[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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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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