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


                    PROFITS OVER CONSUMERS: EXPOSING 
                    HOW PHARMACEUTICAL COMPANIES GAME 
                              THE SYSTEM

=======================================================================

                                HEARING

                               BEFORE THE

            SUBCOMMITTEE ON CONSUMER PROTECTION AND COMMERCE

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 19, 2019

                               __________

                           Serial No. 116-63


      Printed for the use of the Committee on Energy and Commerce
      
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                               __________

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                    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 Consumer Protection and Commerce

                        JAN SCHAKOWSKY, Illinois
                                Chairwoman
KATHY CASTOR, Florida                CATHY McMORRIS RODGERS, Washington
MARC A. VEASEY, Texas                  Ranking Member
ROBIN L. KELLY, Illinois             FRED UPTON, Michigan
TOM O'HALLERAN, Arizona              MICHAEL C. BURGESS, Texas
BEN RAY LUJAN, New Mexico            ROBERT E. LATTA, Ohio
TONY CARDENAS, California, Vice      BRETT GUTHRIE, Kentucky
    Chair                            LARRY BUCSHON, Indiana
LISA BLUNT ROCHESTER, Delaware       RICHARD HUDSON, North Carolina
DARREN SOTO, Florida                 EARL L. ``BUDDY'' CARTER, Georgia
BOBBY L. RUSH, Illinois              GREG GIANFORTE, Montana
DORIS O. MATSUI, California          GREG WALDEN, Oregon (ex officio)
JERRY McNERNEY, California
DEBBIE DINGELL, Michigan
FRANK PALLONE, Jr.,  New Jersey (ex 
    officio)
                            
                            C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Jan Schakowsky, a Representative in Congress from the State 
  of Illinois, opening statement.................................     1
    Prepared statement...........................................     3
Hon. Cathy McMorris Rodgers, a Representative in Congress from 
  the State of Washington, opening statement.....................     3
    Prepared statement...........................................     5
Hon. Debbie Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     6
    Prepared statement...........................................     7
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     8
    Prepared statement...........................................    10

                               Witnesses

Michael A. Carrier, Distinguished Professor, Rutgers Law School, 
  CO-Director, Rutgers Institute for Information Policy and Law..    11
Prepared statement...............................................    14
    Answers to submitted questions...............................    88
David E. Mitchell, Founder, Patients for Affordable Drugs, 
  Patients for Affordable Drugs..................................    17
Prepared statement...............................................    19
Joanna M. Shepherd, Professor of Law at Emory University School 
  of Law.........................................................    31
Prepared statement...............................................    34
    Answers to submitted questions...............................    90
Jeffrey K. Francer, Senior Vice President and General Counsel, 
  Association for Accessible Medicines...........................    47
Prepared statement...............................................    49
    Answers to submitted questions...............................    99

                           Submitted Material

Research of Generic Drugs, Used Textbooks, and the Limits of 
  Liability for Product Improvements, by Timothy J. Muris and 
  Jonathan E. Nuechterlein, George Mason University, submitted by 
  Ms. Schakowsky \1\
Article of December 2018, ``May your drug price be evergreen'', 
  by Robin Feldman, published in the Journal of Law and the 
  Biosciences, submitted by Ms. Schakowsky \2\
Article ``Product Hopping: A New Framework'', by Michael A. 
  Carrier and Steve D. Shadown, submitted by Ms. Schakosky \3\

----------
\1\ Research paper by Timothy J. Muris, George Mason University 
  is available at https://docs.house.gov/meetings/IF/IF17/
  20190919/109970/HHRG-116-IF17-20190919-SD003.pdf.

\2\ Article on ``May your drug price be evergreen'' is available 
  at https://docs.house.gov/meetings/IF/IF17/20190919/109970/
  HHRG-116-IF17-20190919-SD004.pdf.

\3\ Article on ``Product Hopping: A New Framework'' is available 
  at https://docs.house.gov/meetings/IF/IF17/20190919/109970/
  HHRG-116-IF17-20190919-SD005.pdf.

 
PROFITS OVER CONSUMERS: EXPOSING HOW PHARMACEUTICAL COMPANIES GAME THE 
                                 SYSTEM

                              ----------                              


                      THURSDAY, SEPTEMBER 19, 2019

                  House of Representatives,
  Subcommittee on Consumer Protection and Commerce,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:30 a.m., in 
room 2322 Rayburn House Office Building, Hon. Jan Schakowsky 
(chairwoman of the subcommittee) presiding.
    Members present: Representatives Schakowsky, Castor, 
Veasey, Kelly, O'Halleran, Blunt Rochester, Soto, Rush, Matsui, 
McNerney, Dingell, Rodgers (subcommittee ranking member), 
Upton, Burgess, Latta, Guthrie, Bucshon, Hudson, Carter, 
Gianforte, and Walden (ex officio).
    Also present: Representative. Sarbanes
    Staff present: Jeffrey C. Carroll, Staff Director; Evan 
Gilbert, Press Secretary; Lisa Goldman, Senior Counsel; Alex 
Hoehn-Saric, Chief Counsel, Communications and Protection; 
Megan Howard, FDA Detailee; Jerry Leverich, Senior Counsel; Dan 
Miller, Senior Policy Analyst; Alivia Roberts, Press Assistant; 
Tim Robinson, Chief Counsel; Chloe Rodriguez, Policy Analyst; 
Benjamin Tabor, Staff Assistant; Mike Bloomquist, Minority 
Staff Director; Bijan Koohmaraie, Minority Counsel, Consumer 
Protection and Commerce; Tim Kurth, Minority Deputy Chief 
Counsel, Communications and Technology; James Paluskiewicz, 
Minority Chief Counsel, Health; Brannon Rains, Minority Staff 
Assistant; and Kristen Seum, Minority Counsel, Health.
    Ms. Schakowsky. The Subcommittee on Consumer Protection and 
Commerce will now come to order.
    The Chair now recognizes herself for 5 minutes for an 
opening statement.

 OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Throughout today's hearing, you will hear many different 
terms used to describe the problem that we are trying to 
address today--product hopping, hard switching, soft switching, 
and evergreening. But whatever the word is or the phrase, the 
bottom line is this: drug manufacturers are gaming the system 
to make more money at consumers' expense, and that has to stop.
    Big Pharma says that high-priced and high prices and 
exclusivity are essential to innovation. But competition is 
actually more central to innovation, and the opposite of what 
Big Pharma wants. Experts suggest that about 78 percent of the 
drugs that get new patents are not new drugs. They are new 
patents for existing drugs.
    Instead of truly innovating, drug manufacturers are taking 
advantage of the anticompetitive environment we have created by 
recycling old medicines into new formulas--into new formations.
    The problem goes beyond several bad actors, and you will 
hear about over--that you will hear about over and over again 
today--Humira, Revlimid, Suboxone, just to name a few.
    The 100 best-selling drugs on the market, about 70 percent 
have their protective--had their protection extended at least 
once, and about 50 percent have had their protections extended 
more than once. Many companies are actually withdrawing new--
withholding new and beneficial discoveries about their drugs 
from consumers until they can use the innovation to block 
competition.
    Mr. Carrier's testimony provides a series of alarming 
examples. One manufacturer's main reason for not seeking FDA 
approval for off-label uses of their drug was that it ``wanted 
to reserve them for a promotional campaign for its reformulated 
product.''
    Another manufacturer obtained FDA approval for a once-daily 
version of their Alzheimer's treatment but waited three years 
until generic competition for their twice-daily drug was 
imminent before they released it. Big Pharma actually blocked 
the innovation that they claimed to treasure--innovation that 
could have helped patients until the time was most profitable.
    I am proud to preside over this hearing in the Consumer 
Protection Subcommittee because Congress must take direct 
action to protect American consumers from the deceptive 
commercial actions that the drug manufacturers take to gouge 
consumers.
    FDA is responsible for protecting public health by ensuring 
the safety, efficacy, and security of drugs. FDA does not 
adjudicate patient claims, and I agree with the agency's 
conclusion that they should not be tasked with doing so. And 
though the FTC has brought some cases for anticompetitive 
practices, it does not have explicit authority to challenge 
anti-competitive hard and soft switches.
    Americans should not have to hope that the FTC can stop 
Pharma's gaming of the prescription drug market. They should be 
able to count on it. And Americans should not have to wait 
years for costly lawsuits to play out and find that the generic 
has decided to settle with the brand name company for a hefty 
sum to keep their drug off the market, also known as pay-for-
delay.
    So I look forward to learning from our witnesses today as I 
craft a bill to protect consumers from Big Pharma's gaming 
tactics. This legislation will encourage the courts to view 
these gaming practices as anti-competitive and discourage 
manufacturers from engaging in these types of practices to 
begin with.
    So we owe it to the American people, and I will be doing 
everything I can in my power to do so. So I yield back my time.
    [The prepared statement of Ms. Schakowsky follows:]

               Prepared Statement of Hon. Jan Schakowsky

    Throughout today's hearing, you will hear many different 
terms used to describe the problem we are trying to address: 
``product hopping,'' ``hard switches,'' ``soft switches,'' and 
``evergreening
    But whatever the word or phrase, the bottom line is: drug 
manufacturers are gaming the system to make more money at 
consumers' expense.
    Big Pharma says that high prices and exclusivity are 
essential to innovation.
    But competition is actually most central to innovation--and 
the opposite of what Big Pharma wants.
    Experts suggest that about 78% of the drugs that get new 
patents are NOT new drugs.
    They are new patents for existing drugs.
    Instead of truly innovating, drug manufacturers are taking 
advantage of the anticompetitive environment by recycling old 
medicines into new forms.
    The problem goes beyond several bad actors you will hear 
about over and over again today-Humira, Revlimid, Suboxone, 
Namenda, Prilosec.
    Of the 100 best-selling drugs, about 70% had their 
protection extended at least once, and 50% have had their 
protections extended more than once.
    Many companies are actually withholding new and beneficial 
discoveries about their drugs from the consumers until they can 
use this innovation to block competition.
    Mr. Carrier's testimony provided a series of alarming 
examples:
    One manufacturer's main reason for not seeking FDA approval 
for off-label uses of their drug was that it ``wanted to 
reserve them for a . . . promotional campaign for its 
reformulated product.''
    Another manufacturer obtained FDA approval for a once-daily 
version of their Alzheimer's treatment, but waited three years, 
until generic competition for their twice-daily drug was 
imminent, before releasing it.
    Big Pharma actually blocked the innovation they claim to 
treasure--innovation that could have helped patients--until it 
was most profitable.
    I am proud to preside over this hearing in the Consumer 
Protection subcommittee because Congress must take direct 
action to protect American consumers from the deceptive actions 
that drug manufactures take in their commercial practices.
    FDA is responsible for protecting public health by ensuring 
the safety, efficacy, and security of biological products, 
including drugs.
    FDA does not construe patent claims, and I agree with the 
agency's conclusion that they should not be tasked with doing 
so.
    And though the FTC has brought some cases for anti-
competitive product hopping, it does not have explicit 
authority to challenge anticompetitive hard and soft switches.
    Americans should not have to hope the FTC can stop Pharma's 
gaming of the prescription drug market--they should be able to 
count on it.
    And Americans should not have to wait years for costly 
lawsuits to play out--or find that the generic has decided to 
settle with the brand company for a hefty Pay-for-Delay sum.
    I look forward to learning from our witnesses today, as I 
craft legislation to protect consumers from Big Pharma's 
evergreening tactics.
    Such legislation will set a precedent that I hope will

     force courts to recognize the consumer harms in 
evergreening,
     and discourage manufactures from engaging in their 
anticompetitive practices to begin with.

    We owe it to the American people to stop these practices, 
and I will do everything in my power to do so.

    The Chair now recognizes Mrs. Rodgers, our ranking member 
for the Subcommittee on Consumer Protection and Commerce, for 5 
minutes for her opening statement.

      OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON

    Mrs. Rodgers. Thank you, Madam Chair. Good morning and 
welcome to everyone to the Consumer Protection and Commerce 
Subcommittee. I am proud that America has led the world in 
research, cutting edge therapies, cures, saving lives, and 
improving the quality of lives for countless here in America 
and around the world.
    I am also proud of the work of this committee in passing 
21st Century Cures, bipartisan legislation that will continue 
to keep us at the forefront. This really is an exciting time, 
but there are so many possibilities for every disease, every 
condition, and patients should always be put ahead of corporate 
profits.
    So we need to make sure certain companies are not gaming 
the system to increase profits at the cost of patients. 
Patients should also be put ahead of government actions that 
limit access to lifesaving treatment.
     Product hooping occurs when a drug company attempts to 
switch patients from an older version of a drug to a newer 
version. Sometimes they withdraw the old drug and replace it 
with a new modified drug. Or they keep the old drug on the 
market and shift the market towards a new drug with a new 
marketing strategy.
    The concern here is when bad actors use this tactic to game 
the system and limit consumer choices with unaffordable costs. 
We should be focusing on addressing those instances without 
harming innovation. So bad actors who are intentionally acting 
to monopolize the market and limit patient choice are held 
accountable.
    But not all product withdrawals or modifications are anti-
competitive. Bringing improved drugs to the market to compete 
with older products is often what we need. It gives patients 
access to more medications and treatments, and oftentimes in a 
safer, more effective way to heal.
    For instance, there is a drug treatment for degenerative 
muscular disease that has required a delivery of the needle 
through the eye. The company later developed a method for doing 
it in the arm. Now I don't know about any of you, but I think I 
would prefer to have it in my arm. Yet under some current 
proposals, bringing the safer and preferred delivery could be 
labeled ``anti-competitive.'' If a shot in the arm sounds 
better to you, too bad. Government regulations say no. That is 
not how it should be.
    Increasing access to affordable treatments and prescription 
drugs usually is a bipartisan issue. The Energy and Commerce 
Committee unanimously passed several bills this year tackling 
drug prices. Unfortunately, they were packaged with another 
group of bills related to the Affordable Care Act that made it 
partisan when it came to the floor.
    But I am proud that this administration has done more to 
lead in reducing the cost of prescription drugs than, well, 
any--probably at any time. In fact, prescription drug costs are 
coming down in America, and this administration has led to 
breaking records for the amount of generic drug approvals at 
the FDA, bringing down costs.
    This year, for the first time in a long time, prescription 
drugs overall have decreased. And to build on this process, 
Energy and Commerce, through the Health Subcommittee, should be 
encouraging our medical companies to invest in R&D that will 
save lives.
    Product hopping fixes that are broad or ambiguous will 
discourage this. So as we move forward, I encourage this 
committee to be precise. If we are not, the government will 
hinder innovation, America will fall behind, and patients--
patients--will be left waiting for the cures that they long 
for.
    Nearly two-thirds of new drug approvals are for incremental 
innovations. They should be welcomed and protected, not 
demonized. On average, each new drug saves more than 11,000 
lives each year. If we stop innovating, we risk dire 
consequences. Improvements from each new drug can also 
eliminate almost 20 billion in lost wages by preventing lost 
work due to illness. For every incremental dollar spent on new 
drugs, total medical spending decreases by more than $7.
    Americans benefit from innovation, and our healthcare 
system saves money because of it. Again, the U.S. is leading 
the world in medical innovation, developing more lifesaving 
treatments and cures than any other nation in the world. Our 
committee has a history of working in a bipartisan cooperation. 
Any proposal hopefully considered under regular order must 
encourage innovation and go after the clearly anti-competitive 
practices.
    Thank you, and I yield back.
    [The prepared statement of Mrs. Rodgers follow:]

           Prepared Statement of Hon. Cathy McMorris Rodgers

    Good morning and welcome to the Consumer Protection and 
Commerce Subcommittee where today we focus on a healthcare 
competition issue: product hopping.
    Patients should always be put ahead of corporate profits, 
so we need to make sure certain companies are not gaming the 
system to increase profits at the cost of patients.
    Patients should also be put ahead of government actions 
that limit access to their life-saving treatments.
    Product hopping occurs when a drug company attempts to 
switch patients from their older version of a drug to a newer 
version.
    Sometimes they withdraw the old drug and replace it with a 
new, modified drug, or they keep the old drug on the market and 
shift the market towards the new drug with a new marketing 
strategy.
    The concern here is when bad actors use this tactic to game 
the system and limit consumer choices with unaffordable costs.
    We should be focused on addressing those instances without 
harming innovation--so bad actors who are intentionally acting 
to monopolize the market and limit patient choice are held 
accountable.
    But not all product withdrawals or modifications are anti-
competitive.
    Bringing improved drugs to the market to compete with older 
products is exactly what we want.
    It gives patients access to more medications and 
treatments, and often times a safer and more effective way to 
heal.
    For instance, there's a treatment for a degenerative 
muscular disease that required delivery through a needle into 
the eye.
    The company later developed a method for the arm.
    I don't know anyone who would prefer a shot in their eye.
    Yet--under some current proposals--bringing the safer and 
preferred delivery could be labeled anti-competitive.
    If a shot in the arm sounds better to you, too bad.
    Government regulations say ``no.''
    That's not how it should be.
    Increasing access to affordable treatments and prescription 
drugs usually is a bipartisan issue.
    Energy and Commerce unanimously passed several bills this 
year tackling drug pricing only to have them packaged into a 
partisan messaging bill on the floor.
    Fortunately, the Trump Administration has led on this front 
and is breaking records for the amount of generic drug 
approvals at the FDA.
    This year, for the first time in a long time, prescription 
drug prices have decreased overall.
    To build on this progress, Energy and Commerce, through the 
Health subcommittee, should be encouraging our medical 
companies to invest in R&D that will save lives.
    Product hopping fixes that are broad or ambiguous will 
discourage this.
    We must be precise.
    If we aren't, the government will hinder innovation, 
America will fall behind world-wide, and patients will be 
waiting for the cures they need.
    Nearly two-thirds of new drug approvals are for incremental 
innovations.
    They should be welcomed and protected, not demonized.
    On average each new drug saves more than 11,000 lives each 
year.
    If we stop innovating, we risk dire consequences.
    Improvements from each new drug can also eliminate almost 
$20 billion in lost wages by preventing lost work due to 
illness.
    Plus, for every incremental dollar spent on new drugs, 
total medical spending decreases by more than seven dollars.
    Americans benefit from innovation and our healthcare system 
saves money because of it.
    Again, the U.S. has led the world in medical innovation, 
developing more life-saving treatments and cures than any other 
nation.
    Our Committee has a history of bipartisan cooperation in 
building America as the global leader and no one here wants to 
reverse progress we've made because of the 21st Century Cures 
Act.
    Any proposal--hopefully considered under regular order in 
our Health subcommittee--must encourage this innovation and go 
after clearly anticompetitive practices.
    Thank you and I yield back.

    Ms. Schakowsky. The gentlelady yields back.
    And in lieu of the full committee chairman, Mr. Pallone, 
the Chair now recognizes Mrs. Dingell for 5 minutes for an 
opening statement.

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

    Mrs. Dingell. Thank you, Madam Chair. Today we are 
examining an often-overlooked issue in the drug pricing debate 
known as product hopping or evergreening. As the Energy and 
Commerce Committee works together, that is important. That is 
what we should all be proud of, that we have, in many cases, to 
provide relief to Americans from the high cost of prescription 
drugs. We can't leave any stone unturned in examining ways to 
address this issue.
    All of us have heard from constituents who are forced to 
cut pills in half, choose between paying for medication and 
rent, or avoiding taking needed medicines entirely due to cost.
    And we can't stop innovating and researching, but we need 
to make sure--I continue to be horrified for these young 
children. And we talk about insulin, which is one of the ones 
we have to talk about, but the inhaler that now costs $700, the 
EpiPen. People that can least afford it and don't have 
insurance are many times the ones that need these medicines 
more than anybody.
    And part of the reason these costs remain so high is due to 
the loopholes and tactics that some pharmaceutical companies 
use to delay competition from generic drug manufacturers. 
Competition is crucial to lowering prescription drug prices and 
improving America's access to lifesaving medication.
    When generic drugs enter the market in the United States, 
prescription drug prices fall dramatically--try, up to 90 
percent. And this is how a market should work, by rewarding the 
innovation and promoting competition, and then the American 
people benefit.
    Unfortunately, we have been seeing increasing examples in 
recent years of pharmaceutical companies exploiting the current 
structure of our Nation's regulatory and patent system to block 
competition and keep drug prices high through practices like 
product hopping.
    Product hopping or evergreening is the reformulation of a 
drug by a brand-name manufacturer to delay competition and 
protect protection for profit. This often just includes minor 
changes, like reformulating a capsule to a tablet, small 
changes in the dosing, the strength of a branded drug, other 
changes that have little effect or therapeutic value.
    Timed correctly, and combined with tactics like removing 
the older version of the drug from the market or aggressively 
marketing the new version of the product, pharmaceutical 
companies can and do successfully block competing generic 
products from the market. And the reason that this happens is 
simple: a blockbuster drug can bring in hundreds of millions of 
dollars each year in sales while under patent protection.
    In fact, a 2016 study found that these sorts of tactics to 
delay the generic competition cost Americans at least $5.4 
billion annually. Currently, there is little recourse against 
this when it happens. The FTC's authority to address product 
copying is limited and unclear. And as a result, product 
copying and similar practices have proliferated in recent 
years.
    It is my hope that today's witnesses will help us all learn 
more about product hopping, yet their expertise and knowledge 
will point us toward a solution that addresses this problem. I 
want to thank them all for being here.
    Inaction on this issue is not an option. High healthcare 
and prescription drug costs affect all of us, regardless of our 
background or party. I know just from having to buy more than 
20 different prescriptions for John per month--and I had two 
insurances and Medicare--what that cost is. Think of the mother 
working two jobs with a child that has asthma and has to buy a 
$700 inhaler.
    This is an issue where bipartisan action is necessary and 
needed. I know my colleagues share my concern, and it is my 
sincere hope that this hearing forms the basis for future 
actions and reforms.
    Thank you for being here, and I yield back.
    [The prepared statement of Ms. Dingell follow:]

               Prepared Statement of Hon. Debbie Dingell

    Today, we are examining an often-overlooked issue in the 
drug pricing debate known as product hopping or evergreening.
    As the Energy and Commerce Committee works to provide 
relief to Americans from the high cost of prescription drugs, 
we must leave no stone unturned in examining ways to address 
this issue.
    All of us have heard from constituents who are forced to 
cut pills in half, choose between paying for medication and 
rent, or avoiding taking needed medicines entirely due to cost.
    Part of the reason these costs remain so high is due to the 
loopholes and tactics that some pharmaceutical companies use to 
delay competition from generic drug manufacturers.
    Competition is crucial to lowering prescription drug prices 
and improving Americans' access to lifesaving medication. When 
generic drugs enter the market in the United States, 
prescription drug prices fall dramatically, by up to 90 
percent.
    This is how a market should work--by rewarding innovation 
and promoting competition, the American people benefit.
    Unfortunately, we have seen increasing examples in recent 
years of pharmaceutical companies exploiting the current 
structure of our nation's regulatory and patent system to block 
competition and keep drug prices high through practices like 
product hopping.
    Product hopping, or evergreening, is the reformulation of a 
drug by a brand-name manufacturer to delay competition and 
protection their profits.
    This often includes minor changes, like reformulating a 
capsule to a tablet, small changes in the dosing or strength of 
a branded drug, or other changes that have little effect or 
therapeutic value.
    Timed correctly, and combined with tactics like removing 
the older version of the drug from market or aggressively 
marketing the new version of the product, pharmaceutical 
companies can--and do--successfully block competing generic 
products from the market.
    The reason that this happens is simple--a blockbuster drug 
can bring in hundreds of millions of dollars each year in sales 
while under patent protection.
    In fact, a 2016 study found that these sorts of tactics to 
delay generic competition cost Americans at least $5.4 billion 
annually.
    Currently, there is little recourse against these types of 
abuses. The FTC's authority to address product hopping is 
limited and unclear. As a result, product hopping and similar 
practices have proliferated in recent years.
    It is my hope that today's witnesses help us all learn more 
about product hopping, and that their expertise and knowledge 
will point us toward a solution that addresses this problem. I 
would like to thank them all for being here.
    Inaction on this issue is not an option. High healthcare 
and prescription drug costs affect all of us, regardless of 
background or party. This is an issue where bipartisan action 
is necessary and needed.
    I know my colleagues share my concern, and it is my sincere 
hope that this hearing forms the basis for future action and 
reforms.

    Ms. Schakowsky. The gentlelady yields back, and now I 
recognize Mr. Walden, ranking member of the full committee, for 
5 minutes for his opening statement.

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

    Mr. Walden. Good morning, Madam Chair.
    Ms. Schakowsky. Good morning.
    Mr. Walden. Thank you for having this hearing. It is really 
important. We do look forward to the testimony from the 
witnesses. Obviously, this committee has a long history of 
going after these issues and stopping bad behaviors where we 
have led on surprise medical billing, having a discussion about 
that; we passed that out of here unanimously.
    We rewrote the full FDA user fee agreements trying to get 
generics to market sooner. We did that in a bipartisan 
unanimous way--I think it passed. They were able to put 971 
generics into market last year, record number in a single year, 
so we believe in bringing competition to the market.
    We have jointly worked together on Cures, 21st Century 
Cures. And, you know, there is more work to be done there going 
forward, but I think that was pretty much almost unanimous. 
There were a couple of holdouts, I think, in the House. But 
because investing in medical research and all that leads to 
drugs and new treatments and precision medicine--as, my friend 
from Michigan said, these diseases, these problems, hit us 
regardless of background or party.
    We were together in this committee on CREATES, stop bad 
behavior. Unfortunately, after I left our good committee of 
Energy and Commerce, it got wrapped up in partisan politics and 
the poison pills were added on the floor. Otherwise, it would 
have passed unanimously. The same on pay to delay and fixing 
that. It got wrapped up and made poison on the House floor.
    And I guess as we deal with this issue and get into these 
individual problems, what troubles me this morning is we have 
now been told we are going to have a hearing in the committee 
next week, Wednesday, on legislation to completely rewrite how 
we get our drugs and what we pay for them and how the 
government operates.
    And tragically, Republicans have been completely excluded 
from any of those discussions. Completely. It has been done out 
of the Speaker's office behind closed doors. And I don't know 
if you have a copy of the bill, Mrs. Dingell, Ms. Schakowsky, 
or anybody else. I don't. We have seen a summary. But it tells 
me, unfortunately, this has gotten shifted over to be a 
partisan political issue, not a solution for pharmaceutical 
costs gone wild.
    And I would hope that before we notice hearings, and I 
would hope before we take this up next Wednesday, that we would 
have a chance to read through the bill. I am deeply 
disappointed we were not asked to be part of any discussions 
leading up to it, and I know in some of the press clippings I 
have seen already, some of you are not happy, and some of you 
maybe haven't seen the bill either. But that is no way to deal 
with both helping our consumers and making sure we don't trash 
innovation.
    We have proven our ability on this committee. This great 
Energy and Commerce Committee is coming together on these 
issues and letting the committee process work. But I think we 
have all seen in our parties over time, when things get crafted 
outside of our environs, they don't always get it right.
    And then we are going to get jammed with a bill that we are 
going to have very little time to review, and then come back, 
and I am told mark up and vote on. And I just beg you and plead 
with you; it doesn't have to be this way. It doesn't have to be 
this way.
    To your point, Mrs. Dingell, these diseases, they affect us 
all. What you went through with John, what I went through with 
my parents and my wife's mother, who had severe rheumatoid 
arthritis. The poor thing passed away years ago, and she had to 
deal with this her entire life. And we have all been hit by it.
    My wife used to carry EpiPens, and then they became so 
expensive her doc said, ``Well, you can probably get away with 
a little Benadryl.'' Our son, as a youth, had an inhaler 
because he had youthful asthma. Fortunately, he outgrew it.
    We all went after EpiPen. We all went after these things. 
We can all go after really good public policy in this sector, 
too. But, please, let us be part of it. Let us be part of these 
discussions.
    We have really bright, capable people, as you know, on this 
side, as you do on your side. Don't exclude us from the 
legislative process. Don't spring a hearing for next Wednesday 
and not even give us the legislative text, just somebody's 
document on what it may be or not be.
    That is not in the great traditions of this committee, and 
it is not in the best interests of public health and solving 
this problem we have. You have a President that is fully 
committed. I have never--you can like or dislike Donald Trump; 
I have never seen a President more engaged on this issue about 
bringing down pharmaceutical drugs.
    There is an opportunity to be had here to achieve great 
results that will benefit our consumers, maintain innovation, 
and keep America in the lead. And I hope that partisan politics 
do not snuff that out. And with that, I yield back.
    [The prepared statement of Mr. Walden follow:]

                 Prepared Statement of Hon. Greg Walden

    Good morning, Today's hearing is focused on the 
pharmaceutical industry and the practice known as product 
hopping.
    There's no question that Americans pay too much for their 
healthcare, including the cost of prescription drugs. Over the 
past few years, we have made significant efforts to lower the 
cost of prescription drugs for consumers by advancing key 
priorities that are now law, including the 21st Century Cures 
Act, and a reauthorization of the generic drug user fee program 
in the FDA Reauthorization Act. And it is already working--last 
year FDA approved a record number of generic drugs, driving 
competition and giving consumers more choices. Republicans will 
continue to push for legislation that promotes competition, 
lowers the out-of-pocket cost for consumers, and establishes 
transparency and accountability in drug pricing.
    But we should also acknowledge the investment required by 
the industry to remain the global leader in developing 
innovative and essential treatments and the effort and 
ingenuity necessary to counter evolutions occurring in the 
diseases themselves.
    On average, it costs companies more than $2.5 billion to 
bring a new drug to market, but only about 20 percent of the 
marketed drugs ever earn enough to recoup those costs. And once 
the patent exclusivity period is over, brand companies face the 
likely loss of roughly 80-90 percent of their sales to generic 
versions of their drug.
    In large part, this is due to state substitution laws. 
Every state has a substitution law that requires or allows 
pharmacists to offer a generic drug when a patient presents a 
prescription for a brand drug. However, if the brand drug and 
generic drug are not the same, such substitution laws do not 
apply.
    For example, if a drug is not bioequivalent--meaning it is 
able to be absorbed into the body at the same rate or 
therapeutically equivalent--meaning it has the same active 
ingredient, form, dosage, strength, and safety profile, then 
state substitution laws do not apply. Some argue that brand 
drug makers engage in product hopping to usurp these state 
substitution laws and ensure patients use their brand drug.
    Product hopping occurs when brand pharmaceutical companies 
attempt to switch customers from an older version of a drug to 
a newer version. Typically, the newer drug has a longer patent 
exclusivity life which helps pharmaceutical companies maintain 
their market position and ultimately recoup the cost of 
developing new drugs.
    There are two types of product hopping: a hard switch and a 
soft switch. In a hard switch, a brand company completely 
withdraws their product from the market to enter a new product. 
A soft switch occurs when a brand company keeps their older 
product on the market but shifts marketing efforts to the new 
drug.
    Courts have been clear that a product withdrawal or 
improvement alone is not anticompetitive. Rather whether 
product hopping is anticompetitive or not relies heavily on the 
specific facts and circumstances of any given incident and 
requires some additional wrongful conduct.
    To be clear, innovating and replacing older drugs is part 
of the normal competitive process that companies engage in 
routinely. We must be cautious about disincentivizing 
innovation. We know that brand drug companies incrementally 
improve their drugs all the time and that we see great societal 
benefits from such improvements. Most innovation by drug makers 
involves the development of next generation improvements, which 
may include new products that expand therapeutic classes, or 
increase available dosing options, or remedy physiological 
interactions of known medicines, or improve other properties of 
existing medications. These are good things. We benefit from 
them. In fact, according to the World Health Organization, more 
than 60 percent of all drugs deemed necessary for combatting 
prevalent diseases are the result of incremental innovation.
    Today's discussion is important, and I am thankful to the 
panel and to those that traveled to be here with us today.
    Before I yield, I would like to say there is a form of 
product hopping I do support--and that is a product hop to a 
legislative hearing on autonomous vehicles or a hearing on 
privacy, so I'll just say I associate myself with Mrs. Rodgers' 
remarks in that regard. We know there is bipartisan support for 
those two initiatives, and I know the subcommittee members are 
eager to work on them.
    I look forward to hearing more from you all. Thank you. I 
yield back.

    Ms. Schakowsky. The gentleman yields back.
    The Chair would like to remind Members that, pursuant to 
committee rules, all Members' written opening statements shall 
be made part of the record.
    And now I would like to introduce our witnesses for today's 
hearing. Mr. Michael A. Carrier, distinguished professor at 
Rutgers Law School, and co-director of the Rutgers institute 
for Information Policy and Law.
    We have Mr. David Mitchell, founder of Patients for 
Affordable Drugs and Patients for Affordable Drugs NOW.
     We have Ms. Joanna Shepherd, professor of law at Emory 
University School of Law.
    And Mr. Jeffrey Francis, senior vice president and general 
counsel of the Association for Accessible Medicines.
    We want to thank our witnesses for joining us today. We 
look forward to hearing your testimony. And at this time, the 
Chair will recognize each witness for 5 minutes to provide 
their opening statements.
    Before we begin, I just want to explain or remind people 
about the lighting system. In front of you is a series of 
lights. That light will initially be green at the start of your 
opening statement. The light will turn yellow when you have 1-
minute remaining. Please begin to wrap up your testimony at 
that point. And the light will turn red when your time expires.
    So, Mr. Carrier, you may begin, and you are recognized for 
5 minutes.

  STATEMENTS OF MICHAEL A. CARRIER, DISTINGUISHED PROFESSOR, 
    RUTGERS LAW SCHOOL, CO-DIRECTOR, RUTGERS INSTITUTE FOR 
    INFORMATION POLICY AND LAW; DAVID E. MITCHELL, FOUNDER, 
 PATIENTS FOR AFFORDABLE DRUGS, PATIENTS FOR AFFORDABLE DRUGS 
  NOW; JOANNA M. SHEPHERD, PROFESSOR OF LAW, EMORY UNIVERSITY 
 SCHOOL OF LAW; AND JEFFREY K. FRANCER, SENIOR VICE PRESIDENT 
    AND GENERAL COUNSEL, ASSOCIATION FOR ACCESSIBLE MEDICINE

                STATEMENT OF MICHAEL A. CARRIER

    Mr. Carrier. Thank you, Chairwoman Schakowsky, and Ranking 
Member Rodgers. Thank you for holding this hearing. Drug 
companies play games to increase profits, and one of those 
games is product hopping. The product hopping that I am talking 
about today, if we deal with it, it is not going to touch 
innovation at all, but it will bring lifesaving medications 
into the hands of consumers.
    My name is Michael Carrier. I am a distinguished professor 
at Rutgers Law School. I study this area. I have written 115 
articles, 60 on pharmaceutical antitrust law. I am quoted in 
media and courts all the time.
    The first point here is that generic competition is 
crucial. When a generic enters the market, the price can fall 
90 percent overnight. And so, that is a central part of the 
Hatch-Waxman Act. The Hatch-Waxman Act says that the generic 
can rely on the brand firm's clinical studies because we want 
to have generics on the market. That does really good.
    That is also why we have state substitution laws. Every 
state in the country has a substitution law that says you can 
automatically substitute a generic for a brand version, and 
that is crucial as well.
    And the reason we need all of this is something called the 
price disconnect. There is no other industry where you don't 
have one party that makes the price-quality determination. You 
have the doctor that decides what drug to prescribe, and you 
have the patient or insurance company that pays for it. And 
with that disconnect, there is a lot of room for anti-
competitive games.
    Now, it is not the case that every single reformulation is 
a problem. And Ranking Member Rodgers, I completely agree with 
you that we cannot go after serious innovations. If you have 
something that initially is in the eye, and then you do it in 
the arm, that is a really good innovation. That won't be 
touched by any of the cases in the court system by any 
legitimate legislation that your committee considers. That is a 
real change.
    And in fact, 80 percent of the changes take place at a time 
that we don't expect a generic to be on the market because drug 
companies make changes all the time, and most of the changes 
are good. It is just those few bad apples, the few one or two 
percent--and that is all it has been in the cases, one percent 
of the cases. There is not going to be that much brought.
    But in those cases, there is nothing new at all. There is 
no new customer. There is no competition with another brand 
firm. All that happens is that the change is made to keep the 
generic off the market. And so the legislation that is 
considered here really can be reasonable.
    One of the concerns here is that every time that a brand 
company switches from one version of a drug to another, from a 
capsule to a tablet, or a 150-milligram dose to a 140-milligram 
dose. The generic has to go back to the drawing board, 
reformulate the drug, get FDA approval, and be subject to 
patent litigation, so every single time, it is kept off the 
market for years. And this has significant effects on 
consumers.
    And so one study found that $28 billion worth of drugs were 
subject to product hopping. In my testimony, I mention several 
of them--overpaying $1.7 billion for Namenda, and hundreds of 
millions of dollars for other drugs. I talk about prices that 
are so high. Adasuve is $4,500. Put together the component 
parts yourself; it is $45. It really hurts consumers when they 
have to pay a lot more than they should be paying.
    I mentioned the five cases that have gone on in the court 
system. Let me just mention one--Suboxone. Suboxone deals with 
opioid dependency. It is a very important drug. Reckitt, the 
brand manufacturer, switched from one version, the tablet, to 
another version, the film. The tablet was a better version. 
Consumers liked it better. It didn't have safety concerns. In 
the film a kid, puts it in their mouth, and it dissolves 
instantly.
    Nonetheless, the drug company said the old version is the 
unsafe one. Let's pull it off the market, even though it is 
actually safer. They jacked up the price for the old one, even 
though it was cheaper to make than the new one, and they knew 
that they would give up profits, but they just did this to keep 
the generic off the market.
    And so there are some really concerning examples of what is 
going on here. Of course, we have to worry about innovation, 
but it is not the case that taking away antitrust liability 
would help innovation in a lot of these cases. As we have 
heard, the brand company withholds the innovation for years 
until the generic is about to enter the market, and then it 
springs it on the market.
    There are reasonable solutions here. The Senate Judiciary 
Committee passed a product hopping bill 22 to nothing, 
completely bipartisan, deals with hard switches in which the 
old drug is removed from the market, soft switches in which the 
old drug stays on the market, gives the drug companies every 
defense that they could want in terms of showing that it makes 
some sense at all for what they are doing. So there is 
reasonable bipartisan legislation to be had here.
    So at the end of the day, drug companies call this life-
cycle management. It is not. It is really just keeping the 
gravy train of trivial tweaks flowing. What this committee can 
do, can really not touch innovation at all while making 
consumers' lives better.
    Thank you.
    [The prepared statement of Mr. Carrier follows:]
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Schakowsky. Thank you very much, Mr. Carrier.
    And now, Mr. Mitchell, you are recognized for 5 minutes.

                 STATEMENT OF DAVID E. MITCHELL

    Mr. Mitchell. Chair Schakowsky, Ranking Member Rodgers, 
members of the committee, I am honored to be here.
    I am David Mitchell. I am founder of Patients for 
Affordable Drugs. More importantly, I have an incurable blood 
cancer called multiple myeloma, and prescription drugs are 
keeping me alive. Every two weeks, I spend half a day at a 
clinic getting an infusion of drugs that, unfortunately, are 
slowly failing.
    So last night, I started taking a new oral chemo drug. 
Together, my drugs carry an annual list price of $875,000 a 
year. I have relapsed twice. Eventually, I am going to run out 
of options. So the importance of innovation is not theoretical 
to me. It is literally life and death.
    But my experience has taught me one irrefutable fact, and 
that is drugs don't work if people can't afford them. That is 
why today's hearing is so important.
    Take AbbVie and the cholesterol drug TriCor, Catherine of 
Minneapolis told us, ``My price for TriCor went up hundreds of 
dollars per month. The pharmacist whispered to me that if the 
doctor had changed the order to 160-milligram tabs and I broke 
it in half for the 80-milligram dose, it would only have cost 
me 40 bucks.'' Catherine didn't know it, but she was describing 
a classic case of product hopping.
    But to address the problem of out-of-control prices, we 
really have to come to grips with some larger facts. Despite 
what drug companies tell us, sky-high prices are not about 
innovation. Multiple studies show there is no correlation 
between the costs of R&D and the price that is assigned to a 
drug. And taxpayers' foot a huge portion of the bill for basic 
science that leads to new drugs.
    Every single drug approved by the FDA from 2010 to 2016 was 
based on science funded by taxpayers through the NIH. 
Meanwhile, independent analyses show that nine of ten drug 
companies spend more on advertising and marketing than they do 
on R&D.
    Why do drug companies charge so much? Because they can. 
Yes. As drug companies should make a profit when they develop 
innovative drugs, but we are way out of balance, and it is 
costing us all in our family finances, our health outcomes, and 
our lives.
    So I want to suggest three things we could do to rebalance 
the actual risk of innovation with a fair price for patients. 
Reform patent law, including provisions to stop product 
hopping; end the days of monopoly pricing power without 
taxpayer negotiation; force transparency from drug middlemen.
    Let's start with patent law. Brand drug companies are 
abusing our system to extend their government-granted 
monopolies and block competition. There is a whole array of 
tactics. Product hopping is just one.
    The classic version has been described by Professor 
Carrier, so I won't go into that.
    When faced with patent expiration and generic competition 
on its blockbuster drug Suboxone, the maker changed from a 
tablet to a film that dissolved under the tongue. Professor 
Carrier described it.
    We heard from a California woman named Janice. She was 
supporting her son recovering from opioid use disorder. During 
this time, she paid over $250 a month for Suboxone. She was 
forced to take out a loan and depleted all of her savings to 
pay for this medication.
    Now, there are bills in Congress this year that offer 
solutions. I would be glad to discuss them in the Q&A. Yes. In 
all that we do, we have to address--in all that we do to 
address product hopping; we have to ensure that we reward 
genuine innovation and stop anti-competitive practices.
    Next, we need direct Medicare price negotiations. We pay 
two to three times what other countries pay for the exact same 
drugs. One big reason is that they negotiate; we should, too.
    And, finally, we need more transparency around PBMs. These 
huge companies cut deals that determine how much patients pay, 
but it is all secret.
    Right now, there is a fundamental question that drug 
companies want us to ask about drug prices. What are we willing 
to pay to save a life? And I can tell you, that is easy. When 
it is your child on the gurney who can't breathe, when it is 
your cancer, the answer is: anything.
    But that is the wrong question. The right question is: what 
is the amount of money that drug companies should be making on 
these drugs?
    With hundreds of clinical trials underway for exciting new 
cell and gene therapies that are coming to market at a half a 
million dollars or as much as $2.1 million, we cannot afford to 
pay just any price that drug companies demand. Neither American 
families nor our healthcare system can afford that.
    I feel incredibly grateful to be here today, alive and 
representing patients from all across the country. I believe 
the moment is at hand that we can address this problem, and 
with bipartisan support, we will.
    Thank you for having me.
    [The prepared statement of Mr. Mitchell follows:]
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Schakowsky. We are glad you are here and alive as well. 
Thank you for your testimony.
    And now I want to recognize Ms. Shepherd for her 5-minute 
statement. Thank you.

                STATEMENT OF JOANNA M. SHEPHERD

    Ms. Shepherd. Thank you. Chairwoman Schakowsky, Ranking 
Member Rodgers, and distinguished members of the subcommittee, 
thank you for the opportunity to testify today about product 
hopping and the pharmaceutical industry.
    My name is Joanna Shepherd. I am a professor of law at 
Emory University, and I hold a Ph.D. in economics. My research 
focuses on various topics in law and economics, including 
competition and the healthcare industry.
    Replacing older drugs for newer drugs is generally part of 
the normal competitive process. According to the World Health 
Organization, over 60 percent of drugs deemed necessary for 
fighting common diseases are the result of incremental 
innovations.
    Most of this activity is pro-competitive. Consumers have 
access to more products, and newer products are likely to be 
safer and more effective. We should encourage drug companies 
both to invest in improving their products and to bring those 
drugs to market when they are available.
    However, when certain conditions are met, some product hops 
may be anti-competitive, coercing consumers to switch drugs and 
depriving them of choice. It sounds like this committee is very 
interested in finding that balance where we are preventing 
these anti-competitive measures but also protecting innovation 
that is so vital to the consumers--American and around-the-
world consumers of pharmaceutical drugs.
    In this testimony, I am going to focus on how to achieve 
that balance. My testimony is based on both court decisions and 
rulings in past cases, and also existing competition law. I 
will explain that a hard switch that eliminates consumer choice 
with no offsetting consumer benefit is likely an anti-
competitive product hop.
    Similarly, a soft switch that significantly interferes with 
consumer choice, to the point that it effectively eliminates 
it, with no offsetting consumer benefit, is likely anti-
competitive as well.
    So when, in a hard switch, is consumer choice eliminated? 
This happens when consumers are coerced into switching to the 
new product because there are no available alternatives to the 
original product. This would occur, for example, if an older 
drug is pulled from the market right before its patent expires 
so that the generics waiting to enter the market could not use 
automatic substitution laws to penetrate the market of the 
older drug. In this situation, consumers would effectively have 
no choice but to switch to the new drug.
    In contrast, a hard switch would not eliminate consumer 
choice, if it occurred after generics had already penetrated 
the market. In this situation, patients would already be 
accustomed to taking the generic versions of the drug, so 
replacing the older drug would not coerce them into switching 
from the generic they had already been taking.
    In fact, in this case, the product switch would be pro-
competitive because it would give consumers more choice. They 
would still have the generic version of the old drug, plus 
newer drugs available.
    A hard switch would also not eliminate consumer choice if 
brand companies replaced a drug that had plenty of patent life 
remaining and no generics anywhere on the horizon. This switch 
would also not reduce consumer choice because consumers would 
have had one drug to choose from before and one drug to choose 
from after.
    These examples suggest there is a very specific window 
during which a hard switch can be presumed to be anti-
competitive. For conventional small molecule drugs, this window 
likely starts around the time a generic file an acceptable ANDA 
containing a paragraph four challenge. The window ends 
approximately three or so months after generic entry because 
research shows that within three months of generic entry, 
generics have captured about 70 percent of the brand drug's 
market share. So maybe you want to, you know, flex that a 
little bit, but it is around that time.
    Outside of this window, however, a hard switch would 
generally not eliminate consumer choice.
    Moving on to a soft switch, when is consumer choice 
significantly interfered with to the point that it is 
effectively eliminated? This happens when consumers have no 
practical alternative but to switch to the new product.
    For example, if brand drug companies communicate fabricated 
safety concerns about an older product to doctors, as they did 
in the Suboxone case, then patients effectively would have no 
choice but to switch to the new drug.
    Similarly, if a brand company destroys inventory of the 
older drug, the consumers would effectively have no choice. 
However, a soft switch would not significantly interfere with 
consumer choice, if the brand company engages in standard 
business practices that typically accompany the introduction of 
new products. These include reallocating marketing efforts, 
offering price discounts or samples, so patients will try the 
new product, or encouraging doctors in a legal way to direct 
patients to these new products.
    While these practices may shift market share, they do 
nothing to eliminate the availability of the older drug or to 
coerce patients into switching. Moreover, because the older 
drug remains freely available for doctors to prescribe, 
generics can continue to take advantage of automatic 
substitution laws.
    So in a soft switch, the degree of interference to 
effectively eliminate consumer choice will typically require 
some other wrongful conduct that unfairly disadvantages the 
original product. If it does not unfairly disadvantage the 
original product, then patients and their doctors can choose 
which drug they prefer.
    Finally, I will end with a word of caution. Legislation to 
define what activity constitutes anti-competitive product 
hopping could potentially reduce healthcare spending and spur 
innovation by clearing up current ambiguity in the case law.
    However, if the legislation is too broad, in that it covers 
too many standard business practices or too vague, and that 
drug companies can't predict what behavior will lead to 
significant litigation, then the legislation will end up 
reducing innovation. This can have long-term negative effects 
on consumer health and healthcare spending.
    Thank you.
    [The prepared statement of Ms. Shepherd follows:]
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Schakowsky. Thank you very much.
    And now let me welcome Mr. Francer. I pronounced your name 
wrong before, and I want to get it right. And you are 
recognized for 5 minutes.

                STATEMENT OF JEFFREY K. FRANCER

    Mr. Francer. Thank you, Chairwoman Schakowsky, Ranking 
Member Rodgers, members of the subcommittee. Thank you for 
holding this important hearing today and for the committee's 
sustained efforts to bring down prescription drug pricing.
    As stated before, my name is Jeff Francer. I am the general 
counsel of the Association for Accessible Medicines. We are the 
Nation's leading trade association for manufacturers of FDA-
approved generic and biosimilar medicines.
    Competition through the introduction of generic and 
biosimilar methods is a proven solution to lowering the cost of 
prescription drugs for patients. However, the continued 
availability of generic medicines is in jeopardy. Current 
market realities, combined with anti-competitive tactics, 
threaten the long-term stability of generic and biosimilar 
manufacturers.
    Increasingly, brand-name drug companies are building patent 
thickets around their drugs, not just for the original 
innovation but for smaller changes that may not be deserving of 
decades-long monopolies. To cite just one example, Lantus, an 
insulin treatment for diabetes, is protected by 49 patents; 95 
percent of them were filed after the drug was approved. While 
Lantus was approved in the year 2000, it has patent protection 
out now to 2031.
    This problem significantly impairs competition and, not 
surprisingly, increases drug costs for patients. One anti-
competitive tactic that we are discussing today is called 
product hopping. As discussed previously, product hopping 
occurs when a brand drug company seeks to switch patients to a 
new version of its drug just before the original one becomes 
subject to competition.
    In many cases, the switch is forced on patients because the 
brand-name drug companies stop selling the original medicine, 
and this is called the hard switch. The main goal of such 
switches is not to protect our health. Instead, these switches 
are designed to extend the brand-name drug company's monopoly 
pricing and to delay competition.
    Several cases illustrate the potential anti-competitive 
effects of product hopping. Namenda is a treatment for 
Alzheimer's. Ahead of competition, the brand-name drug company 
attempted to withdraw its immediate release formulation from 
the market. The company then tried to switch patients to its 
new extended release formula.
    The drug company did so knowing that physicians would be 
highly reluctant to switch patients back to the earlier 
formulation if lower-cost generics were later approved, and the 
brand-name company's own documents confirm this.
    One of the drug company's employees stated, and I quote, 
``If we do the hard switch, convert patients and caregivers to 
once-a-day therapy versus twice a day; it is very difficult for 
generics to then reverse commute back.''
    Another troubling example that we have discussed is 
Suboxone. In the middle of one of our worst public health 
epidemics, the brand-name drug company delayed patient access 
to a more affordable version of this opioid treatment. Put 
simply, product hopping tactics employed by some brand-name 
companies delay generic and biosimilar competition, and this 
keeps drug prices in the United States the highest in the 
world.
    Here is why. First, product hopping impairs automatic 
substitution. Under many state laws, a generic can 
automatically be substituted for the brand-name drug at the 
pharmacy counter if it is therapeutically equivalent to the 
brand.
    By changing the dosage form or the strength of the brand 
drug, pharmaceutical companies ensure that generic companies 
will not be therapeutically equivalent and, therefore, not 
substitutable.
    Second, brand-name drug companies are able to delay patient 
access to lower-cost medicine by patenting minor modifications. 
To address these anti-competitive tactics, AAM supports 
legislative changes to strengthen competition. Any legislation 
should be carefully calibrated and not overly broad, as we just 
discussed.
    AAM is supportive of innovation, and we recognize that many 
changes to existing medicines result in meaningful health 
benefits.
    In closing, AAM encourages the committee to consider 
several options, including ensuring a date certain for generic 
and biosimilar competition, accelerating the biosimilar patent 
dance in the BPCIA, harmonizing Hatch-Waxman with the America 
Invents Act, requiring more timely FDA action on biosimilar 
labeling carve-outs, and ensuring that generics and biosimilars 
are fully available to patients.
    I describe each of these solutions in more detail in my 
written testimony, and AAM would be glad to work with the 
committee on each of them.
    In closing, I thank you for the opportunity to testify, and 
I also just learned this morning that today is Mr. Mitchell's 
20th wedding anniversary. And I wanted to say for the record, 
Happy Anniversary.
    [Applause.]
    Mr. Mitchell. Thank you.
    [The prepared statement of Mr. Francer follows:]
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Schakowsky. Thanks for updating us about that. 
Congratulations.
    So we have concluded witness opening statements, and at 
this time we will move to member questions. Each member will 
have 5 minutes to ask questions of the witnesses, and I will 
start by recognizing myself for 5 minutes.
    It is clear from the testimony that we have heard today 
that Congress has an opportunity to act to combat the gaming 
tactics of Big Pharma. And I just wanted to say that I do 
appreciate what seems to be the unanimity of carefully crafting 
legislation, and that is what I am currently trying to do to 
prohibit the actions that will soon be considered by the--these 
actions considered by the subcommittee.
    The legislation has a two-fold purpose. First, it will 
provide the Federal Trade Commission with authority to take 
action against a manufacturer engaged in product hopping; two, 
to seek remedies for these tactics, like the collection of 
unjust profits that a drug manufacturer gained as a result of 
inappropriate product hopping.
    And second, my bill will allow for greater transparency in 
drug pricing. The bill will let's see--well, the goal of this 
list is to provide the American taxpayers with the transparency 
that they deserve and to provide physicians with a public 
database to research drug information because--before decisions 
to prescribe them to their patients over generics.
    So, Mr. Carrier, does the FDA currently maintain a list of 
products that are substantially similar, other than a minor 
change in formulation?
    Mr. Carrier. No, it does not.
    Ms. Schakowsky. Is there currently a straightforward online 
resource that physicians can rely on to corroborate the things 
that Pharma sales representatives are telling them about the 
drugs?
    Mr. Carrier. No. I am not aware of anything like that.
    Ms. Schakowsky. Is there a common resource that patients 
could use to confirm whether they need a reformulated brand 
drug over a generic?
    Mr. Carrier. No, there is not.
    Ms. Schakowsky. Thank you.
    Again, Mr. Mitchell, I want to thank you so much for coming 
and sharing both your personal story and the story of so many 
others. You said that you started on a new chemo drug just last 
night. How much does that drug cost, and what is your out-of-
pocket cost?
    Mr. Mitchell. This drug is called Pomalyst. Twenty-one 
capsules in this bottle that I take 21 days off, and then seven 
days--21 days and then seven days off, about $17,200 list. My 
out-of-pocket under Part D is going to be north of $13,000 a 
year for this drug. That is one drug that I take.
    Ms. Schakowsky. My goodness. Can you tell us why 
transparency around product hopping and reformulations would be 
helpful for you as a patient and for your physicians?
    Mr. Mitchell. When a company does what has been described 
here by the experts on both of my sides, it can result in a 
product that does not deliver any improvement for me, 
clinically or therapeutically, may not reduce side effects, and 
may do nothing to help me.
    So having that database that you have described available 
from my physician, or from myself, to be able to go online and 
find out, is this the same drug? Did it really change? Does it 
deliver any incremental benefit? It would be very helpful in 
sizing up choice-making and my ability to have a conversation 
with my physician about whether that is the right drug for me.
    Ms. Schakowsky. I wonder if you wanted to add anything, why 
you believe evergreening is among the most critical of the 
issues for patients.
    Mr. Mitchell. As I said in my opening statement, innovation 
is critical important to me. It is not a theoretical matter. I 
need them to invent new drugs, or I am going to die sooner than 
I hope to.
    So when drug companies can evergreen, extend life 
inappropriately on an existing product, or build a patent 
thicket around their product, so we can't get a new drug, a 
generic drug to market, when they can extend the life and 
profitability of old drugs, they do not spend their money to 
invest in new drugs.
    So, for me, having them have to compete and having them 
have their period of time under Hatch-Waxman or under the ACA 
or under the Orphan Drug Act run out; in terms of their patent 
and exclusivity, so that they need to invest in new drugs, 
helps me.
    Ms. Schakowsky. Thank you so much.
    I now want to recognize Mrs. Rodgers, subcommittee ranking 
member, for 5 minutes to ask questions.
    Mrs. Rodgers. Thank you, Madam Chair. And to our panel, I 
want to say thank you. I completely agree that we should be 
holding companies accountable for anti-competitive behavior. I 
believe that this Congress should pass legislation to increase 
transparency and accountability of PBMs, the middlemen within 
this whole system.
    I also want to associate myself with Representative Greg 
Walden's opening statement. The fact that next week we are 
having a hearing on a major bill to address the cost of 
prescription drugs in America that we haven't even seen yet, I 
believe, is making a point, not solving a problem.
    This committee has a rich history of working together to 
solve problems. And to my colleagues, Republicans, and 
Democrats, I really ask us all to dig deep. It seems like we 
are becoming very good at playing partisan politics. 
Republicans blame the Democrats, and the Democrats blame the 
Republicans. I am personally weary of it. And in the meantime, 
people despair.
    You know, I am giving a lot of thought to the increased 
suicides we are seeing in America. People are despairing. And 
as we fail to act on behalf of the people that elected us, we 
are failing the people of this country. We should be giving 
people hope. Hope for so many who are sick, who are combating 
diseases, or live with a disability, the hope comes through 
research, and it comes through breakthroughs. It is not going 
to come through a bill that is passed by one party that goes 
nowhere.
    So this committee worked in recent years to advance--well, 
bipartisan--to advance the FDA Reauthorization Act, which 
provided FDA with new tools and pathways to bring generic 
brands to market.
    And we heard today how important this is. This 
administration has proved--has successfully approved 781 
generic drugs in 2018, which was a 90 percent increase from 
just four years prior.
    So, Mr. Francer, I wanted to ask just--would you address 
what you think this--how much of an impact this is having as 
far as increasing the competition. That is important to holding 
these companies accountable.
    Mr. Francer. Yes. Thank you very much for the question. 
Generics and biosimilars can bring enormous savings to patients 
like David Mitchell and all of us. They brought about $300 
billion in savings through the whole health system last year 
when you compare the brand price versus the generic price.
    The turnover in competition is critical to allow that, and 
of course, the innovative drug has to have the ability to have 
a return on its investment. That said, I wanted to call your 
attention to an increasing problem whereby Medicare Part D 
plans increasingly aren't even covering the generics when they 
are launched, and that is something that we have to make sure 
that when there is this turnover to competition, patients and 
taxpayers can get the savings there.
    Mrs. Rodgers. Absolutely. Thank you. Thank you for that. 
That is helpful.
    Dr. Shepherd, understanding that we have seen and know how 
important competition is, how can we balance the important need 
for innovation and drug improvements with ensuring generics can 
continue to compete?
    Ms. Shepherd. I think that balance is very important. I 
think it would involve, you know, obviously, defining what is 
anti-competitive conduct, and that being the activity that the 
legislation addresses, and that potential remedies would 
address, but also being extremely clear about what that is and 
what would not be considered anti-competitive, so that any 
legislation is not too broad that it covers standard business 
practices or is not so vague that pharmaceutical companies who 
are often making investment decisions and R&D 10 or so years 
before they would ever have a ruling on whether or not their 
activity is anti-competitive, they can actually predict what 
they are doing and if it makes sense to invest hundreds of 
millions of dollars in a new drug because they can reliably 
predict that it will not be considered anti-competitive under 
legislation.
    Mrs. Rodgers. We understand that replacing older drugs with 
newer, better products is not, alone, anti-competitive, but may 
deter competition in the future. When do such actions become 
anti-competitive?
    Ms. Shepherd. I think for a hard switch, I think that the 
window is very important. So are there generics imminently 
about to enter or have they just recently entered but they 
haven't gained hold yet? I think that is important.
    And the soft switch, I think what is really important is, 
is there other wrongful conduct like falsely disparaging the 
old product in the Suboxone case, or some other sort of 
wrongful conduct? It can't just be that introducing a new 
product and leaving the old product on the market is anti-
competitive. It has to be more.
    Mrs. Rodgers. Thank you. Thank you very much.
    I yield back.
    Ms. Schakowsky. Let me just say to our ranking member, I 
feel that on this subcommittee where we have a very broad 
jurisdiction, we have been able to pass some important bills, 
like we did last week. And I hope going forward, as with this 
piece of legislation, that we can work together on that. I 
think there is a lot of unanimity among our witnesses today, 
and I think that can be true of us as well.
    So I am hoping to maintain an atmosphere on all of the 
bills--of bipartisanship on all of the bills that we deal with.
    So the Chair now recognizes Congresswoman Castor for 5 
minutes.
    Ms. Castor. Well, thank you, Chairwoman Schakowsky. Thank 
you for organizing this hearing on how drug companies are 
gaming the system. Consumers know this. I hear it all the time 
from the families who I represent back home in Florida. They 
are paying astronomical amounts of money for their prescription 
drugs, and it is unconscionable in America that drug prices are 
so high that it is driving some families into bankruptcy and 
into debt.
    In many cases, these drug prices are artificially high. 
Drug companies are gaming the system, and as our witnesses have 
illuminated--and I want to thank you all for your illuminating 
testimony--brand- name drug companies engage in this outrageous 
monopolistic practice known as product hopping. Product hopping 
occurs when one pharmaceutical company's drug is about to lose 
its government guaranteed exclusivity, so the company 
introduces a slightly different drug with the purpose of 
keeping much cheaper drugs--generic drugs--out of the market.
    And this practice has gotten so harmful that the Federal 
Trade Commission and the courts have stepped in to stop it, and 
now we need to develop some legislative remedies as well.
    Manufacturers are doing this in order to delay or 
altogether frustrate competition against their products, and 
consumers are paying the price.
    Let's talk about a real-world example, the drug Namenda 
that was used to treat--that is used to treat dementia 
associated with Alzheimer's. A recent court found that Forest 
Laboratories, the manufacturer, had engaged in both a soft 
switch and a hard switch to thwart generic competition.
    The case revealed that Forest acknowledged that it would 
convert patients and caregivers to a once-a-day therapy versus 
a twice-a-day therapy if it made a hard switch, and most 
troublingly, that they knew this. It is very difficult, then, 
when a generic is introduced to get the patients to convert 
back.
    So the market analysis uncovered that in the Namenda 
proceedings Forest Labs' own data showed that a soft switch in 
their case would switch only 30 percent of patients to the 
newer, more expensive product, but the hard switch would move 
80 to 100 percent of patients.
    Forest Labs, in this case, actively and brazenly sought to 
undermine generic uptake. In reality, this meant that Forest 
Labs unfairly profited off of Alzheimer's patients. This is 
what is going on, and this is unconscionable.
    So I want to ask our witnesses for their help. Mr. Carrier, 
could you please describe the kind of behavior that constitutes 
a hard switch again and maybe give us another example?
    Mr. Carrier. Sure. So a hard switch is when the drug 
company removes the old version from the market, and so there 
are several cases that involve--it is the Doryx case, the acne 
drug in the Third Circuit, involved the brand company pulling 
the old version off the market. The hard switch, the old one is 
gone. The soft switch, the old one technically remains on the 
market.
    Ms. Castor. So, Dr. Shepherd, you had--in your testimony to 
us, you highlighted a possible remedy, possible fix for this. 
Is there a downside for consumers if a hard switch approval is 
delayed until after the generic is introduced on the market?
    Ms. Shepherd. No. There is not a downside for--if it is 
just after the window and generics have been able to come in, 
there shouldn't be much of a downside for consumers.
    Ms. Castor. And there is nothing in the law that regulates 
that now.
    Ms. Shepherd. No.
    Ms. Castor. Is that right?
    Ms. Shepherd. Yes.
    Ms. Castor. So, Chair Schakowsky, I would recommend that 
for your bill as you develop it. That seems to be one answer.
    Mr. Carrier, do you agree?
    Mr. Carrier. So I have offered in my scholarship a generic 
window that is very important, because if the brand company 
makes a change at a time that you don't expect the generic to 
be on the market, I say it should be automatically legal. And 
so my window is a bit different than Professor Shepherd's, but 
I do want to give the brand every benefit of the doubt when 
there is no generic about to enter the market.
    Ms. Castor. Thank you very much. I yield back.
    Ms. Schakowsky. The Chair now recognizes Mr. Latta for 5 
minutes.
    Mr. Latta. Well, thank you, Madam Chair. And thanks very 
much for holding today's hearing, and thanks very much to our 
witnesses for being with us today. And no one can deny that one 
of the greatest concerns that the American public out there has 
is the price of prescription drugs. I have long believed that 
this Congress must take action and work in a bipartisan fashion 
to address the rising cost of prescription drugs.
    At the same time, we should be supporting, not hampering, 
efforts that seek to improve the treatment of diseases and 
health issues.
    If I could start my questions with you, Dr. Shepherd. In 
your testimony, you go into great detail about explaining the 
difference between the hard switching and soft switching of 
products. And on the hard switches, you mention an exception 
for when a new product is safer or significantly more 
effective.
    Would you go in more detail about this exception or give 
any examples of when companies have developed a new product and 
compelled consumers to seek it out by pulling the old product?
    Ms. Shepherd. Sure. So I would include, you know, either a 
product that is clearly safer or significantly more effective 
as allowing a switch that would otherwise be within this window 
that we all seem to agree, you know, should be important. And, 
you know, there is numerous examples of products that have been 
pulled and new ones put on, whether or not there is some sort 
of FDA finding that some small component is not as safe as was 
originally believed, and so the new drug is made with new 
compositions that are found to be safer.
    And there is even other kinds of examples where things that 
we may originally think of as very small formulaic tweaks that 
shouldn't matter end up mattering a lot. So, for example, 
current antimalarial drugs, the tweaks that were made to it 
included combining two drugs, so patients take one drug instead 
of two, extending the shelf life, and making a new pill that is 
dissolvable in water.
    And each of those sound so simple, and like clearly 
somebody is trying to take advantage of something, but they end 
up mattering so much. I mean, shelf life matters in tropical 
climates. When a drug can be dissolved in water, that means 
infants can take it, who are most vulnerable to malaria. And 
combining two drugs into one is really important to reaching 
people where there is an issue of cost and availability of 
drugs.
    And so we just need to be careful about what we define as 
improvement in efficacy because in different situations some 
things can matter a lot, but they wouldn't in others.
    Mr. Latta. Let me follow up with another question for you. 
You also stated that there are dangers with introducing 
legislation to regulate this issue because it could reduce the 
innovation and increase spending.
    Do you see a benefit in allowing the courts to continue to 
interpret the statutes that are already on the books, or in 
determining anti-competitive behavior and practices instead of 
adopting any new legislation?
    Ms. Shepherd. I think new legislation could certainly make 
things a little bit more clear. I mean, there is a lot of 
similarity between the only two Circuit Court decisions we have 
on this issue, but there is also some disagreement, and I think 
there is uncertainty in the industry. So I think that 
legislation that minimizes this uncertainty would definitely be 
helpful to both innovation and to consumers.
    Mr. Latta. And, again, what are some of those unintended 
consequences that are out there that can arise if Congress, 
instead of the courts, might be the ones trying to regulate the 
soft switching of the products?
    Ms. Shepherd. Well, unintended consequences, I think if the 
legislation was too broad, and so by its language caught up 
behavior that could lead to true product improvement and not 
just these kind of sham innovations that we seem to all agree, 
you know, is an issue. So I think overly broad legislation 
would be a problem.
    And also, if it I guess codifies ambiguity, that would be a 
problem as well, because that actually could even increase the 
vagueness in the current law from what we have today if the 
legislation is too kind of vague about what is anti-competitive 
and what isn't.
    Mr. Latta. Well, thank you.
    Madam Chair, I know the clock hadn't started when I started 
my questioning, and so I am going to yield back the balance of 
whatever time is remaining.
    Ms. Schakowsky. I am now recognizing Mr. Van Hollen--
O'Halleran, sorry--I will get these names right--for 5 minutes. 
Sorry.
    Mr. O'Halleran. Thank you, Madam Chairwoman, and Ranking 
Member McMorris Rodgers, for holding this hearing on this 
incredibly important topic, one that I hear a lot about from 
individuals, from families in the 1st Congressional District of 
Arizona.
    I have attended 24 town halls this year alone, and the 
exorbitant cost of healthcare, particularly prescription drugs, 
is the number one issue I hear about from constituents. I am 
pleased that Chairman Pallone and Chairwoman Schakowsky are 
committed to advancing legislation that would address this 
serious issue.
    As we consider proposals this month that aim to lower the 
cost of prescription drugs, I believe it is important that we 
adopt an approach that encourages innovation and competition 
while ensuring that the cost savings are appropriately passed 
down to the consumers.
    After hearing your testimony today, I have a number of 
questions here. But you basically have helped confuse the 
issue, not because of you but because of the seriousness of 
this issue and how the system is put together. I think this 
would be a great time for about an 8-hour session with all four 
of you, but we can't do that today.
    So what I would like to do is go down the table. I am 
concerned about the case law and how we could affect it or not 
affect it if we don't do it. I am concerned about the direction 
we are going in. It is obvious just negotiating drug prices is 
not the bottom line of what we have to accomplish here in 
Congress, that we have to identify how the system cannot be 
worked and manipulated to counter any price changes.
    And so if I can get your opinions and ideas and concepts, I 
would like to start out with Mr. Carrier.
    Mr. Carrier. This is one of the most important drug issues 
that you all can address. I have no faith that courts are going 
to get it right when they keep focusing their analysis on 
choice and coercion and saying, oh, consumers have a choice 
because there are two products on the market. That is what the 
courts have done.
    In the Walgreens case, in the Asacol case, they said 
consumers have a choice because there are two products on the 
market. This is not about consumer choice when you have a price 
disconnect. There is one party that selects the drug. There is 
another party that pays for it. So by making clear that a soft 
switch can present anti-competitive harm, that is a real 
benefit that this committee can do.
    Mr. O'Halleran. Mr. Mitchell?
    Mr. Mitchell. Thank you. I think that Congress passed 
Hatch-Waxman to balance the need for innovation and allowing 
markets and competition to lower the price after a period of 
exclusivity. When drug companies try and bend or abuse that 
framework, then we are not getting the benefits of the Hatch-
Waxman framework.
    So when a practice by a brand drug company that is 
essentially bringing a drug to market with no clinical or 
therapeutic improvement for patients, when they bring that to 
market, in order to defeat generic competition, and especially 
to defeat state substitution laws, which were put in place to 
make Hatch-Waxman have more of an engine, then that would be a 
time when the courts should be told this is a clear case of 
abuse.
    Mr. O'Halleran. Ms. Shepherd?
    Ms. Shepherd. Yes. I would make two points. I think that 
the window is very important. We all seem to agree that, you 
know, the circumvention of the automatic substitution laws is a 
big part of the problem, and so there is a window in which that 
is important. And so limiting any sort of kind of presumption 
of anti-competitive behavior to that window I think would 
eliminate a lot of the problems that we are concerned with.
    And then, second, on the soft switch, I think that is where 
there is the real risk of catching too many behaviors that we 
would just consider normal business behaviors. And so I think 
defining what needs to be present in a soft switch, what kind 
of wrongful conduct are we considering as presumptively anti-
competitive. I think that would be very important as well.
    Mr. O'Halleran. Mr. Francer?
    Mr. Francer. Yes. As the whole committee is looking for 
solutions, I would also look towards, how do we make the patent 
system more effective and less of a blockade? This committee 
passed the BPCIA, which was the Biosimilars Pathway, and we are 
seeing that dozens and dozens of patents are really blocking 
the availability of these drugs, which are essentially the 
generic versions of these very expensive biotech drugs.
    I would try to accelerate the patent dance that occurs and 
try to deal with the costly litigation, which is slowing down 
these approvals and their ability to get on the market.
    Mr. O'Halleran. Thank you.
    And thank you, Madam Chair. I yield.
    Mr. Soto [presiding]. The gentleman yields back.
    The Chair now recognizes Mr. Bucshon.
    Mr. Bucshon. Thank you. I appreciate that. I was a surgeon 
before I was in Congress, so this is kind of very--I have a 
very strong interest in this. First, I want to say I associate 
myself with Ranking Member Walden's statement, and I would 
implore us to bring bipartisan bills passed unanimously out of 
this committee to bring down drug prices to the floor for a 
vote.
    And we see today we have an introduction of a very partisan 
big government bill as it relates to drug pricing, so it may be 
clear--it is kind of clear to me, at least at the leadership 
level on the majority side, that there may not be much interest 
in actually getting something signed into law but to play 
politics primarily against the President.
    That said, you know, I am interested in bipartisan 
solutions, and I think everyone on this subcommittee and the 
Health Subcommittee are. I am very proud of this committee and 
the fact that we have worked in a bipartisan way for many, many 
years on very tough issues and found common ground, and I think 
we can on drug pricing issues also.
    As has been mentioned by both sides, this is a front burner 
issue for everyone that I represent. When I talk to people out 
there, healthcare costs, specifically drug prices, is one of 
their top issues for an American family sitting around the 
kitchen table looking at their budget.
    And so I am hopeful and optimistic that we can address it. 
And I appreciate all of your testimony today. I found a lot of 
harmony in the testimony across everyone. I think there are 
nuanced differences in the approach to maybe address the 
problem, but they are not that far apart, which I think gives 
us a great opportunity in this subcommittee to really find 
common ground to address it.
    A couple of things. Dr. Shepherd, minor changes--``minor 
changes'' to existing drugs that can't be justified by 
innovation and drives up cost to consumers, do you think that--
you know, first of all, do you agree that that is happening a 
lot?
    And also, who is best positioned to determine what 
constitutes a minor change? Because everything here and what we 
do, and in your legal profession, the language matters, right? 
So who is best positioned to assess what minor changes might be 
and what the benefit or detriment to the consumer is?
    Ms. Shepherd. Sure, sure. Well, I guess I will answer your 
last question first. I mean, I would say it is absolutely the 
market. You know, there is a lot of drugs we can look at. I 
will--two examples I might say would be NSAIDs and 
antidepressants--that there is a lot of different drugs on the 
market. They are often just slightly tweaked versions of each 
other, but what we find, what doctors find, is that different 
patients, for whatever body chemistry, you know, reasons, react 
very differently to different drugs.
    And we may--you know, I could imagine if there is a court 
ruling early on, they may think, oh no, this is just a minor 
tweak; it is not worth it. Therefore, you know, we could 
presume that there is anti-competitive behavior associated with 
it.
    But it oftentimes time for the market to realize that 
different people do react very differently to whether it is 
these important drugs or it is contraceptives or things like 
that. Different things have different effects, and the markets 
and the doctors and the consumers are in the best position to 
judge that.
    Mr. Bucshon. I mean, statin agents as an example.
    Ms. Shepherd. Yes.
    Mr. Bucshon. I take a statin agent. I have tried every one 
of them except the one that I am on, and couldn't take the 
others.
    Ms. Shepherd. Right.
    Mr. Bucshon. And many of them are very similar.
    Ms. Shepherd. Yes.
    Mr. Bucshon. But slightly different.
    Ms. Shepherd. Right.
    Mr. Bucshon. Mr. Carrier, do you want to comment on that?
    Mr. Carrier. Sure. So I don't think courts should be in the 
business of determining if a change is minor or not.
    Mr. Bucshon. OK.
    Mr. Carrier. And I don't think anyone believes that. On the 
other hand, you can see, if the change is about the same--so 
think Suboxone. They switch from a tablet to a film, and when 
they go to the FDA and say, ``Please approve my film,'' they 
never did any studies for film. They said, ``Oh, rely on the 
tablet studies, and they are basically the same.''
    So sometimes it is part of an overall effort where you 
badmouth your own product, you jack up the price, you do 
everything else; that comes to the fore. But I don't think a 
court, in any of this legislation, has to decide if it is a 
minor change or not.
    Mr. Bucshon. Yes. I mean, that change specifically could be 
that if you take an oral version, your gastrointestinal tract 
doesn't tolerate it well versus if you take a mucosal membrane 
absorption product, that you can tolerate it. But what you are 
saying is they should be able to show that, and then that is a 
justifiable substantial improvement in the product, and that is 
what you are kind of saying.
    Mr. Carrier. Absolutely. Yes.
    Mr. Bucshon. OK. I yield back. Thank you.
    Mr. Soto. The gentleman yields back.
    The Chair now recognizes Ms. Blunt Rochester.
    Ms. Blunt Rochester. Thank you, Mr. Chairman. And thank you 
to Chairwoman Schakowsky and Ranking Member Rodgers for holding 
this hearing and thank you to the witnesses for a very 
important hearing.
    You know, we have this theme about gaming the system, and 
throughout Energy and Commerce has really been looking at this 
whole issue of drug pricing and trying to figure out why these 
prices are so high.
    And I think one of the things that you said, Mr. Mitchell, 
for me stuck out as a thing that I am holding in the back of my 
mind throughout this hearing, and that is you said, ``Drugs 
don't work if people can't afford them.'' I mean, that is the 
bottom line, and that is what I hear from my constituents. If 
you can't afford them, what is the point?
    And so we thank you for your testimony. We thank you for 
sharing your story. You represent a lot of people in our 
country that are grappling every day.
    I would like to start my questions with Mr. Carrier. You 
talked about the price-disconnect and the fact that the drug 
marketplace is different than other marketplaces. It is not 
like automobile, you know, marketing or anything like that. And 
that this difference makes it especially susceptible to clever 
advertising manipulations.
    What about this marketplace makes it susceptible to the 
manipulations and other anti-competitive practices?
    Mr. Carrier. Thank you for the question. The problem here 
is that there is no other industry where you don't have a 
single party making the determination of price and quality. So 
in any other market--let's say the paperclip market--a new 
paperclip comes on the market, and it is ten percent better 
than the old paperclip.
    Is it worth the increase in price? Let's say it is 25 
percent more price. When you walk into the store, you can make 
that decision? Well, it has improved, but it costs this much 
more. So, therefore, I will or will not buy it. You don't have 
that in the pharmaceutical industry because the doctors are the 
ones subject to all of the advertising and the doctors don't 
have to think about cost when they prescribe it.
    It is the patient or the insurer that has to do it. And so 
that is why doctors are subject to all of this advertising. It 
really makes a difference. There are empirical studies out 
there that show that when doctors are subject to all of this 
advertising, they are more likely to prescribe the drug, and 
that is why it is a real problem here. It is not really about 
coercion or choice. It is about a really price-disconnected 
market.
    Ms. Blunt Rochester. And to follow up on the chairwoman's 
question on transparency, would greater transparency for 
reformulations improve innovation? And how?
    Mr. Carrier. I think so. So let's say that you have the FDA 
that has to list all of the reformulations. So you are drug 
company. You change your product. You list it on the FDA's Web 
site. You show what is different about it. You show that you 
engaged in really interesting clinical trials that come up with 
a whole bunch of improvements. That is something that is worth 
knowing. We don't have that now. Transparency could help.
    Ms. Blunt Rochester. Great. And I want to also shift a 
little bit to, one thing I know for sure is that drug patents 
and approvals are incredibly complex, and it is clear that some 
actors have taken advantage of the system to drive up these 
prices and ultimately reduce access to affordable healthcare 
for Americans.
    This question is to the panel. How do the physicians and 
individuals find out about these reformulations? That is number 
1.
    And then, are there ways that we can use the available 
resources to improve physician education or even consumer 
awareness? And maybe we will start with Mr. Francer.
    Mr. Francer. Sure. Well, I think it can be very difficult, 
actually, to find out about some of the changes, which is why 
some of the suggestions for improved transparency would be 
helpful. I think often physicians are finding out from 
communications directly from the drug company. You can find out 
some of them from the FDA Web site. But as was discussed 
before, it can be very difficult to learn about some of them.
    Ms. Blunt Rochester. Mr. Mitchell?
    Mr. Mitchell. Clearly, physicians are learning through 
medical journals, but they are also learning from detailers who 
are coming from pharmaceutical companies to explain why a given 
drug is superior. Likewise, I know a lot of people with 
diseases at this point, chronic or acute, and they go out and 
try and research.
    And so they will look around to see if there is something 
that helps them understand, is this drug in fact superior? What 
are the side effects that come with it? And so having a 
database where you could go look, especially in situations 
where there are minor changes taking place, would be helpful.
    Ms. Blunt Rochester. Right, right. Anyone else from the 
panel?
    Ms. Shepherd. I agree.
    Mr. Carrier. Yes. So drug companies are the ones that tell 
the doctors, and that is why they have so much power here.
    Ms. Blunt Rochester. Gotcha. Back to the awareness piece, I 
think that you said people are basically doing it on their own 
and really with no help from the government. I have one more 
question, but I will submit it for the record. Again, thank you 
so much for your time and for your testimony.
    And just on the hope piece, this committee passed out of 
committee after markup before the recess 25--I think 25, 24, 
bipartisan bills, and many people didn't hear about that. And 
so if I want to put one other thing on the record, there are 
things that we are doing together, and I think this is an area 
where we all feel there is a need to help the American people.
    Thank you so much. I yield back.
    Mr. Soto. The gentlelady yields back.
    The Chair now recognizes Mr. Carter for 5 minutes.
    Mr. Carter. Well, thank you very much, and I appreciate 
every one of you being here. This is an extremely important 
subject, something that we have been concentrating on on this 
full committee, both in Health Subcommittee and on this 
subcommittee as well, and certainly something the American 
people need help with.
    And no one knows that better in Congress than I do, because 
currently I am the only pharmacist serving in Congress. So I 
have lived this. I have been the one on the other side of the 
counter who has had to tell the patients how much their 
medication is. So this is extremely important, as you can 
imagine, to me.
    Mr. Francer, I want to start with you and ask you, I am 
happy to be talking about the anti-competitive behaviors that 
are used. But I think we would be making a mistake if we didn't 
look at the whole piece of the puzzle, and I want to do that.
    You discuss in your written testimony the problems around 
rebates. In fact, you said, ``Recent analysis found that 
Medicare drug plans are increasingly shifting generic drugs 
from tiers with lower co-payments for patients to brand tiers 
with higher co-payments and co-insurance.'' And this is the way 
that these PBMs are doing this, and this is the way that it is 
increasing costs, particularly to the patients, increasing 
their co-payments.
    Can you just explain how these rebate agreements work very 
briefly?
    Mr. Francer. Yes. And thank you very much for the question. 
This is a case in which the system is failing patients. When 
you go to the pharmacy counter and meet with, you know, your 
former colleagues, you know, you expect that if you are going 
to get the generic version it is going to be pretty cheap. And 
it has taken a long time for it to get that way, but finally 
there is competition.
    We, in our industry, have been surprised by recent findings 
that more and more the generics are being put on these higher 
co-pay tiers, so that it could actually be more expensive to 
the patient at the pharmacy counter to get the generic than the 
brand. I think this is something that the committee should look 
at, whether it is for Medicare, and then to look at the whole 
system.
    Mr. Carter. You are exactly right. I mean, I was appalled 
at times to see that a generic would be on a higher tier than a 
brand-name would. And I knew the reason why the pharmacist is. 
I knew it was because the PBM was getting a higher rebate. No 
other reason except for that, and that is something that it is 
hard to articulate to someone who doesn't necessarily 
understand it.
    Now, most of the members of this committee get it and 
understand it. A lot of the members of the Energy and Commerce 
Committee understand it. But once you get outside of that, 
there are very few who do, and it is hard to explain that and 
getting in the weeds enough to where we can explain it.
    How widespread do you think this is?
    Mr. Francer. Well, we are finding actually more and more. 
We are going to be releasing a paper next week that goes into 
more detail on this, but it is becoming an increasing problem. 
Number 1, the generic just not being covered at launch. And, 
number 2, this placement on tiers.
    So I am happy to provide that for the record and to give 
you more information.
    Mr. Carter. Good, good. So what about biosimilars? We had 
Dr. Gottlieb, Dr. Scott Gottlieb, when he was with the--when he 
was the director--commissioner of the Food and Drug 
Administration, he had suggested that this was one of the 
problems and that the abuse of the rebate system was blocking 
out a lot of affordable biosimilars.
    Would you agree that that is happening there as well?
    Mr. Francer. Well, there is a fairly well-known case in 
which there is litigation between Pfizer, which is trying to 
put a biosimilar on the market, and Johnson & Johnson, which 
has the innovative drug. And evidently the rebate situation has 
essentially made it extraordinarily difficult for the 
biosimilar to get on the market.
    Again, this is a failure of the system. This isn't the way 
it is supposed to work.
    Mr. Carter. How can we fix it?
    Mr. Francer. Well, I think in that case, we have to make 
sure that you treat biosimilars in a way that incentivizes 
their uptake, whether it is sharing the savings with the 
physicians or whether it is making sure that they are on the 
preferred tier.
    There are a lot of different types of solutions, and we 
would be happy to work with you on it.
    Mr. Carter. You know, I get so frustrated because we meet 
with Medicare and we meet with the staff, and we explain it to 
them, and they say, ``Yes, we know. We know.''
    You know and you are not doing anything about it.
    ``Well, if we do something about it, they will just do 
something else in another area.'' It is like squeezing a 
balloon. It is just going to go somewhere else.
    You know, I really get passionate about this and really get 
upset about it, as you can imagine, because when you--I have 
spent over 30 years as the one on the other side of the counter 
having to explain this to people. I am the one who had to see 
the mother in tears because she couldn't afford the medication 
for her child.
    I am the one that saw the senior citizens who were trying 
to decide, literally--and I am not exaggerating--trying to 
decide whether they were going to buy groceries or buy their 
medication.
    What is happening now with the pharmacy benefit managers, 
the PBMs, the lack of transparency in the drug supply chain, is 
criminal. And until we get the resolve in Congress to do 
something about it, it is going to continue on.
    Thank you, Madam Chair, and I yield.
    Mr. Soto. The gentleman yields back.
    The Chair now recognizes Mr. McNerney for 5 minutes.
    Mr. McNerney. I thank the chair, and I appreciate my 
colleague from Georgia's passion on this issue. And I 
appreciate the testimony. It has been very illuminating, so I 
appreciate that.
    Each of you has acknowledged how product hopping impacts 
generic uptick and the market generally. The lack of 
competition in the market directly affects prices that 
consumers pay for their drugs. And to that point, Professor 
Carrie has shared some data from some well-known product hops, 
and I appreciate that, Professor.
    The FTC has acknowledged that product hopping is an abuse 
of the regulatory system, and that it hurts consumers, and the 
FTC has acted in cases to enforce some of the most egregious 
practices. I would like to learn more about what the FTC has 
done and how Congress can ensure that the FTC has the authority 
it needs to stop product hopping.
    So I am going to start with Professor Carrier. Can you 
explain what enforcement authority the FTC currently has to 
address product hopping?
    Mr. Carrier. So the FTC can go after these cases in court 
under its jurisdiction, and it has used that authority in the 
pay-for-delay settlement area. It has barely used it with 
product hopping. There is a 50 million piece of the Suboxone 
billion dollar settlement that was product hopping. That is the 
first time the FTC dealt with it, but legislation that you 
would consider it potentially and that the Senate Judiciary 
Committee consider it, will be incredibly important.
    The FTC does not use its authority a lot. Six times in 20 
years is the only time it has brought a pay-for-delay case. But 
in the most egregious cases, it could be incredibly important.
    Mr. McNerney. Very good. Thank you. What additional 
measures should we consider to further clarify their 
authorities?
    Mr. Carrier. So one other thing that you could do is to ask 
the FTC to do a report on product hopping.
    Mr. McNerney. That was my next question. Should they do a 
report?
    [Laughter.]
    Mr. Carrier. Absolutely. And so one of the difficulties 
here is that it is a nuanced subject. And when you hear about a 
soft switch, you think, oh, maybe it is OK because there are 
two products on the market. Let's get evidence on how soft 
switches can be bad. Let's get evidence on how these concerning 
switches make no economic sense whatsoever. There is a test to 
apply. It makes no sense, other than keeping the generic off 
the market.
    The FTC is uniquely situated to get all of this 
information. And just to go back for one second to 
Representative Carter's question, PBMs are a part of the 
problem here. They should be solving the price quality issue, 
and they are not. And we can still deal with this while still 
dealing with PBMs.
    Mr. McNerney. Thank you.
    Professor Shepherd, would you like to make a comment on 
this?
    Ms. Shepherd. No. No, I would agree with that. I mean, I 
think that some--you know, there has been some kind of like 
small reports, but I do think a larger study of the problem 
would help us get our head around how many times are there an 
innovation that we might consider incremental that are 
happening within this window, have no other offsetting benefit, 
and we can presume them to be anti-competitive. So I would 
agree that----
    Mr. McNerney. Well, it is interesting. Professor Carrier 
just said there is only six times that they have prosecuted 
product hopping. What singles out those six cases that made the 
FTC decide to go after them?
    Mr. Carrier. So it really--so six pay-for-delay cases, the 
FTC has been on the front lines of this for 20 years. They 
really choose the most egregious examples. And so these are the 
worst ones, like in the Cephalon case where the brand company 
paid the generics $300 million, just half the market, use that 
period of time to switch the market from the old version to the 
new version. By the way, product hopping and settlements work 
together a lot of the time. They really picked the most 
egregious example.
    So for anyone worried about innovation, if we are giving 
authority to the FTC, look to pay-for-delay settlements. They 
have had this authority for 20 years. They bring one case every 
three years. This is not going to be an avalanche of 
innovation-hurting activity.
    Mr. McNerney. So do you think the FTC just lacks resources, 
or----
    Mr. Carrier. Yes. I think that these cases are big cases. 
You have the largest firms on the other side. Antitrust 
litigation goes on for years. The FTC certainly could use more 
resources.
    Mr. McNerney. Thank you.
    Dr. Francer, or Mr. Francer, do you believe that sensible 
legislation can be crafted that would use market forces to 
bring drug prices in the U.S. in line with the average 
international market price?
    Mr. Francer. Well, I think that what we are talking about 
today, there is actually a lot of consensus on this panel to 
let competition work. And I am hopeful that the committee will 
continue to work in that way.
    Mr. McNerney. All right. I am going to yield back, Mr. 
Chairman. Thank you.
    Mr. Soto. Mr. McNerney yields back.
    The Chair now recognizes Mr. Gianforte for 5 minutes.
    Mr. Gianforte. Thank you, Mr. Chairman.
    Skyrocketing costs of prescription drugs are making it more 
difficult for Montanans to prosper. I am committed to finding 
commonsense solutions to this problem. Competition is 
incredibly important, as we have discussed here today, in any 
marketplace. And I am glad that we have passed many bills out 
of committee to increase generic competition for generic drugs.
    I am also encouraged by the work of the Trump 
administration that they have been doing in this area. The FDA 
has approved more generics than ever before, and it is driving 
down costs of medications.
    We need to find commonsense solutions that make drugs less 
expensive, increase transparency where it is needed, and put 
patients first.
    I want to focus on biosimilars. They hold enormous 
potential to lower prescription drug prices and enhance patient 
access to lifesaving cures. I am working with Representative 
Schrader to help bring down biosimilars--more biosimilars to 
market and get them in the hands of patients.
    That is our bill. The Biosim Act will temporarily increase 
the reimbursement for biosimilar drugs for the average price of 
the drug plus six percent, increase it to the average price 
plus eight percent, to help utilization.
    I know the FDA has approved 24 biosimilars since 2015, but 
only nine are in the hands of patients now. That is a problem; 
we want to fix it.
    Mr. Francer, what are the barriers to getting more 
biosimilars in patients' hands?
    Mr. Francer. Yes. Thank you for the question. I just want 
to give you one example. The drug Humira, this is a drug that 
is an incredible treatment. It was approved in 2002, and so it 
had its 12 years of exclusivity. That was over in 2014.
    Its compound patent expired in 2016, yet they have 136 
patents surrounding competition for this drug. And the drug 
takes in more revenue every year than all of the NFL teams 
combined. We need to do something about our patent system and 
making sure that drugs don't have a limitless monopoly to have 
competition.
    Mr. Gianforte. OK. Thank you.
    Ms. Shepherd, in your testimony, you suggest that whether 
product hopping is anti-competitive is highly situational 
dependent. Can you please explain what you mean by that?
    Ms. Shepherd. Sure. You know, with the hard switch, it 
depends on when the switch is actually happening. Certainly, if 
a drug company removes their drug from market years after there 
has been generics in the market, it is not going to affect the 
availability of these generics to patients, or if they remove 
their product years before there is a generic even on the 
horizon, it is presumably just an improvement that they find 
necessary. And it is not impeding competition in any way.
    And then with the soft switch, I think it depends so much 
on what is the behavior that is associated with it. Just 
introducing a new product, leaving the old one on the market, 
and even advertising the new product, you know, very 
aggressively. That is not--there is nothing anti-competitive 
about that. There is plenty of choice. Both products are on the 
market. Automatic substitution laws work. It is when there is 
some other clearly wrongful conduct that accompanies a soft 
switch that it would be anti-competitive.
    Mr. Gianforte. So if we want to introduce a bill that 
prevents anti-competitive product hopping, how can we ensure 
that we are not capturing legitimate actions and get swept up 
with the anti-competitive stuff?
    Ms. Shepherd. Well, again, you know, I think on the hard 
switch, defining the window is important. I think on the soft 
switch, just being extremely clear about, what is the behavior 
that will unfairly disadvantage the older product. And when we 
look at most court decisions, they have often--and the FTC, in 
addition, has commented on this--that it typically will require 
some other sort of wrongful conduct that accompanies the soft 
switch.
    Mr. Gianforte. Yes. Could you give a couple of examples of 
past product improvements that could have been considered 
illegal under an overly broad approach to anti-hopping.
    Ms. Shepherd. Sure. Well, I mean, when we look at--you 
know, I mentioned the antimalarials earlier. But when we look 
at the history of oral contraceptives, birth control pills, 
they have--over the last multiple decades they have slowly come 
down in dosage.
    Now, a lot of people would say a slight tweak in dosage, 
that is just an unimportant little improvement that doesn't 
offer real benefits, but over time those add up. And, in fact, 
we have, you know, statements from the--hold on one second--the 
National Research Council that says the cumulative effect of 
incremental innovation is often more transformational than a 
first in class or radical innovation.
    And so, you know, we just need to be careful. When these 
small improvements may one at a time look not so important, 
they do add up to being very important.
    Mr. Gianforte. OK. I want to thank the panel for your 
testimony today. I appreciate your helping with this. It is 
critically important that we get prescription drug prices down, 
so I appreciate it.
    And with that, I yield back.
    Ms. Schakowsky [presiding]. The gentleman yields back.
    Thank you, Mr. Soto, for being in the chair. You are next 
for 5 minutes.
    Mr. Soto. My pleasure, Madam Chair.
    First, I just want to get a clarification, because I have 
been a little confused about it. Is evergreening and product 
hopping the same thing? Or is it two different things? Mr. 
Carrier, my fellow Scarlet Knight, it would be great to hear 
from you first.
    Mr. Carrier. So evergreening is used more loosely to refer 
to not only product hopping but patent thickening as well. So I 
would focus on product hopping as the switch from one version 
to another that really makes no good reason, whereas 
evergreening is more the life cycle management practice that 
drug companies use in many places.
    Mr. Soto. Thank you for that. I wanted to--obviously, this 
committee has worked on pay-for-delay, updating the Orange and 
Purple Books. We are now looking at product hopping and 
evergreening.
    Is there any other unfair deceptive trade practices to 
extend patents that exist right now that we haven't covered 
yet? And we will start with you and we will go across to hear 
from everybody. Mr. Carrier.
    Mr. Carrier. So I would like to continue the discussion on 
biosimilars. There are not enough biosimilars on the market 
today, and there are so many hurdles, not just the patent 
thicket that Mr. Francer talked about, but also the rebates 
that he talked about, the cost of developing the drug, and 
disparagement.
    Biologic companies are disparaging biosimilars, saying, 
``Oh, you could take this, but you might die,'' or something 
like that when under the statute you are not allowed to do 
that. And so that is one other thing to keep in mind.
    And, again, everything else that you have dealt with on 
sample denials, pay for delay, and citizen petitions I would 
say as well are very important.
    And the final piece is the PBM piece. Representative Carter 
made a great point that PBMs are not putting drugs on the 
formularies because they are better drugs. They are putting 
drugs on the formularies because they are getting a big payout 
from the brand company.
    And sometimes we hear, ``Well, we can't do anything about 
brand companies because it is the PBM problem. We can't do 
anything about PBMs because it is a brand company problem.'' Do 
both. You can do both. You can solve everything we have talked 
about this morning, and you can also deal with the PBMs, and 
those are complimentary approaches.
    Mr. Soto. Mr. Mitchell, any additional unfair deceptive 
trade practices that we haven't covered in our initial list?
    Mr. Mitchell. I will just pick up on what Professor Carrier 
just said. It is outrageous for me, as a patient, that I can't 
know if the preferred drug on a formulary is there because it 
is the most effective drug, the least expensive drug among 
equally effective options, or if it is simply there because the 
brand drug company paid the PBM a big rebate, a kickback, which 
you give safe harbor to under law. That is not a good way to 
run a railroad. That is not a good way to do healthcare for 
people.
    So when Mr. Carrier says, ``You could do both,'' this is a 
brand problem and a PBM problem. Fix it, so I can depend that 
the PBM is taking care of me and not his profit needs.
    Mr. Soto. Ms. Shepherd, any additional gamesmanship 
happening to extend patents that either you would like to 
elaborate on or that we haven't discussed yet?
    Ms. Shepherd. No. I think Professor Carrier made the point 
about the citizens' petitions and the sample availability, but 
I would also reiterate, I have done quite a bit of work on the 
PBM rebate issue as well. And so that is creating this just 
kind of absurd incentive within the market that a lot of people 
don't understand how responsible those rebates are for the 
actual list price increases we are seeing.
    Mr. Soto. Thank you. And Mr. Francer.
    Mr. Francer. So agree with what Professor Shepherd just 
mentioned, and the only one I would add is find a way to move 
up the biosimilar litigation, so that it can happen earlier and 
so that it is not blocking availability.
    Mr. Soto. Now it would be great to hear from you all about 
a new bill that was just filed today to allow Medicare and the 
HHS Secretary to negotiate drug prices. It would be great to 
hear a show of hands. How many people--how many of you believe 
that if we allow the HHS Secretary to negotiate Medicare drug 
prices that that would lower prices for the market overall? 
Raise your hand. OK.
    Secondly, if we focused on 250 of the most used, most 
expensive drugs, do you think that is a good start to lowering 
drug prices? Raise your hand if you agree with that statement. 
OK.
    Finally, it would be great to hear from you, Mr. Carrier. I 
know you mentioned a little bit of--a lot of these issues, but 
if you--how key is it for Medicare to be able to negotiate a 
lot of these prices?
    Mr. Carrier. So I have not studied this issue as much as 
the others, but I do think it is important to negotiate.
    Mr. Soto. OK. And Mr. Mitchell?
    Mr. Mitchell. Well, we pay two to three times in this 
country what people pay in other countries. And the principal 
reason is that every other country in the world negotiates 
directly with drug companies; we don't. If PBMs were doing such 
a good job on my behalf negotiating for Part D, for example, 
why am I paying so much more than those other countries? So we 
think that just in the same way that the Federal Government 
negotiates for everything it buys--aircraft carriers, copying 
paper--that we should be negotiating drug prices as well and 
using our purchasing power to help American people get a better 
deal.
    Mr. Soto. Thank you. My time has expired.
    Ms. Schakowsky. Thank you.
    Mr. Guthrie, you are recognized for 5 minutes for 
questions.
    Mr. Guthrie. Appreciate it very much. I wish I had been 
here for this full discussion. But there is another committee 
meeting--subcommittee meeting downstairs, and the chair and I 
just--she was just down there as well, so sorry for not being 
here for the full discussion. But I am the ranking member of 
the Oversight and Investigations Committee, which is meeting, 
not today, but we are currently examining the increases in 
insulin prices, particularly the list price versus the--list 
price versus the discount, what people, what the 
pharmaceuticals or the insurance company actually pays.
    And we looked at that one because it is not--it has been 
around for 100 years. It is not part of the innovation, big 
innovation. There is great innovation in diabetes. But what is 
going on in healthcare, we are getting incredible innovations 
in pharmaceuticals. You mentioned Humira. You mentioned--and I 
know that is a little dated, but you can cure Hepatitis C with 
a pill now. I know it is a procedure we can cure sickle cell 
anemia.
    So we look at just the healthcare, in general. So my 
concern is we--and I really pushed with Chair DeGette to go 
look at insulin because we need to get to the bottom of it. But 
what I am concerned about--and, Ms. Shepherd, I think some of 
your looks and research you look into this--is as we move 
forward--and some are going to say, We don't care about the 
unintended consequences. We are paying too much money.''
    But the unintended consequences would be to kill innovation 
that we have. I think some of the other countries do negotiate 
for drug prices, but they also limit formularies. And so we can 
have that tradeoff as the Congressional Budget Office has said. 
If you want cheaper prices on Medicare Part D, the only way you 
are going to get it cheaper is if you limited formularies, even 
if you negotiate, which means limit what people can have in 
choice.
    So I guess my question I am getting to is, how do we find 
the appropriate balance, Ms. Shepherd, between the need for 
innovation and the need for the competition to bring the prices 
down? Can we have both?
    Ms. Shepherd. I think we can. I mean, you know, each side 
might have to give a bit, but I think it is possible. I think 
it depends on just crafting extremely clear legislation that 
makes it clear what is and what is not anti-competitive, making 
sure you are not capturing any improvements that could be 
innovative.
    Mr. Guthrie. So what would be the ambiguities in some--I 
know in your testimony you talk about ambiguities in law could 
limit innovation. So what are some of the ambiguities that you 
would want to see clear in a piece of legislation that----
    Ms. Shepherd. Sure.
    Mr. Guthrie. You were right where you were going. I just 
want to----
    Ms. Shepherd. Yes, yes, yes.
    Mr. Guthrie [continuing]. My next question.
    Ms. Shepherd. So, for example, if let's say in regards to a 
soft switch, the legislation says ``any soft switch that 
unfairly disadvantages the old product.'' Like I have no idea 
what that means. And, you know, disadvantage, I mean, I think 
most new product innovations disadvantage in some way older 
products because there is more competition on the market.
    Unfairly? That is not a term we see described anywhere to 
really judge what that would be. And so I would just caution 
the subcommittee to think very clearly, maybe with precise 
examples or some real way to kind of--to judge what would 
constitute an unfair disadvantage rather than just throwing it 
out with a bunch of ``mays'' instead of ``wills,'' so that 
nobody really knows what it is.
    Mr. Guthrie. OK. Should the number of generics that already 
enter the market be a factor in determining whether or not 
removal of the brand product is anti-competitive?
    Ms. Shepherd. No. That is not really--as long as one 
generic is on the market, automatic substitution laws are 
working. And more generics, all that is going to do is--will 
bring down the price, and that is important But as long as 
there is one on the market, there is nothing stopping more from 
coming into the market.
     So that is kind of irrelevant from whether or not the 
automatic substitution laws have kicked in and have started 
working.
    Mr. Guthrie. OK. Mr. Mitchell, you had a comment?
    Mr. Mitchell. Yes, sir. I think one of the things that is 
important there is, was it a hard switch? Because if they 
pulled the old product, then there is nothing for a doctor to 
write me a prescription for that is substitutable? And so that 
is the kind of, you know, specific act that you guys could 
clarify on.
    Mr. Guthrie. OK. Yes, Mr. Carrier?
    Mr. Carrier. And just to make even clearer, the no economic 
sense test is the most conservative test in antitrust law. It 
says, ``Drug company, you win, as long as you have one reason 
other than keeping the generic market.'' Much more deferential 
than the rule of reason. That unifies hard switches and soft 
switches.
    In the five cases that have been litigated, there has been 
no reason. Why pull a billion dollar drug off the market? Makes 
no sense. No economic sense. Unifies hard and soft switches and 
does not touch innovation.
    Mr. Guthrie. Thanks. Thanks.
    Mr. Francer, do you have any comment on that? You are the--
and Ms. Shepherd?
    Ms. Shepherd. Yes. On that comment, I think that the no 
economic sense, I think that is very difficult to 
operationalize for various reasons. You know, pharmaceutical 
companies have a lot of overhead. They do a lot of R&D that 
isn't designated to a specific drug. It is spread out across a 
lot of drugs.
    And so the no economic sense test is going to require a 
pharmaceutical company to produce what are the specific costs 
of this drug, and what are the specific benefits. It is very 
difficult for them to do.
    In addition, I just wonder if it doesn't--it is not going 
to encourage gaming. I mean, that would give pharmaceutical 
companies the incentive to spend less on R&D--not what we want 
them to do--in order for the benefits to be more likely to 
exceed the cost. And so it just--I worry about how that could 
be operationalized.
    Mr. Carrier. And just to respond, if you look at the 
litigated cases, these are not close calls. I know there was a 
paper written a few days ago criticizing my test, but the cases 
that have been litigated involve TriCor, a $200 million drug 
pulled off the market; Nexium, a $4 billion drug; $1.5 billion 
in Namenda. These are not close cases. The companies are 
pulling off blockbuster drugs, and there is no sense whatsoever 
that this makes any sense at all.
    Mr. Guthrie. OK. Thank you.
    My time has expired, and I will yield back. Thank you.
    Ms. Schakowsky. Thank you. Well, all time for questioning 
has expired. I certainly want to thank all of our--oh, I am so 
sorry. I yield 5 minutes to Mr. Sarbanes. Forgive me.
    Mr. Sarbanes. Thank you. Thank you, Madam Chair. Thank you 
for the opportunity to waive onto the committee today on a 
very, very important topic.
    Mr. Mitchell, I wanted to ask you some questions. First, 
thanks for your testimony, and thanks for sharing your personal 
story and then channeling that into the effective advocacy that 
you have offered----
    Mr. Mitchell. Thank you.
    Mr. Sarbanes. On so many different venues. You have been 
pushing on this issue of lower drug prices for a long time, and 
you are frustrated, I am sure, as I am, by the lack of progress 
that we have made in terms of addressing the prices of drugs 
and producing meaningful drug legislation that can push back on 
industry and prevent these anti-competitive practices that have 
been detailed today, including product hopping and other things 
of that nature.
    Tell me what you think is creating the barriers up here in 
Congress when it comes to passing and enacting legislation that 
would make a meaningful difference with respect to bringing 
down the cost of drugs for patients.
    Mr. Mitchell. I believe that there is one and a half drug 
company lobbyist for every one of you in Congress right now.
    Mr. Sarbanes. I think it is three, actually.
    Mr. Mitchell. I believe that by definition--and the 
economists flanking me can correct me if I am wrong--by 
definition, monopoly industries have unlimited resources to 
sustain the monopoly with political power. That monopoly power 
is being mobilized forcefully to block anything that will 
effectively lower the list prices of prescription drugs.
    And, remember, we can talk about PBMs, we can talk about 
hospital markups, and we can talk about markups by doctors. The 
headwaters of this problem is the list prices that are set by 
the drug companies. Nobody sets list prices except the drug 
companies. If we lower the list, everybody who is making a 
percentage markup downstream will make less money, and it can 
go back to lower prices for people like me.
    So those are the barriers I think that are chief in the 
way--chiefly in the way of reform.
    Mr. Sarbanes. Well, I agree with you, you won't be 
surprised to hear, 100 percent on that. I have kind of made 
myself a student of how the special interest ecosystem has 
developed here in Washington. Nobody has manipulated that more 
effectively than the pharmaceutical industry in the ways that 
you just described.
    According to the Center for Responsive Politics, that 
industry spent more on lobbying last year than any other 
industry--$280 million--and in the 2018 election cycle donated 
over $41 million to federal candidates and federal committees.
    You just made the point about the number of lobbyists that 
are deployed here on behalf of the industry, some 1,400 
lobbyists last year, according to the Center for Responsive 
Politics. So we are actually being--we are actually being 
teamed at three to one ratio, which is even more than you 
suggested, and it is all about protecting the bottom line.
    Mr. Mitchell. Well, if I may add, the scare tactics really 
offend me as a patient. You know, socialism, I am not going to 
get the drugs I need. There will be no innovation. I am going 
to die. There is room to lower drug prices. The pharmaceutical 
industry has profits that run in excess of two times the S&P 
500.
    There was a piece today in Axios that said that they are 
getting 20 percent of the profits in the healthcare system 
based on 20 percent of their revenues. Fifty percent of the 
profits, I am sorry, based on 20 percent of the revenues. There 
is money in the system to lower drug prices, allow us to have 
innovation, especially given that taxpayers pay so much of the 
money for innovation, to get lower drug prices. It is not going 
to make the world collapse on us as patients.
    But they are shameless in the ways that they go out and lie 
and try and scare people, that if we actually lower drug 
prices, so people don't have to die because they can't afford 
their insulin, that somehow more people are going to die.
    Mr. Sarbanes. Well, I appreciate that. I think you are 
right on the money. And, you know, it is hard sometimes to 
completely diagnose how this influence-peddling system works up 
here. I think it is a combination of conscious active decision-
making on the part of industries like the pharmaceutical 
industry, to protect the bottom line and to maximize their 
profits. And they make those judgments along the way.
    But I also think what operates here is this kind of self-
perpetuating system of influence, which makes it hard, even for 
the more enlightened people within some of these industries and 
companies, who might want to approach things in a different 
way, to break free of that model. It just keeps churning and 
churning and churning.
    And it is up to us here, who are the ones at whom those 
efforts are being directed day in and day out to take action to 
diminish undue influence that comes from these special 
interests and lift up and expand the influence of the average 
person out there. And if we can do that, we will be able to 
address many of the issues I think that you all have brought to 
us today.
    So thank you for your testimony, and I yield back to the 
Chair.
    Ms. Schakowsky. Thank you, Mr. Sarbanes.
    So, once again, let me just thank our witnesses for 
participating in this hearing. I think we learned a lot today, 
especially the kinds of things that we should watch for as we 
work on legislation. And certainly we learned about the 
expertise at hand on this panel when we do so.
    I hope my colleagues will all work with me to address this 
issue of gaming the system and do it right. The time I believe 
to act is now.
    I remind Members that, pursuant to committee rules, that 
they have ten business days to submit additional questions for 
the record, to be answered we hope by the witnesses who have 
appeared, and prompt replies to any of the questions that you 
may receive.
    And now I request unanimous consent to enter the following 
into the record, other informational material. And without 
further objection. A research paper by Timothy J. Muris of 
George Mason University, a journal article published in the 
Journal of Law and Bioscience titled ``May your Drug Price be 
Evergreen,'' and a journal article titled ``Product Hopping: A 
New Framework.''
    Ms. Schakowsky. And with that, the Subcommittee on Consumer 
Protection and Commerce is adjourned. Thank you.
    [Whereupon, at 12:27 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
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