[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                      IMPROVING SAFETY AND TRANSPARENCY IN 
                             AMERICA'S FOOD AND DRUGS

=======================================================================
                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            JANUARY 29, 2020

                               __________

                           Serial No. 116-93
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov

                               __________

                   U.S. GOVERNMENT PUBLISHING OFFICE                    
48-687 PDF                  WASHINGTON : 2024                    
          
-----------------------------------------------------------------------------------                        
                       
                    COMMITTEE ON ENERGY AND COMMERCE

                     FRANK PALLONE, Jr., New Jersey
                                 Chairman
BOBBY L. RUSH, Illinois              GREG WALDEN, Oregon
ANNA G. ESHOO, California              Ranking Member
ELIOT L. ENGEL, New York             FRED UPTON, Michigan
DIANA DeGETTE, Colorado              JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina    ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California          CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           PETE OLSON, Texas
JERRY McNERNEY, California           DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont                 ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico            H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York                 GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice     BILL JOHNSON, Ohio
    Chair                            BILLY LONG, Missouri
DAVID LOEBSACK, Iowa                 LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon                BILL FLORES, Texas
JOSEPH P. KENNEDY III,               SUSAN W. BROOKS, Indiana
    Massachusetts                    MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California            RICHARD HUDSON, North Carolina
RAUL RUIZ, California                TIM WALBERG, Michigan
SCOTT H. PETERS, California          EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas                GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
                                 ------                                

                           Professional Staff

                   JEFFREY C. CARROLL, Staff Director
                TIFFANY GUARASCIO, Deputy Staff Director
                MIKE BLOOMQUIST, Minority Staff Director
                         Subcommittee on Health

                       ANNA G. ESHOO, California
                                Chairwoman
ELIOT L. ENGEL, New York             MICHAEL C. BURGESS, Texas
G. K. BUTTERFIELD, North Carolina,     Ranking Member
    Vice Chair                       FRED UPTON, Michigan
DORIS O. MATSUI, California          JOHN SHIMKUS, Illinois
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           H. MORGAN GRIFFITH, Virginia
BEN RAY LUJAN, New Mexico            GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon                BILLY LONG, Missouri
JOSEPH P. KENNEDY III,               LARRY BUCSHON, Indiana
    Massachusetts                    SUSAN W. BROOKS, Indiana
TONY CARDENAS, California            MARKWAYNE MULLIN, Oklahoma
PETER WELCH, Vermont                 RICHARD HUDSON, North Carolina
RAUL RUIZ, California                EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire         GREG WALDEN, Oregon (ex officio)
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
LISA BLUNT ROCHESTER, Delaware
BOBBY L. RUSH, Illinois
FRANK PALLONE, Jr., New Jersey (ex 
    officio)
                            
                            C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................     2
    Prepared statement...........................................     3
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     4
    Prepared statement...........................................     6
Hon. Debbie Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     7
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     7
    Prepared statement...........................................     9
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, prepared statement........................   170

                               Witnesses

Kao-Ping Chua, M.D., Ph.D., Assistant Professor, Department of 
  Pediatrics, University of Michigan Medical School..............    11
Prepared statement \1\
    Answers to submitted questions...............................   332
Fernando J. Muzzio, Ph.D., Distinguished Professor, Chemical and 
  Biochemical Engineering, Rutgers, State University of New 
  Jersey.........................................................    12
    Prepared statement...........................................    15
Richard Kaeser, Vice President, Global Brand Protection, Johnson 
  & Johnson......................................................    25
    Prepared statement...........................................    27
    Answers to submitted questions...............................   335
Jeff Allen, Ph.D., President and CEO, Friends of Cancer Research.    31
    Prepared statement...........................................    33
Talia Day, Patient Advocate, Food Allergy Research & Education 
  Group..........................................................    75
    Prepared statement...........................................    78
J. David Carlin, Senior Vice President of Legislative Affairs and 
  Economic Policy, International Dairy Foods Association.........    80
    Prepared statement...........................................    82
Sara Sorscher, Deputy Director of Regulatory Affairs, Center for 
  Science in the Public Interest.................................    87
    Prepared statement...........................................    89
Nancy Perry, Senior Vice President, Government Relations, 
  American Society for the Prevention of Cruelty to Animals......    94
    Prepared statement...........................................    96
Answers to submitted questions \2\
Douglas Corey, D.V.M., Past President, American Association of 
  Equine Practitioners Adams, Oregon.............................   106
    Prepared statement...........................................   108
Tom Balmer, Executive Vice President, National Milk Producers 
  Federation.....................................................   116
    Prepared statement...........................................   118
    Answers to submitted questions...............................   337

----------
\1\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200129/110423/HHRG-116-IF14-Wstate-ChuaK-20200129.pdf.
\2\ Nancy Perry, did not answer the question by the time of 
  publication.
Melanie Benesh, Legislative Attorney, Environmental Working Group   122
    Prepared statement...........................................   124
    Answers to submitted questions...............................   339
Paul C. DeLeo, Ph.D., Principal Integral Consulting, Inc.........   137
    Prepared statement...........................................   139
Mardi Mountford, President, Infant Nutrition Council of America..   144
    Prepared statement...........................................   146

                           Submitted Material

H.R. 961, the Safeguard American Food Exports Act of 2019........   171
H.R. 1769, the Defending Against Imitations and Replacements of 
  Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy 
  Everyday Act...................................................   174
H.R. 2117, the Food Allergy Safety, Treatment, Education, and 
  Research Act of 2019...........................................   180
H.R. 2267, the Infant Formula Protection Act of 2019.............   184
H.R. 2827, the Keep Food Containers Safe from PFAS Act of 2019...   186
H.R. 4487, the Codifying Useful Regulatory Definitions Act.......   189
H.R. 4721, the Fairness in Orphan Drug Exclusivity Act...........   194
H.R. 4866, the National Centers of Excellence in Continuous 
  Pharmaceutical Manufacturing Act of 2019.......................   199
H.R. 5663, the Safeguarding Therapeutics Act.....................   209
H.R. 5668, the Making Objective Drug Evidence Revisions for New 
  Labeling Act of 2020...........................................   212
Letter of January 24, 2020, from Khatereh Calleja, J.D., 
  President and CEO, Healthcare Supply Chain Association, 
  submitted by Mr. Engel.........................................   221
Article of September 2019, ``Healthy Beverage Consumption in 
  Early Childhood,'' by Healthy Eating Research, submitted by Mr. 
  Welch..........................................................   222
Letter of January 23, 2019, from Kyle E. Yasuda, MD, American 
  Academy of Pediatrics, to Mr. Gottlieb, submitted by Mr. Welch.   238
Letter of January 29, 2020, from Grace Meng, to Mr. Pallone and 
  Mr Walden, submitted by Ms. Eshoo..............................   241
Letter of January 28, 2020, from Rachel Weintraub, Legislative 
  Director, et al., Consumer Federation of America, Kids In 
  Danger, and Public Citizen, to Mr. Pallone, and Mr. Walden, 
  submitted Ms. Eshoo............................................   242
Letter of January 27, 2020, from Freddie Hudson, Executive 
  Director, U.S. Harness Racing Alumni Association, and Susan 
  Arrington, Director Federal Affairs, to Mr. Pallone, submitted 
  Ms. Eshoo......................................................   244
Letter of January 28, 2020, from Laura Bonar, Chief Program and 
  Policy Officer, Animal Protection New Mexico, and Voters, to 
  Ms. Eshoo, et al., submitted Ms. Eshoo.........................   245
Testimony of January 27, 2020, from Hilary Wood, President, Front 
  Range Equine Rescue, submitted by Ms. Eshoo \3\
 Letter of January 28, 2020, from Michele Simon, Plant Based 
  Foods Association, to Ms. Eshoo and Mr. Burgess, submitted Ms. 
  Eshoo..........................................................   247
Letter of January 28, 2020, from Elizabeth Bartheld, Vice 
  President, Government and Industry Affairs, American Forest and 
  Paper Association, submitted by Ms. Eshoo......................   249
Letter of January 24, 2020, from Thomas E. Menighan, BSPharm, 
  Executive Vice President and CEO, American Pharmacists 
  Association, to Mr. Pallone, et al., submitted by Ms. Eshoo....   251
Testimony of January 27, 2020, from Neda DeMayo, President, 
  Return to Freedom, Wild Horse Conservation, to Ms. Eshoo and 
  Mr. Burgess, submitted by Ms. Eshoo............................   252
Letter of January 28, 2020, from Scott Dorenkamp, Manager, 
  Livestock Welfare and Government Relations, Professional Rodeo 
  Cowboys Association, to Mr. Pallone, submitted by Ms. Eshoo....   255

----------
\3\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200129/110423/HHRG-116-IF14-20200129-SD024.pdf.
Letter of January 29, 2020, from Diane Edquist Dorman, to Mr. 
  Pallone, et al., submitted by Ms. Eshoo........................   256
Letter of January 28, 2020, from Keith Dane, Senior Adviser, 
  Equine Protection, Humane Society of the U.S., to Mr. Pallone, 
  et al., submitted by Ms. Eshoo.................................   258
Letter of January 28, 2020, from Barbara Hodges, Director of 
  Advocacy and Outreach, et al., Humane Society Veterinary 
  Medical Association, to Mr. Pallone and Mr. Walden, submitted 
  by Ms. Eshoo...................................................   260
Letter of January 28, 2019, from Five Livestock Groups, to Ms. 
  Graham, et al., submitted by Ms. Eshoo.........................   262
Letter of January 27, 2020, from John Boyd, President and 
  Founder, National Black Farmers Association, to Ms. Eshoo, 
  submitted by Ms. Eshoo.........................................   264
Letter of January 23, 2020, from Bill Bullard, CEO, R-CALF USA, 
  to U.S. Representative, submitted by Ms. Eshoo.................   267
Statement of the Animal Rights Driven SAFE Act Threatens American 
  Equine Welfare, from Protect the Harvest Action Fund, submitted 
  by Ms. Eshoo...................................................   268
Letter of January 28, 2020, from Julie Caramante, Vice President, 
  Texas State Horse Council, to Ms. Eshoo, et al., submitted by 
  Ms. Eshoo......................................................   269
Letter of January 3, 2020, from Brooke Miller, Vice President, 
  U.S. Cattlemen's Association, to Vice President Pence, 
  submitted by Ms. Eshoo.........................................   270
Letter of January 28, 2020, from Rene M. Lani, Manager, American 
  Chemistry Council, to Members of the Health and Subcommittee of 
  the Energy and Commerce Committee, submitted by Ms. Eshoo......   272
Statement of January 28, 2019, from Robert Simon, FluoroCouncil, 
  to Members of the Health Subcommittee of the Energy and 
  Commerce Committee, submitted by Ms. Eshoo.....................   274
Letter of January 29, 2020, from Nancy Blaney, Director, 
  Government Affairs, Animal Welfare Institute, to Mr. Pallone, 
  et al., submitted by Ms. Eshoo.................................   276
Letter of January 29, 2020, from American Society of Helath-
  System Pharmacists, submitted by Ms. Eshoo.....................   278
Letter of January 28, 2020, from 15 Healthcare Organizations, to 
  Mr. Pallone, et al., submitted by Ms. Eshoo....................   282
Letter of January 29, 2020, from James L. Gagliano, President and 
  Chief Operating Officer, to Mr. Pallone, et al., the Jockey 
  Club, submitted by Ms. Eshoo...................................   284
Statement of the Healthy Beverage Consumption in Early Childhood, 
  submitted by Ms. Schakowsky \4\
Report ``As Baby Power concerns mounted, Johnson & Johnson 
  focused marketing on minority, overweight women'' by Chris 
  Kirkham, Los Angeles, Reuters, submitted by Ms. Schakowsky.....   285
Chart ``Johnson's Baby Power, 2010 Promotional Radio Overview,'' 
  submitted by Ms. Schakowsky....................................   293
Presentation Slides of September 22, 2010, Johnson's Baby Power 
  ``2010 Promotional Radio Program Recap, by Cynthia Alecci 
  Abramson,'' submitted by Ms. Schakowsky........................   295
Presentation Slides ``Johnson's Baby Powder Revitalization 
  Plan,'' submitted by Ms. Schakowsky............................   307
Charts ``Johnson's Baby Sampling Sheets,'' submitted by Ms. 
  Schakowsky.....................................................   318
Slides ``Johnson's Oil and Powder Overview of Promotions and 
  Lesson Learned 2008-2013,'' submitted by Ms. Schakowsky \5\
Letter of December 10, 2019, from Ms. Schakowsky and Ms. Pressley 
  members of Congress, to Mr. Gorsky, submitted by Ms. Schakowsky   321

----------
\4\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200129/110423/HHRG-116-IF14-20200129-SD029.pdf.
\5\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200129/110423/HHRG-116-IF14-20200129-SD035.pdf.
Letter of January 28, 2019, to Mr. Pallone, et al., from Marty 
  Irby, Executive Director, Animal Wellness Foundation and Holly 
  Gann, Director of Federal Affairs, Animal Wellness Action, 
  submitted by Ms. Schakowsky....................................   325
Article ``Exclusive: on Sri Lanka halts imports of Johnson & 
  Johnson Baby Powder pending asbestos tests,'' submitted by Ms. 
  Schakowsky.....................................................   327
Letter of December 20, 2019, from Brian D. Smith, Covington, to 
  Ms. Schakowsky and Ms. Pressley, submitted by Schakowsky.......   329

 
     IMPROVING SAFETY AND TRANSPARENCY IN AMERICA'S FOOD AND DRUGS

                              ----------                              


                      WEDNESDAY, JANUARY 29, 2020

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., in 
room 2322 Rayburn House Office Building, Hon. Anna G. Eshoo 
(chairwoman of the subcommittee) presiding.
    Members present: Representatives Eshoo, Engel, Butterfield, 
Matsui, Sarbanes, Schrader, Kennedy, Cardenas, Welch, Ruiz, 
Dingell, Kuster, Kelly, Barragan, Blunt Rochester, Rush, 
Burgess (subcommittee ranking member), Upton, Shimkus, Guthrie, 
Griffith, Bilirakis, Long, Bucshon, Brooks, Hudson, Carter, and 
Walden (ex officio).
    Also present: Representative Schakowsky.
    Staff present: Joe Banez, Professional Staff Member; 
Waverly Gordon, Deputy Chief Counsel; Tod Guidry, Health 
Fellow; Stephen Holland, Health Counsel; Zach Kahan, Outreach 
and Member Service Coordinator; Aisling McDonough, Policy 
Coordinator; Meghan Mullon, Policy Analyst; Joe Orlando, Staff 
Assistant; Lino Pena--Martinez, Staff Assistant; Alivia 
Roberts, Press Assistant; Rebecca Tomilchik, Staff Assistant; 
Kimberlee Trzeciak, Senior Health Policy Advisor; Jerry Couri, 
Minority Deputy Chief Counsel, Environment and Climate Change; 
Jordan Davis, Minority Senior Advisor; Theresa Gambo, Minority 
Human Resources/Office Administrator; Tyler Greenberg, Minority 
Staff Assistant; Peter Kielty, Minority General Counsel; Ryan 
Long, Minority Deputy Staff Director; and Kristin Seum, 
Minority Counsel, Health.
    Ms. Eshoo. The Subcommittee on Health will now come to 
order.
    Good morning, everyone. We have a lot of work to do today, 
so I am going to--don't try to test my generosity, so that we 
can move along and get all of our work done. Welcome to the 
witnesses.
    I just wanted to mention something. We have a roundtable 
tomorrow with the appropriate agencies relative to the 
coronavirus for our committee. Today there is a briefing for 
the full House. So, it is up to members if you want to leave to 
go to the full one. I am going to stay here so that we can get 
our work done. And, so you have a choice if you can do both, 
but I am not going to stop theto go to the full briefing so 
that we can get our work done.
    I would like to also welcome our colleague, former 
colleague Bart Stupak, who is here. Always a friend. A 
wonderful member of this committee for many years. Bart, 
welcome. It is great to see you.
    The Chair now recognizes herself for 5 minutes for an 
opening statement.

 OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Twenty cents out of every dollar spent by American 
consumers goes toward food or medicine that is regulated by the 
FDA. Today we are going to examine ten mostly bipartisan bills 
to support the FDA's immense mission. Our first panel will 
consider four bills to grant the FDA new authorities to tackle 
challenges that threaten our drug supply.
    Chairman Pallone's legislation to create National Centers 
of Excellence to support research and development of continuous 
manufacturing technology will strengthen and modernize U.S. 
drug production.
    The Safeguarding Therapeutics Act, introduced by 
Representative Brett Guthrie, will protect against counterfeit 
medical devices.
    Representative Doris Matsui's MODERN Labeling Act will make 
sure generic drugs have up-to-date safety labeling.
    Finally, the Orphan Drug Exclusivity Act, introduced by 
Representative Madeline Dean, will close a loophole so that 
orphan drug exclusivity can't be used to deny access to certain 
drugs, especially drugs for opioid use disorder.
    Taken together, these bills improve the drug supply chain 
from the very beginning to the very end, so that patients have 
access to quality products that are genuine and accurately 
labeled.
    On the second panel, we are going to consider six bills 
that affect the FDA's oversight of food products. Many of these 
bills take action on decisions that the FDA has long delayed.
    For example, the FASTER Act, introduced by Representative 
Doris Matsui, lives up to its name. The Act makes the FDA move 
faster in requiring food manufacturers to list sesame as an 
allergen on their products.
    The bill also allows the FDA to add other food ingredients 
as major allergens based on the prevalence and severity of 
allergic reactions. Over a year ago, the FDA issued a request 
for information about requiring the sesame allergen label but 
has not taken any steps since.
    This allergen labeling is very important, especially for 
children, obviously, and their families. An estimated eight 
percent of American children are affected by food allergies. 
And the NIH recently found that sesame allergy is common among 
children with other food allergies, occurring about 17 percent 
of the time.
    But those parents and children cannot easily avoid sesame 
since it is often not listed as an ingredient. Anyone who has 
ever known a child with a serious food allergy knows how dire a 
reaction can be. The FDA needs to move faster to help curb the 
risks these children face. And the FASTER Act will help the FDA 
do just that.
    The Keep Food Containers Safe from PFAS Act, introduced by 
Congresswoman Dingell, forces the FDA to confront the issue of 
PFAS chemical contamination in food wrappers and containers.
    The chemicals have been found to easily accumulate in the 
environment or the human body because they break down very 
slowly. Exposure to PFAS can lead to cancer, weaker immune 
systems, and liver and kidney toxicity.
    The FDA has said that PFAS approved for use on paper or 
cardboard to prevent grease stains can potentially migrate to 
food. Recent studies have found that eating microwave popcorn 
in meals--warning, members, it is in both of our cloakrooms--
recent studies have found that eating microwave popcorn in 
meals from fast food and pizza restaurants was associated with 
levels of PFAS in the blood. But the FDA has not yet limited 
PFAS in food packaging.
    Instead, the FDA says that because of the growing 
scientific evidence, it will review whether the use of PFAS in 
food contact applications is safe. I hope the Agency takes more 
definitive action soon.
    The panel will also consider bills to address unanswered 
questions around the FDA's regulation of dairy and cheese 
products, exportation of horse meat, and infant formula. In 
total, the FDA oversees more than $2.6 trillion in consumption 
of food, medical products, and tobacco.
    I hope today's will help the Agency better shoulder its 
massive responsibility. And we certainly want to work with the 
Agency to make sure that all of this happens.
    [The prepared statement of Ms. Eshoo follows:]

                Prepared statement of Hon. Anna G. Eshoo

    Twenty cents out of every dollar spent by American 
consumers goes toward food or medicine that's regulated by the 
FDA.
    Today, we will examine ten mostly bipartisan bills to 
support the FDA's immense mission.
    Our first panel will consider four bills to grant the FDA 
new authorities to tackle challenges that threaten our drug 
supply.
    Chairman Pallone's legislation to create National Centers 
of Excellence to support research and development of continuous 
manufacturing technology will strengthen and modernize U.S. 
drug production.
    The Safeguarding Therapeutics Act introduced by 
Representative Brett Guthrie will protect against counterfeit 
medical devices.
    Representative Doris Matsui's MODERN Labeling Act will make 
sure generic drugs have up-to-date safety labeling.
    Finally, the Orphan Drug Exclusivity Act introduced by 
Representative Madeline Dean will close a loophole so that 
orphan drug exclusivity can't be used to deny access to certain 
drugs, especially drugs for opioid use disorder.
    Taken together, these bills improve the drug supply chain 
from the very beginning to the very end so that patients have 
access to quality products that are genuine and accurately 
labeled.
    On the second panel, we'll consider six bills that affect 
the FDA's oversight of food products. Many of these bills take 
action on decisions that the FDA has long delayed.
    For example, the FASTER Act introduced by Rep. Doris Matsui 
lives up to its name. The Act makes the FDA move faster in 
requiring food manufacturers to list sesame as an allergen on 
their products.
    The bill also allows the FDA to add other food ingredients 
as major allergens based on the prevalence and severity of 
allergic reactions.
    Over a year ago, the FDA issued a request for information 
about requiring the sesame allergen label but has not taken any 
steps since.
    This allergen labelling is important for children and their 
families. An estimated eight percent of American children are 
affected by food allergies, and the NIH recently found that 
sesame allergy is common among children with other food 
allergies, occurring about 17% of the time.
    But those parents and children can't easily avoid sesame 
since it's often not listed as an ingredient. Anyone who's ever 
known a child with a serious food allergy knows how dire a 
reaction can be.
    The FDA needs to move faster to help curb the risks these 
children face. The FASTER Act will help the FDA do just that.
    The Keep Food Containers Safe from PFAS Act introduced by 
Congresswoman Debbie Dingell forces the FDA to confront the 
issue of PFAS chemical contamination in food wrappers and 
containers.
    PFAS chemicals have been found to easily accumulate in the 
environment or human body because they break down very slowly. 
Exposure to PFAS can lead to cancer, weaker immune systems, and 
liver and kidney toxicity.
    The FDA has said that the PFAS approved for use on paper or 
cardboard to prevent grease stains can potentially migrate to 
food. The Environmental Working Group found that as much as 40 
percent of fast food wrappers tested positive for 
perfluorinated chemicals, but the FDA has not yet limited PFAS 
in food packaging.
    Instead, the FDA says that because of the growing 
scientific evidence, it will review whether the use of PFAS in 
food contact applications is safe. I hope the Agency takes more 
definitive action soon.
    The panel will also consider bills to address unanswered 
questions around the FDA's regulation of dairy and cheese 
products, the exportation of horse meat, and infant formula.
    In total, the FDA oversees more than $2.6 trillion in 
consumption of food, medical products, and tobacco.
    I hope today's hearing will help the agency better shoulder 
its massive responsibility.

    The Chair is now pleased to recognize the ranking member of 
the Subcommittee on Health, Dr. Burgess, for 5 minutes for his 
opening statement.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. And I thank the Chair. And welcome to our 
witnesses, welcome to the witnesses of both panels in fact, 
because we do have a great deal in front of us this morning.
    The Food and Drug Administration is the oldest 
comprehensive consumer protection agency within the Federal 
Government. Dating back to 1906, the FDA has been the 
administrative body tasked with protecting Americans from 
adulterated and misbranded drugs and food. Since 1906, the 
authority of the Food and Drug Administration and its 
responsibilities have grown to include cosmetics, tobacco, and 
other public health programs.
    Today, we are considering a number of drug and device 
policies. Representative Guthrie's bill, H.R. 5663, the 
Safeguarding Therapeutics Act, allows for the Secretary of 
Health and Human Services to destroy certain counterfeit 
medical devices.
    Counterfeit devices do pose a risk to Americans. I actually 
saw this firsthand when I visited the JFK International Mail 
Facility with former FDA Commissioner Scott Gottlieb. To say 
the least, it was unsettling to realize these devices; 
counterfeit devices could not be destroyed but returned to 
sender. And many of those recycled back through several times, 
with the same markings on the package. They need to be 
destroyed when they are encountered.
    Counterfeit facilities that come through facilities like 
JFK, and this bill would allow for such devices to be destroyed 
at the point of entry. Granting authority to the secretary to 
ensure that the devices will be destroyed will help protect 
patients from bad actors who distribute these kinds of devices 
into the marketplace.
    H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, 
seems to seeks to clarify conditions for exclusive approval and 
licensure of drugs that receive orphan drug designation under 
the non-profitability provision of the Orphan Drug Act. The 
government has an important role with respect to orphan drugs. 
Without government assistance, the manufacturers and the 
innovators for drugs for rare diseases may never be able to 
bring these products to market.
    This legislation appropriately balances the support 
necessary to promote orphan drug development without allowing 
for orphan drug manufacturers through infinite competition. It 
is important we walk that fine line between competition and 
encouraging new cures.
    Another bill aimed at innovation as 4866. This would 
designate certain qualifying higher educational institutions as 
National Centers of Excellence in continuous pharmaceutical 
manufacturing to support the advancement and development of 
continuous manufacturing. Continuous manufacturing has many 
benefits, allowing for more flexible tracking and tracing in 
the event of a product failure, and it can eliminate hold times 
between steps of production; important technology, because the 
ability to track and trace during a product failure could 
minimize the risk of a drug shortage. And we have been through 
that in years past.
    Certainly, over my time on this subcommittee the 
subcommittee has held hearings under the food jurisdiction of 
the Food and Drug Administration. And recognizing former 
Chairman Stupak in the back of the room, I think some of those 
hearings were conducted under you and Chairman Dingell, which I 
remember very fondly.
    The Food and Drug Administration is the authoritative 
agency on labeling and nutrition, ingredients and packaging. It 
is important for Americans to be aware of what is in their 
food, from the nutritional value to what additives or allergens 
may be present.
    H.R. 2269, the Infant Formula Protection Act of 2019, would 
require infant formula to be considered adulterated by the FDA 
if it passes the use-by date. That seems a little unusual to 
me, but I'm happy to hear what the, what the evidence shows.
    Some other bills before us today are dealing with food 
requirements that overstep the authority of the Food and Drug 
Administration. They are the expert body on food regulation and 
safety. Well-intentioned legislation may result in unforeseen 
negative consequences, particularly where the FDA has not found 
a need for regulation in the past.
    And, unfortunately, we don't have the FDA here as a witness 
today. At some point, we will need to invite them in. But I do 
want to yield the balance of my time to Mr. Guthrie to speak on 
his bill.
    Mr. Guthrie. Thank you to the Republican leader for 
yielding.
    I was proud to introduce three bipartisan bills today. The 
Modern Labeling Act will modify how certain generic drug labels 
are updated.
    The Safeguarding Therapeutics Act will protect American 
consumers from counterfeit medical devices. Like my friend Dr. 
Burgess, I was floored when I was at JFK Airport and realized 
that we just return counterfeit devices, that by law, we can't 
destroy them. So, we will hopefully fix that this session.
    And then, the Continuous Manufacturing bill will expand our 
work on 21st Century cures to increase research and development 
on continuous manufacturing.
    I would like to thank Representative Matsui, Representative 
Engel, and Chairman Pallone for working with me on these bills.
    Mr. Burgess. I yield back.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    Thank you, Madame Chair. The Food and Drug Administration 
is the oldest comprehensive consumer protection agency in The 
Federal Government. Dating back to the 1906 Pure Food and Drugs 
Act, the FDA has been the administrative body tasked with 
protecting Americans from adulterated and misbranded drugs and 
food. Since 1906, the FDA's authority and responsibilities have 
grown to include cosmetics, tobacco, and other public health 
programs.
    Today, we are considering a number of drug and device 
policies. Representative Guthrie's bill H.R. 5663, the 
Safeguarding Therapeutics Act, allows the Secretary of HHS to 
destroy certain counterfeit medical devices. Counterfeit 
devices pose a risk to Americans. I saw this firsthand when I 
visited the JFK International Mail Facility with Former FDA 
Commissioner Scott Gottlieb and was taken aback. Many 
counterfeit devices come in through facilities like the one I 
saw, and this bill would allow for such devices to be destroyed 
at the point of entry. Granting authority to the Secretary to 
ensure that these counterfeit devices will be destroyed will 
help protect patients from bad actors who distribute 
counterfeit devices into the marketplace.
    H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, 
seeks to clarify conditions for exclusive approval and 
licensure of drugs that receive orphan drug designation under 
the non-profitability provision of the Orphan Drug Act. The 
government has an important role with respect to orphan drugs. 
Without government assistance, the manufacturers and innovators 
of drugs for rare diseases may never be able to bring these 
products to market. This legislation appropriately balances the 
support necessary to promote orphan drug development without 
allowing for orphan drug manufacturers to inhibit competition. 
We must make sure to walk that fine line of competition and 
encourage new cures.
    Another bill aimed at innovation is H.R. 4866. This bill 
would designate certain qualifying higher education 
institutions as National Centers of Excellence in Continuous 
Pharmaceutical Manufacturing to support the advancement and 
development of continuous manufacturing. Continuous 
manufacturing has many benefits, including allowing for more 
flexible tracking and tracing in the event of product failure 
and eliminating hold times between steps of production. This is 
important technology because the ability to track and trace 
during a product failure could minimize the risk of a drug 
shortage. Additionally, a fast and efficient production of 
pharmaceuticals is beneficial to patients.
    Less often has the Health Subcommittee held hearings on the 
food jurisdiction of the FDA. The FDA is the authoritative 
agency on labeling and nutrition, ingredients and packaging, 
and food defense. It is important for Americans to be aware of 
what's in their food-from the nutritional value, to what 
additives and allergens may be present.
    Some bills before us today are aimed at these issues. H.R. 
2117, the Food Allergy Safety, Treatment, Education, and 
Research Act of 2019, would require sesame to be a major 
allergen for the purposes of labeling. H.R. 2269, the Infant 
Formula Protection Act of 2019, would require infant formula to 
be considered adulterated by the FDA if it is passed the use-by 
date.
    Some of the other bills before us today dealing with food 
requirements overstep into the authority of the FDA. The FDA is 
the expert body on food regulation and safety. Well-intentioned 
legislation may result in unforeseen negative consequences, 
particularly where the FDA has not found a need for regulation.
    Unfortunately, the FDA is not a witness today; however, I 
look forward to hearing from our witnesses on these pieces of 
legislation.
    I yield back.
    Ms. Eshoo. The gentleman yields back.
    I was going to recognize Mr. Pallone, but I will instead 
recognize the gentlewoman from Michigan, Ms. Dingell, for 5 
minutes.

 OPENING STATEMENT OF HON. DEBBIE DINGELL, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mrs. Dingell. Thank you, Madam Chair and Ranking Member 
Burgess, for convening this hearing and including important 
public health legislation, including my bill, the Keep Food 
Containers Safe from PFAS Act.
    I am appreciative of the inclusion of a witness from my 
district, Dr. Kao-Ping Chua, who is a professor of pediatrics 
at the University of Michigan Medical School. His background 
and expertise will help the committee better understand the 
intersection of opioid policy and orphan drug policy. And we 
are grateful to have him with us today.
    We look forward to learning more about these important 
issues as we work to ensure that Americans have access to these 
potentially lifesaving drugs. We thank Dr. Chua for his time 
and pioneering work in this area and for the opportunity to 
learn from his expertise.
    I would also like to express my appreciation again for the 
committee's wisdom in inviting a professor from the greatest 
public university in the world. Go Blue.
    Thank you, Madam Chair. And I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    Pleasure to recognize the ranking member of the full 
committee, our friend Mr. Walden, for his 5 minutes for an 
opening statement.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Good morning, Madam Chair. Thank you very much. 
Thanks for having this hearing. Welcome to our witnesses and 
guests.
    As you have heard, we will have an opportunity to review 
legislation that is intended to improve the safety of medical 
products in the United States. We will also review several 
food-related policies.
    I briefly want to extend special thanks and welcome to Dr. 
Doug Corey from Oregon's 2nd Congressional District for being 
here today. While it may seem a little tamer here in Congress 
than what he is used to seeing at the Pendleton Round-Up back 
home, I can assure you we have our fair share of excitement, 
among other things that might resemble what happens at rodeos 
right here at the hearing.
    I appreciate Dr. Corey taking his time to testify, and I 
know his valued expertise for bringing important perspective to 
our discussions about animals.
    I am pleased we will be considering four bipartisan 
priorities on the first panel that aim to improve the safety of 
America's drug supply, bring more transparency to the 
marketplace, and provide additional protections against the 
threat of counterfeit products.
    H.R. 5663, the Safeguarding Therapeutics Act, would extend 
FDA's administrative destruction authority to medical devices. 
That only makes sense. As you have heard, under current law, 
the FDA is authorized to destroy certain imported drugs that 
may pose a threat to public health. However, this authority 
does not extend to medical devices, including some combinations 
in combination products.
    This legislation, introduced by Mr. Guthrie and Mr. Engel, 
would provide the agency with the additional tool to protect 
American consumers against potentially dangerous unapproved 
product.
    Furthering our efforts to protect the country's medical 
products supply chain, we will also be considering H.R. 4866, 
which is the National Centers of Excellent in Continuous 
Pharmaceutical Manufacturing Act. H.R. 4866, introduced by 
Chairman Pallone, would direct the FDA to designate higher 
education institutions as National Centers of Excellence, 
allowing the FDA to work with the centers and industry to 
create a national framework for the implementation of 
continuous manufacturing technology.
    At our October hearing on safeguarding the pharmaceutical 
supply chain, Dr. Woodcock spoke at length about the potential 
advantages of continuous manufacturing, including the potential 
to reduce our dependence on foreign sources of active 
pharmaceutical ingredients, increase our manufacturing 
resiliency, and reduce quality issues that often trigger drug 
shortages.
    Given the potential for this technology, I am pleased we 
are considering this bipartisan legislation to further advance 
its development.
    We will also be considering H.R. 5668, that's the MODERN 
Labeling Act, which will allow the FDA to require modifications 
be made to outdated labeling for generic drugs. Generic drugs 
are generally required to have the same labeling as the brand 
drug they reference. However, once the brand drug is no longer 
on the market, the generic manufacturer is not able to update 
their label to reflect the most accurate and up-to-date 
information, often discovered through post-market use.
    So, the inability to update labeling can result in 
information gaps for providers and patients when discussing the 
most appropriate treatments. H.R. 5668 will help close those 
gaps. That is important.
    Additionally, we will consider H.R. 4712, the Fairness in 
Orphan Drug Exclusivity Act. This legislation will update the 
Orphan Drug Act to require drug manufacturers that receive an 
orphan drug designation under the post-recovery provision of 
the Act to demonstrate that successor drugs eligible for the 
designation do not have a reasonable expectation of recouping 
their research and development costs. H.R. 4712 aims to balance 
the need to maintain existing incentives for orphan drug 
development, while eliminating loopholes that may allow a drug 
manufacturer to actually block competition.
    So, I appreciate the majority's attention to these 
bipartisan proposals and hope they will continue to work with 
us on bipartisan legislation, particularly initiatives focused 
on the reauthorization of critical programs set to expire at 
the end of the year. One of those programs is that rare 
pediatric priority review voucher program, Madam Chair, I know 
you are familiar with.
     Several members of this committee have already worked 
together in a bipartisan manner to introduce the Creating Hope 
Reauthorization Act, which would extend this program. And I 
would ask the chairwoman to consider its inclusion in a future 
hearing.
    Finally, we will be considering several legislative 
initiatives intended to address FDA's regulation of foods. And 
I have heard concerns from dairy and beef producers in my 
district related to standards of identity. And I welcome a 
discussion of these matters today as well.
    However, I also have some concerns that some of the bills 
being considered today may actually have unintended and 
negative consequences and ignore the science-based approach FDA 
takes when regulating products its jurisdiction.
    So, with that, I welcome our witnesses and our guests and 
appreciate the hearing. Just as a footnote, as you know, we 
have another hearing scheduled to start in about 15 minutes 
downstairs. So, I will be bouncing back and forth, as will the 
chairman I am sure.
    With that, I will yield back all 22 seconds.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    At today's hearing, we will have the opportunity to review 
legislation intended to improve the safety of medical products 
in the United States. We will also review several food-related 
policies. I briefly want to extend a special thanks to Dr. Doug 
Corey from Oregon's Second Congressional District for being 
here today. While it may seem tamer here in Congress than what 
he's used to seeing at the Pendleton Round-up back in Oregon, I 
can assure you we have our fair share of excitement here at 
these hearings. I appreciate Dr. Corey taking the time to 
testify and know his valued expertise will bring an important 
perspective to our discussions.
    I am pleased that we will be considering four bipartisan 
priorities on the first panel that aim to improve the safety of 
America's drug supply, bring more transparency to the 
marketplace, and provide additional protection against the 
threat of counterfeit products.
    H.R. 5663, the Safeguarding Therapeutics Act, would extend 
FDA's administrative destruction authority to medical devices. 
Under current law, FDA is authorized to destroy certain 
imported drugs that may pose a threat to the public health; 
however, this authority does not extend to medical devices, 
including some combination products. This legislation, 
introduced by Mr. Guthrie and Mr. Engel, would provide the 
Agency with an additional tool to protect American consumers 
against potentially dangerous, unapproved products.
    Furthering our efforts to protect the country's medical 
product supply chain, we will also be considering H.R. 4866, 
the National Centers of Excellence in Continuous Pharmaceutical 
Manufacturing Act. H.R. 4866, introduced by Chairman Pallone, 
would direct FDA to designate higher education institutions as 
National Centers of Excellence, allowing FDA to work with the 
centers and industry to create a national framework for the 
implementation of continuous manufacturing technology. At our 
October hearing on safeguarding the pharmaceutical supply 
chain, Dr. Woodcock spoke at length about the potential 
advantages of continuous manufacturing, including the potential 
to reduce our dependence on foreign sources of active 
pharmaceutical ingredients, increase our manufacturing 
resiliency, and reduce quality issues that often trigger drug 
shortages. Given the potential for this technology, I am 
pleased we are considering this bipartisan legislation to 
further advance its development.
    We will also be considering H.R. 5668, the MODERN Labeling 
Act, which allows FDA to require modifications be made to 
outdated labeling for generic drugs. Generic drugs are 
generally required to have the same labeling as the brand drug 
they reference, however, once the brand drug is no longer on 
the market, the generic manufacturer is not able to update 
their label to reflect the most accurate and up-to-date 
information, often discovered through post-market use. The 
inability to update labeling can result in information gaps for 
providers and patients when discussing the most appropriate 
treatments. H.R. 5668 will help close those information gaps.
    Additionally, we will consider H.R. 4712, the Fairness in 
Orphan Drug Exclusivity Act. This legislation will update the 
Orphan Drug Act to require drug manufacturers that receive an 
orphan drug designation under the cost-recovery provision of 
the Act to demonstrate that successor drugs eligible for the 
designation do not have a reasonable expectation of recouping 
their research and development costs. H.R. 4712 aims to balance 
the need to maintain existing incentives for orphan drug 
development while eliminating loopholes that may allow a drug 
manufacturer to block competition.
    I appreciate the majority's attention to these bipartisan 
proposals and hope that they will continue to work with us on 
bipartisan legislation, particularly initiatives focused on the 
reauthorization of critical programs set to expire at the end 
of this fiscal year. One of these programs is the rare 
pediatric priority review voucher program. Several members of 
this committee have already worked together, in a bipartisan 
manner, to introduce the Creating Hope Reauthorization Act, 
which would extend this program, and I would ask that the 
Chairman consider its inclusion in a future hearing.
    Finally, we will be considering several legislative 
initiatives intended to address FDA's regulation of foods. I 
have heard concerns from dairy and beef producers in my 
district related to standards of identity, and I welcome the 
discussion on these matters today. However, I also have 
concerns that some of the bills being considered today may have 
unintended consequences and ignore the science-based approach 
FDA takes when regulating products under their jurisdiction.
    I look forward to hearing from our witnesses and appreciate 
your time in being here today. I yield back.

    Ms. Eshoo. We know that you bounce well.
    The gentleman yields back.
    All right. The Chair would like to remind members that, 
pursuant to committee rules, all Members' written opening 
statements will be made part of the record.
    I now have the pleasure of introducing our witnesses to the 
first panel.
    First, Dr. Chua Ping--Dr. Kao-Ping Chua, excuse me, 
assistant professor at the Department of Pediatrics, as 
Congresswoman Dingell said, for the University of Michigan 
Medical School. Welcome to you.
    Dr. Fernando Muzzio, Distinguished Professor, Chemical and 
Biochemical Engineering at Rutgers, the State University of New 
Jersey. Professor, welcome to you as well.
    Mr. Richard Kaeser, Vice President, Global Brand 
Protection, Johnson & Johnson. You are the only one that is not 
a doctor. Time to go back to school.
    [Laughter.]
    Dr. Jeff Allen, President and CEO of the Friends of Cancer 
Research. Welcome to you.
    We look forward to your important testimony. I think you 
are familiar with the light. Green, we go; yellow, watch out; 
red, full stop. OK?
    So, Dr. Chua, you are now recognized for 5 minutes for your 
testimony. And thank you again.

STATEMENTS OF KAO-PING CHUA, M.D., PH.D., ASSISTANT PROFESSOR, 
   DEPARTMENT OF PEDIATRICS, UNIVERSITY OF MICHIGAN MEDICAL 
   SCHOOL; FERNANDO MUZZIO, PH.D., DISTINGUISHED PROFESSOR, 
   CHEMICAL AND BIOCHEMICAL ENGINEERING, RUTGERS, THE STATE 
   UNIVERSITY OF NEW JERSEY; RICHARD KAESER, VICE PRESIDENT, 
 GLOBAL BRAND PROTECTION, JOHNSON & JOHNSON; AND, JEFF ALLEN, 
      PH.D., PRESIDENT AND CEO, FRIENDS OF CANCER RESEARCH

                 STATEMENT OF DR. KAO-PING CHUA

    Dr. Chua. Chairwoman Eshoo, Ranking Member Burgess, 
Congresswoman Dingell, Congressman Upton, and distinguished 
members of the subcommittee, thank you for the opportunity to 
participate in today's hearing.
    I am a practicing general pediatrician and health policy 
researcher with expertise in opioid policy and orphan drug 
policy. These two areas of my research unexpectedly converged 
when Sublocade, a once-monthly buprenorphine injection, was 
approved as an orphan drug to treat opioid use disorder, also 
known as opioid addiction. This approval entitled Sublocade to 
a 7-year period of exclusivity during which no new 
buprenorphine products could be marketed for opioid use 
disorder.
    Although FDA recently revoked Sublocade's orphan approval; 
it could still receive exclusivity if this decision is 
overturned in court.
    Today, I will explain why I strongly support passing H.R. 
4712, the Fairness in Orphan Drug Exclusivity Act. This bill 
will close the loophole that allowed Sublocade's orphan 
approval and block exclusivity for Sublocade, even if FDA's 
decision is overturned, thus promoting public health by 
ensuring competition, innovation, and patient choice in the 
market for buprenorphine.
    Over the past decade opioid overdose has claimed the lives 
of hundreds of thousands of Americans, including the parents 
and siblings of some of my patients. To prevent these deaths, 
federal policymakers must ensure that patients have access to 
safe and effective medications to treat opioid use disorder, 
including buprenorphine.
    However, FDA nearly achieved the complete opposite goal 
when it granted orphan approval to Sublocade, potentially 
allowing the manufacturer Indivior to stifle competition and 
innovation for seven years.
    In addition, Sublocade's orphan approval was an abuse of 
orphan drug policy. This approval occurred under a 23-year-old 
orphan drug designation granted in 1994 to Subutex, a 
predecessor buprenorphine product developed by Indivior's 
parent company Reckitt Benckiser. To obtain this decision, 
Reckitt Benckiser used the Orphan Drug Act's cost recovery 
prong, which requires companies to demonstrate that a drug's 
U.S. sales will be insufficient to recover development and 
marketing costs.
    As it turns out, Reckitt Benckiser's cost recovery analysis 
in 1994 was faulty. Moreover, Subutex had $285 million in sales 
between 2002 and 2011. Despite both of these facts, FDA 
automatically grandfathered Subutex's orphan designation for 
Sublocade when it was approved in November 2017, without 
requiring Indivior to submit another cost recovery analysis 
showing that Sublocade would be unprofitable.
    In April 2019, one of Indivior's competitors filed a 
citizen petition asking FDA to revoke Sublocade's orphan drug 
designation and refuse to grant exclusivity. In November 2019, 
FDA ruled in favor of the petition and denied Sublocade 
exclusivity. For now, this means that competing buprenorphine 
products can enter the market starting in December 2020.
    While FDA's decision is a step in the right direction, it 
could be overturned if Indivior decides to sue. This 
possibility is one of the reasons it is so important to pass 
H.R. 4712. If, even if FDA's decision is overturned, the bill 
would prevent exclusivity for Sublocade unless Indivior 
submitted a cost recovery analysis showing that it did not 
expect Sublocade to be profitable when it was approved in 
November 2017.
    However, such an analysis would be impossible to construct 
because Indivior itself has projected that Sublocade will reach 
$1 billion in peak annual sales.
    H.R. 4712 would also require drug companies to submit cost 
recovery analyses for any future orphan approval under a cost 
recovery prong designation, thus closing the loophole that 
allowed Sublocade's orphan approval.
    One advantage of H.R. 4712 is that its scope is limited. It 
would only affect orphan approvals under cost recovery prong 
designations. And there have only been three such designations 
since 1983. This limited scope does not negate its importance, 
as it will permanently block Sublocade from receiving 
exclusivity that would impede patients' access to lifesaving 
buprenorphine products.
    In my view, passing H.R. 4712 is a common sense step that 
will be good for orphan drug policy, good for public health, 
and good for the millions of Americans with opioid use 
disorder.
    Thank you again for the opportunity to participate in 
today's hearing.
    [The prepared statement of Dr. Chua follows:]
    Ms. Eshoo. Thank you, Doctor. It is important to note that 
the two companies that you are mentioning they are really not 
two companies. It was an original name and then the name was 
changed. So, this is not a dispute between the two companies.
    Dr. Chua. OK.
    Ms. Eshoo. Dr. Muzzio, welcome. We are very happy to see 
you. We appreciate your being here. And you have 5 minutes for 
your testimony.

              STATEMENT OF FERNANDO MUZZIO, Ph.D.

    Mr. Muzzio. Thank you, Chairwoman Eshoo, Ranking Member 
Burgess, and members of the subcommittee. My name is Fernando 
Muzzio. I am a Distinguished Professor of Chemical and 
Biochemical Engineering at Rutgers, the State University of New 
Jersey. I am also the Director of C-SOPS and NSF Engineering 
Research Center, that has been devoted to continuous 
manufacturing research for the past 15 years.
    I greatly appreciate the opportunity to appear in this 
hearing on approving the safety of pharmaceutical manufacturing 
in the U.S. and to express my strong support for H.R. 4866, 
which I believe is essential to maintain the viability of 
pharmaceutical manufacturing in the U.S.
    I want to thank Chairman Pallone for introducing this bill 
and for his leadership in this issue.
    Now, the traditional approach to pharmaceutical 
manufacturing is called batch manufacturing. And this approach 
is slow. It is very difficult to optimize. And it actually 
provides limited ability to assure product quality. Working in 
our center, we have developed a far superior technology, 
continuous manufacturing. As defined in H.R. 4866, in 
continuous manufacturing, you load ingredients at a controlled 
rate into the process, and then you operate the process in a 
state of control every minute of every hour so that you can 
assure the quality of the product that you are making 
consistently. This minimizes quality failure, but it does much 
more than that.
    So, in the last 14 years in our center, we established a 
full ecosystem with multiple universities, FDA, NSF, more than 
60 companies, and the USP. And in the center, we built and 
demonstrated the first continuous manufacturing line to operate 
in a full state of control. And then working in close 
partnership with Johnson & Johnson, we also enabled the 
implementation of the first continuous manufacturing system 
that was approved by FDA for the transition from batch 
manufacturing to continuous manufacturing for the drug 
Prezista.
    Since then, there have been six products approved by the 
Food and Drug Administration. There are many more in the 
pipeline. And this has become a worldwide phenomenon where 
every major country in the world is pursuing the implementation 
of continuous manufacturing.
    The main point of my testimony is that this presents a 
major opportunity for the U.S. to bring back manufacturing to 
the country. The reason is that batch manufacturing requires 
cheap labor, and that is one reason we have lost so much of it. 
Continuous manufacturing requires access to know-how. And right 
now, the U.S. has the largest concentration of know-how on how 
to implement continuous manufacturing systems.
    So, in the next few years, you will witness a transition 
from batch to continuous manufacturing of a large segment of 
the pharmaceutical industry. The question is, where will this 
happen?
    This transition provides a great opportunity for the U.S. 
It has many benefits. It could lower drug prices. It could help 
create many high-paying jobs. It will reduce our dependence on 
imports. And it will lead to faster product and process 
development, which is important because it will give patients 
faster access to cures, and it will also enable a faster 
response to emergencies and shortages.
    Now, there is a threat. The threat is that Europe is on the 
march. They have already funded several centers in this area. 
And also, Europe has most of the companies that produce 
equipment for continuous manufacturing. But we have the know-
how. So, if we articulate a meaningful U.S.-based response, we 
could actually capture much of these conversions from batch to 
continuous and use it to re-grow from pharmaceutical 
manufacturing in this country.
    A suitable U.S. response is for H.R. 4866 because it 
provides the resources to create the partnership between 
academia, government, universities, industry, and the USP, and 
to make the knowledge available to all sectors of the 
pharmaceutical industry, and to other industries that use 
similar manufacturing methods.
    Universities are essential in this endeavor because 
universities provide the long-term research perspective and the 
research strength to create and demonstrate new technology, and 
to train the large number of people that are needed to 
implement the systems.
    So, with that, I thank you once again for inviting me to be 
here. I will request to please incorporate my full written 
testimony into the record. And I will be happy to answer any 
questions you might have. Thank you very much.
    [The prepared statement of Mr. Muzzio follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you, Dr. Muzzio. Everything that you said 
is music to my ears. And, of course, your full testimony will 
be made part of the committee's record.
    It is a pleasure to recognize Mr. Richard Kaeser, Vice 
President of Global Brand Protection at Johnson & Johnson. You 
are recognized for your 5 minutes of testimony.

                  STATEMENT OF RICHARD KAESER

    Mr. Kaeser. Thank you very much. Chairwoman Eshoo, Ranking 
Member Burgess, and members of the committee, good morning. And 
thank you for the opportunity to discuss how we can strengthen 
patient safety by granting the Food and Drug Administration the 
same authority for dealing with certain counterfeit devices as 
it has for drugs that have been refused admission into the 
United States.
    My name is Rich Kaeser, and I am Vice President of Global 
Brand Protection at Johnson & Johnson, and responsible for 
combating illicit trade, including counterfeiting, illegal 
diversion, and tampering across all Johnson & Johnson business 
segments: pharmaceuticals, medical devices, and personal 
healthcare.
    Illicit trade has increased dramatically in recent years, 
impacting nearly every industry. According to one estimate, 
global trade and counterfeit goods will hit $1.9 trillion by 
2023. The problem is obviously a serious concern in our 
healthcare and personal care industries, where patients and 
consumers can be injured or even die due to unsafe counterfeit 
and illicit products.
    In fact, counterfeit drugs are the biggest market, 
estimated at $200 billion per year. Given that figure, it is no 
surprise, but shocking nonetheless, that INTERPOL estimates 
that one million people die each year from taking counterfeit 
medicines globally.
    At Johnson & Johnson, we believe our first responsibility 
is to the patients, to the mothers and fathers, to the doctors 
and nurses, and to all those who use our products and services. 
They must have unequivocal confidence in the quality, safety, 
and authenticity of Johnson & Johnson products. Thus, we have a 
strong, enterprise-wide anti-counterfeiting and brand 
protection strategy in place to proactively and aggressively 
manage risks related to illicit trade and, most importantly, to 
protect patients and consumers from potential harm.
    Our Global Brand Protection team, which I lead, is 
responsible for these efforts across the company. While my team 
is 100 percent dedicated to this mission, effective brand 
protection also requires significant teamwork across our entire 
business, as well as extensive collaboration between industry 
partners, academia, law enforcement, and government agencies.
    Lawmakers play a critical role in strengthening our laws to 
increase penalties and reduce incentives for illegal trade. We 
appreciate the leadership of Representatives Guthrie and Engel 
on this issue. As such, Johnson & Johnson is very pleased to 
support H.R. 5663, the Safeguarding Therapeutics Act, which 
extends FDA authority to destroy counterfeit drugs and devices, 
and combination products valued at $2,500 or less. We believe 
this authority is important to protect the integrity of the 
supply chain by preventing counterfeit products from reaching 
consumers and patients.
    A recent example of counterfeiting that has impacted our 
medical device business involves a product known as Surgicel, a 
bloodclot-inducing material that is used to control bleeding 
during and after surgery.
    We learned that counterfeit products labeled and sold as 
Surgicel were entering the supply chain in the United States 
and other markets through unauthorized gray market 
distributors. A timely investigation identified and shut down 
an international counterfeiting scheme. We engaged our 
customers to notify them about the counterfeit issue, and 
explained that buying our products only from authorized 
distributors is vital to protect patients and providers.
    Importantly, we also involved the FDA, and we are 
cooperating closely with their criminal investigation teams as 
they consider taking enforcement action against the parties 
involved. I am happy to discuss this case in more detail or 
cases like this that put illicit traders on notice and have a 
deterrent effect. Unfortunately, in today's global marketplace, 
we are likely to continue to continue to see illicit medical 
devices, drugs, and personal care products entering the 
legitimate supply chains. Healthcare products will continue to 
be one of the most commonly targeted industries for 
counterfeiters.
    Counterfeit products and illicit trade present a growing 
risk to patients and consumers. We have an opportunity to make 
our world safer by ensuring the FDA has the authority needed to 
destroy counterfeit drugs, devices, and combination products. 
Together, we can work to protect patients and consumers from 
the threat of counterfeit health and personal care products.
    Thank you for your time and attention today to this 
critically important issue. I look forward to answering your 
questions.
    [The prepared statement of Mr. Kaeser follows:]
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    Ms. Eshoo. Thank you very much, Mr. Kaeser.
    Dr. Allen, welcome. And thank you again. You are recognized 
for 5 minutes for your testimony.

                 STATEMENT OF JEFF ALLEN, Ph.D.

    Mr. Allen. Thank you. And good morning, Chairwoman Eshoo. 
Thank you, Member Burgess and members of the committee.
    I am Dr. Jeff Allen, President and CEO of Friends of Cancer 
Research, a research and advocacy organization dedicated to 
accelerating science from bench to bedside. It is an honor to 
testify before you today and provide our perspective regarding 
prescription drug labels.
    When kept up to date, labeling represents the most 
authoritative drug-related information that is available to 
prescribers. However, labeling can become outdated when high-
quality scientific evidence is generated in the post-market 
setting that the drug's manufacturer does not file a 
supplemental application requesting a modified use be added to 
the drug's label.
    Manufacturers have an ongoing responsibility to report 
signals of serious risk to the FDA. And the agency has the 
authority to order changes relating to new safety information. 
However, there is no requirement or authority to update product 
labeling with new or modified uses, though manufacturers may 
choose to do so voluntarily when they wish to market their 
products in these settings.
    Given the pace of research and treatment advances in the 
field of oncology, off-label use is common and important. To 
examine the extent to which labels keep pace over time, we 
evaluated the difference between medically recommended uses of 
a drug included in leading clinical guidelines and compared 
that to the uses contained in the label.
    Our study examined cancer drugs approved over a 12-year 
period. For almost every drug that we looked at, 79 percent to 
be exact, the clinical guidelines had more recommended uses 
than those described in the FDA label. Of the 450 recommended 
uses associated with all the drugs included in the study, 253 
were not listed on FDA approved labels.
    Of these off-label uses, 91 percent were graded as being 
based on strong existing evidence and backed by the uniform 
consensus of the Guideline Advisory Committee. Meaning, up to 
80 percent of these drugs have additional uses reported by 
high-quality evidence missing from their labels.
    When sections of the FDA approved labeling become outdated 
they may lose value for prescribers and fail to communicate 
essential information about drugs to patients and healthcare 
providers.
    A particularly stark example is the drug oxaliplatin, which 
was approved in 2004 for two forms of colon cancer. Since then, 
it has been further tested and recommended in clinical 
guidelines for ten additional disease settings, none of which 
are on the product label. While many expert oncologists have 
access to information and experience with the use of 
oxaliplatin, there are many that still rely on the drug label 
when making treatment decisions. This may be most important to 
a general oncologist in a busy practice or community setting.
    The whole premise of generic drugs is that they are 
materially indistinguishable from their brand name counterparts 
and, as such, under current law, a generic is required to have 
the same level as its branded reference product. But over time, 
some original manufacturers of the older drugs will voluntarily 
withdraw their products from the market for reasons other than 
safety and efficacy, leaving only generic manufactured products 
on the market.
    This situation is often referred to as a withdrawn 
reference listed drug or a withdrawn RLD. And here is the 
problem: in these cases, the labels of the remaining generic 
drugs are still required to match their original reference 
product, even though it has been withdrawn. And even as data 
may continue to evolve, these labels essentially become frozen 
in time and are unable to be updated.
    In collaboration with numerous stakeholders, members of 
this committee have developed the MODERN Labeling Act to 
address the prevalence of outdated labels in cases where there 
is a withdrawn RLD. The legislation addresses this problem by 
establishing a process for updating labels to reflect new 
information relevant to the drug and its optimal use. Restoring 
the relevance of approved labeling is an important public 
health goal. While other high-quality sources of prescribing 
information play an important role in clinical care, labeling 
is the sole source of information that reflects the scientific 
and methodological rigor of the FDA approval process.
    Patients and prescribers can have the assurance that the 
use of medicines in conformity with the drug labeling is 
supported by a positive benefit-risk assessment. The MODERN 
Labeling Act would aid in maintaining up-to-date drug labels 
for certain generic drugs and restore the relevance of the 
label, foster greater trust in medical products for physicians 
and patients.
    I again thank you for the opportunity to testify on this 
important topic, and I look forward to answering your 
questions.
    [The prepared statement of Mr. Allen follows:]
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    Ms. Eshoo. Thank you very much, Doctor.
    We have now concluded the opening statements of our 
witnesses for our first panel. And we will now move to member 
questions. And I am going to recognize myself for 5 minutes to 
do so.
    First I want to go to Dr. Muzzio. I said on the heels of 
your testimony that what you said was music to my ears. I spent 
a good part of last year researching, and studying the whole 
issue of API, of the status of drug manufacturing in the United 
States, and being dependent upon a foreign country that has the 
API, the core ingredients for drugs, and I found it chilling.
    This subcommittee had an extensive hearing on the subject, 
and FDA did testify on the importance and they really looking 
to the future relative to continuous manufacturing.
    Now, I am thrilled to hear about what you are doing. You 
almost make it sound simple, that, you know, that we have the 
silver bullet. Can you tell me or describe the status of where 
we are with continuous manufacturing now? Is it still nascent 
and being researched?
    How many companies are using it in the United States?
    What would the average cost be for establishing a 
continuous manufacturing system in our country? Because, as you 
said, I think most of it has gone overseas, mainly to China and 
to India--that is where generic drugs are made. In fact, my 
chief of staff showed me her prescription bottle and she 
decided to, given the subject matter, because I talk about it 
all the time with my staff, she peeled back her label with her 
name on it, and the date, and all of that, and it came from 
India.
    So, can you answer those questions for me?
    Mr. Muzzio. I can try. Thank you very much for those 
questions.
    Ms. Eshoo. OK.
    Mr. Muzzio. So, we have to distinguish the making of the 
drug substance, the API, from the making of the finished 
product.
    Ms. Eshoo. I understand that.
    Mr. Muzzio. Yes.
    Ms. Eshoo. I understand that.
    Mr. Muzzio. Both can be greatly improved by continuous 
manufacturing methods. The current status is that for the 
finished products, for solid dose product--tablets, and 
capsules--the technology is now robust. It has been implemented 
at about, I would say, 10 to 15 brand-based companies. And so, 
if we want to extend it and really have a major impact, the key 
issue is to make sure that the know-how required to implement 
the technology becomes available to the other sectors of the 
industry, the generic, the over-the-counter manufacturers, et 
cetera.
    The brand-based companies have the know-how in-house.
    Ms. Eshoo. Yes.
    Mr. Muzzio. We also, critically, should create places where 
companies can come and get the help they need in demonstrating 
the technology for their product and in facilitating the 
manufacture of clinical supplies without having to spend $15 or 
$20 million to first get a system implemented. That is a very 
high entry cost for smaller pharma, generic pharma.
    Ms. Eshoo. Let me ask you this.
     Mr. Muzzio. Yes.
    Ms. Eshoo. Given the work that you are doing and what this 
bill promotes, does it shorten the time frame around actual 
continuous manufacturing for the pharmaceutical industry in the 
United States?
    Mr. Muzzio. Yes. For the finished product, it definitely 
will.
    Ms. Eshoo. And what kind of time frame is that?
    Mr. Muzzio. Well, I believe that we could create the 
environment that will help the rest of the industry in just a 
few months because we already have systems implemented and the 
know-how. What we need now is to facilitate access to put in 
place the mechanisms for the rest of the industry to be able to 
access the know-how effectively and quickly.
    Ms. Eshoo. I have only heard of one pharmaceutical company 
that is engaged in continuous manufacturing. Can you name more?
    Mr. Muzzio. Absolutely. I mean, there are four companies 
that have products approved, right: Pfizer, Eli Lilly, and 
Vertex, in addition to Johnson & Johnson.
    We are right now working with another half a dozen 
companies that are also working hard at implementing this 
system. I don't want to violate confidentiality, but I can tell 
you in my--I have firsthand knowledge that every major 
household name brand-based pharmaceutical company is working on 
these. They have all acquired equipment. They are all preparing 
submissions.
    So, for brand-based pharma, this is now a choice that they 
have made to go forward this way.
    Ms. Eshoo. Well, that is very promising. I want to work 
with all of the stakeholders to achieve the goal of bringing 
manufacturing back to the United States. For us to be dependent 
on foreign countries, sometimes real tension surrounding the 
relationships, I think, is really dangerous for the United 
States of America. We owe more to the American people. So, 
thank you.
    I will submit my written questions to the other witnesses.
    I will now recognize the ranking member of the subcommittee 
for his 5 minutes of questions.
    Mr. Burgess. And again, I thank the Chair.
    Well, Mr. Kaeser, let me just start with you because you 
mentioned Surgicel.
    Mr. Kaeser. Yes.
    Mr. Burgess. A product that I used. Not frequently, because 
most of my surgical fields were quite hemostasic. But I 
recognize there are other specialties that may have a 
requirement for an absorbable hemostat like Surgicel.
    Ms. Eshoo. You are going to have to explain these terms. We 
are not all doctors.
    Mr. Burgess. I was having some inside----
    Ms. Eshoo. I could tell.
    Mr. Burgess [continue]. Chat with Dr. Bucshon.
    So, a neurosurgeon is in the middle of an operation, opens, 
or the product is popped out onto the Mayo stand, and he picks 
it up and it doesn't feel right. Is that, do I understand that 
correctly?
    Mr. Kaeser. That is correct.
    Mr. Burgess. At least at that point he has the presence of 
mind to say this is not right. Did he actually use the product 
in that operation?
    Mr. Kaeser. He did not use the product. He asked the 
circulator to hand off another one from another lot, another 
box.
    Mr. Burgess. I see. So, he actually had some real product 
available, which is fortunate. Because I presume----
    Mr. Kaeser. And for the committee, Surgicel is a hemostatic 
patch that is used to control bleeding during and after 
surgery.
    Mr. Burgess. Right. Comes in a foil package.
    Mr. Kaeser. Yes.
    Mr. Burgess. And they pop it open onto the sterile field. 
It looks like a little piece of cloth with a fairly wide weave 
pattern. And you tamp it down into the area where the bleeding 
is problematic, and it provides a matrix for the body's own 
clotting mechanism to adhere to, and that way achieves 
hemostatis or lack of bleeding in that area, which is obviously 
a good thing before you close up the surgical incision.
    And it is absorbable, so it stays in the body and is 
eventually absorbed. So, this product that--did anyone end up 
testing it? And would it actually absorb had it been left in 
this person's brain or spine?
    Mr. Kaeser. Yes, so the product was tested. So, the 
hospital sent it back into our quality organization, who 
conducted tests or investigation, where we identified that it 
was indeed not ours, that it was counterfeit, and it was also 
not sterile, which represents very a significant risk.
    Mr. Burgess. Holy smackers.
    Mr. Kaeser. Yes.
    Mr. Burgess. That is, I can't convey how concerning that 
is.
    Just like Mr. Guthrie, I went to the JFK International Mail 
Facility with Dr. Gottlieb. We saw a number of things. And at 
that point, I think even just the pharmaceutical products could 
not be returned because that was something that occurred as 
part of the SUPPORT Act in H.R. 6. But what was related to us 
that day, that sometimes this package that contains something 
that was highly suspect all they could do was return it to the 
people that had shipped it in the first place. And that, on 
occasion, a package would just simply recirculate. Well, let's 
try it again. And literally have the same markings from either 
Customs, Border Protection, or the FDA on the package.
    So, this is, this is critical to be able to not just 
intercept this stuff but get it out of circulation--no pun 
intended--but to get it out of everyone's lives.
    So, what is the role of, say, your company, Johnson & 
Johnson, throughout the process of notification of a 
counterfeit medical device, and then to remove the device from 
the availability?
    Mr. Kaeser. Well, in this particular case, since we were 
notified by the hospital, we conducted a thorough 
investigation. We identified the source manufacturer in India. 
It was coming through a distributor in Dubai through some rogue 
gray market distributors in Florida, and ultimately into this 
hospital. So, we worked very closely with FDA and other law 
enforcement agencies to take the counterfeiter down quickly.
    We also worked with the FDA to notify customers and to 
communicate out. It is an ongoing investigation that goes 
beyond Surgicel. There are other medical devices that are at 
risk in this investigation as well.
    Mr. Burgess. And when you say ``take down,'' was this 
individual, or were there individuals who were actually 
arrested for this?
    Mr. Kaeser. Yes. In India, there were arrests taken. And 
civil and criminal actions are in progress.
    Mr. Burgess. They are in progress. OK. I was going to ask 
what the result of those were.
    Dr. Muzzio, just before we, before my time expires, back in 
2012, we were doing FDA reauthorization for drugs and devices. 
And at that time, drug shortages were a thing. I know they are 
still a thing, but they were really significant at that point. 
And anesthetic drugs, and emergency room drugs, some really, 
some common, some common stuff, not exotic stuff, was just 
simply unavailable.
    So, and I think at that point, we heard from Dr. Woodcock 
at FDA about some of the things that could be done to assist 
with alleviating or preventing drug shortages. So, continuous 
manufacturing I assume, has a role in this as well?
    Mr. Muzzio. Yes, it does.
    So, there are two different dimensions to this. First, a 
large fraction of drug shortages are caused by emerging quality 
problems. Continuous manufacturing systems are much more 
robust, and they allow much more monitoring. So, the likelihood 
of undetected quality issues when you are making the drugs in a 
continuous method is much lower.
    So, if we were making mainly from a single product using 
continuous systems those quality issues would be less frequent. 
That is one issue.
    But there is another dimension that is equally important. 
One of the biggest advantages of continuous manufacturing 
systems is that they allow you to do experiments much, much 
more quickly that batch systems. Typically, it takes 50 or 60 
experiments to develop a process, you could say. In batch 
manufacturing, that takes weeks, sometimes months. In 
continuous manufacturing, you can do a subject matter expert 
number of experiments in a few days.
    So, if there is a shortage caused by a quality problem with 
one particular formulation and we need to develop an 
alternative formulation, and it is the kind of drug that can be 
manufactured by continuous processes, we could develop a 
substitute product or a substitute process in just days.
    Mr. Burgess. Very good. I see my time has expired, so I 
will yield back to the Chair for that. I may follow up with 
some questions for you on that.
    Ms. Eshoo. The gentleman yields back.
    It is a pleasure to recognize the gentleman from Oregon, 
Mr. Schrader, for his 5 minutes of questions.
    Mr. Schrader. So, Dr. Muzzio, I am a little unclear on how 
continuous manufacturing alleviates the drug shortages. I 
don't--I can see where it is an efficient way to do things, and 
the quality control could be superior because of the ongoing 
manufacturing process. But, you know, how is it going to bring 
back atropine ointment and, you know, phenobarb and prednisone 
on a regular basis? There are shortages of drugs out there. How 
is that going to happen?
    Mr. Muzzio. Well, it is not a magic bullet that you could 
use today for everything. It has been well-developed for 
certain kinds of products. It could also be further developed 
as a technology option for other kinds of products.
    But, for the products, when you can use continuous 
manufacturing, as I mentioned, you can develop an automatic 
manufacturing approach very quickly. You can also use that 
using a relatively small amount of raw materials that might be 
scarce in a situation of shortage.
    Mr. Schrader. But I just don't, I don't see--are any of the 
companies you have talked about looking to do some of these 
drugs that there are shortages of right now?
    Mr. Muzzio. At the present time, I believe most companies 
are focusing on their flagship products.
    Mr. Schrader. Sure. That would be my thinking, too. I am a 
little worried about us kind of picking winners and losers in 
terms of different--because brand names are already doing it. 
They don't need our help. It is the generics; it is small 
companies trying to get started.
    I don't know how we would pick those that get to take 
advantage of the federal process, the federal money, and those 
that don't.
    Mr. Muzzio. Well, maybe I can share one personal 
experience.
    One of our sponsors about five or six years ago challenged 
us to see whether we could actually create new formulations and 
processes for five or six products that they would give us. So, 
they brought raw materials to us and they challenged to us. Can 
you have a working process and a viable product within a month 
for these six products?
    So, two of the six were not suitable. But the other four, 
we were able to within a month create an alternative 
formulation and a process. So, if we had the technology in 
place in enough locations, there will be the ability to do very 
fast development. That would be the response.
    Mr. Schrader. OK. OK. Well, I share the gentleman's 
interest in wanting to make sure we control more of our basic 
active ingredient manufacturing here in this country, and maybe 
some more discussion on how we would use this process as part 
of that.
    I like the idea of having a ubiquitous or at least 
regionally-based manufacturing platform that different 
companies could access. But picking which drugs, I think that 
that would require a lot of work.
    Dr. Chua, the drug exclusivity, why not just get rid of 
criterion number two? Why even, you know, give them a--why 
would a company bring it, go to market if they can't actually 
cover their costs? That makes no sense to me.
    Dr. Chua. It is a good question. I think that cost recovery 
prong was in there in case a drug did not treat a condition 
that was rare, which in that regard is 200,000 or fewer 
Americans, but was still potentially an important drug, just 
not one that could recoup its costs.
    There have only been three of those drugs that have been 
designated through the cost recovery prong since 1983. So, it 
is not a commonly used pathway.
    Mr. Schrader. You know, Madam Chair, I would just say we 
get rid of that criteria. It is confusing. We are adding a new 
layer of interpretation of a criteria that has only been used 
three times since 1983. And I say the manufacturing and the 
pharmaceutical companies have come a long, long way and, you 
know, they are going to be able to go through continuous 
manufacturing or some other process, be able to decide how to 
go about making these great orphan drugs. We are in a whole new 
era than we were, I think back in 1983.
    I guess a question, why, Dr. Allen or others, you know, why 
aren't generics able to update their labels now? I mean, that 
seems like an obvious thing.
    Mr. Allen. In most instances, they are. There is a 
frequently used mechanism, most notably when the RLD is still 
in existence if the brand is still there. The brand may make 
adjustments to its label to reflect changes in the context of 
use. And the generic relatively automatically will reflect 
that.
    The issue that the MODERN Labeling Act is addressing is 
those instances in which the original branded product has 
exited the market. And so those remaining generics are not able 
to change their label under current law.
    Mr. Schrader. But why?
    Mr. Allen. They still have to under law, because they have 
the sameness clause that was established to establish the 
generic market requires them to maintain the same label as the 
original product.
    Mr. Schrader. I understand.
    Mr. Allen. And when that product leaves there is nothing 
to, there is nothing to reflect.
    Mr. Schrader. All right, very good.
     Thank you. I yield back.
    Ms. Eshoo. The gentleman yields back.
    A pleasure to recognize the former chairman of the full 
committee from Michigan, Mr. Upton.
    Mr. Upton. Well, thank you, Madam Chair. I appreciate the 
hearing. And I do have a number of questions.
    Dr. Allen, just a quick thing. You know, it seems like a 
common sense bill, this H.R. 5668, to update the label. Has FDA 
actually, have they asked, are you aware if they have asked 
that we actually update this?
    I mean, it just seems so common sense that you would like 
to think that they would have just said don't need legislation.
    Mr. Allen. Well, I guess to give a little bit of context, 
you know, at least in the oncology space, although this is a 
phenomenon that occurs well beyond oncology. There has been an 
initiative by the FDA's Oncology Center of Excellence through a 
project they called Project Renewal that has begun to identify 
several of these older drug labels that have significantly 
drifted out of date.
    They have identified 44 products so far that will benefit 
from a re-review. The challenge is about a quarter of those 
fall into this withdrawn RLD. So, a quarter of those products 
just simply legally are not able to be updated without the 
passage of the MODERN Act.
    Mr. Upton. And I want to also say, Mr. Kaeser--Kaeser, 
Kaeser, you know, you talked about, and Dr. Burgess has talked 
a lot about this, I have not actually--I try to avoid New York, 
I will confess, particularly Newark or JFK. I don't know where 
you went. I like to take Amtrak. This Safeguarding 
Therapeutics, it just seems so sensible, so sensible to try and 
get it done, H.R. 5663.
    But, in your testimony, you indicated that a million people 
every year, according to INTERPOL, probably die because of 
counterfeit drugs or devices. Mostly in developing countries.
    So, can you explain a little bit about what is, what are 
the drugs that--and, I mean, can you break that down a little 
bit for us?
    Mr. Kaeser. I probably don't have it down to the drug 
level. I would say it is mostly in developing countries. We 
don't see it as much in the United States as we see it in 
Africa, or maybe in India, or other parts of the world.
    Mr. Upton. So, how large a staff do you have?
    Mr. Kaeser. I have 32 people on my team, and 32 direct 
reports.
    Mr. Upton. Wow. So, and you indicated that you would talk a 
little bit more in detail about your work with the FDA. Would 
you like to do that now?
    Mr. Kaeser. I would love to. FDA has been absolutely 
instrumental and critical in the work that we have done with 
the Surgicel. And it is--OCI has been a big part of our ongoing 
investigations. The FDA has also been very helpful in helping 
us communicate to the providers, to the patients to help 
safeguard the patients. So, FDA has continued to be a very 
strong ally for us to work with on my team.
    And I do believe that H.R. 5663 is an opportunity for us to 
even go deeper. And we can continue to develop tools and 
resources from that.
    Mr. Upton. You may know that when I was chair, we passed 
track-and-trace, a bipartisan bill. I think it was at the end 
of the session, but we were able to shepherd it through both 
the House and the Senate. Has that helped give you a little bit 
more resources to work with the FDA to identify these 
counterfeit drugs and devices?
    Mr. Kaeser. Yes. I look at track-and-trace and 
serialization as opportunities to help efforts in brand 
protection. But I can share with you that serialization law is 
a great tool. Serial numbers can be counterfeited as well. And 
whoever brings that serial number to market first, wins.
    Mr. Upton. I yield back. Thank you.
    Mr. Kaeser. Thank you.
    Ms. Eshoo. Would the gentleman give me just----
    Mr. Upton. Sure.
    Ms. Eshoo [continue]. Ten seconds?
    Dr. Muzzio, I wanted to ask you, you have talked about 
thename-brand drugs and continuous manufacturing. Ninety 
percent, approximately 90 percent of the drugs that the 
American people take, are generics. So, are generic companies 
accessing----
    Mr. Muzzio. We are aware----
    Ms. Eshoo [continue]. Continuous manufacturing?
    Mr. Muzzio. So, we are aware that some of the largest 
generic companies have been attempting to do that.
    Ms. Eshoo. What does that mean, attempting?
    Mr. Muzzio. Have been trying, yes.
    Ms. Eshoo. Trying.
    Mr. Muzzio. Trying.
    Ms. Eshoo. What does trying mean?
    Mr. Muzzio. We know that in a couple of cases, they bought 
equipment, they installed it, they tried to make it work. But 
there is a large amount of know-how that is required that the 
brand companies created over, over a decade. And----
    Ms. Eshoo. Do you think that there is an issue as to 
whether they want to make the investment?
    Mr. Muzzio. I believe that there might be an issue about 
whether they have the ability to see the path to success, not 
having necessarily all of the know-how available in-house.
    Ms. Eshoo. I will follow up with more. Yes, thank you.
    Mr. Upton. I will reclaim the remaining ten seconds of my 
ten seconds that I gave you.
    Dr. Allen, I just want to say, you all, Friends of Cancer, 
have been; you were so helpful as we worked on 21st Century 
Cures. And as you know, I think as you know, we are working on 
2.0 again, a bipartisan idea. We have had a number of 
roundtables. Just we are looking forward to hearing, you I 
think will participate, but we are looking still. The door is 
open for us to get ideas in terms of how we can expand this.
    I just wanted to thank you for your work and your 
organization's work.
    And with that, I yield back my ten seconds.
    Ms. Eshoo. I thank the gentleman. And he yields back.
    The gentlewoman from California is recognized, Ms. Matsui, 
for her 5 minutes of questions.
    Ms. Matsui. Thank you very much.
    Ms. Eshoo. Thank you for your legislation.
    Ms. Matsui. Thank you very much for holding this important 
hearing.
    I am pleased we have the opportunity today to discuss a 
bill I recently introduced with Representative Guthrie to 
modernize outdated drug labels. The FDA-approved label is the 
most independent and authoritative source of safe and effective 
prescribing information for healthcare providers and their 
patients.
    I am greatly concerned that there is no existing mechanism 
to update certain generic drug labels to reflect current 
commonly-accepted uses despite the critical role labels play in 
informing treatment decisions, safeguarding the public health, 
and facilitating greater use of lower-cost generics.
    Our legislation works to specifically address outdated 
generic labels in situations where the brand has left the 
market and, therefore, there is no ability to update the 
generic drug label. I know that some stakeholders have raised 
concerns about certain provisions in the bill. And I look 
forward to working with them as we move through the regular 
order. Introducing this bill is just the first step of this 
process, and because I am committed to finding the best path 
forward to protect consumers and modernize drug labeling while 
still allowing FDA to require updated labeling for drug 
products if new safety information emerges.
    That said, we need a targeted solution now that gives both 
patients and providers access to accurate and updated 
information for the generic drug products they are using in 
order to make safe and effective treatment decisions.
    Dr. Allen, thank you very much for being here today to 
discuss this important legislation. I appreciate all the work 
that Friends of Cancer Research has done to help identify this 
issue and craft a potential solution.
    Dr. Allen, under the current law if FDA wanted to update an 
out-of-date label for certain generic drugs, could the update 
include any information about new or existing conditions of 
use, labeling standards, or additional uses?
    Can generics make these updates on their own?
    Mr. Allen. If there is an existing RLD.
    So, thank you, and to Mr. Guthrie, for introducing this 
bill because this is a narrow window in which these products 
are essentially frozen. So, when the original RLD has been 
withdrawn, there is no mechanism to update for the situations 
that you have mentioned.
    Ms. Matsui. OK.
    Mr. Allen. The authority for safety----
    Ms. Matsui. Right.
    Mr. Allen [continue]. Still exists. And I want to be clear 
about that because we have gotten those questions, too.
    Ms. Matsui. Absolutely.
    Mr. Allen. So this still maintains that.
    Ms. Matsui. Absolutely.
    So, can we talk a bit more about off-label prescribing. Why 
is this practice particularly common in cancer drugs?
    Mr. Allen. I think given the pace of research and the 
investments that the country has made, facilitated by this 
committee and others, of course, and funding entities like the 
NIH, you see a lot of research on drugs once they are on the 
market. And this continues to grow in areas around, like, 
electronic health data capture.
     So, we continue to learn about drugs as they are used in 
different populations more broadly.
    But, the ability to have off-label use is really important 
in terms of access and the continuing evolution of learning. 
And I think what, you know, so I think the cancer community 
benefits from some of the guidelines that we have been talking 
about. But that is not the case in all therapeutic areas.
    Ms. Matsui. OK. So, if these off-label uses are already 
widespread and well-accepted, why is it still important to 
update a drug's label? What impact would this have on patients?
    Mr. Allen. I think, as you mentioned, the drug label itself 
is the most authoritative, unbiased, accessible source of 
information. We know patients get information about medical 
products that range from sophisticated mechanisms like 
compendia, working with their doctors, and even the internet. 
But, to have the FDA to have the ability to have greater 
flexibility and authority to make sure these labels are 
updated, I think we need to feel confident in the most 
accessible form of information. It is on their Web site.
    Ms. Matsui. Yes. So, while FDA does have the ability to 
require generic makers to change a label, these changes are 
limited to information pertaining to a product's safety?
    Mr. Allen. Correct.
    Ms. Matsui. So, in order to provide patients and providers 
with the safest, up-to-date, and highest-quality prescribing 
information, we need a process like the one created under 
MODERN.
    Mr. Allen. Yes.
    Ms. Matsui. And it is very strategically and narrowly 
written so that we can do that.
    OK. Well, thank you very much for being here, and all the 
work that the Network has done. And appreciate your being here.
    Thank you so much. I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    It is a pleasure to recognize Mr. Guthrie of Kentucky for 
his 5 minutes of questions.
    Mr. Guthrie. Thank you very much.
    A couple of these bills are so common sense that the 
questions have already been asked, it seems, moving forward. 
But when I was at the JFK, coming forward, I wish people could 
sit there and see that because you see counterfeit drugs, you 
see them standing in front of you, sitting in front of you. And 
people are, if they are going outside the normal distribution 
chains and a lot of times, people are doing it because of 
access to affordable prescription drugs. And hopefully, we, as 
a Congress, can get back to focusing on that and get a bill the 
President can sign.
    But in the meantime it is just not safe. If you are going 
to go on Web sites and try to--and we have an investigation 
beginning on counterfeit tickets to events--if you buy a 
counterfeit ticket; you have a bad night. If you buy a 
counterfeit drug, you can ruin your life. And so it is 
important.
    And I just want people to understand that I am standing 
there and watching somebody, if it was a, if it was a drug, 
they could destroy it. But if the drug was packaged with a 
syringe, so therefore, a medical device, they couldn't. And so, 
Mr. Kaeser, can you explain under current law what happens when 
counterfeit products are discovered?
    What is an example of a combination product which cannot be 
destroyed?
    And why H.R. 5663 would improve the ability of the Federal 
Government to stop the supply of counterfeits?
    Mr. Kaeser. So, the first question was?
    Mr. Guthrie. Well, the first question is, under current law 
what happens when a counterfeit is discovered?
    Mr. Kaeser. Well, current law for medical devices, 
combination products, they are typically shipped back to 
whoever sent it. So, thus, it typically remains in the supply 
chain, and many times it comes back through.
    So, that represents a significant risk.
    Mr. Guthrie. Yes. So, but why wasn't it destroyed?
    Mr. Kaeser. Because it doesn't fall under the current law. 
Right? So, what you're asking for in the new law would allow us 
to destroy medical devices and combination products under 
$2,500.
    Mr. Guthrie. Yes, I understand. I just wanted you to bring 
that out.
    Mr. Kaeser. Yes.
    Mr. Guthrie. And then, so what is an example of a 
combination product? I mean, I saw a syringe with a vial of I 
guess it was insulin.
    Mr. Kaeser. Yes, that is an example.
    Mr. Guthrie. And they couldn't--if it was just insuli; they 
could have destroyed it. Because it was packaged with it, they 
couldn't, by law, which is what we need to do.
    Mr. Kaeser. That is a great example.
    Another one might be coronary stents, drug-eluting coronary 
stents. A stent creates the scaffolding to keep an artery open. 
If it is coated with a drug elution, a drug that would admit to 
helping with cell proliferation.
    So, I think those are a couple good examples of combination 
therapy.
    Mr. Guthrie. Well, I had a border--one of our FDA agents 
say at JFK that they literally have packaged, opened it, 
discovered it. They had to ship it back because they couldn't 
destroy it. They can store it but then they ship it back. And 
it comes back to JFK exactly as they wrapped it up and sent it 
back.
    So, people are actually ordering these. But the people who 
they are going to send them to are not even--who knows that 
they even put--I mean somebody could have changed the whole 
product inside and sent it back. This is how bad these people 
are who are trying to put this stuff through, and why we have 
to fix this. And it should not--it should be absolutely against 
the law to move forward.
    On the labeling, I think we discussed a lot of the reasons 
for that. When I first started looking at it I thought it was 
the label on the container. But that is not what we are talking 
about.
    Can you explain what labeling actually is? I think all of 
us think, as a matter of fact, it is something we need to fix, 
if you get over-the-counter, it seems like we have so much 
stuff required. I can't even find do I take one or two? Is it 
every 6 or 12 hours? Because you got to keep peeling things 
back to be able to see if we take that over-the-counter, do we 
have too much?
    But your labeling is different you're talking about. Could 
you just explain that?
    Mr. Allen. It generally refers to the entire package of 
information that is submitted and associated with the drug that 
often evolves over time. It includes things like the package 
insert that you've mentioned here.
    And I think that is a good point with the bill that you 
have introduced here will allow some of these older drugs to 
actually conform to a new format of labeling that the FDA put 
forth in 2006. Some of these drugs don't even conform to that 
at this point, and they can't be changed.
    Mr. Guthrie. Right.
    Mr. Allen. But by doing so, the intention there was to 
allow the drug label to be more accessible and more usable for 
the consumer.
    Mr. Guthrie. So, currently if it is not labeled, an updated 
label like it could be, what is happening to the patients 
currently? How are physicians, are they not able to use it in 
the prescribed way that they think would be used?
    Mr. Allen. In many instances, particularly in oncology, 
there is the accessibility to expert-developed guidelines. 
Things like the National Comprehensive Cancer Network have 
regularly updated guidelines. But those are typically 
accessible to expert oncologists, perhaps in an academic 
setting.
    So, still, the most accessible source of information would 
be to look up the drug label around things like different 
doses. And those doses can change over time, depending on the 
context of use. So----
    Mr. Guthrie. Oncologists may not have access to the best 
information for a specific drug for a specific patient.
    Mr. Allen. Not on these outdated labels. They would have to 
look elsewhere than the label in order to access it.
    Mr. Guthrie. Thanks. I look forward to more testimony from 
Dr. Muzzio on the bill. And I assume, Dr. Pallone, I mean Chair 
Pallone, I am out of time. But I know you--I was going to talk 
about drug shortages. And you just addressed that. So thank you 
for that.
    Mr. Allen. Thank you.
    Mr. Guthrie. Thank you. And I yield back.
    Ms. Eshoo. The gentleman yields back.
    I now would like to recognize the gentleman from Vermont, 
Mr. Welch, for his 5 minutes of questioning.
    Mr. Welch. Thank you, Madam Chair.
    I want to talk about the orphan drug bill in particular. I 
want to thank my colleagues, including Representatives Carter 
and McKinley and this subcommittee, for introducing their bill, 
which is very similar to a bill I introduced on orphan drugs.
    We all support the orphan drug program and it provides 
those incentives to get drugs to treat rare diseases. But I am 
really concerned about what I regard as the significant abuse 
of the bill. Pharmaceutical companies are seeking orphan drug 
status for some of their best-selling drugs. That is not what 
that orphan drug designation was about.
    In November of 2018, there was the GAO report on orphan 
drugs that found that 38 percent of the drug approvals from 
2008 to 2017 were for drugs that had been previously approved 
for either mass market or rare disease use. And some of the 
best-selling drugs on the market now have orphan status, 
including Humira, Remicade, and Enbrel. These drugs have 
billions of dollars in annual sales, and they don't need the 
orphan status. That is certainly as I see it.
    It is also becoming a real problem in the 340(b) program 
because drug manufacturers want to avoid including these drugs 
in the 340(b) program even though they are used for many and 
fairly common treatments.
    So, I do strongly support 4712, H.R. 4712, because it would 
take steps to begin to close loopholes and ensure orphan drug 
status is only being used for true orphan drugs.
    Mr. Kaeser, I want to ask you about Johnson & Johnson's 
drug Imbruvica. Am I saying that right?
    Mr. Kaeser. Imbruvica.
    Mr. Welch. Imbruvica, as I understand it, had about $2.6 
billion in sales in 2018, and sales are expected to range from 
$5 to $9.5 billion in 2020. And the drug currently has ten 
orphan indications. Is it your view at Johnson & Johnson that 
the orphan drug program was intended to be used ten different 
times for one drug?
    Mr. Kaeser. Representative Welch, that is a fantastic 
question. But it is----
    Mr. Welch. What is the answer.
    Mr. Kaeser [continue]. Way outside the scope of----
    Ms. Eshoo. Pull that microphone up.
    Mr. Kaeser. My microphone is on, yes.
    The focus of my work is in counterfeiting and brand 
protection. And I would be very happy to work with my 
Government Affairs team, my team back in New Jersey. I could 
come back with something.
    Mr. Welch. You know, with all due respect, I mean it is 
not--we have a hearing today scheduled on orphan drugs. So, it 
is not like this should be a surprise that this question gets 
raised. Johnson & Johnson is doing a 10-for-1 situation here 
with this drug.
    You want to check with somebody now, use your phone? Tell 
us what Johnson & Johnson's position is on whether this is an 
abuse of the orphan drug status?
    Mr. Kaeser. I would be happy to work with our folks back in 
Johnson & Johnson to get the right person to come back and 
speak to you.
    Mr. Welch. Yes, OK. I am going to express my frustration 
here. We hear that a lot from witnesses.
    Mr. Kaeser. OK.
    Mr. Welch. And then you are gone. I mean, the hearing is 
now. It was noticed. We knew we were going to be talking about 
orphan drugs. I am asking a simple, straightforward question 
and you are telling me you will get back to me. And once you 
walk out that door, you will be gone and I will never hear from 
you again.
    So, anyway, no more.
    Let me ask Dr. Chow--did I pronounce your name correctly?
    Dr. Chua. It's Dr. Chua.
    Mr. Welch. Chua. Thank you very much.
    What is the best way to address this issue of what I am 
defining, as I see it, the abuse of the orphan drug status?
    Dr. Chua. I think this is a difficult issue. I think these 
``partial'' orphan drugs, those with both orphan and non-orphan 
indications it is true that they tend to be extreme best 
sellers. In fact, I think seven of the ten top-selling drugs in 
the world are these partial orphan drugs. And it does raise 
difficult questions about whether orphan drug incentives are 
being used in a manner consistent with the purpose of the 
Orphan Drug Act, which was designed really to incentivize 
development of treatments that otherwise would have limited 
economic potential.
    Mr. Welch. Well, is it your experience that if there is any 
room for a loophole, then the pharmaceutical companies will 
drive their truck through it to be able to get the highest 
price possible at the expense of taxpayers and employers who 
are paying for these prescriptions?
    Dr. Chua. I think pharmaceutical companies have incentives 
to maximize their profit. And if there is an opportunity to--if 
the rules allow for that----
    Mr. Welch. OK.
    Dr. Chua [continue]. Then there will be certain----
    Mr. Welch. Well, I just----
    Dr. Chua. Then yes.
    Mr. Welch. Thank you. My time is up. But I just want to 
strongly endorse this bipartisan legislation that would try to 
start addressing this abuse on pricing powered by pharma.
    Thank you. I yield back.
    Ms. Eshoo. The gentleman yields back.
    Let me just make a quick comment. And that is that that I 
don't know a time when if a witness cannot give an answer that 
members have come forward and said they have never answered the 
question. It is my understanding that Mr. Kaeser is here 
relative to a specific issue. The one that you, the question 
that you asked is a very important one. But that is not his 
expertise.
    So, we will work together and make sure that you get the 
full information from Johnson & Johnson. But it is a little 
unfair to press him. He is here representing another 
department, another issue. And he is being honest in saying I 
can't give you; I am not the one that can give you the answer.
    You need, we all need to get the answer. You have raised a 
very important question. But we all need to appreciate that Mr. 
Kaeser is not the one that--he doesn't know. He is being 
honest. So, we will get the information.
    Who is next? The gentleman from Oregon, Mr. Walden.
    Mr. Walden. Thank you, Madam Chair.
    Ms. Eshoo. You are on. You are on.
    Mr. Walden. As fate would have it, I have a question for 
Mr. Kaeser about counterfeit products. And what I want to know 
is how Johnson & Johnson typically becomes aware that a 
counterfeit of one of their products has entered the supply 
chain? How does that happen? Give us the steps.
    Mr. Kaeser. Well, we do ongoing market monitoring. So, 
physical market surveys, online market surveys, constantly 
monitoring the internet 24/7 all around the world. So, we make 
it our business to constantly survey the world to see what is 
going on.
    Mr. Walden. All right. And how do these counterfeit 
products typically make their way into the U.S. market? We know 
about some of the mail facilities, and Dr. Burgess has been up 
to see some the last Congress. youtube the above statement
    Mr. Kaeser. I was going to say the IMFs, right, the 
International Mailing Facilities are a source.
    Mr. Walden. Yes.
    Mr. Kaeser. But it is the internet. It is the internet and 
unauthorized----
    Mr. Walden. Direct shipping?
    Mr. Kaeser. I am sorry?
    Mr. Walden. Just direct shipping?
    Mr. Kaeser. Direct shipping, yes.
    Mr. Walden. Yes. All right. And then how would extending 
FDA's administrative destruction authority to medical devices 
complement Johnson & Johnson's efforts to keep these 
potentially dangerous counterfeit products out of the hands of 
the unwitting providers and patients?
    Mr. Kaeser. Excellent question. I think this is right in 
front of us with H.R. 5663, it would be a great opportunity for 
us to extend that authority to the FDA on this inbound at these 
International Mail Facilities.
    Mr. Walden. OK. Let me ask you this, too. When you find 
these counterfeit products on the internet, what kind of 
relationship do you have with some of the internet companies to 
get those products, get those ads, those whatever taken down, 
taken off? Do you have a good relationship there? Do they 
respond? Do they not respond? Are some better than others?
    Mr. Kaeser. Some are better than others. But typically, we 
have very strong relationships with them. We have to. But, just 
like Johnson & Johnson or any other company, people come and 
go. And when----
    Mr. Walden. Yes.
    Mr. Kaeser [continue]. People go sometimes you have to 
start all over again.
    But my team is very closely connected with these 
marketplaces and constantly helping to improve.
    Mr. Walden. And so do any of them, like, push back and say, 
no, we are not going to do that, that is your problem?
    Mr. Kaeser. Probably not that blatantly, no. They at least 
put a good face forward.
    Mr. Walden. And they say, oh, we will take a look at it and 
never get back to you?
    Mr. Kaeser. I would say they are becoming much amenable.
    Mr. Walden. All right. Is there anything we need to do in 
that space?
    Mr. Kaeser. Well, I think, I think, for starters, let's 
push 5663 through. And I do think that there are opportunities 
for other tools, other resources, and how we can expand the 
authorities into other areas.
    Mr. Walden. I know in prior Congresses, we have had 
hearings with counterfeit medicines. I remember one year ago 
when they brought in samples in bags and said, you pick the one 
that is counterfeit. And none of us could. I mean, they looked 
exactly alike.
    Mr. Kaeser. Yes.
    Mr. Walden. So, how pervasive is this?
    Mr. Kaeser. It is a pervasive problem. And it is getting 
much worse. I think the counterfeits are very agile; they are 
very good. Many times the packaging that counterfeiters use are 
as good or better than what we use.
    Mr. Walden. Yes.
    Mr. Kaeser. Because there is really nothing good inside of 
it.
    Mr. Walden. And where is this coming from mostly?
    Mr. Kaeser. It is, I would say it is an equal opportunity 
world, but predominantly from Asia, a lot from China, and 
India, Middle East.
    Mr. Walden. Yes. All right. All right.
    Ms. Eshoo. Would the gentleman yield?
    Mr. Walden. Yes, sir. Yes.
    Ms. Eshoo. Mr. Kaeser, is there, would there be a--would 
the following put a dent in what you are describing, if there 
was a requirement for internet providers to flag and say ``not 
FDA approved''?
    Mr. Kaeser. Yes, absolutely.
    Ms. Eshoo. OK.
    Mr. Walden. Yes, Dr. Burgess, I would yield to you.
    Mr. Burgess. But, Mr. Chairman, just to answer part of your 
question, at the International Mail Facility,----
    Mr. Walden. Yes.
    Mr. Burgess [continue]. And I know it is not under our 
jurisdiction, but it is really pretty primitive. I mean, these 
are buildings that were built back in the 1930s. In some 
places, they lack internet access in some segments of the 
building. Customs and Border Protection is good about providing 
the FDA with the space that they have. But I know it is an 
Oversight Government Reform Committee challenge, but perhaps we 
ought to help them.
    And I have talked to members of that committee. The 
facility needs significant upgrading. And I suspect there are 
other facilities that do as well. Maybe that can be part of the 
infrastructure package.
    Mr. Walden. Yes, that would be good.
    And let me just suggest there is nothing that is not 
actually under our jurisdiction. As a former chairman, I just 
want to put that on the record. We start there and then make 
them try and claw it out of our hands.
    Ms. Eshoo. Very important statement.
    Mr. Walden. Is that correct? All right.
    Ms. Eshoo. Yes. That is going to be enlarged in the 
committee's print.
    Mr. Walden. With that, Madam Chair, I will yield back the 
balance of my time. Thank you.
    Ms. Eshoo. Thank you.
    The gentlewoman from New Hampshire, Ms. Kuster, is 
recognized for her 5 minutes of questions.
    Ms. Kuster. Thank you very much.
    I was thinking we would go to Michigan first. So, my 
apologies.
    Thank you, Madam Chair. And I am delighted to be here with 
all of you today. I wanted to focus in on the Dairy Pride Act. 
I served for six years on the Agriculture Committee. And I 
think I am in the first panel. I am sorry.
    I am sorry, let me skip to the Orphan Drug Act. I 
apologize.
    By monopolizing the market, how many have been unable to 
access lifesaving medication? And I am wondering how many have 
been deterred from evidence-based treatment out of fear for the 
current formulation?
    These are questions that we need to address. And I want to 
turn to Dr. Chua if I could. In 1994, the FDA granted Subutex, 
commonly known as buprenorphine, orphan drug status even though 
opioid use disorder is not a rare disease.
    Your testimony described Sublocade's orphan approval as an 
abuse of orphan drug policy, but also a catastrophe in the 
treatment of opioid use disorder. Can you detail how the cost 
of buprenorphine is a barrier to opioid use disorder treatment 
and how the gaming of the Orphan Drug Act has contributed to 
that prohibitive cost?
    Dr. Chua. Thank you for that question.
    So, the current list price for Sublocade for each shot of 
monthly shot is $2,000. What that does are two things. One is 
that it makes insurers reticent to cover it, or at least more 
willing to put up barriers such as prior authorization.
    The other things that it does is that it exposes patients 
to out-of-pocket costs, particularly those who are privately 
insured and who have to pay a portion of a drug's price due to 
deductibles or co-insurance.
    So, absolutely the price of buprenorphine products and of 
opioid use disorder medications more generally can be a 
deterrent to receipt of safe and effective care.
    Ms. Kuster. And one of the greatest challenges associated 
with medication-assisted treatment in the criminal justice 
setting has been the fear of diversion. Subutex and Suboxone 
were tablets placed under the tongue, while newer, extended-
release formulations by another company could not enter the 
market due to this monopoly established by the gaming of the 
Orphan Drug Act.
    How might the entrance of new formulations of buprenorphine 
improve treatment in vulnerable populations?
    Dr. Chua. Right. That is a really good question, too.
    So, these extended-release once-monthly injections have a 
couple of advantages. One of them is that you don't have to 
remember to take your buprenorphine every day, so it is going 
to promote adherence.
    The other in this particular instance is that if you 
substitute a monthly injection for a prescription, for example, 
Suboxone film, there is less potential for that film to be 
diverted on the black market because the buprenorphine is being 
controlled essentially in that sense by a monthly injection.
    Ms. Kuster. Thank you. And how is the legislation before us 
today effective in closing the loophole that has prevented 
other companies from entering the market with new formulations?
    Dr. Chua. This bill, H.R. 4712, would close the loophole 
that allowed Sublocade to gain orphan exclusivity in the first 
place--sorry, orphan drug status, that wasn't approved. And if 
in the event that FDA's decision to revoke Sublocade's orphan 
status is overturned, it would permanently bar the possibility 
of exclusivity for Sublocade which, as mentioned before, would 
block out new buprenorphine products until 2024.
    Ms. Kuster. So, you think overall that would be beneficial 
for Americans, including vulnerable populations and those that 
are receiving their medically-assisted treatment, that this 
will improve access----
    Dr. Chua. Yes.
    Ms. Kuster [continue]. To treatment for substance use 
disorder?
    Dr. Chua. Yes. We know that medications for opioid use 
disorder are extremely effective. And, yet, they are widely 
underused.
    So, we need to do whatever we can to increase use, increase 
choice, increase innovation, make sure that there are products 
that work for patients because each one of these products has 
different properties, they are administered differently, and 
they have different kinds of advantages and disadvantages. And 
we just need to make sure that we are doing everything that we 
can to give people the best chance to treat opioid use 
disorder.
    Ms. Kuster. Well, I want to thank you for being with us 
today. And certainly, on behalf of my constituents and on 
behalf of our bipartisan Opioid Task Force, I appreciate what 
you are doing. And I would urge my colleagues to support the 
bill.
    And with that, I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    It is a pleasure to recognize Mr. Griffith from the great 
state of Virginia for his 5 minutes.
    Mr. Griffith. Thank you very much, Madam Chair.
    Dr. Muzzio, we have all been following the coronavirus 
outbreak over the last couple of weeks. Your testimony 
discusses the ability of the continuous manufacturing process 
to more quickly respond to emergency needs. In a world where 
continuous manufacturing was the norm, how would you foresee a 
response to an outbreak like the one we are currently watching 
play out?
    Mr. Muzzio. Thank you for the question. I think it is an 
excellent question.
    So, if we had the technologies in place so that we could 
implement these rapid development methods for a wide variety of 
products, if some of the products or the, you know, the drug 
substances that are known or we would want to see whether they 
are good and effective for treating an emerging disease were 
manufacturable by continuous manufacturing systems, the 
response would be to assign the task of creating multiple 
versions of a potential product to a manufacturer that is 
enabled and knowledgeable, that manufacturer could come back 
with suitable versions of a possible product in days or weeks, 
which is much faster than you can do today.
    Mr. Griffith. Thank you very much. That is what I was 
looking for: much faster than what we can do today.
    I am going to yield now to my good friend from Indiana, Dr. 
Bucshon.
    Mr. Bucshon. Thank you for yielding.
    Mr. Kaeser, I was interested when we were talking about 
deaths related to counterfeit medications or devices. And it 
seems to me that likely that is related to people not getting 
the active component of the drug they are supposed to be 
getting and, therefore, they will, you know, not do well and 
they pass away based on the fact they are not getting it.
    Or, is it because of the toxicity? Do we know? Because I 
think when you throw out the number of a million people dying 
from counterfeits, I do think from a public perception 
standpoint it is important to understand conceptually, you 
know, what does that actually mean? I mean, what, is the 
American public, you know, you take the pill and you die, you 
know? Or is it just because you have--they are getting a 
chemotherapeutic agent that doesn't have active component?
    Do you have any breakdown on that at all?
    Mr. Kaeser. A great question. And I really don't. The 
INTERPOL data doesn't get that deep on specific products. You 
know, I can speak to some of the things that we have seen. It 
is both. There can be toxic things in the drug, or there could 
be a lack of an API that would cause interruption in therapy. 
But, regardless, if it is not coming from an authorized 
manufacturer, you are at risk.
    Mr. Bucshon. Yes, I am not implying that it is bad--you 
know, that it is not bad to have counterfeit drugs or products, 
right? I am just saying that I think when, you know, when we 
have public hearings, it is important, you know, the American 
people are watching that, you know, a million people are dying 
from counterfeit drugs that it is important for people to 
understand why is that.
    Is it because, like I said, you take the pill and, you 
know, you don't want people to stop taking their medicine? That 
is what my point is that I am getting at. Because people will 
do that based on these types of things; right? And so it is 
important to understand that most likely, in my view, it is 
probably because the active component is much less prominent in 
the counterfeit than it would be in a Johnson & Johnson drug or 
product. But, I don't know, and that would be important to 
understand.
    So, Dr. Muzzio, why hasn't the private sector in the United 
States adopted continuous manufacturing? I mean, you know, it 
is a free market. If it--it seems like, you know, in a lot of 
other industries you have this type of continuous process, why, 
why haven't we done it?
    Mr. Muzzio. It is a really good question.
    Technology-wise we could have done this 30 years ago. I 
think it is because it took universities to procure the 
funding, create the partnership, demonstrate that the 
technology would work, and be able to work in a non-adversarial 
way with the regulators. FDA played a phenomenal leadership 
role, very quickly promoting adoption, very quickly telling 
companies it was safe to do.
    When I started working on this 20 years ago; pharmaceutical 
companies were telling me that the FDA was never going to let 
them do it.
    Mr. Bucshon. Right. Because that----
    Mr. Muzzio. When I talked to FDA, FDA said, oh, we want 
them to do it. And then it happened.
    Mr. Bucshon. To finish up, that was the other part of the 
question I was going to ask. What is currently the greatest 
barrier and what has been the greatest barrier to the adoption? 
Is it just the marketplace hasn't supported it? Or is there, 
are there government barriers? And you, I think you mentioned 
the FDA, but what can we do here to change that?
    Mr. Muzzio. Well, so the greatest barrier to adoption by 
companies that are not doing it yet is what I said earlier 
several times is that there is a large amount of know-how that 
you need and they need to be able to access that know-how.
    Mr. Bucshon. OK, thank you. I yield back to Morgan.
    Mr. Griffith. And I yield back to the Chair. Thank you.
    Ms. Eshoo. The gentleman yields back.
    A pleasure to recognize the gentlewoman from Delaware, Ms. 
Blunt Rochester, for her 5 minutes of questions.
    Oh, I am sorry. Who is it? Ms. Kelly from the great State 
of Illinois is recognized for 5 minutes.
    Ms. Kelly. Thank you, Madam Chair. Thank you for your 
testimony today. And thank you, Chairwoman Eshoo, for holding 
this important hearing on the safety and transparency of food 
and drugs.
    The Orphan Drug Act was a critical piece of legislation 
that encouraged the development of drugs for rare diseases that 
may otherwise not have been developed. However, as Dr. Chua 
mentioned in his testimony, there have been instances in which 
this policy has been abused.
    In your testimony you mention how Sublocade's orphan drug 
approval is an abuse of orphan drug policy. Can you explain how 
this abuse impacts patient's access to affordable drugs by 
preventing other treatments from the market?
    Dr. Chua. So, when you get orphan drug exclusivity, what 
that means is that FDA can't approve any other competing 
products that contain the same medication, which in this case 
is buprenorphine, to treat the same disorder, which in this 
case is opioid use disorder, for seven years.
    So, given the timing of Sublocade's approval, which was 
November of 2017, that meant that if exclusivity had been 
granted to Sublocade, there would be no competitors, no new, no 
innovation, and no new buprenorphine product until December 
2024. In the midst of the worst public health crisis, arguably, 
of this generation, that strikes me as the definition of abuse 
of an orphan drug policy.
    Ms. Kelly. While many of us have concerns about access to 
affordable medicine, we all recognize the need to develop drugs 
to treat rare orphan diseases. We want to make sure that we 
have a policy that is tailored to fix this particular problem. 
Can you speak to the scope of the fix included in H.R. 4712? 
Will this bill do anything to harm the incentives we have----
    Dr. Chua. That's a great question.
    Ms. Kelly [continue]. To treat these patients of rare 
diseases?
    Dr. Chua. This is a great question. And I want to emphasize 
that the scope of H.R. 4712 is limited. It would only affect 
the three drugs that have ever been designated through the cost 
recovery prong designation, which is the unprofitability kind 
of pathway. And, actually, only two because one of them, one of 
them, Subutex's has been revoked, the designation has been 
revoked. So, it is actually only two drugs.
    And it would also affect any future approvals that occurred 
under a cost recovery prong designation.
    So, it really does not affect a lot of drugs. But, again, I 
want to emphasize how important this bill is, even though it 
has a limited scope, which is that it is going to protect 
patients from the possibility of not being able to access new, 
innovative buprenorphine products until 2024.
    Ms. Kelly. Thank you so much.
    And, Madam Chair, I yield back the balance of my time.
    Ms. Eshoo. The gentlewoman yields back.
    The gentleman from Florida, Mr. Bilirakis, is recognized 
for his 5 minutes of questions.
    Mr. Bilirakis. Thank you, Madam Chair, I appreciate it.
    Mr. Kaeser, does the rise of e-commerce create additional 
challenges in monitoring for counterfeit goods? I think I know 
the answer to that question.
    If so, in what ways do they?
    Mr. Kaeser. I have been involved with brand protection, and 
anti-counterfeiting for seven years, and it has, I would say, 
been a very dark shadow in my life, and I see the world a 
little bit different. I see that the e-commerce space, the 
internet, provides the perfect playground for bad actors. Many 
times counterfeiters are third-party sellers that are hiding 
behind a brand name that is very reputable. But when you 
purchase, if you don't look closely, you can end up with 
counterfeit goods.
    Mr. Bilirakis. Yes. Are brands working with e-commerce 
businesses to crack down on counterfeit goods? If so, how?
    Mr. Kaeser. I am sorry; what was the question?
    Mr. Bilirakis. OK. Are brands working with e-commerce 
businesses to crack down on counterfeit goods?
    Mr. Kaeser. We are constantly working across the e-commerce 
platforms to protect ongoing illicit trade and to take them 
down. We at Johnson & Johnson, our illicit trade analytics, and 
we work with external companies to help us to constantly 
monitor the internet, the e-commerce space. And we take down 
tens of thousands of sites per year.
    Mr. Bilirakis. OK, good.
    Do all products run the same risk of being counterfeited? 
If not, which products carry the most risk of being 
counterfeited?
    Mr. Kaeser. Counterfeiters are very shrewd businessmen. 
They are looking for big brands, recognizable brands, that 
typically have strong market share and strong margins. So, I 
would say if you are a big brand and you are making money, you 
have a big target on your back.
    Mr. Bilirakis. OK. Do patients and consumers play a role in 
addressing the problem of counterfeited goods? If so, in what 
way? And does Johnson & Johnson partner with consumer goods 
groups, consumer groups or their healthcare stakeholders?
    Mr. Kaeser. I think that there is an opportunity for more 
consumers, and more general awareness around the risks imposed 
by illicit trade and counterfeiting. But, they do play an 
important role that if a consumer has a bad experience or they 
suspect counterfeit, on all of our packaging, there is a toll-
free number to contact us.
    And we urge anybody that has a bad, I will say, event with 
a Johnson & Johnson product to let us know.
    Mr. Bilirakis. OK. How might Congress further support 
efforts to protect consumers from counterfeit goods?
    What other authority should the Federal Government have to 
curtail the supply of counterfeit medical devices?
    Mr. Kaeser. As I said multiple times, I think the support 
of this bill is an enormous opportunity. I think it is low-
hanging fruit. And I have alluded to that I think getting this 
in place, and opportunities to explore other tools.
    I have heard many references to the International Mailing 
Facilities and the resources there, that they are old or they 
lack resources. And I will share an example or an analogue that 
I got from a friend who is at Homeland Security. And if you 
know anything about counterfeiting, it used to be, you know, 
the slow boat from China per se. It was cargoes, it was 
containers, they were large containers coming in.
    With e-commerce it has changed. It is small parcels coming 
in through these mailing facilities. And the analogue that this 
Homeland Security agent shared with me said in the old days it 
was as if somebody was rolling a bowling ball across the table. 
You knew it was awkward, it was going to be heavy, but you 
could probably stop it.
    Mr. Bilirakis. Right.
    Mr. Kaeser. Today it is like somebody has opened up a 
bucket of marbles and rolled it across the table. And you can 
catch a few, but a lot more are going to get through.
    Mr. Bilirakis. Yes.
    Mr. Kaeser. So, I think that we have a lot of opportunities 
to continue to improve.
    Mr. Bilirakis. All right. Thank you very much.
    Anyone want my time?
    Ms. Eshoo. I do.
    Mr. Bilirakis. Oh, OK, please. Please. I yield.
    Ms. Eshoo. I thank the gentleman for yielding.
    Do you believe that the most effective thing that we could 
do is to add to the bill that since these are--it is illicit--
--
    Mr. Kaeser. Yes.
    Ms. Eshoo [continue]. That no platform be allowed to carry 
them, to advertise them?
    Dr. Burgess just showed me--well, no, it was on your iPad. 
I opened kind of----
    Mr. Burgess. It was on sale, 80 percent off.
    Ms. Eshoo. Yes, 80 percent off on fentanyl. So, why don't 
we just shut this--do the strongest language just to shut this 
thing down?
    Mr. Kaeser. If it is that blatantly obvious, I completely 
agree.
    Ms. Eshoo. Good. OK.
    I thank the gentleman for yielding.
    Mr. Burgess. Would the gentleman yield to me for one 
additional second?
    Mr. Bilirakis. Oh, absolutely.
    Mr. Burgess. And just, really, the gentleman had a good 
observation. One of the things I saw when I was at the 
International Mail Facility, it wasn't a device; it was a drug. 
It was botox, counterfeit botox. And, man, the packaging was 
just superb. You could not tell any difference between regular 
allergen-produced botox.
    The problem with botox is, well, one thing, if it is not 
sterile, as you said with Surgicel, but if the potency is off, 
OK, if it is too mild, the wrinkle is still there. If it is too 
potent, that is a potent neurotoxin and it could be fatal.
    So, that is the reason we need to be so focused on this.
    I thank the Chair, and I thank the gentleman. I will yield 
back to the gentleman from Florida.
    Ms. Eshoo. The gentleman yields back.
    I am happy to recognize the gentlewoman from California, 
Ms. Barragan, for her 5 minutes.
    Ms. Barragan. Thank you.
    Mr. Kaeser, one of your most striking parts of your 
testimony was the estimate that a million people, mostly in 
developing countries, die each year from taking counterfeit 
medicine. There is a real danger that is posed when the 
counterfeit medical devices are in the supply chain. And we 
must ensure that the proper resources and mechanisms are in 
place to eliminate these products so patients are protected.
    Additionally, representing the district with the Port of 
Los Angeles, I know firsthand the difficulties that the ports 
face when it comes to inspecting and securing the large number 
of products that come into the country.
    Can you, can you tell me about if you have any information 
on some of the more common counterfeited medical products? And 
what are the dangers posed from these products entering the 
market? And if you happen to have any idea, maybe how some of 
that comes through the ports?
    Mr. Kaeser. I apologize; your question is, what are some of 
the more counterfeited products coming into the United States?
    Ms. Barragan. Do you have any information on some of the 
common counterfeited medical products and the dangers from 
those products? And if you have any information, maybe as it 
pertains to those coming through ports?
    Mr. Kaeser. Yes, it has, I have to say, in the United 
States, it has been a more recent surge of counterfeit products 
coming into the U.S. And associated with the Surgicel 
investigation, the more we look, the more we find. And we have 
also found, Dr. Burgess might appreciate, LIGACLIPs. LIGACLIPs 
are stainless steel clips that are used for surgical 
procedures.
    Imagine you are having, you know, a lung removed and you 
need to cut the blood supply off to that, to the lung to remove 
it. You clip it, clip it, cut it.
    These clips are also counterfeit, and non-sterile. And 
there is also a feature on those that allow the clip to close 
securely. These don't have those serrations. So, post-op in 
recovery, with the pulsation of those vessels, those clips 
could potentially slide off.
    Stapling devices, we are finding counterfeit stapling 
devices.
    So, this is, it is, right now it looks like it is probably 
the same source, which will help us significantly. But it is a 
big challenge.
    Ms. Barragan. Do you have any insight on what more can be 
done to increase resources at the ports to be able to conduct 
the number of inspections necessary to dramatically reduce the 
number of counterfeited medical devices that are coming in 
through our ports?
    Mr. Kaeser. Yes, I am not an expert on what we would do to 
necessarily upgrade the ports. The industry is doing, I think, 
a good job. We are doing a much better job of working with 
Customs officials training them on what to look for, training 
them on what inbound freight from a company like Johnson & 
Johnson where it should be coming from----
    Ms. Barragan. Right.
    Mr. Kaeser [continue]. Versus where the counterfeit is 
coming from, to help them to identify it.
    So, it is an evolution. And I have to say that I take my 
hat off to Homeland Security, Customs and Border Patrol, are 
outstanding partners in our efforts.
    Ms. Barragan. Yes, I have done a tour down at the port. 
And----
    Mr. Kaeser. Yes.
    Ms. Barragan [continue]. The collaboration is key in 
knowing what to look for. And they have an entire room where 
you can walk in and see counterfeit purses. And I am sure those 
are a little easier to identify maybe than some of these 
medical devices.
    So, for Dr. Chua, rare diseases are those that affect fewer 
than 200,000 people. Like with many diseases, various rare 
diseases have substantial racial disparities. This includes 
sickle cell disease, which occurs in about 1 out of every 365 
African American births.
    Like we have discussed today, medications that treat these 
rare diseases receive orphan drug designations, such as ARU-
1801, a potential gene therapy for sickle cell disease that the 
FDA recently gave orphan drug status.
    Because of exclusivity rules it is harder for lower-cost 
generics to come to market quickly. While the rules are 
beneficial to help incentivize the development of orphan drugs, 
we must make sure there aren't bad actors that are taking 
advantage of the system.
    How will the Orphan Drug Exclusivity Act help reduce the 
overall cost of prescription drugs so that patients can afford 
the treatments they require?
    Dr. Chua. So, I agree with all your points. I think they 
are very good points.
    Again, this bill has a very limited scope. It would only 
affect orphan drug designations that occurred under the cost 
recovery prong, which has only happened three times in the 
history of the Orphan Drug Act.
    To your question about cost, right now, Sublocade has a 
three-year period of exclusivity because it is just a standard 
exclusivity that is granted for a new formulation of a 
previously approved drug. So, right now, as I mentioned, the 
list price for each multi-shot is 2,000. And that is because 
the company Indivior can charge what it wants. It is the only 
medication on the market.
    And again, that, there is a tradeoff for that, right? We 
want to be able to reward companies for innovation. But there 
are downsides to that as well. And so, walking that fine 
balance is very important.
    In this situation, I think the idea of extending that 
monopoly to 2024 is unconscionable--I can't even say that 
word--unconscionable in the context of the opioid epidemic.
    Ms. Barragan. Thank you. I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    A real pleasure to recognize the gentlewoman from Indiana, 
Ms. Brooks.
    Ms. Brooks. Thank you, Madam Chairwoman. And thank you so 
much for holding this really important hearing. I think it 
builds on past hearings we have had, specifically as it relates 
to active pharmaceutical ingredients.
    And I would like to talk to you, Dr. Muzzio, about the 
continuous pharmaceutical manufacturing that you are such an 
expert in. I represent Indiana, one of the largest 
manufacturing states in the country. Purdue University has been 
one of the--one of those universities that have partnered to 
help advance continuous manufacturing research, and then also 
Eli Lilly in Indianapolis I represent. And these are employers 
that are--employees that are trailblazers in the field.
    And I have toured their manufacturing facilities. But one 
of the concerns that this committee, I think has learned a lot 
about, and we are continuing to explore, is the real threat 
posed by China, India, and overseas with respect to the active 
pharmaceutical ingredient adulteration. And now that we are so 
focused on, the chairwoman of this committee and I have been 
very focused on the biological threat. And now, with what is 
happening with coronavirus, how can we accelerate in this 
country the continuous manufacturing in this country?
    Certainly we, I think, probably need to have a reduction in 
many ways on foreign manufacturers, although many of our 
companies are international and are multinational companies. 
But if we want to bring back more continuous manufacturing 
processes here, you have connected our universities, and you 
have said the largest amount of know-how comes from the 
universities; why is it the manufacturers themselves are 
apparently choosing to rely on the universities?
    And what do we need to do to accelerate either the 
expertise in both our higher ed institutions, as well as our 
manufacturers?
    Mr. Muzzio. That is a very good question. Thank you.
    So, I think historically the reason why it took the 
partnership is because of the ability to build a different 
relationship with regulators as well as to demonstrate a 
technology in a non-competitive, non-confrontational situation 
where everybody could benefit from it.
    So, that was our role historically. And you are absolutely 
correct, Purdue was one of our most appreciated partners we 
worked together on this.
    Going forward, now you have some companies that do know how 
to do this, and you have many, many companies that don't. So, 
one way to accelerate this is to, as I said already, make the 
knowledge available. But, in addition to that, create an 
environment where the technology can be demonstrated, where 
they can come with their drug substance and we can create a 
process and turn it into the product.
    Also, I want to talk for just one second about the APIs 
that you referred to; right? We had to distinguish,and finish 
those manufacturing from API manufacturing. Continuous 
manufacturing can help us well, in API manufacturing, in 
creating agile ways to recreate a manufacturing capacity that 
we have lost. It is a slightly different application, but the 
principles are similar.
    So, you asked me what you can do. To provide the support, 
to provide the resources so that we can create the centers that 
can do these jobs and can help everybody move forward.
    Ms. Brooks. And what would you say with respect to the 
grants? The 21st Century Cures was all about really advancing 
continuous manufacturing. How, how widespread do we need for 
these grants to, you know, what amount might we say is needed 
to help our higher ed institutions get engaged in this 
process----
    Mr. Muzzio. Well----
    Ms. Brooks And in, you know, securing these grants?
    Mr. Muzzio. So, I don't have the exact number in mind right 
now, but I could come back to you with it. But Europe has 
allocated in the order of billions of euros to this activity.
    Ms. Brooks. To their higher ed institutions?
    Mr. Muzzio. To their initiatives in advanced pharmaceutical 
manufacturing. There was a major initiative in the U.K. that 
was worth well over a billion euros. There has been what they 
call their 2020 right, which they started several years ago. 
They had very large amounts of funding allocated to this, 
specifically promoting the creation of government/academia 
partnerships so that they could march on quickly.
    Their centers are larger than the ones that we have got 
funded. They also have a much more focused mandate on creating 
and demonstrating technology and basic research. We are behind 
in this area.
    We greatly appreciate the resources that have been made 
available through 21st Century Cures and now, hopefully, 
through the new bill. But I have to say, Europe has invested 
much more steadily on this.
    Ms. Brooks. OK, thank you.
    And I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    And now the gentlewoman from Delaware, Ms. Blunt Rochester.
    Ms. Blunt Rochester. Thank you, Madam Chairwoman, and thank 
you, Ranking Member Burgess, for this important hearing on 
improving safety and transparency in America's food and drugs.
    I also want to thank the panel for your testimony. And, Dr. 
Chua, I want to also specifically reference the fact that you 
really reinforced that decades ago, Congress passed the Orphan 
Drug Act to incentivize the development of new therapies for 
diseases affecting less than 200,000 people, or for drugs 
unlikely to be profitable.
    In May of last year I, too, was concerned to learn that 
Sublocade--Sublocade, buprenorphine, drugs used to treat those 
with substance use disorder, could be granted orphan drug 
manufacturing exclusivity, even though millions of Americans 
suffer from addiction, and the drug generates multi-million 
dollars in profits each year.
    While the FDA ultimately reversed their decision, this 
would have potentially kept competing products off the market, 
artificially reduced treatment options, and potentially made a 
lifesaving medication more costly for those who need it.
    I recently visited a small business in my state of 
Delaware, and it was a family-owned business, a car dealer. And 
we spent time talking about training. We talked about, you 
know, cars, electric vehicles. But the thing that stuck out 
most was the impact that the opioid crisis is having on his 
employees and the families that he works with. Our nation is in 
the middle of an opioid crisis. There are an average of 130 
Americans dying from an opioid overdose every single day. And 
in Delaware we lose someone every 22 hours to an overdose.
    Simply put, extending orphan drug designation in this 
manner would have been inconsistent with the intention of the 
Orphan Drug Act.
    Dr. Chua, in your testimony, you state that buprenorphine 
is an under-used treatment, even with the severity of the 
opioid epidemic. Can you share with us why? And how is patient 
access to buprenorphine impacted by requirements that 
prescribing physicians obtain an X waiver?
    Dr. Chua. These are all really good questions.
    I think that waiver is in fact, one of the major barriers 
to buprenorphine prescribing. So, just to put this in 
perspective, there are three drugs to treat, FDA-approved 
medications to treat opioid use disorder: buprenorphine, 
methadone, and extended-release naltrexone.
    Each of them have advantages and disadvantages. An 
advantage of buprenorphine is that it can be prescribed in 
office-based settings, whereas methadone can only be dispensed 
in methadone treatment centers. So, that makes it more 
convenient and accessible, provided that you can find somebody 
who actually prescribes it.
    In order to find somebody who prescribes it, that somebody 
has to go through eight hours of training, and has to apply for 
a waiver in order to prescribe buprenorphine. And data show 
that most of the people who might be candidates to prescribe 
buprenorphine, many primary care physicians, for example, have 
not gone through that process.
    So, I think the waiver is certainly a big, or exing the 
waiver would be something that would greatly increase access.
    Ms. Blunt Rochester. I have two different sets of questions 
that I am trying to decide between, so I might have to follow 
up with you. One was going to be focused on adolescents and 
lack of research or data that is out there and what your 
thoughts are on that.
    But what is really pressing to me, we saw a JAMA Network 
open study that found that for every three additional payments 
that manufacturers make to physicians per 100,000 people in the 
country, opioid overdose deaths increased by 18 percent. But 
the study suggests that it was the frequency of the marketing 
interaction, not individual payment amounts, that had a greater 
impact on physicians' opioid prescribing.
    More interactions led to increased awareness of the 
product, interest trust at the company, and then different 
prescribing practices.
    And so, in the limited time that I have, time versus money, 
are there any limits on the number of interactions or amount of 
direct payments that manufacturers can make to physicians?
    Dr. Chua. Not really as far as I can--there is no, there is 
no, as far as I am aware, there is no cap on the amount of 
payments that can be made.
    Ms. Blunt Rochester. And my follow-up question--and we will 
follow up with you in writing--will be about just the 
relationship between manufacturers and physicians and how it 
develops over time, and how that impacts the prescribing rate.
    I thank you and I yield back. I am out of time, but I yield 
back. Thank you.
    Ms. Eshoo. The gentlewoman yields back.
    A pleasure to recognize the only pharmacist in the 
Congress, the gentleman from Georgia, Mr. Carter.
    Mr. Carter. Thank you, Madam Chair. And thanks all of you 
for being here. This, all of this is important.
    Dr. Chua, I want to stay with you because the opioid 
epidemic is something that I have had firsthand experience at 
as a practicing pharmacist, as a legislator as well. In 2009, 
during what could be arguably called the epitome of this 
problem, I was the lead sponsor of the legislation that created 
the Prescription Drug Monitoring Act in Georgia.
    And this is something that is very important to me. And I 
am the lead sponsor on the Fairness--the lead Republican 
sponsor on the Fairness in Orphan Drug Act, so I wanted, I want 
to thank you for your testimony here today because it is very 
important, extremely important.
    So, let's, let's talk about it. And you talk about why the 
bill is so important. And under the current statute, because 
there is a real loophole here, and we are closing that 
loophole. Can you address it very quickly?
    Dr. Chua. So, essentially any time anybody wants to get an 
orphan approval and, therefore, exclusivity under a cost 
recovery prong designation in the future, they would have to 
prove at the time of approval that there was no expectation of 
profitability. Let me just give an example.
    So, it turns out that one of the other--I had mentioned 
that there were three designations in the history of the Orphan 
Drug Act under the cost recovery prong--one of the other ones 
is Suboxone, which was also designated in 1994 also for the 
company Reckitt Benckiser which is now--which Indivior spun off 
from in 2014.
    Mr. Carter. And it is important to note that this was pre 
the opioid crisis.
    Dr. Chua. This is correct, yes. That is absolutely correct.
    And so, with the loophole as is, in theory, Indivior could 
develop a new formulation of Suboxone, which is, I think the 
best-selling buprenorphine drug in the world, and automatically 
gain orphan status for that new formulation because essentially 
the designation for Suboxone in 1994 would be automatically 
grandfathered.
    So, essentially that would just be a repeat of what the 
company did for Sublocade.
    Mr. Carter. Right.
    Dr. Chua. And this bill would close that possibility.
    Mr. Carter. And it is only a small change.
    Dr. Chua. That is right.
    Mr. Carter. It is only a small change. And it is obviously 
a necessary change.
    So, again, I want to thank you because this is extremely 
important. And I just appreciate you being here and appreciate 
your testimony.
    Dr. Allen, I want to ask you, under the Modern Labeling Act 
who, the updates, if there are updates to a label of a drug, 
who is to communicate that to the doctor and to the pharmacist? 
Whose responsibility is it, is it the FDA, or is it the 
manufacturer, or who?
    Mr. Allen. So, generally speaking, that information would 
be first listed in the label, which would allow it to be the 
basis of communication. So, FDA would communicate the label 
that would be accessible to the prescriber. And for the 
information that is in the label, that could then be actively 
communicated by the manufacturer.
    Mr. Carter. Well, with all due respect, I didn't just start 
reading the label to see if anything had changed. I mean, 
somebody needs to notify the pharmacist, and somebody needs to 
notify the doctor that a labeling change has been made. Whose 
responsibility is that?
    Mr. Allen. I think in instances where it is a safety 
concern, there are more active mechanisms that that can be 
pushed out. For some of these others, they may be more just a 
reference as opposed to every modification that could occur to 
a drug over the life cycle.
    Some of that may not even raise to the point of a label 
change, for example, because I think the important thing that 
hasn't necessarily been mentioned in our discussions today or 
on this bill is the standards for the information that would be 
put in the label here will be consistent with current law that 
has been in place for decades.
    Mr. Carter. But, I mean, if there is a new indication for a 
drug, it is going to be communicated most probably by the 
manufacturer. I mean, they are going to want the physician and 
the pharmacist to know there is a new indication for this.
    Mr. Allen. If it is updated in the label.
    Mr. Carter. Right.
    Mr. Allen. If it is supported in scientific evidence, there 
may be limitations in terms or how they might be able to 
communicate that.
    Mr. Carter. OK. Mr. Kaeser, I wanted to ask you regarding 
counterfeit medical devices; this is obviously something that 
has evolved over time. And is it getting more detailed, is it 
getting more complex as time goes on?
    Mr. Kaeser. From what I have seen, counterfeiting is 
evolving. I do believe that they are getting better at what 
they do, which is really forcing our hands to get better at 
what we do. So, the short answer is yes.
    Mr. Carter. And, I want to just issue a warning. As we talk 
about prescription drug prices and how we are going to control 
those prices, and we open up markets outside of the United 
States, this is a very big concern of mine. I, in my years of 
practicing pharmacy, I have had people bring products to me: I 
got this through the mail; is this the right thing?
    And, you know, I mean, I don't have a laboratory there that 
I can ascertain whether it is or not. So, I just think there is 
a big warning there that we need to all heed to.
    So, thank you very much.
    Mr. Kaeser. Thank you.
    Mr. Carter. And I yield back.
    Ms. Eshoo. The gentleman yields back.
    It is a pleasure to recognize the gentleman from New York, 
Mr. Engel, for his 5 minutes of questions.
    Mr. Engel. Thank you, Madam Chair. And thank you very much 
for holding today's legislative hearing and including my 
bipartisan legislation, the Safeguarding Therapeutics Act, 
which I drafted with my friend Congressman Guthrie.
    Counterfeit drugs and medical devices pose a significant 
health risk to the American public, which can lead to serious 
patient harm or even death. Just last November, the DEA 
reported that 27 percent of the counterfeit pills it had seized 
contained potentially lethal doses of fentanyl.
    Since 2008, the FDA has frequently participated in an 
international initiative known as Operation Pangea to prevent 
the sale of counterfeit healthcare products.
    The Safeguarding Therapeutics Act provides the FDA with 
another tool to protect Americans from counterfeit medical 
products. Specifically, this bipartisan legislation provides 
the FDA with the authority to destroy counterfeit medical 
devices.
    Chairwoman Eshoo, I would like to ask unanimous consent to 
submit into the record a letter of support for H.R. 5663 from 
the Healthcare Supply Chain Association.
    Ms. Eshoo. So ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Engel. Thank you.
    Mr. Kaeser, thank you for joining us today and sharing your 
insights on protecting the healthcare supply chain from 
unscrupulous actors I know much earlier in the testimony you 
mentioned to us.
    In your written testimony you share a recent example of how 
a counterfeit version of Johnson & Johnson's medical device 
known as Surgicel, which is critical to controlling patient 
bleeding during and after surgery, nearly ended up in patient 
care. Mr. Kaeser, how did this product end up in the supply 
chain?
    What steps can policymakers take to educate healthcare 
providers and patients about counterfeit medical products?
    Mr. Kaeser. Representative Engel, first of all, thank you 
very much for your sponsorship of this bill. It is very 
important.
    Going back to the example with Surgicel, the counterfeit 
Surgicel was manufactured in India, went through a distributor 
in the Middle East based in Dubai, and eventually landed in 
three distributors in Florida. So, best for our investigation, 
these distributors contact hospitals offering lower-cost 
Johnson & Johnson products, and they took the bait.
    So, it was through an unauthorized gray market distributor 
is how they acquired that.
    Mr. Engel. Well, thank you very much. And thanks for 
helping us to expose it.
    Dr. Muzzio, let me say this. I am going to talk about drug 
shortages, which is certainly a priority for the New York 
hospitals. Drug shortages can hamper patient care. They delay, 
obviously, medical procedures, or lead to the substitution of 
recommended treatments with alternative therapies. And these 
shortages have increased in recent years, putting an 
unnecessary burden on safety-net hospitals in my home state of 
New York.
    In September, I led a bipartisan letter with Congressman 
Guthrie, signed by over 90 House members, to the FDA which 
prompted the agency to release a report on approaches to reduce 
drug shortages. And I also want to thank Chairman Pallone for 
supporting us on this issue.
    His bill, the National Centers for Excellence and 
Continuous Pharmaceutical Manufacturing Act, which I have co-
sponsored, would expand federal support for promising 
technology that could help address drug shortages.
    Dr. Muzzio, could you describe how continuous manufacturing 
is more expeditious in responding to drug shortages than 
traditional batch manufacturing?
    Mr. Muzzio. Yes. Thank you very much, Congressman, for your 
co-sponsorship of the bill.
    So, when you have to develop a product or a process in 
batch manufacturing, typically you have to make a full batch of 
product many times over to obtain the information needed to 
figure out what are the right parameters to make the product. 
You make each of those batches under different conditions, and 
from that you determine how to make the product going forward. 
So, each time in batch you end up making a full batch.
    Or you make a small scale batch, and then you have to do 
scale-up studies to be able to then implement the process at 
the full scale. This takes many weeks, sometimes months.
    In continuous manufacturing you are feeding your 
ingredients to a system that turns those ingredients into 
finished product in a matter of minutes. And if you want to 
explore many conditions, you modify your settings, and every 10 
or 15 minutes you have a full new experiment. So, the entire 
large set of experiments that you need to do to find the right 
way to make the product or the process takes a day or two.
    Even if you want to repeat your studies, all you end up 
needing is a few weeks at the most. So, the intrinsic nature of 
continuous processes is much faster.
    One more thing that is important. As you do those 
experiments you are collecting information about what the 
process is doing every second. So, you have much more 
information about how those experiments tell you how to 
implement the process. And, as a result, you can implement any 
process and find the right conditions much more quickly.
    Mr. Engel. Well, thank you very much. And thanks to 
everybody on the panel. It has been really very enlightening 
and interesting.
    And thank you, Madam Chair. I yield back.
    Ms. Eshoo. Thank you, Mr. Engel. And I know you waited a 
long time to speak. And appreciate the good words that you, 
both your questions and the good words about the excellent 
witnesses.
    A pleasure to recognize the gentleman, and my pal from 
Illinois, Mr. Shimkus, for his 5 minutes.
    Mr. Shimkus. Thank you, Madam Chairman. I see my colleague 
from Illinois has been also waiting patiently, Ms. Schakowsky.
    Ms. Eshoo. She is waiving on though.
    Mr. Shimkus. OK. I am going to yield back my time. I 
appreciate you all being here.
    Ms. Eshoo. OK, moving right along, we will recognize the 
gentlewoman from Illinois, Ms. Schakowsky, who is waiving on to 
the subcommittee.
    Ms. Schakowsky. Thank you, Madam Chairman. And I thank you 
for the opportunity once again to waive on to this, this 
committee.
    I heard what you said to Congressman Welch about the 
relevance of some of the questions for this panel, which is an 
excellent panel. I do want to raise another issue, but I do 
also want to connect it to Johnson & Johnson and Mr. Kaeser's 
presence here today.
    I do want to tell you that on December 10th, 2010, 
Representative Pressley and I sent a letter to the CEO at 
Johnson & Johnson, Alex Gorsky, about the targeted marketing 
and sale of your talc-based baby powder and its potential to 
cause harm, particularly to women and girls of color, due to 
asbestos contamination. I don't know if you are familiar with 
that letter at all, Mr. Kaeser.
    Mr. Kaeser. No, ma'am.
    Ms. Schakowsky. I didn't expect so.
    In 2006, Johnson & Johnson's talc supplier warned the 
company that perineal use of talc could be possibly 
carcinogenic. That information actually didn't get passed on to 
consumers, and instead there was a multi-cultural marketing 
campaign for your baby powder targeted to black and Latino 
women.
    The response letter that I got didn't come from the 
chairman of the company. And I actually am now seeking a 
meeting.
    And I would like to have permission to enter in the record, 
Madam Chair, the 2010--2019 Reuters article that revealed that 
Sri Lanka halted imports of Johnson & Johnson baby powder until 
they can prove the product is free from cancer-causing 
asbestos.
    [The information appears at the conclusion fo the hearing.]
    Ms. Schakowsky. And this is where I get to the issue of 
importing and also exporting. I wonder if you are aware, Mr. 
Kaeser, yes or no, do Sri Lankan sales of your baby powder, 
have they fallen under the--under your job? Does that fall 
under your job description at all?
    Mr. Kaeser. That does not fall under my job description.
    Ms. Schakowsky. Well, let me just say, let me just say 
this. We are concerned about counterfeit drugs coming into, and 
medical devices coming into the United States, but I think it 
is worth pointing out that other countries are afraid of 
importing a Johnson & Johnson product that may contain--that do 
contain asbestos-contaminated baby powder.
    But I guess you are saying this is not something under your 
jurisdiction.
    Mr. Kaeser. That is correct.
    Ms. Schakowsky. OK. Well, I certainly hope that the company 
will take this seriously, even as it looks at imports that it 
ought to look at the question of exports and the concerns that 
other countries have with products that are made by Johnson & 
Johnson.
    I would also like, Madam Chair, if I can, to enter into the 
record my letter to Johnson & Johnson and the response that we 
received from Johnson & Johnson's consulting firm including 
documents that revealed that Johnson & Johnson partnered with a 
manufacturing agency that specialized in ``ethnic consumers'' 
to distribute a hundred thousand gift bags containing baby 
powder and other Johnson & Johnson baby products in black and 
Hispanic communities and neighborhoods in Chicago and that 
Johnson & Johnson launched a campaign to boost sales of baby 
powder to ``curvy Southern women, 18 to 49, skewed African 
American'' that increased sales by nine percent.
    And so, I think that when we are talking about the problem 
of these kinds of drugs coming into the country, these 
counterfeits, it is very important. I appreciate the work that 
you are doing, but we also have to consider what is being 
marketed to Americans and exported to other countries that 
don't want that product. Thank you. I yield back.
    Ms. Eshoo. Was the gentlewoman asking for something to be 
placed in the record?
    Ms. Schakowsky. I am. I mentioned or said what they were, 
yes.
    Ms. Eshoo. The letters?
    Ms. Schakowsky. Yes.
    Ms. Eshoo. Yes.
    Ms. Schakowsky. Letters and some other article.
    Ms. Eshoo. And the newspaper article.
    Ms. Schakowsky. A newspaper article and other----
    Ms. Eshoo. Without objection.
    Ms. Schakowsky. Thank you.
    Ms. Eshoo. Without objection.
    [The information appears at the conclusion fo the hearing.]
    Ms. Eshoo. I want to be clear about something that I said 
earlier, and this committee has always, I think, really 
conducted itself with a great deal of respect to our witnesses 
whether we agree or disagree with maybe the company's policy, 
what we want to do in the Congress, et cetera, et cetera, but 
we don't badger witnesses and that was my point this morning.
    So I appreciate the gentlewoman coming and raising what she 
wished to raise, but I want it to be very clear why I spoke up 
relative to Mr. Kaeser, and I think what I said earlier stands 
and I stand by it. We don't badger witnesses. So, thank you.
    So I think this concludes the work of this panel and its 
witnesses. I think you have been outstanding answering the 
questions and helping us to understand different parts of the 
policies that are being advanced how they will really benefit 
the American people.
    Dr. Muzzio, I want to particularly follow up with you 
relative to the continuous manufacturing, because we have a big 
job to do to what I think is a necessity and that is overhaul 
our country's drug supply. So thank you to each one of you for 
giving your time, your professionalism, your expertise, your 
considerable intellect on each of the bills that we were 
considering and we will ask--you can now be excused.
    And I would ask the staff to prepare the witness table for 
the next panel, panel two. Thank you again. You have been 
absolutely terrific.
    Ms. Eshoo. All right, so we have the majority of witnesses 
seated. We are now going to hear from the second panel of 
witnesses on the important issues that we are taking up today. 
The bills that we are dealing with now center in and around 
food and FDA, and so welcome to each one of you. I think I 
recognize you because most of you have been sitting and waiting 
patiently, but I am sure you enjoyed the testimony from the 
first panel too because we are all learning together. So 
welcome.
    We have Ms. Talia Day, a patient--where am I?
    Am I not--there you are. Someone's hair down there is in 
the way. Who is that? There you are. Why are you on the floor 
like that? Oh, you have a camera. I see.
    Ms. Talia Day, welcome to you. She is a patient advocate 
with the Food Allergy Research & Education group, sometimes 
known by the word FARE, F-A-R-E. Our next witness, I can't see 
because we have the water jug there. I think it is Sara. Is it 
Sara? Sara Sorscher, Deputy Director--oh, I am sorry--of 
Regulatory Affairs Center for Science in the Public Interest. I 
skipped over Mr. Carlin. I apologize.
    Mr. David Carlin, Senior Vice President of Legislative 
Affairs and Economic Policy with the International Dairy Foods 
Association, welcome to you this afternoon. Ms. Nancy Perry, 
welcome to you. She is Senior Vice President Government 
Relations, American Society for the Prevention of Cruelty to 
Animals. Welcome to you, thank you for the work of your 
organization. Dr. Douglas Corey, welcome to you, past 
President, American Association of Equine Practitioners.
    Mr. Tom Balmer, welcome to you, Executive Vice President, 
National Milk Producers Federation. I want you to know I love 
milk, I really do. I love that ad, you know, with the--mmm. Ms. 
Melanie Benesh, Legislative Attorney, Environmental Working 
Group, thank you, welcome to you. Dr. Paul DeLeo, Principal at 
Integral Consulting, Inc.
    And where is--Ms. Mountford is not here. Anyone know about 
Ms. Mountford? OK, we are checking. At any rate, we hope that 
she will be here because she is the President of the Infant 
Nutrition Council of America. So thank you to each one of you. 
We have a very full, wonderful panel and we will begin with Ms. 
Day. You have 5 minutes for your testimony.

    STATEMENTS OF TALIA DAY, PATIENT ADVOCATE, FOOD ALLERGY 
   RESEARCH & EDUCATION GROUP; J. DAVID CARLIN, SENIOR VICE 
     PRESIDENT OF LEGISLATIVE AFFAIRS AND ECONOMIC POLICY, 
 INTERNATIONAL DAIRY FOODS ASSOCIATION; SARA SORSCHER, DEPUTY 
   DIRECTOR OF REGULATORY AFFAIRS, CENTER FOR SCIENCE IN THE 
PUBLIC INTEREST; NANCY PERRY, SENIOR VICE PRESIDENT, GOVERNMENT 
 RELATIONS, AMERICAN SOCIETY FOR THE PREVENTION OF CRUELTY TO 
    ANIMALS; DOUGLAS COREY, D.V.M, PAST PRESIDENT, AMERICAN 
ASSOCIATION OF EQUINE PRACTITIONERS; TOM BALMER, EXECUTIVE VICE 
PRESIDENT, NATIONAL MILK PRODUCERS FEDERATION; MELANIE BENESH, 
  LEGISLATIVE ATTORNEY, ENVIRONMENTAL WORKING GROUP; PAUL C. 
    DELEO, PRINCIPAL, INTEGRAL CONSULTING, INC.; AND MARDI 
   MOUNTFORD, PRESIDENT, INFANT NUTRITION COUNCIL OF AMERICA

                     STATEMENT OF TALIA DAY

    Ms. Day. Thank you. Chairman Eshoo, Ranking Member Burgess, 
and members of the subcommittee, my name is Talia Day and all 
three of my children have severe food allergies, including to 
sesame. I want to thank you for the opportunity to explain why 
the FASTER Act will have an enormous and positive impact on 32 
million Americans living with food allergies and their 
families. These allergies are not only life-threatening, they 
are life-altering.
    My son Zachary was diagnosed with several severe food 
allergies in infancy. When he was just three years old, Zachary 
ingested dairy at school and had an anaphylactic reaction. Let 
me tell you in simple terms what this means. Almost instantly, 
his blood pressure began to drop, his throat began to close, 
and he struggled to breathe. His eyes and face began to swell. 
Luckily, epinephrine was promptly administered and Zachary 
recovered.
    I wish I could say this only happened once and that since 
then we have been able to avoid his allergens, but I cannot. 
Since then, Zachary has had multiple anaphylactic reactions, 
each one landing us in the emergency room not knowing whether 
he would live or die, and paralyzing me with overwhelming fear 
and anxiety.
    Just this last summer, Zachary, now ten years old, was off 
to summer camp. We did everything we are supposed to do as 
parents of a child with life-threatening food allergies. We met 
with camp directors and staff; we provided detailed, written 
instructions around his dietary limitations; we supplied 
substitute foods and epinephrine auto-injectors. None of that 
mattered though, because due to a simple oversight, pure human 
error, Zachary was given the wrong food one afternoon, sending 
him into his worst anaphylactic episode to date. The situation 
was so dire, we thought the unthinkable: his food allergies 
were going to cost him his life. We would lose our son to 
something that should be preventable. While most parents who 
send their child to camp or school worry about homesickness or 
scrapes on the playground, our reality is different. Our 
greatest fear is that he will be accidentally exposed to sesame 
or one of his other allergens and not come home at all. This is 
our reality every single day.
    As I mentioned, 32 million Americans have food allergies 
with a rise of nearly 400 percent in the number of 
hospitalizations for food allergies from just 2007 to 2016. One 
in thirteen children have a life-threatening food allergy. That 
is roughly two children in every classroom. The trend is 
frightening. Imagine how many people in the next generation 
could be at risk. We need to do more.
    Today, sesame remains the most common allergen that is not 
required to be written on food labels and is often hidden on 
labels as spices or natural flavors. How are parents, schools, 
and other caretakers supposed to keep children like Zachary 
safe if companies aren't even required to label for their 
allergens. Nearly 1.5 million Americans are allergic to sesame.
    When you consider this combined with the rapid increase in 
overall food allergies, it is clear we must act now. We are 
thankful for organizations like FARE, who advocate on behalf of 
the food allergy community, and Congresswoman Matsui for 
introducing this important legislation. H.R. 2117 stands to 
drastically improve our day-to-day lives and change our 
reality. If passed, it will require the federal government to 
gather comprehensive information about who has food allergies, 
the kind of food allergies they have, and what types of food 
allergies occur most often. Further, it will update allergen 
labeling laws to include sesame and it would require labeling 
standards for additional allergens as new scientific evidence 
emerges.
    We need this for me, for my family, and for families all 
over the country in every state and district. Now is the time 
to pass the FASTER Act. Thank you.
    [The prepared statement of Ms. Day follows:]
    [GRAPHIC] [TIFF OMITTED] T8687.001
    
    [GRAPHIC] [TIFF OMITTED] T8687.002
    
    Ms. Eshoo. Thank you very much, Ms. Day, for your powerful 
testimony. It is now a pleasure to recognize Mr. Carlin. You 
have 5 minutes for yours.

                   STATEMENT OF DAVID CARLIN

    Mr. Carlin. Chairwoman Eshoo, Mr. Shimkus, and members of 
the subcommittee, thank you for inviting me to testify at 
today's hearing in support of the Codifying Useful Regulatory 
Definitions Act, which would define the term ``natural cheese'' 
in federal statute. My name is David Carlin and I am the Senior 
Vice President of Legislative Affairs and Economic Policy at 
the International Dairy Foods Association which represents the 
nation's dairy manufacturing and marketing industry.
    U.S. cheesemakers have used the term ``natural cheese'' for 
more than 70 years to describe a particular category of cheese 
and to differentiate it from processed cheese in the 
supermarket. Natural cheeses are made directly from milk, while 
processed cheese is made by combining various natural cheeses 
to achieve certain characteristics desired by consumers such as 
how well a cheese will melt. Consumers know that a natural 
cheese like Cheddar or Havarti would be appropriate to serve at 
a social function and that processed cheese is perfect for 
making a grilled cheese sandwich.
    The term ``natural cheese'' has also been used extensively 
over several decades by FDA, USDA, Congress, and the courts to 
describe a particular category of cheese. Unfortunately, the 
ability of U.S. cheesemakers to continue to use the term 
``natural cheese'' on their packaging is now threatened. Four 
years ago, the FDA initiated a separate process to define how 
the term ``natural'' may be used to make product claims such as 
100 percent natural or all-natural.
     Even though the term ``natural cheese'' is not a product 
claim and is only used to define a particular category of 
cheese, U.S. cheesemakers find themselves caught up in an 
unrelated policy debate that could force them to change 
decades' worth of labeling practices that generations of 
consumers have come to rely on when choosing the right cheese 
for every occasion. Defining the term ``natural cheese'' in 
statute will clarify its specific meaning and narrow the scope 
of FDA's work so that it can focus on how the term ``natural'' 
may be used to make product claims.
    I would also like to note that FDA's technical experts have 
reviewed the CURD Act extensively over the past two years and 
all of their substantive comments have been addressed by the 
bill's sponsors. On behalf of our cheesemaking members, I would 
like to express our sincere appreciation for FDA's careful 
review and extensive input regarding this legislation. The CURD 
Act is strongly supported by natural and processed cheesemakers 
and by the National Milk Producers Federation which represents 
dairy farmer cooperatives.
    I would also like to use the rest of my time to address 
some of the misconceptions regarding this legislation. First, 
this would not be the first time that Congress has acted to 
define a dairy term or a type of food in federal statute. 
Definitions of butter and nonfat dry milk are already included 
in the Federal Food, Drug, and Cosmetic Act. Congress also 
passed legislation in 2002 that added definitions of ginseng 
and catfish to the act.
    Second, the CURD Act does not change in any way the 
ingredients that may be used to make standard and 
nonstandardized cheeses. In other words, if a cheesemaker was 
permitted to use a particular ingredient to make a standardized 
cheese before this bill was enacted, the cheesemaker will still 
be able to use that same ingredient after enactment of this 
bill. Conversely, if a particular ingredient was not permitted 
to be used before, it would not be permitted to be used after 
enactment.
    Third, the CURD Act does not change FDA's policy on the use 
of the term ``natural'' or all-natural claims and it does not 
establish a product's specific definition of natural. The bill 
would simply codify a definition of natural cheese as a 
category of cheese. It does not define the term ``natural'' 
with respect to product claims. As stated earlier, Section 3 of 
the bill contains language that explicitly states that any 
cheese that makes a product claim such as 100 percent natural 
or all-natural must continue to comply with FDA's current 
regulations regarding those terms.
    Finally, the CURD Act would not in any way create an 
inconsistency between FDA and USDA regarding the use of natural 
claims on labels. As members of this subcommittee well know, 
FDA regulates most food products including cheese, while USDA 
regulates meat, poultry, and certain egg products. Therefore, 
USDA's definition of ``natural'' only applies to those meat, 
poultry, and egg products that fall under its jurisdiction. FDA 
regulates cheese and, accordingly, the only definition of 
``natural'' that is relevant to this discussion is FDA's 
definition of that term.
    As stated previously, even if this bill is enacted, U.S. 
cheesemakers will continue to be required to comply with FDA's 
current policy and any future regulations governing the use of 
the term ``natural'' for product claim purposes. By preserving 
our industry's ability to use the term ``natural cheese'' to 
describe a category of cheese, the CURD Act would ensure 
continued clarity in the marketplace for consumers and codify 
the historical regulatory use of the term by both FDA and USDA.
    Thank you for inviting me to participate in today's hearing 
and I look forward to answering questions from members of the 
subcommittee.
    [The prepared statement of Mr. Carlin follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you, Mr. Carlin.
    Ms. Sorscher, you are recognized for 5 minutes for your 
testimony.

                   STATEMENT OF SARA SORSCHER

    Ms. Sorscher. Good afternoon. Thank you, Chairwoman Eshoo, 
Ranking Member Burgess, and members of the committee. I am 
pleased to testify today on behalf of Center for Science in the 
Public Interest, America's food and health watchdog.
    Since 1971, CSPI has represented consumers in advocating 
for a safer, healthier food system and has played a major role 
in pushing for laws governing food labeling including the 
Nutrition Facts panel, menu labeling, and allergen labeling. 
Our work is funded by individual subscribers to our Nutrition 
Action Healthletter and donations from individuals and 
foundations. We do not accept donations from corporations or 
government grants, allowing us to serve as an independent voice 
for consumers.
    I will speak today primarily on two bills that would impact 
food labeling, the FASTER Act and the CURD Act. CSPI supports 
the FASTER Act which, among other things, would update the U.S. 
list of major allergens to include sesame. When Congress passed 
FALCPA in 2004, it created an important new requirement for 
labeling the so-called major food allergens which were the 
eight most common allergens that had been identified at the 
time. The law also authorized FDA to label additional non-major 
allergens through separate regulations.
    In 2014, CSPI was the first group to urge FDA to make use 
of that new authority by petitioning the agency for sesame 
allergen labeling. Recent studies have shown that sesame 
allergy is similar in prevalence and greater in severity than 
some of the big eight major food allergens required to be 
labeled. Importantly, a greater fraction of adults with sesame 
allergy report having an ER visit in the past year than adults 
with any other major food allergy, illustrating how difficult 
it is even for adults to avoid undeclared sesame in foods.
    In addition, in 2018, CSPI reported that a majority of 22 
large food companies that we surveyed were already voluntarily 
labeling for sesame and more indicated that they could easily 
do so if given clear direction from regulators. FDA opened a 
docket to collect data on sesame labeling in 2018, but it has 
taken no further action since that docket closed in December of 
that year. Given the clear and urgent need for sesame labeling 
and ongoing delay by the agency, we urge Congress to add sesame 
to the list of major allergens through legislation.
    CSPI opposes the CURD Act as this bill would confuse 
consumers by defining as ``natural'' any cheese product that 
does not meet the narrow regulatory definition of processed 
cheese. The ostensible purpose of the bill is to draw a clear 
line for consumers by defining processed cheese and 
differentiating it from natural cheese, yet processed cheese is 
already clearly labeled as such and there is no evidence that 
manufacturers are currently representing that such products are 
natural.
    Instead of protecting consumer interest, the bill addresses 
the interests of cheese manufacturers who wish to be sheltered 
from litigation by consumers alleging that they were misled by 
natural claims on cheeses that contain artificial ingredients. 
For example, in 2016, Kraft was sued for natural cheeses 
alleged to contain artificial coloring; more recently, Sargento 
was sued based on feeding and rearing practices for the cows 
that produced the milk for its line of natural cheeses. CSPI is 
not involved in either of these cases and has not taken a 
position on the litigation, but we do oppose any legislative 
effort to distort the meaning of natural for the purpose of 
denying consumers their day in court.
    While traditional cheesemaking involves only a few 
ingredients--high-quality milk, salt, and cultures--the cheese 
industry today employs a host of novel processes and additives 
that can cut the time and expense required to produce cheese. 
These novel ingredients are not necessarily reviewed for safety 
by the FDA, which permits companies to self-certify new 
ingredients as generally recognized as safe without even 
notifying the agency or making safety data available to the 
public.
    Certain artificial ingredients are also expressly legally 
permitted under the standards of identify for cheese. For 
example, artificial coloring is expressly allowed in many 
standardized cheeses. While legally permitted, many American 
consumers would not consider these cheeses to be natural. For 
example, a nationally representative telephone survey conducted 
in May 2018 by Consumer Reports found that more than 80 percent 
of consumers say ``natural'' should mean no artificial 
ingredients were used. That is why the USDA permits the term 
``natural'' only on products containing no artificial 
ingredients or added color and that are only minimally 
processed.
    FDA is also currently working on a definition of 
``natural'' that ideally will be non-misleading and apply 
uniformly across all FDA-regulated foods. The CURD Act would 
seek to short-circuit that process by carving out a special 
definition for ``natural'' that would only apply to cheese and 
run counter to consumer expectations. Finally, because the CURD 
Act also defines milk as lacteal secretions from an animal, it 
could be interpreted to prohibit the use of the term 
``natural'' on nondairy alternatives eaten by consumers who are 
vegan, allergic to milk, or otherwise wish to avoid dairy 
cheeses. Use of the term ``natural'' should not be prohibited 
on these products, provided the products otherwise meet 
consumer expectations for that food. So we therefore urge 
Congress not to act prematurely and define ``natural cheese'' 
in a way that will confuse consumers and make the rule 
inconsistent with other labeling.
    [The prepared statement of Ms. Sorscher follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you for your testimony.
    And now, pleasure to recognize Ms. Perry for your 5 minutes 
of questioning.

                    STATEMENT OF NANCY PERRY

    Ms. Perry. Thank you. Chairwoman Eshoo, Congressman 
Shimkus, and distinguished members of the subcommittee, thank 
you for inviting me to offer our support for the SAFE Act to 
end horse slaughter. The American Society for the Prevention of 
Cruelty to Animals is a leading voice for animal welfare as the 
very first humane organization established on this continent in 
1866.
    We strongly support the Safeguard American Food Exports Act 
as a critical missing link in the existing systems vital for 
protecting American equines. It has 225 bipartisan House 
cosponsors and every major animal welfare organization, along 
with 80 percent of the American public who support it. The 
ASPCA believes horse slaughter prevents serious food safety 
concerns, is a primary obstacle to achieve equine welfare by 
interfering with and depriving horses of good homes, and is, 
itself, a form of serious equine cruelty.
    Congress has effectively banned horse slaughter since 2007 
in annual spending bills with strong bipartisan support. Both 
Presidents Obama and Trump requested this ban in their budget. 
Unfortunately, a loophole that still allows tens of thousands 
of American horses to be shipped over our borders for 
slaughter, the SAFE Act will close this loophole to protect our 
horses as well as human health.
    Horse meat is unsafe. Horses are not raised for food in the 
U.S. and those who wind up for slaughter are not unwanted, but 
rather unlucky during career shifts from racetracks, riding 
camps, show barns, and ranches. They don't come from a setting 
where anyone ever expected they might become food. 
Veterinarians, owners, and trainers regularly administer myriad 
therapeutic treatments during daily horse care, many of which 
are expressly banned by the FDA for use on animals for human 
consumption.
    Since horses are not raised for food, we don't track any of 
these treatments and horses change hands on average eight times 
throughout their lives, so it would be nearly impossible to do. 
In contrast, animals raised in our food system are closely 
tracked, fed approved feed, and are given approved drugs from 
birth to death. The FDA routinely visits farms enforcing its 
regulations when animals are given prohibited substances or 
even if records are inadequate or missing.
    Phenylbutazone or bute is one of the most prevalent drugs 
given to horses and the most toxic to humans. This carcinogen 
induces blood dyscrasias as well as hypersensitivity reaction 
in the liver which can cause renal failure and death. Due to 
its idiosyncratic health risks to humans, bute is only approved 
for use in dogs and horses. In FDA's own words, there are 
currently no approved uses of bute in food-producing animals. 
Also, there are no safe residue levels and no withdrawal 
periods for bute.
    We have provided the committee with a list of more than 100 
banned and dangerous substances commonly given to horses 
including dewormers, fly sprays, hoof hardeners, tranquilizers, 
hormone regulators, and anesthetics that are carcinogens or 
cause developmental issues in children, cardiovascular illness, 
or hormone-dependent cancers. FDA banned these drugs for 
consumption because they are toxic and should not be present in 
any concentration in our food.
    Suggesting that we should send known toxic meat to other 
countries and export this obvious public health risk is 
irresponsible. The good news is that the number of American 
horses shipped to slaughter is actually declining, down to 
under 62,000 from over a hundred thousand in recent years, and 
welfare organizations and re-homing programs with industry 
engagement are at an all-time high. However, without a ban, we 
actually incentivize slaughter instead of rescue, and 
compromise equine welfare.
     Kill buyers bid against and outbid good homes at auctions, 
squandering resources by predatorily driving up prices. Even 
more insidious, these kill buyers then hold online auctions 
seeking ransoms for horses they would ship to slaughter, taking 
advantage of the public while competing with our rescuers. The 
ASPCA has compelling evidence now that horse slaughter actually 
causes neglect. More than 70 percent of owners surrendering 
horses to our support centers report keeping horses past the 
point of good care because they so feared their horse would end 
up at slaughter.
    Horse slaughter is equine cruelty. These animals are not 
suited for this purpose due to their physiology, their flight 
response, and the slaughterhouse equipment for stunning. We 
support humane euthanasia for horses when quality of life is 
impaired, but slaughter is not euthanasia. Americans 
overwhelmingly oppose the slaughter of horses. It is a public 
health risk that we shouldn't be exporting to our neighbors. It 
is time to close this loophole, and I thank Representative 
Schakowsky and Buchanan for leading a bipartisan effort to pass 
the SAFE Act. Thank you.
    [The prepared statement of Ms. Perry follows:]
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    Ms. Eshoo. Thank you. We haven't had any lunch here, but I 
just lost my appetite.
    Ms. Perry. Sorry.
    Ms. Eshoo. Thank you, Ms. Perry.
    Dr. Corey, it is a pleasure to recognize you for your 5 
minutes of testimony.

                   STATEMENT OF DOUGLAS COREY

    Dr. Corey. Thank you. Chair Eshoo and Ranking Member 
Burgess and distinguished members of the subcommittee, thank 
you for the opportunity to appear here today. My name is Dr. 
Douglas Corey and I have been an equine veterinarian for more 
than 40 years. I am here today not only as a longtime horse 
owner, but also as a past president of the American Association 
of Equine Practitioners, a professional association which 
represents the vast majority of equine veterinarians in the 
country. I have served as chair of the AAEP's Equine Welfare 
Committee, the American Veterinary Medical Association Animal 
Welfare Committee, and the Unwanted Horse Coalition. I also 
serve on the American Horse Council Welfare Committee.
    There is little evidence that shows consuming equine meat 
from horses raised in the United States poses a threat to 
public health. Each country accepting horse meat is responsible 
to ensure that the product is safe for citizens to consume. As 
an example, horses being transported to Canada for processing 
must be held in holding facilities for six months to ensure 
there are no medication residues. Additionally, the meat of 
horses processed in Mexico and Canada is tested for drug 
residues, heavy metals, bacterial contamination, exactly like 
what is done with beef, pork, sheep and, in addition, the 
European Union has its own regulations regarding drug residues 
in horse meat.
    Our primary concern is this bill will negatively impact the 
health and welfare of horses across the country and offers no 
solution to the problem of the unwanted horse. The unwanted 
horse represents a group of horses within the domestic equine 
population that are no longer wanted, needful or useful, or 
their owners are no longer interested in them or are not 
financially able to provide the horse with appropriate care.
    Our chief welfare concerns in the bill are, number one, the 
long-term placement of these unwanted horses. It is estimated 
that there are approximately eighty to a hundred thousand 
horses are transported to Canada and Mexico for processing 
annually. The proponents of the legislation suggest that these 
additional horses will be absorbed by the alternative homes, 
the rescues, and retirement facilities. However, these options 
are already under stress and overcrowded. With a life 
expectancy of 20 to 30 years, where will the additional 
facilities and funding come from to care for these animals? In 
addition, many of the individuals who adopt horses are often 
unprepared for the cost to adopt and provide proper care and 
feeding for a horse.
    While many of these people are well-intentioned, the sad 
fact is that without proper resources many of these horses are 
headed for a much worse fate of starvation, neglect, and 
abandonment. It would be nice to absorb every unwanted horse 
into the equine society, but as history has proven there simply 
are not enough people with the desire, the means, the 
knowledge, and/or assets available to respond to the need.
    Two, the bill does not address the funding required for the 
care of these additional horses. To provide a horse's basic 
needs, the funding needed for one year per horse is 
approximately $1,800. Inadequate funding often leads to 
inadequate care. Third, in regards to the bill itself, it will 
not stop the transportation of horses for other reasons such as 
sporting events, sales, recreation. Once they cross the border, 
this language would not stop horses from being processed.
    The AAEP partners with a number of equine welfare 
organizations that have enhanced efforts and outreach to 
improve rescue, retirement, and re-homing facilities, promoted 
more adoptions, and offer a safety net of programs for owners 
in need including stallion castrations, euthanasia, and 
disposal assistance. As you can see, this industry is coming 
together to address the problem and we are pleased that this 
concerted effort is reducing the number of unwanted horses.
    The AAEP believes that processing is not the ideal solution 
for addressing the large number of unwanted horses. However, if 
a horse owner is unable or unwilling to provide humane care and 
no one can assume that responsibility, humane euthanasia at a 
processing facility in accordance with AVMA's euthanasia 
guidelines is an acceptable alternative to a life of 
starvation, neglect, or abuse.
    In summary, we all must work together to address the root 
cause of this unwanted horse. We need proactive solutions and 
believe that the AAEP and equine welfare advocates are 
developing these solutions that will continue to help decrease 
the number of unwanted horses. However, and most importantly, 
supporting this bill will not improve the welfare of the horse. 
Thank you for the opportunity to address you today and I would 
be happy to answer questions at the end.
    [The prepared statement of Dr. Corey follows:]
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    Ms. Eshoo. Thank you, Dr. Corey.
    Mr. Balmer, you are now recognized for your 5 minutes of 
testimony and thank you.

                    STATEMENT OF TOM BALMER

    Mr. Balmer. Chairwoman Eshoo, Ranking Member Burgess, 
members of the subcommittee, my name is Tom Balmer and I serve 
as Executive Vice President of the National Milk Producers 
Federation, the voice of America's dairy cooperatives and their 
farmer owners for over 100 years. I thank you for the 
opportunity to testify on the DAIRY PRIDE Act, a bipartisan 
bill intended to finally enforce or, excuse me, to finally 
compel FDA to enforce its existing standards of identity for 
dairy products.
    Mr. Welch, we commend you for introducing this legislation 
and thank your co-author Mr. Simpson and many others for their 
support. We also commend Senator Baldwin and Risch for 
authoring this measure in the Senate.
    At its core, the DAIRY PRIDE Act would ensure the accurate 
and appropriate labeling of nondairy foods that use 
standardized dairy terms, an issue with significant 
implications for consumers. Federal standards of identity were 
established to promote honesty and fair dealing in the interest 
of consumers by promulgating reasonable definitions for food 
products. These defined terms have come to carry distinct 
meanings in the minds of consumers.
    Dairy farmers work hard to make products that are 
wholesome, nutritious, and in compliance with these standards. 
However, for decades the FDA has been negligent in their 
enforcement, particularly with respect to the clear requirement 
that a product labeled as milk or yogurt, for example, 
originates from cows and other lactating food animals. 
Unfortunately, grocery stores today are filled with copycat 
products that flout these long-established standards of 
identity and mislead consumers about their nutritional 
equivalents with real dairy products.
    Real milk is a nutritional powerhouse. It is full of 
numerous vitamins, minerals, and other nutrients essential to 
human health. Milk is the number one source of nine nutrients 
in children's diets including potassium, calcium, and Vitamin 
D. According to the 2015 Dietary Guidelines for Americans, 
these are three of the four nutrients for public health 
concern.
    These guidelines also recognize that most plant-based 
imitation milk products are not nutritionally equivalent to 
milk. Plant-based food processors like to use terms such as 
``milk'' on their products in a blatant attempt to trade on the 
health halo and other positive attributes of the real thing. 
The widespread marketing of these imitation products has 
created an abundance of consumer confusion. Evidence shows that 
consumers think that plant-based products are nutritionally 
equal to or better than those from cow's milk. An Ipsos survey 
conducted in 2018, found that 73 percent of consumers surveyed 
believed that almond-based beverages have as much or more 
protein than a serving of milk. In reality, milk has up to 
eight times as much protein per serving.
    The 2015 Dietary Guidelines also found that most Americans 
don't meet the recommended intake for dairy. The upshot of this 
is that there are real consequences to a drop in the intake of 
nutrients that dairy provides. Recognizing this, four leading 
health groups, the American Academy of Pediatrics, the American 
Heart Association, the Academy of Nutrition and Dietetics, and 
the American Academy of Pediatric Dentistry issued a report 
last fall urging that young children not be fed most plant-
based imitation products in place of cow's milk as their 
nutrition profiles are largely not equivalent to real milk.
    My organization has repeatedly raised concerns with FDA 
regarding its failure to enforce the law. We were encouraged 
when former Commissioner Gottlieb announced in 2018 that FDA 
would finally look at this issue. During the FDA's review 
process, multiple health stakeholders voiced concerns about 
consumers not grasping the nutritional differences between real 
dairy products and imitators. Although we were hopeful that FDA 
would finally act, their timeline has continually shifted with 
no endpoint in sight. Unless Congress acts, FDA's follow-
through remains uncertain.
    That is why we are encouraged that the DAIRY PRIDE Act is 
included in today's hearing. The bill is not complicated. It 
simply directs FDA to promptly explain how it will enforce 
existing standards of identity for milk and other dairy foods. 
It would require foods that use standardized dairy terms 
inappropriately to be considered misbranded on under the law 
and subject to enforcement.
    Speaking of misbranded, I would be remiss if I did not 
point out that imitation dairy products labeled as plant butter 
are currently in the marketplace and are in violation of the 
statutory definition of butter established by the Butter Act of 
1923. In past years, FDA has stated that any product that used 
the term ``butter'' and does not meet the enacted definition is 
misbranded. Nonetheless, the word ``butter'' is now being used 
to market imitation products nationwide.
    FDA's decision not to enforce the definition amounts, in 
effect, to an agency rewriting an act of Congress. I point this 
out to underscore a widespread pattern of deception that can 
cause consumers to make well-intentioned but misguided 
purchasing decisions for themselves and their families.
    Madam Chair, I want to thank you once again and the ranking 
member for holding today's hearing. We appreciate the 
opportunity to testify and look forward to answering any 
questions members may have.
    [The prepared statement of Mr. Balmer follows:]
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    Ms. Eshoo. Thank you, Mr. Balmer.
    I love hearings. I just learn so much from what everyone 
has to say.
    I now have the pleasure of recognizing Ms.--is it Benesh 
or?
    Ms. Benesh. Benesh.
    Ms. Eshoo. Benesh--for your testimony. You have 5 minutes, 
and you can proceed.

                  STATEMENT OF MELANIE BENESH

    Ms. Benesh. Thank you for the opportunity to testify.
    Ms. Eshoo. Welcome.
    Ms. Benesh. PFAS chemicals are in the blood of virtually 
every living being and have been linked to serious health 
threats including kidney and testicular cancer, reproductive 
harms like lower sperm counts and lower birth weights, 
developmental harms like altered mammary gland development, and 
even immunotoxic effects like reduced effectiveness of 
vaccines. When released into the environment, PFAS chemicals 
stay there forever.
    The Environmental Working Group has identified nearly 1,400 
communities with contaminated water, but unless you live in one 
of those highly contaminated communities your primary source of 
PFAS exposure is actually from your food. PFAS gets into food 
in many ways, one of which is through migration from food 
packaging like pizza boxes, sandwich wrappers, and microwave 
popcorn bags, but PFAS also gets into food from PFAS in 
irrigation water or biosolids that are applied to farm fields 
that then build up in livestock, plants, and even in milk.
    Many PFAS chemicals were allowed for use in food packaging 
before FDA understood the risks, but chemical companies have 
also hidden the risks of PFAS from FDA. Dupont and 3M have a 
long history of hiding the risks, of hiding information about 
the toxic effects of PFAS from regulators like EPA and FDA, and 
some companies continue to hide the risks from FDA. More 
recently, between 2008 and 2016, Daikin, a Japanese company 
that makes PFAS chemicals, submitted applications to FDA for 
the use of a PFAS chemical in food packaging, but withheld 
information from two of their own internal company studies that 
showed toxic effects to the liver and kidney, and FDA did 
approve those food contact notifications. And companies also 
take advantage of a legal loophole in the law that allows them 
to use PFAS chemicals without any FDA review at all and without 
even notifying FDA.
    But FDA has also failed to protect us. FDA has known at 
least since 2005 that PFAS chemicals migrate from food 
packaging into food, but failed to take action until 2016 and 
only then after response from a petition from NGOs. When 
companies do submit a chemical to FDA for approval either for 
use in food or food packaging, the law requires that industry 
show with reasonable certainty that that chemical is safe. But 
for PFAS chemicals industry has consistently failed to meet 
that legal burden, like failing to provide FDA with studies 
about the reproductive harms or immunotoxic effects from PFAS 
chemicals even though we know that those health effects are 
associated with PFAS chemicals even at low doses.
    In turn, when FDA reviews those submissions, the law 
explicitly requires that FDA take into consideration the 
cumulative risks from chemicals like PFAS; that is not only the 
PFAS that is in the food wrapper, but also your other exposures 
from PFAS in food, water, air, or other household products, and 
yet FDA has consistently failed to provide that cumulative risk 
analysis. And, in fact, FDA has not even established safety 
values to calculate what it considers to be a safe amount of 
PFAS in food.
    And yet, despite these glaring data gaps and the lack of 
scientific information, FDA has continued to authorize PFAS 
food contact substances and these decisions were made through a 
process that involves no public involvement or oversight, 
minimal transparency, and no clear way for consumers to 
challenge FDA's decisions. We cannot afford to wait and see if 
FDA will finally follow the law and properly review PFAS in 
food packaging. Given the risks posed by PFAS, Congress should 
take action to end nonessential uses like PFAS in food 
packaging.
    Cleaning up the legacy of PFAS pollution from polluters 
like Dupont, 3M, the Department of Defense, and other bad 
actors who have been emitting PFAS and dumping PFAS into 
waterways for more than 50 years is a complex problem and it 
will take decades to clean up that legacy pollution. But by 
contrast, eliminating a nonessential use like PFAS in food 
packaging is relatively simple. Congress can simply ban it and 
remove that source of exposure.
    This is an emergency. States and local governments have not 
been waiting for FDA to take action. Washington State banned 
PFAS in food packaging in 2018 and that ban will take effect in 
2022. The City of San Francisco has already implemented a ban 
on PFAS in food service ware. Retailers like Giant, Food Lion, 
Stop & Shop, Panera, Taco Bell, McDonald's, Burger King, are 
also not waiting for FDA to take action and have indicated that 
they are moving to alternatives.
    And Congress should not wait for FDA to take action either. 
We urge you to support H.R. 2827, the Keep Food Containers Safe 
from PFAS Act, and thank you for the opportunity to testify and 
I look forward to your questions.
    [The prepared statement of Ms. Benesh follows:]
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    Ms. Eshoo. Thank you very much.
    Dr. DeLeo, it is a pleasure to welcome you. You have 5 
minutes for your testimony.

                   STATEMENT OF PAUL C. DELEO

    Mr. DeLeo. Good afternoon, Chairwoman Eshoo, Representative 
Shimkus, and members of the subcommittee. Thank you for the 
invitation to speak before the subcommittee today. My name is 
Paul DeLeo and I am a principal at Integral Consulting, an 
international science and engineering consulting firm of 150 
employees nationwide. I am based in Annapolis, Maryland.
    I am pleased to be here today to express my scientific 
opinion on H.R. 2827, the Keep Food Containers Safe from PFAS 
Act of 2019. However, I would like to note that no client or 
any other entity has retained me to offer this position. I am 
here today based on my firm's expertise of PFAS and my 
firsthand knowledge of the regulatory process for the safety 
assessment of food contact substances, having worked for 6-1/2 
years at the Food and Drug Administration in the office with 
those responsibilities.
    I testify here today in opposition of H.R. 2827 as 
unnecessary, overly broad, and contrary to the well-established 
scientific processes for the premarket evaluation of the safety 
of chemicals in the United States. FDA has had the 
responsibility for the regulation of food additives since 1938. 
FDA has well-trained and highly dedicated staff who are fully 
capable of evaluating PFAS chemistries in food packaging. Prior 
to 2000, FDA authorized uses of food contact substances through 
the food additive petition process. However, since 2000, FDA 
authorizes the use of food contact substances through the food 
contact notification program.
    According to FDA online databases, the current universe of 
regulated PFAS food contact substances is approximately 100 
substances. This is a modest number of substances, all of which 
have been evaluated by FDA staff prior to being permitted to 
come to market as a food contact substance. There are 
substantial data requirements associated with the food contact 
notification program and the agency has the authority to object 
to any notification if it does not believe the proposed use of 
a food contact substance is safe.
    In addition, the Federal Food, Drug, and Cosmetic Act gives 
the agency authority to require or accept submission of a food 
additive petition for the food contact substance in cases where 
it is necessary to provide adequate assurance of safety of that 
substance. Once a food contact substance is on the market, FDA 
has the ability to track the safety of these chemicals and has 
a record of doing so for PFAS. For at least 15 years, 
scientists at FDA have been publishing peer-reviewed scientific 
papers regarding the potential for PFAS to migrate from food 
contact substances and the safety of those exposures. Moreover, 
FDA can revoke food contact authorizations when scientific data 
demonstrate that the authorized uses of a food contact 
substance are no longer safe, or remove food contact substances 
from the market through voluntary agreements.
    Recently, FDA revoked several food contact authorizations 
based on their abandonment by the manufacturer. H.R. 2827 is 
overly broad because it would apply to any PFAS used in food 
contact substances without consideration for its safety. For 
example, polymeric PFAS, also known as fluoropolymers, are not 
bioavailable or bioaccumulative and they satisfy the widely 
accepted assessment criteria to be considered polymers of low 
concern around the globe. Therefore, they are considered to be 
of low hazard to human health in the environment.
    More importantly, the impacts of H.R. 2827 would be very 
broad because although the number of individual PFAS food 
contact substances may be modest, PFAS have been safely used 
throughout the food supply in a variety of applications for 
decades. Therefore, it is not possible to predict the 
implications for food safety and the potential unintended 
consequences such legislation might precipitate. The rapid and 
broad changes would lead to disruption and confusion in the 
food industry and potentially compromise the safety of the U.S. 
food supply.
    Consumers in the U.S. benefit from a robust regulatory 
regime that requires new chemicals and new chemical 
applications to be evaluated for safety before they are 
permitted to be brought to the market. These programs have a 
long track record of success and Congress has a long track 
record of successful oversight and reform when it is necessary 
to adapt those programs. The hallmark of safety regulation in 
the U.S. is a transparent, scientifically rigorous, risk-based 
process. The arbitrary declaration of an indeterminate number 
of PFAS applications as unsafe flies in the face of the track 
record of success of U.S. regulatory agencies and programs with 
unpredictable, potentially wide-reaching, disruptive 
consequences.
    In conclusion, by recommendation to Congress would be to 
the extent there is concern regarding PFAS that it work closely 
with FDA to understand the safety of currently permitted uses 
of PFAS as food contact substances, to retrospectively analyze 
the assessment process, and to make sure that the agency has 
the tools and resources necessary to fully address PFAS's food 
contact substances.
    Thank you again for this opportunity to share my 
perspective. I look forward to your questions.
    [The prepared statement of Mr. DeLeo follows:]
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    Ms. Eshoo. Thank you very much for your testimony.
    Welcome to the table, Ms. Mountford. Glad you made it. You 
have 5 minutes to present your testimony to us, and thank you 
again for being with us.

                  STATEMENT OF MARDI MOUNTFORD

    Ms. Mountford. I am on? OK. Good afternoon.
    Ms. Eshoo. Move it closer, so----
    Ms. Mountford. OK, there we go.
    Ms. Eshoo [continue]. We don't miss a word.
    Ms. Mountford. Good afternoon. I am Mardi Mountford, 
president of the Infant Nutrition Council of America, or INCA, 
and I appreciate the opportunity to address H.R. 2267, the 
Infant Formula Protection Act of 2019. INCA is an association 
representing manufacturers of infant formula who make over 95 
percent of the formula fed in the United States.
    The primary focus of INCA and its member companies is and 
will always remain the health and welfare of infants and young 
children. That is why we share Congresswoman Meng's goal of 
preventing the purchase of infant formula that is past its use-
by date and we support the intent of H.R. 2267. Most babies in 
the United States receive infant formula, which is the only 
safe and medically recommended alternative to human breast 
milk, at some point during their first year of life. Most new 
moms initiate breastfeeding when their baby is born, but may 
supplement or switch to infant formula during the first year. 
For this reason, ensuring the quality of infant formula is very 
important to manufacturers as well as millions of parents, 
caregivers, and infants.
    Infant formula is one of the most highly regulated foods in 
the world because it may be fed as a sole source of nutrition 
at a critical time of infant growth and development. This makes 
quality a key factor for regulatory oversight. U.S. infant 
formulas are manufactured with high quality ingredients and 
with strict adherence to the U.S. Infant Formula Act and to 
FDA's Good Manufacturing Practices.
    All infant formulas are required by law to include a use-by 
date on the container which ensures that throughout the 
product's shelf life it provides the 30 essential nutrients 
listed on the label. Infant formula fed past the use-by date 
may not deliver all the nutrients at the exact levels that are 
listed on the label because some of the nutrients degrade over 
time. Thus, the use-by date is primarily an indicator of 
product quality, not safety.
    By contrast, the term ``adulterated'' as defined by FDA 
generally means a product that is harmful or injurious to human 
health because it contains a poisonous or deleterious 
substance. And although the definition of adulterated includes 
specific infant formula provisions, they refer to manufacturer 
activities rather than retailers. Accordingly, calling an 
infant formula that is past its use-by date adulterated would 
be inconsistent with existing definitions in the law and would 
not address the issue of concern that is selling expired 
formula.
    Therefore, INCA suggests alternative language that would 
instead more clearly prohibit the retail sale of infant formula 
past its use-by date. Indeed, Congress took a similar approach 
in 2011 with the passage of the Food Safety Modernization Act 
when it implemented preventive controls and created a new 
``prohibited act.'' We suggest the Infant Formula Protection 
Act of 2019 be implemented in a similar manner.
    INCA and its member companies consistently work with 
stakeholders to ensure infant formula is safe and nutritious. 
INCA meets regularly with the FDA's Office of Nutrition and 
Food Labeling to share information on infant feeding issues of 
mutual importance. INCA is working with the retail industry to 
develop a joint resource guide outlining best practices for 
handling infant formula returns and ensuring returned or 
expired product is never reshelved. INCA is also engaged with 
USDA regarding strengthening recommendations that state WIC 
agencies do not accept expired or returned infant formula or 
allow it to be given to area food banks or distributed through 
any other channels due to potential safety and quality 
concerns.
    In summary, INCA supports the intent of the Infant Formula 
Protection Act of 2019, but believes the best way to accomplish 
the goal of legislatively precluding the retail sale of expired 
infant formula is to amend Section 301 of the Federal Food, 
Drug, and Cosmetic Act. Failure to abide by this restriction 
would constitute a prohibited act. We believe this would be the 
most effective way of supporting the collective goal of 
establishing statutory measures that ensure formula-fed infants 
receive safe, nutritious products while continuing to reassure 
parents and caregivers about the high quality of that formula.
    INCA and its members look forward to working with the bill 
sponsor, the committee, and all interested stakeholders to 
determine a workable solution to this issue. Thank you for the 
opportunity to testify today and I am happy to answer any 
questions.
    [The prepared statement of Ms. Mountford follows:]
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    Ms. Eshoo. Thank you very much for your testimony and that 
of all of the witnesses. I think you all have done a superb 
job. So now we have concluded your opening statements. We are 
going to move to member questions now, and I will recognize 
myself for 5 minutes kicking that off.
    The FDA regulates about 77 percent of the U.S. food supply. 
That is a lot, 77 percent. This includes, and this was 
mentioned earlier, I don't know, by testimony or maybe one of 
the opening statements of a member that it includes everything 
we eat except meat, poultry, and some egg products.
    I am concerned that the FDA may not have the adequate staff 
and the resources to carry out--it has extraordinary 
responsibilities, but there is also, just as there is here, 
political will, I think sometimes that may be missing at the 
FDA as well to make the hard choices about food regulation and 
safety because they are controversial. I mean we hear the 
differences right here on the panel. But, very importantly, it 
shows up in delays in FDA regulatory or enforcement action and 
I think that is where we come in on this.
    So let me start with, you can just answer this really very 
quickly starting with Ms. Day, how long have you been waiting 
for the FDA to take action on sesame allergen labeling? You 
know, it has never been done. I don't know.How old is your son 
now?
    Ms. Day. My son is ten years old.
    Ms. Eshoo. OK. Well, and you gave the example of when he 
was three?
    Ms. Day. Yes.
    Ms. Eshoo. OK. That says something.
    Ms. Day. And I will say I would like to add in that sesame 
is labeled in Canada, in the European Union, in many places in 
Asia already, so America is behind.
    Ms. Eshoo. Yes, I am on this. I called over to the FDA and 
spoke to the lovely person that heads up the division or the 
department on this to see if it was better if we just get this 
done administratively or should we go the legislative route. 
Administratively it was going to take five to seven years; five 
to seven years, I mean, you know, that is a long time. So, 
thank you for your answer.
    Ms. Benesh, how long has the Environmental Working Group 
been petitioning the FDA on the issue of PFAS contamination in 
food?
    Ms. Benesh. Environmental Working Group has been working on 
PFAS chemicals for 20 years no, and the first action that we 
took on food packaging was in 2003.
    Ms. Eshoo. But petitioning the FDA?
    Ms. Benesh. We have only--we were part of the NGO petition 
that was filed in 2015, but we have been raising concerns about 
this issue for the last 15 years.
    Ms. Eshoo. OK, so it has been a long time.
    Ms. Sorscher, how long have you been waiting for the FDA to 
define ``natural'' in food products?
    Ms. Sorscher. I would say it has been a while, yes.
    Ms. Eshoo. Well, what does that mean though, because we 
need that for the testimony for the record.
    Ms. Sorscher. Yes, so FDA had this issue in its unified 
agenda for some time. I have the----
    Ms. Eshoo. I think in your testimony you said four years?
    Ms. Sorscher. So we have been waiting on sesame labeling 
since 2014.
    Ms. Eshoo. Dr. Balmer, how long have you been petitioning 
the FDA to make a decision on the use of ``dairy'' to describe 
certain foods?
    Mr. Balmer. We submitted our first complaint to FDA on this 
subject in 1979.
    Ms. Eshoo. Holy moly. And I remember 1979, so I have been 
around for a while.
    Ms. Sorscher, should the FDA--this is a broad question, but 
it is something that I have thought for many years. And going 
back to when Senator Kennedy was still with us, we did 
legislation, myself in the House, he obviously in the Senate, 
to make the FDA an independent agency with a 6-year term for a 
commissioner so there wouldn't be any political entanglements 
with the agency. And we can see from your testimony there are 
really some split decisions between FDA and other agencies.
    Do you have a view on that, both Ms. Sorscher and Ms. 
Benesh? If you don't, it is OK. You look floored by my comment, 
but.
    Ms. Benesh. Particularly about the----
    Ms. Eshoo. About FDA. About FDA. As public health 
advocates, do you think that if the FDA were an independent 
agency that that would, A) that it would be able to make 
decisions that were more timely on any of the issues that are 
before us at the table--we have two, four, six, eight 
witnesses.
    Ms. Benesh. We think what is clear is that FDA has been 
slow to act on this particular issue and----
    Ms. Eshoo. Got it.
    Ms. Benesh [continue]. We are one of many organizations 
that are frustrated by that.
    Ms. Eshoo. Anyone else? Anyone else have--my time is 
expired, so did you want--does anyone else want to comment?
    Ms. Sorscher. I would say it is very important for FDA to 
be able to preserve that independence. I don't know if I can 
comment on the particular legislation.
    Ms. Eshoo. Right. Thank you.
    All right, my time is expired. I am pleased to call on--and 
it is not Dr.----
    Mr. Shimkus. Burgess.
    Ms. Eshoo [continue]. Burgess. It is Mr. Shimkus from the 
state of Illinois, recognized for 5 minutes of questioning.
    Mr. Shimkus. Thank you, Madam Chairman.
    Dr. DeLeo, anyone else a scientist on this panel? So timing 
is an interesting thing and, you know, I am on the toxic 
chemical committee. The scientific process, just going through 
the deliberations of how long it takes to prove something is 
safe or not, Dr. DeLeo, just how long does it take for a 
scientific process to go through the multiple generations, 
would you say?
    Mr. DeLeo. With regard to this issue it is an activity that 
the agency FDA can do in a manner of months. Now the issue 
becomes if there are questions and new data what happens then, 
and there are time constraints around the food contact 
notification process where the agency can stop the clock and 
get the data it needs.
    Mr. Shimkus. Well, let me go in this route then. Per-and 
polyfluorinated compounds, commonly known as PFAS, there is a 
list of about 7,866 at least through the EPA. To make things--
so that is a lot. So I had--my total always, my concern is 
throwing all 7,866 under a bright line of this is bad and it is 
really doing great damage to society is not fair nor is it 
correct without doing the due diligence of the scientific 
community. It is easy for us emotionally to do this, but it is 
not scientific in the application. So we can briefly break up 
this 7,866 into long chain and short chain, and you, I think, 
in this world of packaging, you mentioned a hundred of the 
7,866----
    Mr. DeLeo. Right.
    Mr. Shimkus [continue]. That are commonly used. In the 
U.S., are older long-chain fluorinated chemistries such as PFOA 
and PFOS still used for grease-resistant and moisture coatings 
on food packaging?
    Mr. DeLeo. It is my understanding that they are no longer 
used.
    Mr. Shimkus. And that for my colleagues, those two were the 
real big debate in the bill that went to the floor. Following 
up on that question, is there specific short-chain PFAS 
chemistry currently used in food packaging subject to careful 
review and approval by the FDA?
    Mr. DeLeo. Yes, they all would have been gone through the 
approval process at FDA.
    Mr. Shimkus. So that means careful review?
    Mr. DeLeo. Absolutely.
    Mr. Shimkus. And approval?
    Mr. DeLeo. Correct.
    Mr. Shimkus. Part of the debate that we have had too on the 
other bill was that this stuff has been vetted by the FDA.
    Mr. DeLeo. Yes, and they have opportunities again to ask 
for more data, to stop the clock, to object if they don't 
believe in the safety of those applications.
    Mr. Shimkus. Do you have confidence that the FDA has highly 
dedicated and capable staff to conduct these evaluations and 
ensure the safety of food packaging and public health?
    Mr. DeLeo. Yes. Having worked with those staff personally, 
they are excellent, well-trained, highly-trained national, if 
not global, experts in this area.
    Mr. Shimkus. Does FDA have sufficient staff resources to 
review complex chemistries such as per-and polyfluorinated 
compounds?
    Mr. DeLeo. I believe they have the resources they need for 
the day-to-day review of applications. The question of, you 
know, a retrospective look at, you know, what has occurred, I 
don't know the extent to which that might require additional 
resources. That is probably something you would want to check 
with the agency about.
    Mr. Shimkus. Should Congress circumvent FDA's expertise and 
authority to regulate PFAS chemistries in food packaging?
    Mr. DeLeo. I think FDA is the best agency to regulate these 
chemistries in food contact applications.
    Mr. Shimkus. So if this bill were to pass what would be the 
real-world implications of this ban?
    Mr. DeLeo. I think you would have a lot of disruption 
because you have a lot of uses, and I think the food industry 
that would be impacted wouldn't know about it and would 
suddenly be faced with the question of, do I have something to 
replace it. As was discussed previously, Washington State is 
implementing a ban on PFAS in food packaging, but that only 
goes into place if there are alternatives available.
    So that question of, is there an alternative available for 
what would be banned is not considered in this legislation and 
you could have broad-reaching implications. We have, you know, 
folks from the dairy industry here who could be impacted and 
much of the other industries in the food supply.
    Mr. Shimkus. Yes, and so I think the other concern is, what 
do they replace it with and going through the vetting process 
and the like. This fight will continue. And I would just end on 
we need to do the scientific process. We don't need to move and 
regulate based upon emotion, but let science lead the debate 
and discussion and then move forward. So with that, I thank you 
for your time and I yield back.
    Ms. Eshoo. The gentleman yields back. Pleasure to recognize 
the gentlewoman from California, Ms. Matsui.
    Ms. Matsui. Thank you, Madam Chair.
    Ms. Day, welcome to the Energy and Commerce Committee and 
thank you for sharing your personal story on parenting a child 
with life-threatening food allergies. I can relate to this, 
your story about Zachary and camp. And I have a grandson who 
has a peanut and nut tree allergy and he is begging to go to 
camp and, finally, this year we are going to let him do that. 
But what you said about talking to the camp counselors and 
packing an encyclopedia of dos and don'ts and packing the 
EpiPens, that is what we are facing. So this is a real thing 
that we have to deal with every single day and I applaud you 
for coming here today.
    And I also want to thank the Center for Science in the 
Public Interest for supporting my bill, the FASTER Act. We know 
that 32 million Americans have food allergies, including one 
out of every thirteen children. Their daily lives center around 
avoiding certain foods and taking precautions against 
accidental exposure to allergens. Given the dramatic increase 
in the prevalence and severity of food allergies over the past 
few decades, it is likely that many people in this room have a 
friend or a family member impacted by food allergies. I myself 
have a crab and lobster allergy which, I guess, is crustacean/
shellfish.
    In order to advance treatment and improve the lives of 
people with food allergies, we must do more to recognize and 
study food allergies as a public health issue. That is why I 
have introduced the FASTER Act, legislation that updates 
allergen labeling laws, increases research, expands patient 
experience data to include food allergies, and studies the 
economic cost of food allergies. By improving the ways in which 
we monitor and manage these complex and multifaceted diseases, 
we can better understand, treat, and maybe one day prevent food 
allergies.
    I want to spend some time talking about sesame, as the 
FASTER Act has a provision requiring that foods containing 
sesame disclose its ingredient on the food label. When 
discussing my bill, I often find there is some confusion around 
whether food manufacturers must list all their ingredients on 
labels.
    Ms. Sorscher, under current law, what major food allergens 
must be disclosed on food labels?
    Ms. Sorscher. So, currently, the eight most prevalent 
allergens have to be disclosed on food labels and sesame is 
number 9 so it is not required to be disclosed.
    Ms. Matsui. Number 9, OK. And it is clear that the FDA can 
act on its own to update the list of major allergens. Why do we 
need legislation to achieve this goal?
    Ms. Sorscher. So we have urged FDA to update the list and 
as I said we submitted a petition in 2014 and we have just been 
waiting a very long time. They did open a docket in 2018 and 
received comments. They have more than adequate data to make 
this decision and it has just been delay, delay, delay.
    Ms. Matsui. OK.
    Ms. Day, without an explicit requirement in some cases 
sesame is listed in nonspecific terms like tahini and spices, 
correct?
    Ms. Day. Correct, yes.
    Ms. Matsui. OK, then. Tell me, how do you manage to avoid 
exposing Zachary to sesame when it isn't labeled?
    Ms. Day. So I will say it is quite difficult. The onus is 
very much on the caretaker or the parent to read every label 
which already takes a lot of time and resources. And then when 
you also need to look for terms like spices, natural flavors, 
when you see that you know it can be hidden and so you have to 
then call the company and see if they will tell you if sesame 
is included in that term.
    Ms. Matsui. Right, right.
    Ms. Day. So there are often products out there that I 
imagine he could eat if it were labeled, but I can't give it to 
him and take that chance.
    Ms. Matsui. Oh, exactly. I read labels all the time and it 
is just endless. It is terrible, and they are very small too.
    Ms. Day. Yes.
    Ms. Matsui. You also mentioned the number of 
hospitalizations for food allergies has increased by 400 
percent in the last decade. A 400 percent jump is an astounding 
increase and it is certainly a public health problem especially 
when we are talking about the kinds of very serious, life-
threatening reactions many children are experiencing. Do we 
know why we are seeing such a rapid increase?
    Ms. Day. So the answer is we don't. I wish we knew. All we 
can say is----
    Ms. Matsui. We need more research.
    Ms. Day [continue]. There is proof that there is this rapid 
increase, the reason why still needs more research.
    Ms. Matsui. Right. So that is what this bill is all about 
too, increasing the research so that we can understand why we 
have the allergens, what people react to on that nature too. 
But in the meantime, you know, the only way that we can 
actually avoid this is really know what is in the food we have, 
so that is why this labeling is so important.
    I have had experience of reading these labels and I have to 
read them twice and then I also have to call too. I mean we are 
very much concerned about, especially with Robby going to camp 
and you never know because you are in an accidental type 
situation there too. So, anyway, this is something that people 
really have read about and have to understand when you have a 
family member or friend who is exposed to some sort of 
allergen, it is serious. So anyway, I yield back. Thank you.
    Ms. Eshoo. I thank the gentlewoman and thank you for your 
important work on this legislation. Pleasure to recognize the 
patient Dr. Bucshon from Illinois for his 5 minutes of 
questions.
    Mr. Bucshon. Thank you very much. I mean, I am intrigued by 
this hearing because it is, you know, if the American public 
are listening, I don't think there is anything safe left in 
food in America. It is just striking.
    A couple of questions, Ms. Mountford. You stated that the 
use date is an indicator of product quality not safety, so 
infant formula consumed past the use date is not unsafe?
    Ms. Mountford. No.
    Mr. Bucshon. It just doesn't provide the nutrients that 
are----
    Ms. Mountford. At the level that they are listed on the 
label, correct.
    Mr. Bucshon. Correct. So what are the health implications, 
potentially, of using it after the use date then? I mean other 
than the specific things that are in there, there is no 
negative health implication, per se, of using it, it is just 
there is a negative health implication because you are not 
getting the nutrients there.
    Ms. Mountford. That is correct.
    Mr. Bucshon. OK.
    Ms. Mountford. And not getting the nutrients like for one 
day would obviously not be a problem.
    Mr. Bucshon. Probably not do anything.
    Ms. Mountford. You would have to not get the nutrients for 
a long time, so.
    Mr. Bucshon. Right, so the term ``adulterated'' could be 
misleading; that was your testimony.
    Ms. Mountford. Absolutely.
    Mr. Bucshon. Because reading about what that means, that 
means it wasn't even processed or developed based on the 
criteria that would be safe, potentially.
    Ms. Mountford. Adulterated means that it has something 
harmful in it.
    Mr. Bucshon. There is potential, so adulterated would mean 
that there actually is a safety concern, not a quality concern.
    Ms. Mountford. Absolutely.
    Mr. Bucshon. Right.
    Ms. Mountford. Yes.
    Mr. Bucshon. So I think that was kind of my concern with 
what we are maybe putting that language in, in the way it is 
described.
    I am interested in the milk situation, Mr. Balmer. I mean, 
I have children who are in their 20s and they drink, you know, 
almond milk-milk, so to speak and all that and we have actually 
had this conversation in my household and asked them to 
actually look at what is labeled on the product.
    And honestly, just personally, I do have a problem labeling 
things incorrectly. Not just this, but anything, because 
fundamentally I think it is a marketing, deceptive marketing 
practice to grab market share which is--and so, in general, as 
a member of Congress, anything that companies, no matter what 
industry they are in that purposefully, deceptively, try to 
gain market share by mislabeling things is an issue.
    And I guess I am struggling to find out why, you said 1979 
you voiced this complaint, why the FDA in this particular 
instance has refused to do it. Is the industry out there that 
is producing these? And, honestly, some of it is probably going 
to be cultural and social pressure right now not to enforce it, 
I would say. I mean why do you think the FDA is not doing 
anything when it is pretty clear that--and I am not criticizing 
the other companies. I am just saying in general I don't like 
it when people try to market things to people when they know, 
they know that it is a marketing tool and not really has no--
and the product is not labeled properly. Why is the FDA not 
doing anything about it?
    Mr. Balmer. We appreciate your comments and obviously would 
concur. For years, we were told by FDA that it wasn't a 
priority because it was a labeling issue and it wasn't of 
public health concern and their first order of business is 
always public health maybe as it should be. But we have 
experienced now this growth of these imitation dairy products 
not meeting nutritional equivalents.
    Mr. Bucshon. Right so--yes.
    Mr. Balmer. There are episodes now where there are 
malnourished children out there because well-meaning parents 
are feeding the substitute products and assuming because they 
carry the standardized dairy term that they are being 
adequately nourished. So we believe now FDA should be aware 
that there is a public health concern and that this should be 
brought to the fore.
    Mr. Bucshon. Sounds kind of similar to the past date baby 
formula, right?
    Mr. Balmer. Perhaps.
    Mr. Bucshon. I mean because you are assuming based on it 
saying ``milk'' that it has the same nutritional value as milk 
as defined and that may not be true, so it is deceptive and 
people may not be getting the product that they want.
    Mr. Balmer. Yes. I highlighted an example of the almond 
product having only two grams of protein versus eight.
    Mr. Bucshon. Yes.
    Mr. Balmer. That type of thing.
    Mr. Bucshon. My objection to some of these things, like I 
said I am not criticizing any one specific company. We are 
seeing more and more and more of deceptive labeling especially 
as it relates to genetically-engineered food products and other 
things to maintain market share, to get market share. It has 
nothing to do with nutrition and it has nothing to do with you 
are getting a better product. It is purely marketing and market 
share.
    And I think that as a society, you know, we need to be 
careful because it is ultimately going to be found out that 
people have now a massive market share and their product 
doesn't provide what people are thinking it provides. I yield 
back.
    Ms. Eshoo. The gentleman yields back. Pleasure to recognize 
the gentleman from Oregon, Mr. Schrader.
    Mr. Schrader. Thank you, Madam Chair.
    I would first like to just take a couple minutes to talk 
about the CURD Act of which I am a proud sponsor and feel it is 
time to put to rest, you know, a controversy that has been 
around a long, long time. For 80 years ``natural cheese'' has 
been used to distinguish from processed cheese. I think that is 
extremely important for the industry that men and women that 
are in the industry it will preserve the cheesemakers' ability 
to use the term ``natural cheese'' to help provide consistency 
for the consumer as they have for decades, and I think that is 
really important getting to the comments about truth in 
labeling.
    And until the 2014 lawsuit, I was unaware that anyone 
viewed this as an issue. I have had zero comments at my office 
in D.C., my office back home in Oregon, so just wonder why, you 
know, they are trying to change things. We have had four rounds 
of technical assistance on this bill with the FDA. They have 
indicated their opinion. The passage of this bill would not 
lead to consumer confusion as some people would have. The 
Senate actually passed this bill by unanimous consent. That 
does not happen every day in the United States Congress, so I 
think we should act on this bill and move forward.
    Mr. Balmer, switching gears to the PRIDE Act a little bit, 
it is my understanding that other countries more consistently 
enforce dairy terms than we do. You alluded to the butter issue 
in your opening remarks. Could you expand a little bit, please?
    Mr. Balmer. Sure. You won't be able to see this graphic, 
but I have an illustration here of three products, excuse me, 
the same product in three different containers sold in three 
different countries. So other countries are doing a better job 
on enforcing labeling provisions of their standards. Same 
product, it is an almond-based beverage product sold in the 
United States, sold in the United Kingdom, and sold in Canada; 
sold under three different names of the food presentations. In 
the United Kingdom it is sold as a dairy-free milk alternative. 
In Canada it is sold as a nondairy beverage. We hear this 
complaint often, ``It is a necessity that we call this 
product--blank--milk.'' We beg to differ because we see its 
success for marketing in other countries.
    Mr. Schrader. Very good. Thank you.
    Switching gears to the horse bill, as an equine 
veterinarian for 30-plus years I appreciate the intent behind 
the bill, but I am a little concerned about the welfare of the 
horse itself in this country. There was some testimony about 
horses being injected on a daily basis or fed things on a daily 
basis, medications that could be toxic to humans. Is that your 
experience, Dr. Corey?
    Dr. Corey. Well, I think to be an equine veterinarian and 
you are going to take care of horses, you are going to inject, 
you know, some with different products over the life of a 
horse. But as these----
    Mr. Schrader. But how many do you do on a daily basis? I 
mean there is one horse, the implication is that these horses 
that you see or I see on a regular basis, we are out there 
daily injecting them with medication or feeding them 
pharmaceutical products. Is that your experience?
    Dr. Corey. Well, I would say that probably--that is a 
difficult question not knowing the practice types you are in. 
But if you are in a busy practice, you know, most horses will 
probably end up with an injection of some sort for something, 
probably. Does that answer your question?
    Mr. Schrader. Yes. Well, at some point in time. I totally 
agree.
    Dr. Corey. Oh, yes.
    Mr. Schrader. There are withdrawal periods, I know that we 
have those in our livestock industry. And you testified that 
Mexico, Canada, the EU also have withdrawal periods that they 
require before an animal is allowed for consumption.
    Dr. Corey. Yes. Canada and Mexico have the six-month 
withdrawal and any of the meat that--Canada has a zero 
tolerance and once this meat is processed after six months or 
more, these horses have been in a large area, they are testing. 
A rigorous testing is done for drug residues, and I think 
anything, any meat that has, horse meat that has been found to 
have drug residues then it is tossed. It is thrown out. So I 
think they are very serious about it.
    Mr. Schrader. I think we have the same standards here in 
this country, you know, with cattle, sheep, hogs, pigs, 
chicken, you know, we withdraw them.
    Dr. Corey. I hope so.
    Mr. Schrader. So I guess I am just concerned that, you 
know, the idea that the medications are all dark and evil and 
meant to contaminate the food supply is wrong. They are done 
for the health of the horse in necessary situations.
    Dr. Corey. Oh, absolutely. I mean that is what 
veterinarians do every day.
    Mr. Schrader. Right, OK. Thank you.
    Ms. Perry. Can I respond, Dr. Schrader?
    Mr. Schrader. Well, my time is expired.
    Ms. Perry. OK.
    Ms. Eshoo. The gentleman yields back. Pleasure to recognize 
the ranking member of our subcommittee, Dr. Burgess.
    Mr. Burgess. I will yield to Mr. Carter first.
    Ms. Eshoo. OK.
    Mr. Burgess [continue]. Our ranking pharmacist first.
    Ms. Eshoo. All right. We will go to, as I said at the first 
panel, the only pharmacist in the Congress----
    Mr. Carter. Thank you.
    Ms. Eshoo. Mr. Carter from Georgia.
    Mr. Carter. Thank you, Madam Chair.
    Did somebody want to respond to that last question?
    Ms. Perry. Yes, I was hoping to just add that there really 
are no safe residue level or withdrawal periods per the FDA for 
phenylbutazone, which I am sure you are familiar with bute for 
horses. It is a common pain relief analgesic. I give it to my 
three rescue horses on a regular basis when they are sore. And 
the FDA has been very clear that there is absolutely no 
appropriate use for a horse that has received bute in the food 
supply.
    I brought from my barn this morning, Dormosedan gel which 
is a sedative that I use for my mini-horse because he is afraid 
of the veterinarian and it says do not use in horses intended 
for human consumption. Ivermectin, a dewormer regularly 
provided to horses, same label. So I think it is proper and we 
want horses to receive these drugs and treatments and 
therapies. In the summer, my horses are sprayed for flies every 
single day, so they are definitely not candidates for 
slaughter. And I think it is really important to realize that 
we know this already here in the U.S. per the FDA, so that is 
what we lean on is that expertise.
    Mr. Carter. OK, thank you. Thank you.
    OK, enough horsing around, let's--argh. Thank all of you 
for being here. This is extremely important.
    I wanted to ask you, Mrs. Mountford, ``adulterated,'' and I 
am following along the same lines as Dr. Bucshon's questioning, 
but it is defined by the FDA to mean a product that is harmful 
or injurious to human health. And, you know, well know, how 
parents are especially with the first or second child, you 
know, by the time you get to the third or fourth, it doesn't 
matter. But the first and second you are very, very--well, I 
mean you are very, very careful and we know how they are. How 
do you think that or what are your concerns with parents 
reacting to this classification of ``adulterated?'' I mean is 
that going to, do you think that could possibly lead them to 
switch to nonregulated alternatives?
    Ms. Mountford. Well, it is a very frightening term and I 
think if there were any concern that something was adulterated, 
absolutely yes. They turn to homemade formula which obviously 
is of concern and is not recommended, or some other 
alternative.
    Mr. Carter. Well, what about the use of nonregulated 
formula alternatives that might be past the use-by date; is 
that ever a concern?
    Ms. Mountford. I am sorry. Could you----
    Mr. Carter. The nonregulated alternatives that are not 
adulterated, not labeled as that but they are nonregulated, and 
if they are past their use-by date is that a concern for 
people?
    Ms. Mountford. It would probably depend on the product that 
you are talking about.
    Mr. Carter. OK. OK. Well, let me ask you this. You 
mentioned in your testimony that you would support taking steps 
to ensure that expired infant formula wasn't being sold at 
retail, and I was surprised to learn that this was a problem to 
be quite frankly with you. Is it that common?
    Ms. Mountford. It isn't extremely common. Safety is a top 
priority, so of course we support any measures that could 
eliminate this issue. It seems to occur not often but sometimes 
in smaller stores, convenience stores, not--it is less common 
in the bigger retail chains.
    Mr. Carter. Whose responsibility is it? Is it the retailer 
to make sure that doesn't happen or?
    Ms. Mountford. Retailer, yes.
    Mr. Carter. OK. Are there any kind of fines or anything 
associated with that? Is it different state by state or what?
    Ms. Mountford. It is the retailer's responsibility, and to 
be honest I am not sure state to state how it is.
    Mr. Carter. Right, right. You know, it is hard to believe 
that that is happening in our current system. You know, as a 
pharmacist I know that we have an expiration date and we 
certainly have the responsibility to make sure that we are not 
using a product past its expiration date. But in our case, a 
lot of times it is based on the efficacy of the product and not 
necessarily other things, so.
    Ms. Mountford. This is different though. This is a use-by 
date, not an expiration date. So use-by again is a quality 
issue.
    Mr. Carter. Use-by is a quality issue as opposed to a 
expiration date being----
    Ms. Mountford. You should not use it.
    Mr. Carter [continue]. You should not use it past this 
date.
    Ms. Mountford. It is my understanding, yes.
    Mr. Carter. OK, fair enough. OK, well, thank you very much 
for that information.
    Madam Chair, I yield back.
    Ms. Eshoo. The gentleman yields back. Pleasure to recognize 
the gentleman from Vermont, Mr. Welch, for his 5 minutes of 
questions.
    Mr. Welch. Thank you, Madam Chair. Before I begin, I would 
like to ask unanimous consent to submit for the record two 
documents from public health organizations. One is a consensus 
statement last fall from four public health groups which notes 
that plant-based beverages are not nutritionally equivalent to 
cow's milk and voices agreement with the Dietary Guidelines for 
Americans that these products are generally not good 
substitutes for meeting recommendations for dairy intake.
    And the second is a letter from the American Academy of 
Pediatrics which notes that pediatricians have noted that using 
the term ``milk'' on imitation products has caused parental 
confusion and led to parents buying imitation products for 
their children under the mistaken belief that they contain 
similar nutritional components to real dairy. So with your 
permission?
    Ms. Eshoo. So ordered.
    [The information appears at the conclusion fo the hearing.]
    Mr. Welch. And I am glad to see the DAIRY PRIDE Act is 
being considered. Mr. Schrader was just speaking about that and 
it is a big deal for our dairy farmers. And some of the 
pushback comes from folks that say it is not really a big deal, 
but here is what just ought to be the rule: a label is a label. 
And as Scott Gottlieb said when he was still in that position, 
if it is not lactation, then a nut, a seed, these other 
products that can be good, do not meet the definition of a 
dairy product.
    So it is really just a simple question of having accuracy 
in labeling. And there were some folks who were pushing back 
saying there really isn't consumer confusion. We are not going 
to go out and test it, but why don't we have labeling accuracy? 
And if we are--all we are asking the FDA to do in this bill, 
Madam Chair, is to enforce the labeling rules that already 
exist and they may need a nudge with legislation saying that we 
need them to do their job.
    Mr. Balmer, I heard your statement and appreciate it, but I 
have heard some claims that the DAIRY PRIDE Act in enforcing 
standards of identity somehow violates the First Amendment and 
interferes with marketing of other common foods. Do you want to 
take a shot at addressing those claims?
    Mr. Balmer. Likewise, Mr. Welch, we have heard the same 
issue being raised and we are not in agreement. There is 
enforced government speech on food labels all the time and the 
issue, for instance, of the Nutrition Facts panel required on 
every package. And so, we see that the government does have the 
ability to impose certain labeling on food products, so we 
would--we think there are many examples of this.
    Mr. Welch. And, thank you. And can you elaborate on the so-
called ``health halo'' effect of real milk and why nondairy 
alternative beverages may want to associate themselves with 
dairy milk?
    Mr. Balmer. Yes. As I mentioned earlier, milk being the 
source of nine essential nutrients and obviously an attractive 
target to hitch one's wagon to, if I can mix my metaphors 
there, but, you know, with the accepted knowledge of milk's 
importance in the nutrition of children and adults, it is very 
easy for marketers of imitation products to glom on to the 
halo.
    Mr. Welch. Thank you very much. I hope we can move forward 
on this just so that we give integrity to whatever the label 
is. And I thank the panel for your testimony in other matters 
as well. Being from Vermont, dairy being under siege and 
wanting to do everything we can for our farmers, I focused 
obviously on the DAIRY PRIDE Act. But I will yield back, Madam 
Chair. Thank you.
    Ms. Eshoo. The gentleman yields back with our gratitude for 
the important work that he is doing on this bill and so many 
other matters. Does the--I want to recognize the ranking 
member----
    Mr. Burgess. Thank you, Madam Chair.
    Ms. Eshoo [continue]. For your 5 minutes.
    Mr. Burgess. Ms. Mountford, I just wanted to kind of close 
the loop on this issue that we have talked about on 
adulteration. This committee, this subcommittee, heard 
extensive testimony back in 2007, 2008 on the issue of melamine 
contaminating, first, pet food, and then fortunately not in 
this country but melamine contaminating infant formula, 
melamine being the substance that basically countertops are 
made of. And if melamine is ground up and added to a product it 
significantly increases the qualitative test for nitrogen, and 
the inference is that hey, the protein potency of this product 
is good, it is way up there, so pet food was affected in this 
country.
    I don't know, after talking to veterinarians in my district 
after the revelation no one could give me figures, but there 
was a significant increase of pets that were lost to kidney 
failure that was one of the consequences of ingesting this 
stuff. And then, Mr. Stupak is still with us here in the 
audience, he will remember the reports coming out of China 
where there was Chinese infant formula that was contaminated 
with melamine, and yes, it was a scandal and the Chinese head 
of the food and drug administration was dealt with very, very 
harshly.
    But to me that is adulterated formula, not something that 
is past its use-by date. So I appreciate your comments and I 
appreciate your delineation of that. Sure, if the folic acid 
content has diminished by the use-by date, we should be aware 
of that but at the same time it is not truly an adulterated 
product. We have seen adulterated products and this is not 
that.
    Ms. Mountford. Correct. And we would be happy, as I said, 
to support the intent of this bill because we certainly want 
good quality products out there, nutritious products, and this 
would help to avoid having products that are less nutritious 
sold.
    Mr. Burgess. You know, Chair, this seems like it is China's 
impact on the health of America day. I have got a coronavirus 
hearing that I am trying to get to, we just had on the floor 
the extension of the scheduling for fentanyl analogues that are 
coming into this country from China, and then, of course, I was 
reminded of the Chinese melamine issue. So yes, we can't be too 
careful.
    I would like to yield the rest of my time to Mr. Griffith 
from Virginia, please.
    Mr. Griffith. Thank you very much, Dr. Burgess.
     Dr. Corey, domestic horse slaughter effectively ceased 
around 2007. Given Congress's prohibition on the use of federal 
funds to inspect horses intended for human consumption, what 
was the result of this de facto ban on domestic horse 
slaughter?
    Dr. Corey. I think that the GAO had a report out in 2011. 
Let me----
    Mr. Griffith. Well, time is a-ticking.
    Dr. Corey. Yes.
    Mr. Griffith. You can get that to us at a later date. What 
is your recollection of what it----
    Dr. Corey. It is actually highlighted as action needed to 
address the unintended consequences of cessation of domestic 
slaughter. The bottom line is that there were a rise in 
investigations of horse neglect and more abandoned horses since 
2007 and up more than 60 percent in Colorado and California, so 
I think that that is what has happened.
    Mr. Griffith. So what you are saying is, is that it 
actually had a negative impact on the horse welfare.
    Dr. Corey. Negative, yes.
    Mr. Griffith. All right. Now given your experience in the 
field, how will H.R. 961 place additional burdens on efforts to 
re-home unwanted horses?
    Dr. Corey. Well, it is going to place burdens because we 
have that many more horses to deal with and we just don't have 
the facilities. And I think we are going to see these burdens 
via our state, local municipalities having to deal with these 
horses that owners can't take care of; they don't have the 
funds to take care of them. So, yes.
    Mr. Griffith. And, in fact, in our area where they don't 
really--I live in southwest Virginia so it is not really, 
doesn't make sense to market them north or south. We are just 
kind of in the middle. And what happened in the past, it hasn't 
happened recently, but you had to lock up your fields and your 
horse or your cattle haulers when you went to market because 
you would come back after selling your cows and find somebody 
had left you some unwanted horses and then you had to deal with 
them either in your field or otherwise.
    So people were not worried about horse thieves, they were 
worried about people dumping horses and that is probably----
    Dr. Corey. Well, actually, in the West we have found that 
to be true. And I have talked to several state veterinarians 
that have indicated that horses were abandoned and turned out, 
out in the wild with the wild roaming horses, and that is fact, 
yes.
    Mr. Griffith. All right, I appreciate it and I yield back.
    Ms. Perry. Could I comment on that?
    Ms. Eshoo. You have time, yes. Well, it is a little over 
time, but go ahead.
    Ms. Perry. I just wanted to mention that the only science 
that tries to make any correlation between abandonment and 
neglect of horses can tie it to economic downturns. And in 2007 
when GAO based its conclusion on purely anecdotal information, 
no data whatsoever, we have since then seen economists come out 
tying that to the economic downturn and not at all to the 
cessation of slaughter. And I think the data today would bear 
that out.
     Unfortunately, no state actually accurately tracks equine 
neglect or abandonment. We don't have that kind of data to help 
us see, but we are data-driven on this issue and it does 
matter. I really appreciate your question. Thank you.
    Ms. Eshoo. The gentleman yields back.
    Did you say that the GAO gave anecdotal information? Was it 
a survey?
    Ms. Perry. No, they----
    Ms. Eshoo. The first time I have ever heard anyone say GAO 
has given anecdotal information.
    Ms. Perry. I know. It was an anomaly. And they had a lot of 
good data in that report, but they did receive information from 
state vets who reported horses being abandoned and neglected. 
And our sense in looking back at that and economic experts who 
have looked back at that say it was tied to the recession which 
started exactly at the same time that the domestic horse 
slaughter; that we haven't continued to see that.
    Ms. Eshoo. OK, thank you. I appreciate it. All right. I 
would now like to recognize the gentlewoman from Michigan, Ms. 
Dingell.
    Mrs. Dingell. Thank you, Madam Chair. Thank you for holding 
this hearing. In my bill, the Keep Food Containers Safe from 
PFAS Act is one of the bills that we are considering or having 
hearings on today. With the passage of the--with the PFAS 
Action Act earlier this month, the committee has taken big 
strides needed to kickstart the cleanup of legacy PFAS 
contamination, limit discharges of PFAS waste into air and 
water, help community water systems upgrade their 
infrastructure to filter out PFAS, and much more, though we 
need the Senate to act for it to really happen.
    However, one of the more troublesome exposures to PFAS that 
often goes unnoticed is the use of these chemicals in food 
packaging. Last year, Congress took an important first step in 
the NDAA bill to ban the use of PFAS in food packaging for 
MREs. My bill, the Keep Food Containers Safe from PFAS Act, 
would build on this success to provide FDA to deem PFAS 
substances in any food containers or cookware unsafe.
    So I am going to direct these questions to Ms. Benesh.Ms. 
Benesh, what do we know about the health effects PFAS in food 
packaging? Does FDA have a safety threshold for PFAS that it 
uses to calculate how much PFAS in food is safe?
    Ms. Benesh. So we do know that PFAS migrates from food 
packaging into food, and we know that some of the health 
effects broadly associated with PFAS chemicals includes some 
kinds of cancers and then at much lower doses reproductive 
harms, developmental harms, and reduced effectiveness of 
vaccine. What is really concerning to me is FDA has said it is 
using EPA's reference dose for drinking water for PFOA and 
PFOS, which are two of the food packaging chemicals that are no 
longer being used.
    But for all the PFAS that are still in food packaging, they 
have not calculated a reference dose and so they are using the 
kinds of assumptions that they apply to other chemicals that 
don't operate in the body the same way that PFAS do. And so, I 
am a bit at a loss of how FDA has determined that these 
chemicals are safe without determining what their safety 
threshold is first.
    Mrs. Dingell. So if Americans currently have concerns about 
PFAS, which I think they should, and food packaging, can they 
shop around this problem if they are looking in PFAS food 
packaging?
    Ms. Benesh. Unfortunately not. Unlike the ingredients in 
food that do have to be on the label or the ingredients in a 
cosmetic product that have to be on the label, there is no 
requirement that the ingredients in a food packaging material 
have to be on the label. So it is very difficult to avoid if 
consumers do want to shop around it.
    Mrs. Dingell. Has FDA even withdrawn a food contact 
notification for PFAS chemical on its own?
    Ms. Benesh. No, only in response to industry abandonment, 
but never on its own because of a health concern.
    Mrs. Dingell. Is that why we need Congress to do something?
    Ms. Benesh. We do think that Congress needs to step in 
because FDA hasn't appreciated the urgency of this issue. No 
one knows better than Michigan how urgent this problem is and 
how overburdened many communities already are.
    Mrs. Dingell. You know, it is not just Michigan though, 
just as you say that. We have tested for it. Flint water taught 
us something. As other states start to test, they are going to 
be as bad as Michigan which is what is so scary. And food isn't 
just marketed to Michigan, it is marketed in every state.
    Are industry safety data backing up new approvals of food 
contact substances made public by the FDA?
    Ms. Benesh. They are only through the food contact 
notification system, which is the way that FDA has approved 
food contact substances since 1997. You can only get that 
underlying scientific information through a public records 
request. It is not easy for the public to access.
    Mrs. Dingell. I am going to ask you one more question 
because I am going to run out of time, but I don't think people 
understand this. I want to put something to bed that often gets 
raised. If we designate PFAS as hazardous substances under 
CERCLA, which we need to do and haven't, or Superfund, would 
food companies no longer be allowed to use PFAS in food 
packaging?
    Ms. Benesh. Thank you for the question and thank you for 
your leadership on this issue. We couldn't agree more that 
PFOA, PFOS and other PFAS chemicals urgently need to be 
designated as Superfund chemicals under our hazardous 
substances law. But Superfund is a clean-up law. It has no 
bearing on the use, other uses of PFAS in commerce. And we have 
looked at this issue and found that 80 percent of the roughly 
800 hazardous substances under Superfund are still in commerce 
and many of them continue to be in very wide production. So the 
only way to ban PFAS in food packaging is to ban PFAS in food 
packaging as you have proposed.
    Mrs. Dingell. Which is why we need the bill. And it is in 
the blood, for everybody here, of 99 percent of the people in 
this country and they don't know it. Thank you very much and I 
yield back.
    Ms. Eshoo. The gentlewoman yields back. I now recognize the 
gentleman from Virginia, Mr. Griffith, for his 5 minutes of 
questioning.
    Mr. Griffith. Thank you very much.
    Ms. Day, I know that it is a struggle and my question to 
you is, you have three children all of whom have severe 
allergies, if I remember your testimony correctly. Do they have 
the same allergies?
    Ms. Day. Ah, unfortunately, no. There are some overlaps, 
but I mean if I told you, my oldest daughter is allergic to 
tree nuts; my middle is allergic to dairy, eggs, sesame, 
mustard, and fish; and my youngest is allergic to peanuts, 
eggs, flax seed, sesame, and mustard.
    Mr. Griffith. Yes. I come from an allergy family. We don't 
have the same allergies, thus the question, so my wife has to 
make three sets of a number of foods that we eat. If we order 
pizza, even if it is just me and the two boys, we get three 
pizzas because each one of us has a different dietary concern.
    Ms. Day. Yes.
    Mr. Griffith. So that raises a question where I think we 
can get the language straightened out and I don't think you 
would object to it. In the bill it talks about doing a study. 
In one of the studies it says a study of the economic cost of 
food allergies in the United States both individually and the 
food allergy population, and the problem is every family is 
going to be different. I don't know how you study it 
individually without having a hundred thousand different 
studies, so I think we need to tighten that language up.
    You would not have any problem with tightening that 
language up and looking at the costs overall, and maybe it 
means medical costs, but when you are looking at the cost of 
food, everything costs more when you have food allergies, 
doesn't it?
    Ms. Day. Yes.
    Mr. Griffith. Because you are doing three or four types of 
the same thing and the ingredients cost more sometimes, or most 
of the time.
    Ms. Day. So that is certainly an issue in my family and it 
sounds like in your family.
    Mr. Griffith. Yes, ma'am.
    Ms. Day. Sesame though has come to the top of the list. We 
already----
    Mr. Griffith. Absolutely in favor of that. I am just 
talking about the study where it talks about the economic cost 
of food allergies, and I just don't know how you do that 
individually without studying hundreds of thousands of 
different scenarios.
    Ms. Day. So I am not a research expert in that so I can't--
--
    Mr. Griffith. OK. We will work on that. All right.
    Slightly shifting gears, Ms. Benesh, at one time, and I 
haven't had this issue lately, but they had boiling bags and I 
would have a reaction to foods that were processed or boiled in 
a boiling bag. Is that PFAS or is that something else?
    Ms. Benesh. PFAS chemicals are usually, typically, used as 
anti-grease proofing agents, so in pizza boxes, sandwich 
wrappers or used to line a popcorn bag.
    Mr. Griffith. So probably not.
    Ms. Benesh. It is possible that they have been used in 
plastic bag lining, but I am not aware of that particular use.
    Mr. Griffith. And I am trying to get to the facts and 
figure this stuff out.
    So, Dr. DeLeo, and I don't--we may end up with a little 
spat going here and that is OK. I want to get the information. 
And, Ms. Benesh, polymeric PFAS versus non-polymeric PFAS, 
explain that and why is it scientifically different and is 
there some way that--is there a need to distinguish between the 
two, or Ms. Benesh, do you see them as being identical where 
Dr. DeLeo in his testimony indicated that there is differences?
    Ms. Benesh. Well, there are lots of different uses of PFAS, 
and the use in PFAS typically----
    Mr. Griffith. Well, I think he was talking about different 
types of PFAS.
    Ms. Benesh. Yes. So one use of PFAS is to create these long 
polymers that are then applied to food packaging. The real 
concern is that particularly if you apply a hot food, those 
long polymers can then break down and then the PFAS chemical 
gets into the body, is my lawyer's understanding of the 
science.
    Mr. Griffith. OK, understand.
    Dr. DeLeo, do you want to respond?
    Mr. DeLeo. So PFAS is a chemistry, as was mentioned is 
thousands of chemicals and they are very diverse. There are 
some that are hazardous and there are some that are not 
hazardous. There are polymers; there are non-polymers. H.R. 
2827 is a pretty blunt instrument taking a broad brush at 
allPFAS chemistries and I think that is not a good way to 
approach policy. And so I think you really need to look at all 
the differences and applications of these chemicals rather than 
painting everything with the same broad brush.
    Mr. Griffith. I appreciate that.
    Ms. Perry, Dr. Corey, you all are obviously on opposite 
sides of the horse issue. Both of you have raised good points. 
I did think it was interesting, Dr. Corey, you mentioned 
retirement homes for horses. That is a term I have often used. 
We are spending more than 80 million dollars a year on 
retirement homes for horses. There are not enough families out 
there who want to adopt or enough facilities that want to adopt 
horses, which is why we have approximately 50,000 horses from 
federal lands that are now in what I call retirement homes. Is 
that fairly accurate according to the information that you have 
as well?
    Dr. Corey. I think the retirement and the re-homing is, we 
are doing a good job.
    Mr. Griffith. Well, I am talking about putting them on 
farms where we are paying to subsidize their life after they 
are removed from federal lands because there are too many of 
them on federal lands.
    Dr. Corey. Oh, you are referring to the wild horse and 
burro.
    Mr. Griffith. I am.
    Dr. Corey. Well, that is a whole other issue. So we have 
got a hundred thousand horses there, and now with this 
legislation we are going to create another additional potential 
eighty to a hundred thousand horses.
    Mr. Griffith. My time is up. I would love to discuss this 
further, but my time is up and I yield back.
    Dr. Corey. I would also.
    Ms. Perry. Me too.
    Ms. Eshoo. The gentleman yields back. I am more accustomed 
in the Health Subcommittee to talking about nursing homes, 
convalescent homes when it comes to the people in our country, 
so now it is very interesting to me to hear the same words used 
being applied to horses. So thank you. I keep learning.
    I don't think there is anyone left except Ms. Schakowsky is 
waiving on and--or Mr. Long.
    Mr. Long. Thank you, Madam----
    Ms. Eshoo. The gentleman from Missouri, Mr. Long.
    Mr. Long. Thank you.
    Ms. Eshoo. Who, in addition to his legislative skills, is a 
great, great auctioneer in case anyone, maybe some of these 
people who have the horses can make use of his talents. You are 
recognized for 5 minutes.
    Mr. Long. I thought you were going to say poodle wrangler, 
since I broke my shoulder before Christmas wrangling my 
daughter's 5-month-old poodle. That didn't work out too well.
    Mr. Carlin, we have heard several examples showing that the 
term ``natural cheese'' has a long history. The term even 
appears in the FDA regulations as you know. Shouldn't cheese 
products be permitted to be labeled with a term that has been 
in use for more 70 years?
    Mr. Carlin. Yes.
    Mr. Long. Can you speak to why there is a need to define 
natural cheese in statute and why this is different than 
changing the FDA's policy on the use of natural or all-natural 
for product claims?
    Mr. Carlin. Yes. As you know, processed cheese is reflected 
in the current standards of identity, but for whatever reason 
natural cheese has never been officially defined. As FDA looks 
at the term ``natural,'' since 1992 by the way is when they 
started looking at how a product claim with natural would be 
defined, FDA has said that that is something that they are 
going to try to do, but it has obviously been pending for quite 
some time.
    This legislation would not affect the cheesemakers' ability 
to use the term ``natural'' for product claim purposes. They 
would have to continue to comply with FDA's rules and 
regulations on that front. So this just provides consumers with 
information in the grocery store that they already have and 
they have had for a long time. It doesn't create anything new. 
It just preserves the ability to use that label going forward.
    Mr. Long. You say in your testimony that the FDA's 
technical experts have reviewed the bill extensively. Can you 
elaborate on the FDA's input?
    Mr. Carlin. Yes. So over the past two years we have had 
three rounds of technical assistance from FDA. We have also 
consulted with them informally as have the bill's sponsors on 
other occasions. They helped us define the term ``natural 
cheese'' in a more enforceable way from their standpoint, 
referencing the international codex standard, for example. They 
also made the suggestion that we particularly call out in the 
bill that natural claims, natural product claims would not be 
covered by this legislation to make it very clear so that there 
would be no misunderstanding.
    This is just a simple, a label for ``natural cheese,'' 
those two words in quotes, nothing else about all-natural or a 
hundred percent natural. So that was another FDA suggestion.
    Mr. Long. Yes, OK. And there is also a question of whether 
or not the CURD Act will create confusion between the FDA and 
the USDA regarding the use of natural claims on labels. Can you 
talk about whether there will be inconsistencies between the 
FDA and the USDA on this?
    Mr. Carlin. Well, as I said in my testimony, Congressman, 
the only definition of natural that is relevant here is the FDA 
definition because that is the only definition that applies to 
cheese. So the USDA has used the term ``natural cheese'' just 
has FDA has for many, many decades to talk about a category of 
cheese. That won't change and that is perfectly consistent 
across these two agencies.
    Mr. Long. OK, and I am going to move down the line to Mr. 
Balmer, a question for you. I have heard claims that the DAIRY 
PRIDE Act would somehow disrupt the consumer market. It seems 
to me that clearer transparent labeling actually should help 
the market by making sure shoppers have accurate information 
about products on the shelves. What is your take?
    Mr. Balmer. Well, we are not quite of the opinion that this 
would be disruptive to the marketing of these imitation 
products because as I showed a little while ago, we have the 
same product produced in the same plant called by three 
different names in three different countries. Only in the 
United States is the term ``milk'' involved. In Canada, a 
different term; in the U.K., a different term.
    So we don't see how this legislation which simply is asking 
for FDA to do its job and enforce what is on the books now, we 
don't see how it would interfere with continued growth in that 
category. And we have no problem as long as those products are 
labeled correctly.
    Mr. Long. OK, thank you. And thank you all for being here 
today. And I will go on the record as saying when I go to the 
Capitol Hill Club over here across the street, I walk in, you 
know, everybody knows what everybody's favorite drink is, and 
as soon as I walk in they always put down a big glass of milk 
for me and everyone laughs at me. But I have done that my whole 
life. I yield back.
    Ms. Sorscher. Could I clarify a point on the CURD Act? 
There is nothing that would----
    Ms. Eshoo. You can proceed, go ahead.
    Ms. Sorscher. Were the FDA to define natural, there would 
be nothing stopping a company from putting ``natural cheese'' 
on their product provided they also met the FDA requirements, 
which would likely include no artificial ingredients. And I 
think even though cheesemakers have used this term for many 
years as a term of art, what goes on the label has to make 
sense to consumers as well, and we don't distinguish between a 
product name and a claim.
    Ms. Eshoo. Thank you very much.
    The gentleman has yielded back. On milk, I think that there 
are two things that the senators are allowed to have as the 
trial is taking place: one is water, the other, Mr. Balmer, is 
milk. How is that? I just hope it is not warm milk because it 
will put them all to sleep.
    Mr. Griffith. They don't need that.
    Ms. Eshoo. Yes, they don't need that. They could do that 
naturally.
    A pleasure to recognize the gentlewoman from Illinois, Ms. 
Schakowksy, for 5 minutes of questions.
    Ms. Schakowsky. Thank you, Madam Chair. Thank you not only 
for letting me waive on to this subcommittee, but also for 
including my legislation in there, which is the SAFE Act, 
Safeguarding America's Food Supply, food exports, and it now 
has 224 cosponsors. I also want to thank Nancy Perry from the 
ASPCA for being here to testify in favor of this legislation.
    So the Food and Drug Administration is responsible for 
protecting public health through protecting our food supply, 
and I think it is doing generally working very hard, but horse 
meat has definitely fallen through the cracks. We know that my 
bill addresses the danger of consuming horse meat. So I want to 
talk not just about nursing homes or whatever for horses, but I 
want to talk about the dangers of allowing prohibited 
ingredients to be in the horse meat that is still not 
prohibited for eating in the United States of America.
    So we know also that horses are legally being exported for 
the purpose of slaughter for consumption. Kill buyers purchase 
these horses at auction, ship them mostly to Canada and Mexico 
to be slaughtered for food, and even Ferdinand, the winner of 
the 1986 Kentucky Derby, fell victim to the horse slaughter 
industry. The consumption of horse meat poses a grave threat to 
public health. Horses are routinely treated with phenylbutazone 
and other extremely potent bans--products that are banned.
    And so, Ms. Perry, has the FDA banned the use of these 
drugs in animals that we eat?
    Ms. Perry. Yes, they have. There is no legal use of 
phenylbutazone and many of the hundred substances that we 
provided in our written testimony for provision to food-
producing animals, so there is no food use for most of those 
chemicals.
    Ms. Schakowsky. And, Ms. Perry, are there any animals, any 
equine, raised for food in the United States?
    Ms. Perry. There are not. There are not.
    Ms. Schakowsky. And can you explain why horse meat poses a 
food safety hazard?
    Ms. Perry. Well, I rely on the Food and Chemical Toxicology 
Journal peer-reviewed piece from Dr. Nick Dodman that was 
published in 2010 that reviews and tracks horses that were 
funneled into the slaughter pipeline from the U.S. and looks at 
the phenylbutazone content in their tissues after they were 
slaughtered, and that article is frightening. It really 
demonstrates that those residues are there.
    Again, no level of residue is appropriate or legal or safe 
and there is no phase-out period for that particular drug and 
again many of the more than hundred substances that we have 
provided to the committee. But that article indicates and 
documents how the FDA determined the health impacts of just 
phenylbutazone alone, if we just look at that one drug which is 
probably the one that has been under the microscope the most.
    Most of this has flown directly under the radar because 
nobody even knows this is happening it is such a shadowy 
industry. But I will just list that aplastic anemia, 
leukopenia, agranulocytosis, thrombocytopenia are just some of 
the serious illnesses that can lead to death. They are 
basically blood platelet and bone marrow immunity diseases.
    Ms. Schakowsky. So these are the horses that are being 
purchased----
    Ms. Perry. American horses.
    Ms. Schakowsky [continue]. And exported for the purpose of 
being eaten.
    Ms. Perry. That is correct.
    Ms. Schakowsky. So could you please describe some 
circumstances for which the FDA has issued warnings----
    Ms. Perry. Sure.
    Ms. Schakowsky [continue]. To take action against food 
products in the United States for violating FDA standards?
    Ms. Perry. I don't think it is common knowledge, but the 
FDA actually has a ready availability of this information on 
their Web site. You can look at their enforcement records, and 
we have been stunned to see the number of times they have taken 
action when phenylbutazone has been given to food-producing 
animals and often dairy cows.
    Ms. Schakowsky. Let me just----
    Ms. Perry. Sure.
    Ms. Schakowsky [continue]. End because my time is running 
out. So what this legislation does, what the SAFE Act would do 
would explicitly ban consumption of horse meat in the United 
States and the import and export----
    Ms. Perry. Correct.
    Ms. Schakowsky [continue]. Of horses and equine parts. I 
think it is really important that we take action and that the 
FDA finally enter the picture to protect our food supply and 
that of what we are exporting. Thank you.
    Ms. Perry. Thank you.
    Ms. Eshoo. The gentlewoman yields back. I want to thank 
each one of you. You have spent a long time here today and we 
appreciate it. But we also appreciate the knowledge that you 
have shared with us, firsthand knowledge--Ms. Day, about your 
children--and each one of you on the bills that were part of 
this discussion and your comments on the bills that deal with 
food and FDA.
    I want to thank--they are not in the room, but I want to 
acknowledge and I did earlier, but I want to acknowledge again 
the authors of the legislation for the work that they have 
done. A lot goes into bills before they ever come into this 
room and have expert witnesses come in and comment on it which 
is a very important part of our process. But I think we took up 
how many bills today? Ten bills.
    And as long as I am around we are going to keep rolling on 
taking up as many bipartisan bills, bills that members sponsor 
and have cosponsorship not only from this committee but from 
outside the committee. I think it is an important thing to do. 
I don't think the American people really ask for that much, but 
these are all things that they can't do for themselves. We are 
the ones that have to make the decision, so thank you----
    Ms. Schakowsky. Madam Chair?
    Ms. Eshoo [continue]. For everything that you have done to 
assist us.
    Yes?
    Ms. Schakowsky. I am wondering if at this point I could ask 
to add into the record a letter from the AWA in favor of the 
SAFE Act. Thank you.
    Ms. Eshoo. Certainly. So ordered.
    [The information appears at the conclusion of the hearing.]
    Ms. Eshoo. And I am requesting unanimous consent to enter 
into the record the following documents: A statement from 
Representative Meng in support of her bill, H.R. 2267; a 
statement from the Consumer Federation, Kid's in Danger, and 
Public Citizen, in support of 2267; a letter from the United 
States Harness Racing Alumni Association in support of 961; a 
letter from Animal Protection of New Mexico in support of 961; 
the testimony of Hilary Wood, president of the Front Range 
Equine Rescue in support of 961; a letter from the Plant Based 
Foods Association opposing 1769; a statement from the American 
Forest and Paper Association opposing H.R. 2827; a letter from 
the American Pharmacists Association.
    Where is Mr. Carter? I will have to tell him--in support of 
5663; a letter from Return to Freedom in support of 961; a 
letter from the Professional Rodeo Cowboys Association opposing 
961; a letter from--isn't it marvelous all the associations and 
organizations we have in the United States of America? It never 
ceases to amaze me--a letter from Diane Dorman in support of 
4712; a letter from the Humane Society of the United States and 
the Humane Society Legislative Fund in support of 961; a letter 
from the Humane Society Veterinary Medical Association in 
support of 961; a letter from five livestock groups opposing 
961; a letter from the National Black Farmers Association in 
support of 961; a letter from R-CALF, c-a-l-f, opposing 961; a 
one-pager on 961 developed by Protect the Harvest Action Fund; 
a letter from the Texas State Horse Council in support of 961; 
a letter to Vice President Pence from the United States 
Cattlemen's Association opposing 961--they could write to us 
too; a letter from the American Chemistry Council opposing 
2827; a letter from FluoroCouncil opposing 2827; a letter from 
the Animal Welfare Institute in support of 961; a statement 
from the American Society of Health-System Pharmacists, but it 
doesn't say whether they oppose or support, but it is a 
statement so we will have to read it; a statement from 15 
healthcare organizations in support of 5668; a letter from the 
Jockey Club in support of H.R. 961--I doubt that is the 
restaurant though, do you? I don't think so.
    So without objection?
    Mr. Griffith. No objection.
    Ms. Eshoo. So ordered.
    Ms. Eshoo. So at this time, the subcommittee is adjourned. 
Thank you, everyone.
    [The information appears at the conclusion of the hearing.]
    [Whereupon, at 2:27 p.m., the subcommittee was adjourned.]

                Prepared statement of Frank Pallone, Jr.

    Today, the Subcommittee is meeting to continue our strong 
history of working to ensure the quality and safety of our 
country's food and drugs. We're here to learn about several 
proposals to increase transparency, set clear standards for 
certain foods, support the development of modern drug 
manufacturing, and reduce the gaming of incentives for drugs 
intended to treat rare diseases.
    In Panel I, we will examine four bills aimed at increasing 
patient access to lifesaving drugs and providing consumers with 
up-to-date and accurate information through modified labeling. 
The first bill, H.R. 4712, the ``Fairness in Orphan Drug 
Exclusivity Act,'' would update the Orphan Drug Act of 1983 by 
requiring that manufacturers seeking orphan drug designations 
demonstrate a lack of any reasonable expectation that the costs 
incurred by manufacturing and distributing said drug would be 
recovered in U.S. sales, and to continue to make such 
demonstrations over a seven-year period of market exclusivity. 
It would further direct FDA and manufacturers to take into 
account the sales of all drugs for a specific rare disease or 
condition developed by the same manufacturer as well as all 
drugs containing the same components.
    The next bill, H.R. 4866, the ``National Centers of 
Excellence in Continuous Pharmaceutical Manufacturing Act,'' 
introduced my Mr. Guthrie and myself, would amend the 21st 
Century Cures Act to direct FDA to designate National Centers 
of Excellence in Continuous Pharmaceutical Manufacturing 
(NCEs), which would work with FDA and industry to create a 
national framework for continuous manufacturing implementation, 
including supporting additional research and development of 
this technology, workforce development, standardization, and 
collaborating with manufacturers to support adoption of 
continuous manufacturing. We will then discuss H.R. 5663, the 
``Safeguarding Therapeutics Act,'' which would extend FDA's 
administrative destruction authority to medical devices.
    Finally, rounding out our first panel, we have H.R. 5668, 
the ``Making Objective Drug Evidence Revisions for New Labeling 
Act of 2020,'' or the ``MODERN Labeling Act of 2020.'' This 
bill would give FDA authority to require updates of outdated 
labeling for generic drugs and requires that FDA report any 
actions taken under the bill to update labeling for covered 
drugs, including the number of drugs, description of the 
changes and the rationale behind them, as well as any FDA 
recommendation to modify the program.
    Panel II will cover five bills involving food safety: H.R. 
961, the ``Safeguarding American Food Exports Act of 2020,'' 
H.R. 1769, the `` DAIRY Pride Act,'' H.R. 2117, the ``FASTER 
Act of 2019,'' H.R. 2267, the ``Infant Formula Protection Act 
of 2019,'' H.R. 2827, the ``Keep Food Containers Safe from PFAS 
Act of 2019," and H.R. 4487, the ``CURD Act.''
    I want to thank all of the witnesses for taking the time to 
speak to us today, and I am confident that this hearing will 
serve as another example of the Energy and Commerce Committee's 
dedication to protecting Americans and their peace of mind when 
it comes to the safety of their food and drugs.
    Thank you, I yield back.
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