model (version 1.0 also released in January 2019) 
together produce an equivalent basis, compared to the traditional 
pathways, for determining reasonable assurance of safety and 
effectiveness for a SaMD product prior to its introduction to the 
market. During this test phase, FDA is iteratively evaluating and 
modifying the appraisal and submission elements of the Pre-Cert 
framework, as appropriate. As the Pre Cert model continues to be 
refined, FDA anticipates that fewer changes to the model will be 
required with each iteration. At the conclusion of the Test Plan, FDA 
intends to demonstrate whether the totality of evidence collected 
through the Excellence Appraisal and Streamlined Review processes align 
to and satisfy the regulatory requirements for making a determination 
of reasonable assurance of safety and effectiveness.
    If so, FDA will begin to implement the Pre-Cert program under the 
De Novo pathway, as described in the Regulatory Framework for 
Conducting the Pilot Program within Current Authorities (released 
January 2019). This phased approach is an important first step to 
inform how we establish the Software Precertification Program and scale 
it for broader use.
                        rmat designation process
    Question. How does FDA evaluate the potential for a particular 
therapy when reviewing an RMAT submission? ls the same standard applied 
consistently across all RMAT submissions in different indications?
    Answer. Under section 506(g) of the FD&C Act, as added by the 21st 
Century Cures Act, a drug is eligible for RMAT designation if:

  --It meets the definition of regenerative medicine therapy,

  --It is intended to treat, modify, reverse, or cure a serious or 
        life-threatening disease or condition; and

  --Preliminary clinical evidence indicates that the drug has the 
        potential to address unmet medical needs for such disease or 
        condition.

    Regarding the preliminary clinical evidence to demonstrate the 
potential of a regenerative medicine therapy to address unmet medical 
needs, FDA generally expects that such evidence would be obtained from 
clinical investigations specifically conducted to assess the effects of 
the therapy on a serious or life-threatening disease or condition. Such 
clinical investigations, particularly at the initial stages of product 
development, may not always be prospective clinical trials with a 
concurrent control. In some cases, clinical evidence obtained from 
clinical investigations with appropriately chosen historical controls 
may provide sufficient preliminary clinical evidence of the potential 
to address an unmet medical need. In other cases, preliminary clinical 
evidence could come from well-designed retrospective studies or 
clinical case series that provide data systematically collected by 
treating physicians. Such clinical evidence may be from studies 
conducted outside of the United States. In any case, it is essential 
that the preliminary clinical evidence be generated using the product 
that the sponsor intends to use for clinical development.
    When determining whether the preliminary clinical evidence is 
sufficient to support RMAT designation, the Agency intends to consider 
factors, including but not limited to: the rigor of data collection; 
the consistency and persuasiveness of the outcomes; the number of 
patients or subjects, and the number of sites, contributing to the 
data; and the severity, rarity, or prevalence of the disease or 
condition. In addition, FDA intends to consider the potential that bias 
(e.g., bias in the study design, treatment assignment, or outcome 
assessment) may be a factor in the evidence provided in support of RMAT 
designation.
    The process and criteria for RMAT designation are discussed in 
``Expedited Programs for Regenerative Medicine Therapies for Serious 
Conditions; Guidance for Industry'' published in February 2019. The 
Agency will make designation decisions on a case-by-case basis, but, in 
doing so, will always review designation requests against the criteria 
for designation set forth in section 506(g) of the FD&C Act, that is, 
whether the drug meets the definition of regenerative medicine therapy; 
whether it is intended to treat, modify, reverse, or cure a serious or 
life-threatening disease or condition; and whether preliminary clinical 
evidence indicates that the drug has the potential to address unmet 
medical needs for such a disease or condition.
                                 ______
                                 
             Questions Submitted by Senator Mitch McConnell
    Question. FDA has signaled it could take years to develop a 
regulatory pathway to provide certainty for CBD as a food additive or 
dietary supplement. The authority is clearly within FDA's jurisdiction 
and specifically maintained under the 2018 Farm Bill. Why would a 
regulation of this nature take longer than the standard time required 
to issue a regulation?
    Answer. Three to 5 years is the Agency's best estimate of an 
expedited timeframe for completing notice-and-comment rulemaking from 
start to final rule for a substantive issue where there is significant 
public interest. The Agency notes that even under optimal circumstances 
with a short, uncomplicated rule and no delays in the rulemaking 
process (some of which is outside the agency's control) , a minimum of 
2 years is necessary to complete a rulemaking. However, a two-year 
period represents an optimistic timeframe, especially for rulemaking on 
which the Agency anticipates receiving significant public comment. 
Under the Administrative Procedure Act, the Agency has a legal 
obligation to consider all relevant comments received on a proposed 
rule before it can issue a final rule, and to respond to all 
significant comments. Based on past experience, the comments on a 
rulemaking docket of significant public interest can number in the 
hundreds-of-thousands. Addressing that volume of comments can take 
time.
    In addition, these timeframes would apply only once the agency 
reaches a preliminary determination regarding whether it is appropriate 
to allow CBD in dietary supplements and/or the conventional food 
supply, and whether any other restrictions or policy measures should 
apply. Making such a determination involves obtaining and assessing 
safety and relevant public health input to inform a decision that will 
address consumer access in a way that protects public health, maintains 
incentives for cannabis drug development, and creates a robust 
administrative record needed to support the initiation of any 
rulemaking. There are significant gaps in knowledge of the potential 
safety risks of CBD, such as the effects of CBD exposure from consumer 
products over an extended period. For this reason, FDA is prioritizing 
the collection of data and other types of information that can support 
sound, science-based policymaking regarding CBD. For example, FDA hopes 
to obtain and assess relevant safety data and other input through its 
public hearing and associated public docket, as well as through the 
efforts of the Agency's CBD Policy Working Group. FDA will evaluate all 
information once the public docket closes on July 16, 2019.
    Question. FDA recognizes that the rulemaking timeframe is long and 
that there is growing interest in CBD. This is why the Agency's CBD 
Policy Working Group is considering whether any legislative options 
might lead to more efficient and appropriate pathways than might be 
available under current law. However, the Agency's priority is 
obtaining and assessing safety data to inform science-based 
decisionmaking consistent with FDA's public health mission. The Agency 
believes any policy decisions should be based upon the outcome of the 
Agency's scientific and public health process to assess safety data and 
associated policy considerations. FDA also is committed to an open and 
transparent process, with robust engagement with all relevant 
stakeholders. Does the agency foresee a need to promulgate multiple 
regulations as it relates to CBD?
    Answer. FDA is still evaluating potential paths forward, and 
procedural efficiency is a key consideration. If FDA decides that 
rulemaking is the appropriate path forward, it will seek to proceed in 
a manner that provides clarity and regulatory certainty for affected 
stakeholders as early as possible. This could mean consolidating 
elements into a single rulemaking to the greatest extent possible, or 
breaking elements into separate rulemakings, depending on what actions 
the FDA takes.
    Question. Before his departure, Commissioner Gottlieb said FDA may 
ask Congress to legislate a pathway forward for providing regulatory 
clarity for CBD sold in the marketplace as a dietary supplement or food 
additive. However, even if Congress enacted legislation, it would be up 
to the FDA to implement and regulate the statute. What sort of 
legislative action does FDA see as necessary to move this process 
forward within a shorter period of time? Please provide proposed 
legislative language for statutory changes.
    Answer. Due to a lack of research, there remain many unanswered 
questions related to the safety of products containing CBD, especially 
outside the approved drug context. For example, there are open 
questions relating to cumulative exposure, impacts to special 
populations (e.g., children, the elderly, and pregnant or lactating 
women), and interactions with other drugs or foods. FDA is currently 
evaluating the available data and information related to the potential 
risks associated with the availability of CBD in products such as 
conventional foods and dietary supplements. These efforts are ongoing 
and will inform FDA's evaluation regarding the extent to which existing 
regulatory pathways may be available and appropriate for bringing such 
products to market. FDA looks forward to working with your office and 
intends to keep Congress informed of any updates and recommendations.
    Question. Does FDA believe Congress should grandfather CBD products 
into the marketplace?
    Answer. FDA does not believe that Congress should use the 
legislative process to ``grandfather'' these products into the 
marketplace prior to a thorough review of the scientific evidence about 
the safety of these products. As discussed above, a careful scientific 
evaluation is critical to determining the appropriate path to protect 
public health. CBD is known to have toxicities, including liver injury, 
and allowing the legal marketing of these products could be harmful. It 
could also undermine incentives for continued scientific research into 
CBD uses.
    In addition, many of these products are currently being marketed in 
interstate commerce in violation of Federal law, including products 
that make unsupported claims about therapeutic benefits. We have also 
heard significant concerns that some products on the market may contain 
harmful contaminants, or otherwise put consumers at risk. In contrast, 
some companies have held back developing and marketing CBD products in 
situations where FDA has stated that doing so would violate the FD&C 
Act. ``Grandfathering'' the violative products already on the market, 
while establishing a different process for products not yet on the 
market, could have the unintended consequence of providing a commercial 
advantage to segments of the market that have a record of jeopardizing 
consumer safety.
    Question. FDA has noted that more research is required on the 
impact CBD has to health. Is the agency seeking funding from Congress 
for this purpose?
    Answer. The President's fiscal year 2020 Budget Request does not 
include funding for research specific to the health effects of CBD 
products. However, as the marketplace evolves and interest in producing 
and consuming products containing CBD continues to grow, this may be 
part of a future request.
    Question. If so, how much, and to what programs or accounts?
    Answer. Currently, FDA's knowledge about the health effects of CBD 
products, beyond that of Epidiolex, is limited. Funding provided by 
Congress could be used to help FDA support research and evidence 
generation to continue to identify and fill gaps in research.
                                 ______
                                 
            Questions Submitted by Senator Susan M. Collins
    Question. I want to thank Dr. Gottlieb for his work on the 
Biosimilars Action Plan. As he noted, biologics represent 70 percent of 
the growth in drug spending from 2010-2015. I recently introduced 
bipartisan legislation, the Biologic Patent Transparency Act, that 
would require important enhancements to what is commonly referred to as 
the Purple Book, and require the makers of approved biological products 
to disclose to the FDA the list of patents that cover their products. 
The bill will help biosimilar products reach consumers more quickly and 
prevent the use of so-called ``patent thickets'' that are used by some 
companies to intentionally stifle competition. What recommendations do 
you have for additional steps we can take to encourage competition and 
address these harmful patent strategies so that patients can access 
lower-cost alternatives?
    Answer. FDA is committed to facilitating the entry of lower-cost 
alternatives and improved patient access to affordable medicine.
    The Agency is continuing to take steps to implement Congress's 
direction that FDA transition approved applications for the subset of 
biological products, which for complex historical reasons have been 
approved as drugs under section 505 of the FD&C Act, to biologics 
licenses under section 351 of the Public Health Service Act. This 
transition will help promote competition by enabling the marketing of 
products that are biosimilar to, or interchangeable with, these 
biological products. Once an interchangeable product is approved and 
available on the market, it can be substituted for the reference 
product at the pharmacy, potentially leading to increased access and 
lower costs for patients. The Agency is approaching the March 23, 2020, 
transition in a manner that provides clarity and predictability to 
manufacturers who have relied on FDA's recommendations regarding 
product development plans, helps ensure stability for patients using 
currently marketed products, and facilitates the development of new 
products that are biosimilar to, or interchangeable with, these 
transitioned products.
    FDA supports transparency and is committed to making improvements 
to the Purple Book to help promote robust competition for biologics. 
FDA is currently in the process of implementing BsUFA II commitments to 
improve the Purple Book interface, include key information for each 
entry (i.e. the BLA number, product name, proprietary name, date of 
licensure, interchangeable or biosimilar determination, and whether the 
BLA has been withdrawn), and to provide timely updates of FDA 
determinations of whether a reference product has qualified for 
reference product exclusivity. These improvements are designed to 
increase the Purple Book's value as a resource for industry and other 
stakeholders. The Agency looks forward to working with you more on your 
bill, S. 659, the ``Biologic Patent Transparency Act,'' as it continues 
to move forward.
    Question. Drug shortages have become an ever-increasing burden for 
patients, providers, and the healthcare system as a whole. I hear from 
panicked constituents on a regular basis on this topic, including 
patients, pharmacists, physicians, and hospitals. A constituent with 
Mast Cell Activation Syndrome wrote how she was feeling helpless as two 
lifesaving drugs she needs were experiencing shortages. One major 
health system in Maine told me that they have to commit three to four 
unbudgeted, full time employees each week to address approximately two 
new significant shortages a week. Another hospital had to manage a 
shortage of a certain endocrine drug by turning to another product that 
cost ten times as much. I'm encouraged FDA has convened a Drug Shortage 
Task Force, and I am also developing legislation to help address this 
critical issue. What are the most promising recommendations to emerge 
from the Task Force's recent workshop?
    Answer. FDA established the Task Force, which includes Federal 
officials from several agencies, to identify the root causes of drug 
shortages and to advance potential solutions. The Task Force has also 
included opportunities for public input on the issue. These have 
included:

  --Public Meeting--The Task Force hosted a public meeting on November 
        27, 2018, in Washington, D.C.

  --Stakeholder Listening Sessions--The Task Force held a series of 
        stakeholder listening sessions in September and October 2018. 
        The sessions were held with nationally recognized experts on 
        the drug supply chain and leaders of organizations representing 
        broad segments of the healthcare system.

  --Public Docket--FDA opened a docket to receive comments from 
        stakeholders about the root causes of drug shortages and 
        potential enduring solutions. The docket closed on January 11, 
        2019.

    FDA is currently reviewing input from the public meetings and the 
meetings with members of the Task Force. The Task Force intends to 
issue a report which will include recommendations from the Task Force 
based on input from stakeholders and may discuss new authorities that 
could further support FDA's ability to address drug shortages. It is 
too early in the process to provide the recommendations that may be 
discussed in the final Task Force report.
    However, FDA would like to point to the proposals included in the 
``Department of Health and Human Services fiscal year 2020 Food and 
Drug Administration Justification of Estimates for Appropriations 
Committees" \1\ document. In this document, FDA discusses three 
legislative priorities to help prevent or mitigate drug shortages. The 
proposals include:
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    \1\ https://www.fda.gov/media/121408/download

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  --Lengthening Expiration Dates to Mitigate Critical Drug Shortages

  --Improving Critical Infrastructure by Requiring Risk Management 
        Plans

  --Improving Critical Infrastructure Through Improved Data Sharing: 
        Requiring More Accurate Supply Chain Information

    Question. Are new authorities needs to make greater progress?
    Answer. See response above.
    Question. The safety of personal care products is an issue of 
growing interest to many Americans. The average consumer uses IO 
personal care products every day, yet the laws governing such products 
haven't been updated since 1938, and states have been acting on their 
own in the absence of a national standard. I have been working with 
Senator Feinstein on legislation that would modernize cosmetic safety 
laws and provide greater transparency for consumers and regulatory 
certainty for manufacturers. During Commissioner Gottlieb's nomination 
hearing, Dr. Gottlieb committed to working with Congress to explore 
options to modernize FDA's authorities, and I am pleased that the 
agency is taking action on lead acetate. What other actions is the 
Agency taking in regards to the regulation of personal care products?
    Answer. On March 5, 2019, FDA issued a statement outlining new 
steps the Agency could take to better ensure the safety of cosmetic 
products, including steps to reinforce the obligations of manufacturers 
to assure the safety of their products.\2\ Although FDA does not have 
pre-market authority for cosmetics, there are other tools that the 
Agency can use to ensure the safety of such products. The Food, Drug 
and Cosmetic Act imparts on FDA the responsibility to monitor cosmetics 
on the market and to take action to protect consumers if 
``adulterated'' or ``misbranded'' cosmetics are marketed. Three recent 
examples of actions the Agency has pursued to protect consumers are the 
recall by Claire's in March 2019 of three talc-containing products (eye 
shadow, compact powder and contour palette) due to the presence of 
fibers consistent with asbestos contamination, an updated safety alert 
in June 2019 regarding recalls of two additional talc-containing 
products (a contour palette and a makeup set) with asbestos 
contamination, and six tattoo inks that were recalled from March 
through April 2019 because of microbial contamination. To ensure that 
consumers were aware of these issues, FDA made certain that the 
information was conveyed through a variety of media outlets, including 
the Agency's website, Twitter, and social media venues.
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    \2\ https://www.fda.gov/news-events/press-announcements/statement-
fda-commissioner-scott-gottlieb-md-and-susanmayne-phd-director-center-
food-safety-and
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    In addition, FDA is committed to working with stakeholders and 
Congress to modernize the outdated regulatory framework for cosmetics 
that FDA has been operating under for more than 80 years. There are 
basic elements to a modern regulatory framework to promote and protect 
public health including: registration and listing of products and their 
ingredients, so the Agency knows who's making the regulated products 
and what's in them; explicit authority to establish good manufacturing 
practice regulations; company reporting of adverse events; access to 
records (including consumer complaints) during routine or for-cause 
inspections; mandatory recalls; disclosure of known cosmetic allergens 
on a product's label; and sufficient resources to implement these 
public health protections. FDA recognizes that some elements of the 
legislation that you have introduced align with these priorities. FDA 
looks forward to working with you on this important issue in the months 
ahead.
    Question. In 2017, the FDA reported that cosmetic imports, by 
volume, are one of the FDA's largest categories of imports, consisting 
of more than 2.9 million entry lines in 2016. Have cosmetics imports 
risen since 2016?
    Answer. The data shows that the number of imported cosmetic lines 
declared to FDA has decreased slightly from fiscal year 2016 to fiscal 
year 2018:




    Question. Do such imports receive a physical examination by FDA 
inspectors?
    Answer. FDA electronically screens 100 percent of import entries 
prior to the products being permitted into the country and directs 
inspection resources to those entries that are found to be higher-risk 
and may have the greatest impact on public health. FDA's screening tool 
for imports, the Predictive Risk-based Evaluation for Dynamic Import 
Compliance Targeting (PREDICT), enhances the Agency's ability to target 
higher-risk products for further review and improves FDA's ability to 
detect trends and investigate import entry patterns. FDA staff 
physically inspect and/or sample a subset of import entries at varying 
rates, depending on the type of product and the risk factors.
    Question. The FDA noted that is inspectors reported adverse 
findings, including the presence of microbial contamination and illegal 
color additives, with 15 percent of cosmetic imports that received 
physical inspections in 2017. Since that time, has the FDA been issuing 
import alerts and for what types of adverse findings?
    Answer. An import alert allows FDA to detain, without physically 
examining, products that either have or potentially could violate the 
Federal Food, Drug, and Cosmetic Act. The alert lets FDA field staff 
know that the Agency has enough evidence or other information to refuse 
admission of future shipments of an imported article.
    Import alerts include lists of products and their manufacturers who 
have a history of violative products specific to the problem covered by 
the import alert (such as adulteration due to the presence of mercury). 
A single import alert will often list multiple product/firm 
combinations. At this time, FDA has 10 active cosmetics-related import 
alerts covering various types of violations, such as undeclared and 
non-permitted color additive violations, the presence of 
microbiological contamination, and the presence of mercury. Each active 
import alert associated with a specified type of violation may be 
revised to add firm/product combinations to be subject to detention 
without physical examination. In the past three fiscal years (fiscal 
year 2016-fiscal year 2018), FDA added a total of 169 firm/product 
combinations to these 10 cosmetics-related import alerts: 150 additions 
to import alerts for color issues; 18 additions to import alerts for 
microbiological contamination issues; and 1 addition to the import 
alert for a violation due to the presence of mercury.
    Question. I appreciate Commissioner Gottlieb's commitment to help 
protect pure maple syrup and honey producers from labeling requirements 
that could have created widespread consumer confusion and negatively 
affected these industries by revising the final rule regarding ``added 
sugar'' Nutrition Facts labeling requirements for single-ingredient 
sweetener products. Will you please provide the committee with a status 
update on the FDA's ``added sugar'' rulemaking and treatment of single-
ingredient sweeteners like pure maple syrup and honey?
    Answer. In March 2018, FDA published a draft guidance outlining its 
thinking at the time on how single-ingredient honey and maple producers 
could flexibly provide additional information to explain that no sugars 
are added to these single-ingredient products. FDA received nearly 
3,700 comments to the draft guidance. Subsequently, the President 
signed into law the Agriculture Improvement Act of 2018 on December 20, 
2018. The law exempts any single-ingredient sugar, honey, agave, or 
syrup that is packaged and offered for sale as a single-ingredient food 
from bearing the declaration ``Includes Xg Added Sugars.'' FDA is 
considering the statutory provisions of the Agriculture Improvement Act 
of 2018 and the comments received on the draft guidance and plans to 
issue the final guidance very soon.
    Question. I am concerned that the FDA has yet to issue guidance 
regarding a product called allulose, despite the fiscal year 2018 
report language requiring the FDA to do so. Allulose is a naturally 
occurring sugar that does not act like a traditional carbohydrate/
sugar, in that it adds negligible calories, is not metabolized, and 
does not raise blood glucose levels. Would you please provide a status 
update on the treatment of allulose under the ``added sugars'' 
regulation and the timeline for the issuance of this guidance?
    Answer. FDA issued draft guidance on April 17, 2019, about the 
declaration of allulose on the Nutrition Facts label. The guidance 
advises manufacturers that FDA intends to exercise enforcement 
discretion to allow for the exclusion of allulose from the amount of 
Total Sugars and Added Sugars on the Nutrition Facts label. Allulose 
still must be included in the amount of Total Carbohydrates on the 
Nutrition Facts label. The draft guidance also advises manufacturers of 
FDA's intent to exercise enforcement discretion to allow manufacturers 
to use a caloric value of 0.4 calories per gram to calculate the 
caloric contribution of allulose instead of 4 calories per gram of 
sweetener. Comments on the draft guidance should be submitted by June 
17, 2019 to ensure that they are considered before FDA begins work on 
the final guidance.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Dr. Gottlieb, Canada imports most of its drugs from other 
countries. It is my understanding that, while Canada's regulators 
oversee the safety of the supply of medicines intended for and used in 
Canada, they do not apply those standards to drugs intended only for 
export. As a result, drugs imported to the United States form Canada 
could be coming from another country and simply passing through Canada. 
Is it possible to ensure the drugs imported into the U.S. from Canada 
have appropriate safety, quality, and effectiveness so that they do not 
put U.S. patients at risk, and if so, how would we do that?
    Answer. FDA understands the importance of Americans having access 
to high-quality medicines they can afford. The Agency is an important 
partner in bringing forward innovative, life-saving therapies and 
expanding the therapeutic options available to patients. FDA takes very 
seriously our responsibility to ensure that the drugs Americans take 
are safe and effective, and that our actions live up to our reputation 
as the world's ``gold standard.''
    Section 804(b) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) allows for the importation of prescription drugs from Canada if 
the Secretary first certifies that the importation would pose no 
additional risk to the public's health and safety and would result in 
significant cost savings to American consumers. Any such certification 
by the Secretary would be made only after careful consideration of 
numerous factors. The answers to these questions will help ensure that 
any importation policy developed by FDA meets the requirements of 
section 804 and safeguards the reputation of FDA's drug approval 
process. In addition, any resulting importation policy would be 
narrowly tailored to avoid the risks of counterfeits or other unsafe 
drugs getting into the U.S. supply chain that a broader importation 
policy would present.
    Question. FDA cannot ensure the safety and effectiveness of 
products that come from unknown sources and foreign locations, or that 
may not have been manufactured under proper conditions. These unknowns 
put patients' health at risk if they cannot be sure of the product's 
identity, purity, and source. How would we be able to trace the origin 
of a drug imported into the U.S. from Canada if there were a problem or 
need for investigation?
    Answer. Additional requirements that could apply to drugs imported 
from Canada include, but are not limited to, those that were put in 
place by the Drug Supply Chain Security Act (DSCSA) to protect the 
security of the supply chain from suspect and illegitimate products. 
The DSCSA outlines steps to build an electronic, interoperable system 
to identify and trace certain prescription drugs as they are 
distributed in the United States.
    The DSCSA requirements apply to manufacturers, repackagers, 
wholesale distributors, third-party logistics providers (3PLs), and 
dispensers (primarily pharmacies). These requirements include:

  --Appropriate State or Federal licensure or registration with FDA, as 
        applicable

  --Reporting licensure to FDA by wholesale distributors and 3PLs

  --Product tracing, which involves providing transaction documentation 
        to the purchaser with each sale

  --Product verification, which includes quarantine and investigation 
        of suspect and illegitimate product, and notifications of 
        illegitimate product to FDA and certain immediate trading 
        partners

  --Product identification on each package of product by manufacturers 
        and repackagers

    If these requirements were applied to drugs imported into the U.S. 
that were originally intended for the Canadian market, these 
requirements would enhance FDA's ability to help protect consumers from 
exposure to drugs that may be counterfeit, stolen, contaminated, or 
otherwise harmful. The system will also improve detection and removal 
of potentially dangerous drugs from the drug supply chain to protect 
U.S. consumers. Additional information about the DSCSA can be found on 
FDA's website at: https://www.fda.gov/Drugs/DrugSafety/
DrugintegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/
default.htm.
    Question. The fiscal year 2019 Consolidated Appropriations Act 
enacted into law on February 14, 2019, provided a near 9 percent 
increase in FDA's budget. It reflects the agency's largest increase in 
a number of years, and specifically provides $2 million for standard of 
identity and product labeling. How does FDA intend to use the 
additional $2 million in funding for standard of identity and product 
labeling, and will these funds be used to ensure that products labeled 
as rice are indeed rice?
    Answer. FDA appreciates the support from Congress in providing 
additional funding to help the Agency further its mission to advance 
the health and safety of the American public. The Agency notes that the 
Consolidated Appropriations Act, 2019, provided an increase of 6.8 
percent in total program level funding when compared with the fiscal 
year 2018 Omnibus.
    FDA is using the $2,000,000 Congress provided in fiscal year 2019 
to accelerate FDA's work on standards of identity and related product 
labeling by hiring additional staff with expertise in food processing 
and technology. Additionally, FDA will use the funds to engage with 
stakeholders and otherwise expand FDA's understanding of market trends 
and economic factors, as well as consumer understanding and perceptions 
of standardized and non-standardized foods and their labeling.
    FDA's efforts to modernize standards of identity is multipronged. 
First, FDA is considering a broader approach to make the current 
standards framework more flexible, which would benefit multiple 
industries. The Agency indicated its intent in the Fall 2018 Unified 
Agenda to reopen the comment period on a 2005 proposed rule, issued 
jointly with the U.S. Department of Agriculture's Food Safety and 
Inspection Service, to establish general principles as a first step in 
modernizing the standards of identity framework. Second, FDA is 
planning to issue a final rule amending the standard of identity for 
yogurt. Third, FDA is also planning to propose revoking the standards 
of identity for French dressing and frozen cherry pie; if finalized, 
those actions may provide manufacturers with greater flexibility in the 
production of those products.
    FDA is sensitive to concerns about the use of the term ``rice'' for 
non-grain products and is engaging with the rice industry to better 
understand their concerns and perspective. FDA maintains a strong 
interest in monitoring the marketplace for potentially false and 
misleading labeling.
    Question. Over the past 2 years, the number of products using the 
term ``rice'' to describe products made from other vegetables has 
increased dramatically. Examples range from ``RightRice'' derived from 
vegetables and a little rice flour, to ``Rice made from chickpeas'' or 
``Rice made from legumes.'' Rice is grown--not manufactured--and this 
puts America's rice farmers at a disadvantage.
    What does your agency plan to do about products such as these which 
are misleading to consumers?
    Will standards of identity and product labeling continue to be a 
priority in fiscal year 2019 and fiscal year 2020 following your 
departure?
    Answer. FDA is sensitive to concerns about non-grain products 
labeled with the term ``rice'' in their names. FDA has met, and will 
continue to engage, with representatives of the rice industry to better 
understand the rice industry's concerns and perspective.
    FDA maintains a strong interest in monitoring the marketplace for 
potentially false and misleading labeling. FDA considers taking action 
as appropriate, consistent with our priorities and resources, against 
products that are misbranded. In addition, FDA is reviewing a citizen 
petition from The Good Food Institute that asks FDA to issue 
regulations clarifying how foods may be named by reference to the names 
of other foods (Docket No. FDA-20l 7-P-1298).
    FDA's work on food labeling, including food naming issues, is a 
priority, and the Agency fully expects to continue this important work 
in fiscal year 2020. In addition, the Agency's work on modernizing 
standards of identity also continues to be a priority and will carry 
over to fiscal year 2020.
    Question. Pan American Grain, Inc. based in Guaynabo, Puerto Rico 
is an importer and packager of both foreign-origin and U.S.-origin 
rice. U.S. rice producers and millers have raised concerns that Pan 
American has been engaging in some, if not all, of the following 
illegal activities: fictitious Country-of-Origin markings; deceptive 
marking concerning rice sources; and undervaluing and under-reporting 
customs entries. The rice appears to be marketed as Medium Grain Rice, 
when it is actually Short Grain Rice and being labeled as product of 
U.S. and/or China, which is not consistent with Customs and Border 
Protection or FDA labeling regulations (19 C.F.R. Sec. 134.46 and 21 
C.F.R. Sec. 101.l 8(c), respectively). This is an egregious example of 
intentional mislabeling of not only the origin of the product, but also 
description of the type of rice on the label. This was raised with U.S. 
Customs and Border Protection officials in San Juan in January, and 
just last week on March 19th , Pan American Grain was fined by the 
Puerto Rico Department of Consumer Affairs for fake advertising. How is 
FDA using its resources to combat false labeling like this example of 
improper origin labeling?
    Answer. FDA shares the Committee's concern for the truthful 
labeling of products and the importance of having consumers be able to 
make informed choices about their foods. FDA maintains a strong 
interest in monitoring the marketplace for potentially false and 
misleading labeling and works closely with U.S. Customs and Border 
Protection (CBP) to monitor imported products for compliance, taking 
action against products that are misbranded as appropriate, consistent 
with our priorities and resources.
    A statement of the country of origin on the label of imported foods 
is not required under the Federal Food, Drug, and Cosmetic Act. 
However, a false or misleading country of origin on labeling is a 
violation of the both FD&C Act and the Tariff Act of 1930, and is 
generally enforced by CBP. Standards for milled rice are established by 
the U.S. Department of Agriculture (USDA) and FDA would refer possible 
violations to USDA.
    Question. The draft guidance that FDA released on March 13th 
regarding deemed tobacco products lacks clarity. Once the proposal goes 
into effect, which according to the guidance is 30 days after the 
guidance is finalized, will it be legal for any type of retail outlet 
to sell flavored e-cigarette products (other than mint, menthol and 
tobacco) that have not received pre-market approval? And, if so, what 
retail outlets will be able to sell those products?
    Answer. As you note, on March 13, 2019, FDA announced a proposed 
modification of its enforcement policy aimed at preventing youth access 
to, and appeal of, flavored tobacco products, including e-cigarettes 
(``March 13 draft guidance''). In that draft guidance, the Agency 
explained that it had reconsidered and was proposing to modify its 
previously articulated compliance policy as to the premarket 
authorization requirements for certain Electronic Nicotine Delivery 
Systems (ENDS) products that were on the market on August 8, 2016, when 
the deeming rule took effect and they became subject to FDA regulation. 
The March 13 draft guidance proposes to modify the policy that had been 
articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). The draft guidance is premised on the reality 
that all new ENDS products that lack marketing authorization are not 
lawfully on the market, and that, to protect our nation's youth from 
the growing epidemic of e-cigarette use, it is appropriate to revisit 
the August 2017 compliance guidance. In the draft guidance, FDA 
proposes to prioritize enforcement for lack of marketing authorization 
against flavored ENDS products (other than tobacco-flavored, mint-
flavored, and menthol-flavored ENDS products) that are offered for sale 
in ways that pose a greater risk for minors to access the products--
whether the sale is online or at retail establishments. The March 13 
draft guidance, as drafted, would apply to such products as they are 
offered for sale by all retailers, such that no type of retailer would 
be singled out. The draft guidance provides examples of products that 
are offered for sale in ways that pose greater risk for minors to 
access such products. These examples include products offered for sale 
both in brick and mortar stores and online.
    FDA sought comment on its proposed approach and on the most 
appropriate means to prevent youth access to ENDS products. Interested 
persons had until April 30, 2019, to submit comments before the Agency 
began work on the final version of the March 13 draft guidance, and FDA 
is carefully reviewing over 15 ,000 comments received. In addition, 
please note that the Agency's August 2017 compliance guidance was the 
subject of litigation and on May 15, 2019, the U.S. District Court for 
the District of Maryland ruled against the FDA, vacated the August 2017 
compliance guidance, and ordered the parties to brief remedies. The 
parties are awaiting the Court's order on remedies.
    Question. Once the draft guidance is finalized and goes into 
effect, do you expect that e-cigarettes in flavors other than tobacco, 
mint and menthol will continue to be sold? If so, in what types of 
outlets will those flavors be sold?
    Answer. See response above.
    Question. Will the final guidance explain to the regulated 
community which retailers will be able to sell exactly what e-cigarette 
products and what those retailers need to do in order to be able to 
sell those products?
    Answer. See response above.
    Question. The draft guidance seems to make enforcement against 
stores that allow minors to enter the store its number I enforcement 
priority and example in the guidance. But, we have seen data indicating 
that Internet sellers and adult only stores such as vape shops and 
tobacco stores sell more e-cigarettes to minors than all of the outlets 
that allow minors to enter. Why would FDA prioritize enforcement 
against retail outlets making the fewest sales to minors, when the data 
shows these outlets have fewer sales to minors that adult-only 
locations?
    Answer. FDA is committed to addressing the alarming trend of youth 
use of electronic nicotine delivery systems (ENDS). Minors are 
accessing such products through both brick-and-mortar and online 
retailers. FDA wishes to clarify that the March 13 draft guidance 
(``March 13 draft guidance'') does not propose to give a higher 
priority to enforcement against brick-and-mortar retailers, as compared 
to online retailers. FDA has proposed prioritizing enforcement for 
flavored ENDS products (other than tobacco-flavored, mint-flavored, and 
menthol-flavored ENDS products) that are offered for sale in ways that 
pose a greater risk for minors to access the products--whether the 
product is offered for sale online or at retail establishments. The 
guidance, if finalized as drafted, would apply to all products offered 
for sale by retailers, such that no type of retailer would be singled 
out.
    The March 13 draft guidance provides examples of products that are 
offered for sale in ways that pose greater risk for minors to access 
such products. These examples include products offered for sale both in 
brick-and-mortar stores and online stores.
    FDA sought comment on its proposed approach and on the most 
appropriate means to prevent youth access to ENDS products. Interested 
persons had until April 30, 2019, to submit comments before the Agency 
began work on the final version of the March 13 draft guidance, and FDA 
is carefully reviewing over 15,000 comments received. In addition, 
please note that the Agency's August 2017 compliance guidance was the 
subject of litigation and on May 15, 2019, the U.S. District Court for 
the District of Maryland ruled against the FDA, vacated the August 2017 
compliance guidance, and ordered the parties to brief remedies. The 
parties are awaiting the Court's order on remedies.
    Question. The draft guidance that FDA released on March 13th 
regarding deemed tobacco products including e-cigarettes says that FDA 
will prioritize enforcement for flavored e-cigarettes that are sold 
``in ways that pose a greater risk for minors to access such 
products.'' The guidance says that means FDA will enforce in locations 
where minors are able to enter. But, the same guidance also says that 
more minors reported getting e-cigarettes from vape shops, which are 
only open to adults, than from convenience stores, which are open to 
minors as well. The enforcement priority in guidance is contradicted by 
the facts in the guidance itself. Why would enforcement focus on places 
that actually have a lower risk of selling to minors?
    Answer. FDA is committed to addressing the alarming trend of youth 
use of electronic nicotine delivery systems (ENDS). Minors are 
accessing such products through both brick-and-mortar retailers 
(including a range of different types of establishments) and online 
retailers. Accordingly, the March 13 draft guidance (``March 13 draft 
guidance'') focuses on all types of retailers and no type of retailer 
is being singled out. FDA has taken swift action aimed at the 
manufacturers and retailers of youth-appealing ENDS products and 
continues to take action to stop sales to minors.
    The March 13 draft guidance provides examples of products that are 
offered for sale in ways that pose greater risk for minors to access 
such products. The examples provided include sales that happen both in 
brick-and-mortar stores and online stores. Please note that the term 
``vape shop,'' as used in the guidance, is in reference to the study 
conducted by S.T. Liu et al., which appears to encompass a wide variety 
of establishments, and FDA is not aware of evidence that all vape shops 
permit only adults to enter.
    During the draft guidance comment period, FDA sought comment on its 
proposed approach and on appropriate means to prevent youth access to 
ENDS products. The comment period for the March 13 guidance closed on 
April 30, 2019, and FDA is carefully reviewing over 15,000 comments 
received. In addition, please note that the Agency's August 2017 
compliance guidance was the subject of litigation and on May 15, 2019, 
the U.S. District Court for the District of Maryland ruled against the 
FDA, vacated the August 2017 compliance guidance, and ordered the 
parties to brief remedies. The parties are awaiting the Court's order 
on remedies.
    Question. The American Journal of Health Promotion published a 
study in August 2018 that showed that online sellers, vape shops, and 
tobacco stores all sold many more e-cigarettes to minor s than 
convenience stores, grocers, drug stores and others that are open to 
the general public. Doesn't that mean your proposed enforcement 
priority is the wrong one?
    Answer. FDA is committed to addressing the alarming trend of youth 
use of electronic nicotine delivery systems (ENDS). Minors are 
accessing such products through both brick-and-mortar (including a 
range of different types of establishments) and online retailers. 
Accordingly, the March 13 draft guidance (``March 13 draft guidance'') 
focuses on all types of retailers and no type of retailer is being 
singled out. FDA has taken swift action aimed at the manufacturers and 
retailers of youth-appealing ENDS products and continues to take action 
to stop sales to minors.
    The March 13 draft guidance proposed to modify the policy that had 
been articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). In the March 13 draft guidance, FDA was 
proposing to prioritize enforcement, on a case-by-case basis, of, among 
other things, flavored ENDS products (other than tobacco-flavored, 
mint-flavored, and menthol-flavored ENDS products) that are offered for 
sale in ways that pose a greater risk for minors to access such 
products.
    The March 13 draft guidance provides examples of products that are 
offered for sale in ways that pose greater risk for minors to access 
such products. These examples include sales that happen in brick-and-
mortar stores (and without distinction as to whether the stores meet 
any particular definition of ``vape shop,'' ``grocer,'' or other term) 
and online stores.
    During the draft guidance comment period, FDA sought comment on its 
proposed approach and on appropriate means to prevent youth access to 
ENDS products. The comment period for the March 13 guidance closed on 
April 30, 2019, and FDA is carefully reviewing over 15,000 comments 
received. In addition, please note that the Agency's August 2017 
compliance guidance was the subject of litigation and on May 15, 2019, 
the U.S. District Court for the District of Maryland ruled against the 
FDA, vacated the August 2017 compliance guidance, and ordered the 
parties to brief remedies. The parties are awaiting the Court's order 
on remedies.
    Question. The draft guidance that FDA released March 13th says that 
enforcement against the sale of flavored e-cigarettes will be 
prioritized in outlets where minors are able to enter the retail 
establishment ``or an area within the establishment.'' What does an 
area within an establishment mean and where in the guidance does it 
explain to retailers what that means and how to have an adult-only 
area?
    Answer. FDA is committed to addressing the alarming trend of youth 
use of electronic nicotine delivery systems (ENDS). Minors are 
accessing such products through both brick-and-mortar and online 
retailers. FDA has taken swift action aimed at products that are 
offered for sale in ways that pose greater risk for minors to access 
such products and continues to take action to stop sales to minors.
    Question. As you note, in March, FDA issued a draft guidance ('' 
March 13 draft guidance'') proposing to modify the policy that had been 
articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). In the March 13 draft guidance, FDA has 
proposed to prioritize enforcement of flavored ENDS products (other 
than tobacco-flavored, mint-flavored, and menthol-flavored ENDS 
products) that are offered for sale in ways that pose a greater risk 
for minors to access such products. The draft guidance document 
provides flexibility for retailers so they can decide how to further 
restrict the access of these products to youth based on their specific 
circumstance. The intent is that the flavored products would be 
maintained in an age restricted location. FDA requested and received 
comments on this issue during the public comment period and plans to 
address the comments in the final guidance.
    FDA sought comment on its proposed approach. Interested persons had 
until April 30, 2019, to submit comments before the Agency began work 
on the final version of the March 13 draft guidance, and FDA is 
carefully reviewing over 15 ,000 comments received, including some 
addressing age restricted locations. In addition, please note that the 
Agency's August 2017 compliance guidance was the subject of litigation 
and on May 15, 2019, the U.S. District Court for the District of 
Maryland ruled against the FDA, vacated the August 2017 compliance 
guidance, and ordered the parties to brief remedies. The parties are 
awaiting the Court's order on remedies.
    For example, if e-cigarette products are kept behind the sales 
counter of a store and only adult employees are allowed behind that 
counter, is that an adult-only area of a store that would mean it would 
not be an enforcement priority?
    Answer. See response above.
    Question. The study from the American Journal of Health Promotion 
that FDA cited in its proposal shows Internet sellers, vape shops and 
tobacco stores are the top three types of retail outlets where youth 
reported acquiring e-cigarettes. Vape shops and tobacco stores are 
adult only and under the FDA's proposal, they plus Internet sellers 
will be able to sell flavored e-cigarettes while stores that sell far 
fewer of these products to minors will get most of the enforcement. 
That seems like it will hurt the problem more than help. Don't you 
agree?
    Answer. FDA is committed to addressing the alarming trend of youth 
use of electronic nicotine delivery systems (ENDS). Minors are 
accessing such products through both brick-and-mortar retailers 
(including a range of different types of establishments) and online 
retailers. Accordingly, the March 13 draft guidance (``March 13 draft 
guidance'') focuses on products offered for sale at all types of 
retailers and no type of retailer is being singled out. FDA has taken 
swift action aimed at products that are offered for sale in ways that 
pose greater risk for minors to access such products and continues to 
take action to stop sales to minors.
    The March 13 draft guidance proposed to modify the policy that had 
been articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). In the March 13 draft guidance, FDA has 
proposed to prioritize enforcement, on a case-by-case basis, of 
flavored ENDS products (other than tobacco-flavored, mint-flavored, and 
menthol-flavored ENDS products) that are offered for sale in ways that 
pose a greater risk for minors to access such products.
    FDA sought comment on its proposed approach and on the most 
appropriate means to prevent youth access to ENDS products. Interested 
persons had until April 30, 2019, to submit comments before the Agency 
began work on the final version of the March 13 draft guidance, and FDA 
is carefully reviewing over 15,000 comments received. In addition, 
please note that the Agency's August 2017 compliance guidance was the 
subject of litigation and on May 15, 2019, the U.S. District Court for 
the District of Maryland ruled against the FDA, vacated the August 2017 
compliance guidance, and ordered the parties to brief remedies. The 
parties are awaiting the Court's order on remedies.
    Question. The second priority for enforcement under the draft 
guidance includes online sellers that have sold to minors after the 
guidance. But, the guidance indicates that online enforcement will 
focus on those online sellers that don't have purchase quantity limits 
or don't use third party identity verification services. So, this seems 
like a self-fulfilling prophecy that as long as an online seller has 
purchase quantity limits and uses third party identity verification it 
can avoid enforcement and, of course, avoid having violations. This 
seems like a big loophole for online sellers to be able to sell 
products that other retailers can't sell and potentially sell them to 
minors without real oversight, don't you think?
    Answer. FDA has proposed prioritizing enforcement of flavored 
electronic nicotine delivery system (ENDS) products (other than 
tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) 
that are offered for sale in ways that pose a greater risk for minors 
to access the products--whether the sale is online or at retail 
establishments. The March 13 draft guidance applies to such products as 
they are offered for sale by all retailers and no type of retailer is 
being singled out.
    The March 13 draft guidance provides examples of products that are 
offered for sale in ways that pose greater risk for minors to access 
such products. FDA would like to clarify that the examples are not 
listed in any priority or weighted order. Although the example of 
products sold through retailers (i.e., brick-and-mortar and online 
sellers) that have sold to minors after issuance of the final guidance 
is listed as the second example, it is not more or less important than 
the other examples provided. The examples provided in the March 13 
draft guidance include products offered for sale both in brick-and-
mortar stores and online. For example, flavored ENDS products (other 
than tobacco-flavored, mint-flavored, and menthol-flavored ENDS 
products) sold in locations where minors can enter at any time (e.g., 
the entire establishment or an area within the establishment); or, for 
online sales, products sold without limits on the quantity that a 
customer may purchase within a given period of time, and products sold 
without independent, third-party, age- and identity-verification 
services that compare customer information against third-party data 
sources, such as public records. An example that applies to products as 
they are sold by both types of retailers is the consideration of the 
sales history of retail establishments and online retailers to minors 
after issuance of the final guidance. FDA maintains a searchable, 
publicly available retail inspection database that contains information 
about sales to minors.
    FDA sought comment on its proposed approach and on the most 
appropriate means to prevent youth access to ENDS products. Interested 
persons had until April 30, 2019, to submit comments before the Agency 
began work on the final version of the March 13 draft guidance, and FDA 
is carefully reviewing over 15,000 comments received.
    The March 13 draft guidance proposes to modify the policy that had 
been articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). Please note that the Agency's August 2017 
compliance guidance was the subject oflitigation and on May 15, 2019, 
the U.S. District Court for the District of Maryland ruled against the 
FDA, vacated the August 2017 compliance guidance, and ordered the 
parties to briefremedies. The parties are awaiting the Court's order on 
remedies.
    Question. The Tobacco Control Act limits the FDA's authority to 
regulate the sale and distribution of tobacco products. It says any 
such regulation must be the product of full notice and comment 
rulemaking. Why is FDA using guidance to effectuate e-cigarette sales 
policy changes when the Act so clearly calls for a rulemaking in this 
situation?
    Answer. FDA's draft guidance related to enforcement of the Tobacco 
Control Act's premarket review requirements. Currently, all electronic 
nicotine delivery systems (ENDS) products are on the market in the 
United States without a premarket authorization by FDA. In addition, 
certain cigar products that meet the statutory definition of a new 
tobacco product likewise remain on the market without FDA premarket 
authorization. To address the epidemic rise in youth use of ENDS 
products and public health concerns regarding flavored cigars (other 
than tobacco flavored), FDA's draft guidance proposed to modify the 
Agency's existing policy of exercising enforcement discretion regarding 
the (lack of) premarket authorization for these products. These 
proposed changes did not seek to impose a new regulatory requirement; 
rather, they sought to prioritize FDA enforcement of the existing 
premarket authorization requirement in ways that would maximize the 
public health benefit of FDA's potential enforcement activity.
    Question. In contrast, an action to ban menthol in cigarettes would 
require notice and comment rulemaking. Section 907 of the Federal Food, 
Drug, and Cosmetic Act gives FDA the authority to issue tobacco product 
standards that are appropriate for the protection of public health, but 
only via notice-and-comment rulemaking. Why then is the policy change 
to ban menthol in cigarettes going through the full notice and comment 
rulemaking process?
    Answer. See response above.
    Question. The last published Population Assessment of Tobacco and 
Health (PATH) study from FDA found that among the 14 percent of young 
people that did get their e-cigarettes from stores, 76% said they got 
them from vape shops and only 16 percent said they got them from 
convenience stores. Why does the FDA proposal focus on prohibiting and 
enforcing against the sale of flavors in convenience stores and not in 
vape shops if the data shows that many more kids buy e-cigarettes from 
vape shops rather than convenience stores?
    Answer. FDA is committed to addressing the alarming trend of youth 
use of electronic nicotine delivery systems (ENDS). Minors are 
accessing such products through both brick-and-mortar and online 
retailers. FDA has taken swift action aimed at the manufacturers and 
retailers of youth-appealing ENDS products and continues to take action 
to stop sales to minors.
    On March 13, 2019, FDA issued a draft guidance which proposed to 
modify its previously articulated compliance policy as to the premarket 
review of certain ENDS products as an additional way to help prevent 
youth from accessing and using these products. For example, under the 
draft guidance, FDA proposes prioritizing enforcement of flavored ENDS 
products (other than tobacco-flavored, mint-flavored, and menthol-
flavored ENDS products) that are offered for sale in ways that pose a 
greater risk for minors to access the products--regardless of whether 
the product is offered for sale from vape shops (however that term is 
defined) or from convenience stores. The draft guidance applies to such 
products as they are offered for sale by all retailers and no type of 
retailer is being singled out. Please note also that the term ``vape 
shop'' appears to encompass a wide variety of establishments, and FDA 
is not aware of evidence that all vape shops permit only adults to 
enter.
    The draft guidance provides examples of products that are offered 
for sale in ways that pose greater risk for minors to access such 
products. The examples provided include products as they are offered 
for sale both in brick and mortar stores (of various types) and online 
stores. For example, the draft guidance uses as an example flavored 
ENDS products (other than tobacco- flavored, mint-flavored, and 
menthol-flavored ENDS products) sold in locations where minors can 
enter at any time (e.g., the entire establishment or an area within the 
establishment); or, for online sales, products sold without limits on 
the quantity that a customer may purchase within a given period of 
time, and products sold without independent third-party, age- and 
identity-verification services that compare customer information 
against third-party data sources, such as public records. An example 
that applies to products as they are sold by both types of retailers is 
the consideration of the sales history of retail establishments and 
online retailers to minors after issuance of the final guidance; 
information about sales to minors identified by FDA is publicly 
available on FDA's searchable retail inspection database.
    FDA sought comment on its proposed approach in the draft guidance 
and on the most appropriate means to prevent youth access to ENDS 
products. Interested persons had until April 30, 2019, to submit 
comments before the Agency began work on the final version of the 
guidance, and FDA is carefully reviewing over 15,000 comments received.
    The March 13 draft guidance proposes to modify the policy that had 
been articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). Please note that the Agency's August 2017 
compliance guidance was the subject of litigation and on May 15, 2019 , 
the U.S. District Court for the District of Maryland ruled against the 
FDA, vacated the August 2017 compliance guidance, and ordered the 
parties to brief remedies. The parties are awaiting the Court' s order 
on remedies.
    Question. The FDA draft guidance references internal analyses of 
Population Assessment of Tobacco and Health (PATH) data a number of 
times. Please provide all of those internal analyses to this committee. 
Why haven't those analyses and all of the most recent PATH data been 
published?
    Answer. The draft guidance issued on March 13, 2019 proposed 
changes to the Agency' s previously articulated compliance policy 
(``August 2017 compliance guidance'') as to the premarket authorization 
requirements for certain electronic nicotine delivery system (ENDS) 
products and flavored cigars that were on the market on August 8, 2016, 
when the deeming rule took effect and they became subject to FDA 
regulation. The draft guidance puts manufacturers and retailers on 
notice of FDA's enforcement priorities. In that guidance, FDA has 
proposed to prioritize enforcement, on a case-by-case basis, of 
flavored ENDS products (other than tobacco-flavored, mint-flavored, and 
menthol-flavored ENDS products) that are offered for sale in ways that 
pose a greater risk for minors to access such products.
    When the draft guidance was issued, FDA posted in the docket a memo 
entitled, ``Summary of Internal Analyses from Wave 4 of the Population 
Assessment of Tobacco and Health (PATH) Study.'' The memo provides a 
summary of FDA's internal analyses, including the estimates and 
information from the PATH study upon which they rely. Data from the 
PATH Study are available in restricted-use and public-use files. The 
Restricted Use File (RUF) is available to researchers by application 
through the National Addiction & HIV Data Archive Program (NAHDAP) at 
the University of Michigan. The RUF is accessed through a virtual data 
enclave (VDE) which the University of Michigan oversees. The Public Use 
File (PUF) is available for download, also through NAHDAP. Those 
interested in downloading the PUF are required to create a user 
account. These files, along with additional study documentation, can be 
found at https://doi.org/10.3886/Series606. The Wave 4 RUF was released 
to the public on May 31, 2019. Public release of the Wave 4 PUF is 
anticipated for Fall 2019.
    The PATH data is not the sole basis for the draft guidance; FDA 
referenced several other sources of data in explaining the reasoning 
behind the proposed revisions to its compliance policies. For example, 
the guidance also cites 2018 National Youth Tobacco Survey (NYTS) data, 
National Adolescent Drug Trends in 2018 from Monitoring the Future, and 
other research published in medical journals. The evidence FDA 
considered highlighted the need for the Agency to revisit its 
compliance policies in a timely manner with respect to the continued 
marketing of deemed tobacco products that have not obtained premarket 
authorization.
    Question. Please note that the Agency's August 2017 compliance 
guidance was the subject of litigation and on May 15, 2019, the U.S. 
District Court for the District of Maryland ruled against the FDA, 
vacated the August 2017 compliance guidance, and ordered the parties to 
brief remedies. The parties are awaiting the Court's order on remedies. 
Why would you move forward with a proposed new policy before the PATH 
study is finished and public?
    Answer. See response above.
                                 ______
                                 
              Questions Submitted by Senator John Kennedy
    Question. Recently, FDA took decisive action to reduce youth access 
toe-cigarettes. There is draft guidance and it needs to be implemented. 
When will the recently announced ENDS (electronic nicotine delivery 
system) guidance be final?
    Answer. On March 13, 2019, FDA announced a new proposed policy 
aimed at preventing youth access to, and appeal of, flavored tobacco 
products, including e-cigarettes and cigars (``March 13 guidance''). In 
that guidance, the Agency explained that it had reconsidered and was 
proposing to modify its previously articulated compliance policy as to 
the premarket authorization requirements for certain Electronic 
Nicotine Delivery Systems (ENDS) products and flavored cigars that were 
on the market on August 8, 2016, when the deeming rule took effect and 
they became subject to FDA regulation. The March 13 guidance proposed 
to modify the policy that had been articulated in a guidance issued in 
August 2017 (``August 2017 compliance guidance'').
    The comment period for the March 13 guidance closed on April 30, 
2019, and FDA is carefully reviewing over 15,000 comments received. In 
addition, please note that the Agency's August 2017 compliance guidance 
was the subject of litigation and on May 15, 2019, the U.S. District 
Court for the District of Maryland ruled against the FDA, vacated the 
August 2017 compliance guidance, and ordered the parties to brief 
remedies. On June 13, 2019, the Agency filed its response in the case 
and the litigation is still pending. In the meantime, FDA remains 
committed to tackling the troubling epidemic of e-cigarette use among 
kids. Preventing youth access to and use of ENDS remains one of FDA' s 
top priorities.
    Question. I understand that the 2019 National Youth Tobacco Survey 
is in the field now and that you expect to see early results this 
summer. Knowing FDA's actions will take a period of time to be 
finalized and enforced, the 2019 results won't be able to capture the 
effects of the ENDS guidance. When can we reasonably expect that the 
data will reflect youth trends reversing?
    Answer. While FDA is not able to predict when youth use of 
electronic nicotine delivery system (ENDS) products will begin to 
decline, the Agency is committed to addressing this alarming trend. 
Minors are accessing such products through both brick-and-mortar and 
online retailers, and FDA has taken swift action aimed at the 
manufacturers of youth-appealing ENDS products and continues to take 
action to stop sales to minors.
    In fiscal year 2018 and 2019, as part of the Youth Tobacco 
Prevention Plan, FDA took multiple enforcement actions to stop youth 
use of, and access to, e-cigarette products. For example, FDA has sent 
letters to more than 60 companies seeking information on over 90 brands 
of tobacco products, including ENDS, to determine the date on which 
those products entered the market. FDA also requested a meeting with 
the corporate management of Walgreen Co. to discuss the company's track 
record of illegally selling tobacco products, including ENDS, to kids. 
Other national retail chains have similar track records and FDA plans 
to hold those companies accountable as well. The Agency held a public 
hearing to discuss efforts to eliminate youth e-cigarette use, with a 
focus on the potential role of drug therapies to support cessation 
among youth, and the issues impacting the development of such therapies 
for children. FDA also conducted a nationwide blitz to crack down on 
the sale of e-cigarettes to minors at both brick-and-mortar and online 
retailers, and subsequently issued more than 1,300 warning letters and 
civil money penalty complaints to retailers who illegally sold e-
cigarette products to minors. The Agency has partnered with the Federal 
Trade Commission (FTC) to issue warning letters to manufacturers, 
distributors, and retailers for selling e-liquids used in e-cigarettes 
with labeling and/or advertising that falsely and/or misleadingly cause 
the products to imitate food products, particularly ones that are 
marketed toward, and/or appealing to children such as juice boxes, 
candy, or cookies some of them with cartoon-like imagery. Further, FDA 
requested that certain e-cigarette manufacturers submit documents to 
help the Agency better understand the reportedly high rates of youth 
use and youth appeal of e-cigarette products, and also issued letters 
to the manufacturers of five top-selling vape product brands asking 
each company to submit plans addressing youth access and use of their 
products. The Agency also investigated e-cigarette companies that may 
have been illegally marketing their products to youth. Finally, FDA 
contacted eBay to raise concerns over several listings of JUUL products 
listed for sale on their website, which appeared to be inconsistent 
with eBay's policy on tobacco products. As a result, eBay removed the 
listings and voluntarily implemented measures to prevent future 
listings from being posted on their website.
    Throughout fiscal year 2018 and 2019, FDA took many more similar 
actions against retailers for selling e-cigarettes and other tobacco 
products to minors. From the start of fiscal year 18 through March 31, 
2019, FDA conducted 214,293 inspections of retail establishments that 
sell tobacco products, issued 20,121 warning letters to retailers for 
violating the law, and initiated about 5,729 civil money penalty cases. 
FDA also issued 54 No-Tobacco-Sale Orders, which can result in 
retailers being prohibited from selling tobacco products for specified 
periods of time.
    FDA also expanded its successful ``The Real Cost'' public education 
campaign to address Youth E-Cigarette Prevention, aimed at educating 
kids about the dangers of e-cigarettes. The campaign targets nearly 
10.7 million youth, aged 12-17, who have used e-cigarettes or are open 
to trying them, and features hard-hitting advertising on digital and 
social media sites popular among teens, as well as placing posters with 
e-cigarette prevention messages in high schools across the nation. FDA 
has also joined forces with Scholastic to provide educational resources 
to more than 750,000 high school educators. Resources include the 
National Youth Tobacco Survey (NYTS) infographic, an e-cigarette 
``mythbusters'' infographic, a lesson plan and an activity sheet. All 
materials are available online at: www.scholastic.com/youthvapingrisks.
    On March 13, 2019, FDA issued a draft guidance (``March 13 
guidance'') proposing to modify the compliance policy that had been 
articulated in a guidance issued in August 2017 (``August 2017 
compliance guidance''). In the March 13 guidance, FDA was proposing to 
prioritize enforcement, on a case-by-case basis, of flavored ENDS 
products (other than tobacco-flavored, mint-flavored, and menthol-
flavored ENDS products) that are offered for sale in ways that pose a 
greater risk for minors to access such products. The comment period for 
the March 13 guidance closed on April 30, 2019, and FDA is carefully 
reviewing over 15,000 comments received. In addition, please note that 
the Agency's August 2017 compliance guidance was the subject of 
litigation and on May 15, 2019, the U.S. District Court for the 
District of Maryland ruled against the FDA, vacated the August 2017 
compliance guidance, and ordered the parties to brief remedies. On June 
13, 2019, the Agency filed its response in the case and the litigation 
is still pending.
    These are just some examples of the work FDA has done to protect 
children from tobacco products, but the Agency still has much work to 
accomplish. FDA will continue to take strong action to protect youth 
and will monitor the effectiveness of our actions. FDA's comprehensive 
approach to date of addressing youth use of ENDS reflects a careful 
balancing of public health considerations.
    Question. Last year I met with hundreds of shrimpers who told me 
they're struggling to compete with imported seafood that drives down 
the cost of their product. The prices have gotten so low that you'd 
think it was the 1980s if the cost of living weren't so high. As one 
shrimper put it, he can't make it on cents. He needs dollars. Foreign 
seafood is full of antibiotics. It's subsidized by foreign governments. 
And it's reaching U.S. tables and undercutting the market because we 
can't inspect enough of it and filter out the cheaters. The fiscal year 
2019 appropriations bill included my amendment to increase imported 
seafood inspections by 26 percent to $15 million. In order for your 
staff to do the job that they need to, how much funding would you need?
    Answer. Consistent with the Consolidated Appropriations Act, 2019, 
FDA will dedicate at least $15 million of our base resources toward 
foreign seafood inspections and seafood import field examinations in 
fiscal year 2019.
    Question. While sampling and testing food before admitting it into 
the country is one effective method for detecting contamination, it is 
labor-intensive and costly. Therefore, FDA uses an approach for 
examinations and sampling that targets the highest-risk products, 
allows regular monitoring and surveillance of imported products, 
facilitates targeted assignments to collect data that informs oversight 
activities, and assists with verification of other countries' related 
programs. FDA plans to evaluate the use of artificial intelligence and 
machine learning, a method of data analysis, for screening of imported 
food, including seafood, to assess the applicability of emerging new 
technologies in fiscal year 2020. What else can be done to tackle the 
issue with foreign seafood coming through our ports?
    Answer. FDA relies on a number of tools to prevent food safety 
problems in the foreign supply chain prior to entry into the United 
States, to detect and to refuse entry of unsafe foods at U.S. borders, 
to respond quickly when FDA learns of unsafe imported foods, and to 
measure our progress to ensure that our imported food safety program 
remains effective and efficient. Inspections are just one important 
tool that FDA relies on to meet these goals. Seafood importer 
inspections are conducted in the United States and are a review of the 
importer's compliance with the importer verification requirements under 
the seafood Hazard Analysis and Critical Con trol Points (HACCP) 
regulations. In addition to these importer inspections, FDA also 
conducts foreign surveillance inspections at overseas manufacturing 
sites. FDA's foreign surveillance inspections are designed to identify 
potential food safety problems before products arrive in the United 
States, to determine the compliance status of facilities with FDA's 
requirements and food safety standards, to help the Agency make 
admissibility decisions when food products are offered for importation 
into the United States, and to help ensure that imported food products 
under FDA's jurisdiction meet U.S. requirements under the Federal Food, 
Drug, and Cosmetic Act. These routine inspections are an important way 
for FDA to ensure that foreign food facilities exporting to the United 
States, and their products, meet U.S. requirements.
    While FDA does not have the resources to inspect every foreign 
facility, the Agency uses additional programs and tools to help ensure 
that food produced in foreign facilities is safe. Programs like the 
Voluntary Qualified Importer Program and third-party audits are 
resources that complement our facility inspections and help ensure the 
safety of our food supply. Regulatory partners here in the United 
States and abroad play an important role in identifying and rejecting 
unsafe food offered for import into the country as well as marshalling 
effective responses when foodborne illness or injury does occur. The 
Agency also monitors imported food safety through sample collections 
and field exams of food products at the border.
    FDA also works to ensure that problematic foreign seafood and other 
imported foods are detected and refused during the import process. FDA 
electronically screens all commercial entries and targets its work on 
high-risk products in import sampling and examination, as well as by 
relying on other types of evidence. To accomplish this task, FDA uses 
its Predictive Risk-based Evaluation for Dynamic Import Compliance 
Targeting (PREDICT) system, an automated import screening tool that 
helps us to identify high-risk shipments of food offered for import.
    Additionally, the Agency may list a firm on an Import Alert, which 
informs the FDA field staff and the public that the Agency has enough 
evidence to allow for Detention Without Physical Examination (DWPE) of 
products that appear to be in violation of FDA laws and regulations. 
Violations may be related to the product, manufacturer, shipper, or 
other information. Based on the information in an Import Alert, FDA 
field staff may detain the product without physically examining it, and 
potentially refuse admission into the United States if the shipper does 
not provide evidence to FDA to overcome the appearance of the 
violation. The Agency currently has several Import Alerts that address 
hazards in shrimp, including country-wide Import Alerts, Import Alerts 
for unapproved aquaculture drugs in shrimp, and Import Alerts for 
undeclared sulfites in shrimp. More information on Import Alerts, 
including shrimp-related Import Alerts, can be found on the FDA 
website.
    FDA field laboratories currently test imported seafood for a wide 
variety of the most commonly found drug residues. The Agency is always 
working to expand the types of drug residues the labs can test for to 
include the latest residues of interest and to update the testing 
methods to use the newest detection platforms available.
    FDA is working to use these various tools in combination as 
effectively as possible to address potential food safety hazards. 
Further information about these tools is available in the ``FDA 
Strategy for the Safety of Imported Food,'' which the Agency released 
on February 26.
    In addition, the Agency continues to consider new methods to ensure 
the safety of imported seafood, such as exploration of the use of 
artificial intelligence and machine learning, as discussed in the 
previous response.
                                 ______
                                 
 Questions Submitted by Senator Merkley on behalf of Senator Murkowski
    Question. One issue that is important to this Subcommittee on both 
sides of the aisle is ensuring that pregnant women receive the best, 
science-based advice they can on how to make healthy decisions during 
their pregnancy. To this end, the Food and Drug Administration 
published a comprehensive analysis of the net effects of seafood 
consumption for pregnant women, nursing mothers and young children in 
June 2014. In January 2017, however, FDA published advice that does not 
reflect the findings of the net effects report. FDA's published advice 
not only fails to promote the actual nutrient value of fish and the 
benefits of consumption for fetal and child development, but it 
contradicts science-the FDA's own nutrition science, the Dietary 
Guidelines, and others. For instance, the advice on FDA's website 
recommends pregnant women limit seafood consumption of halibut, 
sablefish, snapper and albacore tuna to 1 serving per week, when the 
FDA's own nutrition science, the June 2014 Net Effects Report, 
concludes pregnant women benefit from eating over 14 servings of these 
fish per week. The advice also strongly implies that parents avoid 
seafood for children under age 2 when the American Academy of 
Pediatrics recommends introducing seafood starting at 4 to 6 months. 
The Consolidated Appropriations Act of 2019 requires FDA to reissue, 
following the traditional interagency review process, the seafood 
advice so that it is consistent with the agency's recognized science on 
the net effects of seafood consumption. Will the FDA commit to promptly 
reissuing the January 19, 2017 advice to pregnant women in a manner 
that is consistent with nutrition science recognized by the FDA in the 
June 2014 Net Effects Report?
    Answer. FDA shares the Committee's interest in ensuring that 
pregnant and breastfeeding women and caregivers of young children have 
clear, useful, and science-based information that encourages them to 
eat more fish. FDA is currently working to address the directive in 
Section 773 of the Consolidated Appropriations Act of 2019.
    The Agency notes that the 2017 advice was based on a scientific 
evaluation that accounts for the net effects- the Agency did consider 
net effects evidence in developing the advice. The 2017 advice is also 
consistent with the latest nutrition science. FDA has looked at the 
totality of the scientific evidence, and based on that evidence, FDA 
remains confident that the advice meets the goal of encouraging 
pregnant women, breastfeeding women, women considering becoming 
pregnant, and young children to eat more fish, particularly fish lower 
in mercury, and supports that the vast majority of fish species can be 
consumed on a regular basis.
    While FDA released the net effects report in connection with the 
draft advice issued in 2014, additional analyses, studies, and comments 
received on the draft advice caused FDA and EPA to base final fish 
consumption categories on methylmercury exposure. Specifically, newer 
research has brought into question the validity of several assumptions 
underpinning the net effects report. As stated above, FDA considered 
the results of the net effects report in developing the 2017 fish 
advice but did not use the net effects report as the basis for 
determining the categories of species of fish.
    The current 2015-2020 Dietary Guidelines for Americans provides 
quantitative recommendations for amounts of seafood to consume to 
promote health for the general population, pregnant and breastfeeding 
women, and young children (over 2 years), noting pregnant and 
breastfeeding women should make choices lower in methylmercury. The 
2015-2020 Dietary Guidelines, however, do not provide information on 
levels of methylmercury in fish, and instead acknowledge the 2017 FDA/
EPA fish advice as a tool that pregnant and breastfeeding women can use 
to make informed choices when it comes to fish that are healthy and 
safe to eat. The 2017 fish advice provides an easy-to-use reference 
chart that sorts 62 types of fish into three categories: ``best 
choices,'' ``good choices,'' and ``fish to avoid.'' The relatively 
small list of ``fish to avoid'' helps the target audience narrow down 
the fish that should be avoided, while giving many examples of fish 
that should be consumed. As a science-based agency, FDA continues to 
monitor and consider an array of scientific literature relevant to the 
2017 fish advice in addition to the net effects report.
    The process to develop the 2020-2025 Dietary Guidelines for 
Americans is under way and will include a comprehensive review of 
scientific evidence and development of guidance for infants and 
toddlers from birth to 24 months, as well as for women who are 
pregnant. USDA and HHS have published topics and priority scientific 
questions \3\ for review by the Dietary Guidelines Advisory Committee, 
which were open for public comment, including questions related to the 
benefits of seafood consumption during pregnancy. The 2020-2025 Dietary 
Guidelines are expected to be signed into policy by Secretary Azar and 
Secretary Perdue in late 2020. FDA is committed to ensuring that its 
fish advice is consistent with the Dietary Guidelines and supports 
consumers as they work towards meeting these guidelines. FDA looks 
forward to their availability to further promote the role of fish 
within a healthy dietary pattern for these populations.
---------------------------------------------------------------------------
    \3\ About the Dietary Guideline Advisory Committee--Topics and 
Questions to be examined by the Committee. Available at https://
www.dietaryguidelines.gov/work-under-way/review-science.
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                          SUBCOMMITTEE RECESS

    Senator Hoeven. And with that, we are adjourned.
    [Whereupon, at 11:37 a.m., Thursday, March 28, the 
committee was recessed, to reconvene subject to the call of the 
Chair.]