[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
TREATING THE OPIOID EPIDEMIC:
THE STATE OF COMPETITION IN THE MARKETS FOR ADDICTION MEDICATION
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON
REGULATORY REFORM,
COMMERCIAL AND ANTITRUST LAW
OF THE
COMMITTEE ON THE JUDICIARY
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 22, 2016
__________
Serial No. 114-97
__________
Printed for the use of the Committee on the Judiciary
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://judiciary.house.gov
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COMMITTEE ON THE JUDICIARY
BOB GOODLATTE, Virginia, Chairman
F. JAMES SENSENBRENNER, Jr., JOHN CONYERS, Jr., Michigan
Wisconsin JERROLD NADLER, New York
LAMAR S. SMITH, Texas ZOE LOFGREN, California
STEVE CHABOT, Ohio SHEILA JACKSON LEE, Texas
DARRELL E. ISSA, California STEVE COHEN, Tennessee
J. RANDY FORBES, Virginia HENRY C. ``HANK'' JOHNSON, Jr.,
STEVE KING, Iowa Georgia
TRENT FRANKS, Arizona PEDRO R. PIERLUISI, Puerto Rico
LOUIE GOHMERT, Texas JUDY CHU, California
JIM JORDAN, Ohio TED DEUTCH, Florida
TED POE, Texas LUIS V. GUTIERREZ, Illinois
JASON CHAFFETZ, Utah KAREN BASS, California
TOM MARINO, Pennsylvania CEDRIC RICHMOND, Louisiana
TREY GOWDY, South Carolina SUZAN DelBENE, Washington
RAUL LABRADOR, Idaho HAKEEM JEFFRIES, New York
BLAKE FARENTHOLD, Texas DAVID N. CICILLINE, Rhode Island
DOUG COLLINS, Georgia SCOTT PETERS, California
RON DeSANTIS, Florida
MIMI WALTERS, California
KEN BUCK, Colorado
JOHN RATCLIFFE, Texas
DAVE TROTT, Michigan
MIKE BISHOP, Michigan
Shelley Husband, Chief of Staff & General Counsel
Perry Apelbaum, Minority Staff Director & Chief Counsel
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Subcommittee on Regulatory Reform, Commercial and Antitrust Law
TOM MARINO, Pennsylvania, Chairman
BLAKE FARENTHOLD, Texas, Vice-Chairman
DARRELL E. ISSA, California HENRY C. ``HANK'' JOHNSON, Jr.,
DOUG COLLINS, Georgia Georgia
MIMI WALTERS, California SUZAN DelBENE, Washington
JOHN RATCLIFFE, Texas HAKEEM JEFFRIES, New York
DAVE TROTT, Michigan DAVID N. CICILLINE, Rhode Island
MIKE BISHOP, Michigan SCOTT PETERS, California
Daniel Flores, Chief Counsel
Slade Bond, Minority Counsel
C O N T E N T S
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SEPTEMBER 22, 2016
Page
OPENING STATEMENTS
The Honorable Tom Marino, a Representative in Congress from the
State of Pennsylvania, and Chairman, Subcommittee on Regulatory
Reform, Commercial and Antitrust Law........................... 1
The Honorable Henry C. ``Hank'' Johnson, Jr., a Representative in
Congress from the State of Georgia, and Ranking Member,
Subcommittee on Regulatory Reform, Commercial and Antitrust Law 2
The Honorable John Conyers, Jr., a Representative in Congress
from the State of Michigan, and Ranking Member, Committee on
the Judiciary.................................................. 3
The Honorable Bob Goodlatte, a Representative in Congress from
the State of Virginia, and Chairman, Committee on the Judiciary 59
WITNESSES
Anne McDonald Pritchett, Ph.D, Vice President, Policy and
Research, Pharmaceutical Research and Manufacturers of America
(PhRMA)
Oral Testimony................................................. 6
Prepared Statement............................................. 9
David R. Gaugh, R.Ph., Senior Vice President for Science and
Regulatory Affairs, Generic Pharmaceutical Association
Oral Testimony................................................. 20
Prepared Statement............................................. 22
Mark Merritt, President and Chief Executive Officer,
Pharmaceutical Care Management Association
Oral Testimony................................................. 31
Prepared Statement............................................. 33
Eric Ketcham, M.D., American College of Emergency Physicians
(ACEP), Medical Director, Emergency Department and Urgent Care,
Co-Medical Director, EMS San Juan Regional Medical Center
Oral Testimony................................................. 40
Prepared Statement............................................. 42
Robin Feldman, Esq., Harry and Lillian Hastings Professor of Law,
Director of the Institute for Innovation Law, UC Hastings
College of the Law
Oral Testimony................................................. 55
Prepared Statement............................................. 57
LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING
Material submitted by the Honorable Henry C. ``Hank'' Johnson,
Jr., a Representative in Congress from the State of Georgia,
and Ranking Member, Subcommittee on Regulatory Reform,
Commercial and Antitrust Law................................... 64
APPENDIX
Material Submitted for the Hearing Record
Response to Questions for the Record from Anne McDonald
Pritchett, Ph.D, Vice President, Policy and Research,
Pharmaceutical Research and Manufacturers of America (PhRMA)... 80
Response to Questions for the Record from David R. Gaugh, R.Ph.,
Senior Vice President for Science and Regulatory Affairs,
Generic Pharmaceutical Association............................. 83
Response to Questions for the Record from Mark Merritt, President
and Chief Executive Officer, Pharmaceutical Care Management
Association.................................................... 85
Response to Questions for the Record from Robin Feldman, Esq.,
Harry and Lillian Hastings Professor of Law, Director of the
Institute for Innovation Law, UC Hastings College of the Law... 87
Review--``From morphine clinics to Buprenorphine: regulating
opiod agonist treatment of addiction in the United States''.... 92
Prepared Statement of Property Casualty Insurers (PCI)
Association of America...................................101
deg.OFFICIAL HEARING RECORD
Unprinted Material Submitted for the Hearing Record
Prepared Statement of Louis J. Milione, Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration. This
material is available at the Subcommittee and can also be accessed
at:
http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=105353
Memorandum from Charles O'Keeffe, Professor, School of Medicine,
Department of Pharmacology and Toxicology, Virginia Commonwealth
University. This material is available at the Subcommittee and can
also be accessed at:
http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=105353
TREATING THE OPIOID EPIDEMIC: THE STATE OF COMPETITION IN THE MARKETS
FOR ADDICTION MEDICATION
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THURSDAY, SEPTEMBER 22, 2016
House of Representatives,
Subcommittee on Regulatory Reform,
Commercial and Antitrust Law
Committee on the Judiciary,
Washington, DC.
The Subcommittee met, pursuant to call, at 2 p.m., in room
2237, Rayburn House Office Building, the Honorable Tom Marino,
(Chairman of the Subcommittee) presiding.
Present: Representatives Marino, Goodlatte, Collins,
Ratcliffe, Bishop, Johnson, Conyers, DelBene, Cicilline, and
Peters.
Staff Present: (Majority) Anthony Grossi, Counsel; Andrea
Woodard, Clerk: and (Minority) Slade Bond, Minority Counsel.
Mr. Marino. The Subcommittee on Regulatory Reform,
Commercial and Antitrust Law will come to order. Without
objection, the Chair is authorized to declare recesses of the
Committee at any time. And I would like to make clear for our
guests that are here, votes have been moved up and another
series has been put in.
We have about 2 hours, maybe a little less, before they are
going to call votes and I have asked my colleagues, and they
agree we are going to stick to the 5-minute rule on questions.
So, when we break, it will be the end of the hearing because I
do not want to keep you people here for an hour and a half to 2
hours.
We welcome everyone to today's hearing on ``Treating the
Opioid Epidemic: The State of Competition in the Markets for
Addiction Medicine,'' and I now recognize myself for my opening
statement.
Sadly, the opioid epidemic facing our country is an issue
that we are all too familiar with. In 2014, drug overdoses
overtook car crashes as the leading cause of accidental death
for the first time in history.
In response to this growing epidemic Congress passed a
``Comprehensive Addiction and Recovery Act of 2016'' which was
signed into law on July 22 of this year. This legislation,
which included several bills that originated in the Judiciary
Committee, is an important measure that will help aid State and
Federal authorities in fighting opioid abuse and addiction.
However, one aspect on the opioid epidemic that has not
received significant attention, is the market for the drugs
that treat opioid overdoses and addiction.
Today's hearing will focus on this issue and explore the
state of competition in these important markets. There are a
number of drugs that are used to treat opioid overdoses and
addiction, but two of these drugs have become prominent and
will be the principal focus on our hearing. The first is
Naloxone and the second is Buprenorphine. Did I have that
correct, doctors? Fine, because from now on it is just going to
be BUP.
Recently, its primary use has been to treat opioid
overdoses in an emergency setting. The next drug that we will
touch a little bit on in addition to BUP, as I said earlier,
will be Naloxone. Naloxone is a drug that's been around since
the 1970s.
Its effect is swift and dramatic, and it can literally
bring an overdosed person back to life. BUP has also existed
for decades and is a drug that is used in the treatment of
opioid addiction. BUP generally is used as part of an ``opioid
substitution treatment plan'' where it replaces a more potent
and harmful opioid. The goal of this type of treatment is
tapering the patient completely off of all opioids, including
BUP. The period that a patient is prescribed the drug can vary
greatly, from a little as a few weeks to years. Because BUP is
an opioid, it is a regulated and controlled substance by the
United States Drug Enforcement Agency, otherwise known as the
DEA. Further owning to its abuse potential, BUP oftentimes is
combined Naloxone to mitigate the possible misuse of the drugs.
In recent years, demand for these drugs has increased
sharply. As a result, there have been reports that they have
become hard to obtain, and in some instances prices for these
drugs have risen during this period of increased demand. At the
same time, innovative new applications of long developed drugs
present first responders and family members with the ability to
address overdose and addiction. As a strong support of the free
markets, I believe that the best remedy to address scarcity and
high prices is increased competition.
And so, today we will explore the complex factors that
influence competition in the market for addiction medicine.
Specifically, we will hear details about whether prices are in
fact increasing for these drugs, the level of competition that
exists in these markets, how Federal regulation influences
competition, whether the antitrust laws are equipped to address
any anticompetitive conduct, and whether the Antitrust
Enforcement Agencies are appropriately policing unlawful
behavior in these markets. We have an excellent panel of
witnesses that will provide invaluable insight to these
important issues, and I look forward to hearing their
testimony.
The Chair now recognizes the Ranking Member of the
Subcommittee on Regulatory Reform, Commercial and Antitrust
Law, Mr. Johnson of Georgia, for his opening statement.
Mr. Johnson. Thank you, Mr. Chairman. Today's hearing is an
important and welcome opportunity to discuss drug price
competition in the market for treating opioid addiction. Opioid
addiction is a devastating public health emergency in many of
our communities. Strongly linked to the prescription of opioid
pain killers, the Center for Disease Control reports that
opioids contributed to the deaths of 28,647 Americans in 2014.
While there are many factors that have contributed to this
crisis concerns have been raised that common treatments for
opioid addiction have become more costly. In November 2014, the
New York Times reported that Naloxone----
Mr. Marino. There are several ways to say that, believe me.
I checked it on the Internet there are multiple ways to say it.
Mr. Johnson. Naloxone, okay. It has been reported that this
drug, a common treatment for opioid addiction and overdoses,
had experienced severe price spikes. Alarmingly in my home
State of Georgia police departments report that the price of
drug kits containing Naloxone have increased from $22 to $40. I
am concerned that in addition to costing States millions of
dollars, these spikes have decreased access and undermined the
ability of law enforcement agencies and local health responders
to combat exploding opioid crisis.
Unfortunately, for many, these concerns extend to the
markets for other lifesaving treatments as well. For example, I
am personally concerned about the high cost of the new
treatment for Hepatitis C, a virus that affects more than 4
million Americans and which costs nearly $75,000.
While this form of treatment is a significant advancement,
particularly for patients with a form of the disease that is
difficult to treat, there is little doubt that Americans should
not have to choose between liver disease and extreme financial
hardship when making healthcare choices. As millions of
American struggle in the fight against this silent epidemic,
treatments must be accessible and affordable.
According to a study by Dr. Aaron Kesselheim and others
recently published in the Journal of American Medical
Association, one of the driving forces in high drug prices is
protection from competition through market exclusivity. Our
patent system is designed to promote innovation by conferring a
limited monopoly on inventions that are novel, useful, and non-
obvious. It is critical that our polices continue to place a
high value on innovation. As the Department of Health and Human
Services found in 2012, leading research indicates that the
economics literature generally indicates that innovation in
medical products has produced tremendous benefits for U.S.
consumers lead longer and healthier lives.
But it is equally important that patent extension
applications are carefully scrutinized to ensure competition in
drug markets through generic drug availability. As Dr.
Kesselheim's study noted, there is little evidence that pro-
competitive policies will hamper innovation. In fact, they may
even drive new therapies to market. I look forward to today's
hearing. We have a truly excellent panel of witnesses and I
yield back the balance of my time.
Mr. Marino. Thank you. The Chair now recognizes the Ranking
Member of the full Judiciary Committee, Mr. Conyers of
Michigan, for his opening statement.
Mr. Conyers. Thank you, Mr. Chairman. Welcome to our
distinguished panel, particularly Professor Feldman of the
Hastings College of Law. Sudden and sharp increases in the cost
of lifesaving prescription medications have caused much public
outcry. Most recently regarding substantial spike in the price
of EpiPen which is used to treat life threatening allergic
reactions.
Although today's hearing focuses on competition in the
markets for a particular set of lifesaving drugs, namely those
that treat opioid addiction, I hope that there are some broader
lessons that we can draw from our discussion today.
To that end, I would like our witnesses to address, if they
can, the following issues. The witnesses should discuss the
real life consequences of the opioid addiction epidemic and the
impact of rising prices for medications that treat opioid
addiction. According to the Centers for Disease Control and
Prevention, there are more than 28,000 deaths in 2014 resulting
from opioid overdoses. In fact, 6 out of 10 drug overdose
deaths that year resulted from opioid overdoses.
Medications like Naloxone revive an opioid overdose victim
in the critical moments after he or she stops breathing as the
result of an overdose. Yet, the price of this drug, in both its
generic and branded forms, has skyrocketed in recent years.
According to public health and police officials, prices for the
drug have increased by 50 percent or more according to some
reports.
As a result, the ability of emergency responders and
individuals to purchase this critical lifesaving medication is
being jeopardized. Other generic and branded medicines that are
designed to gradually ween addicts from their opioid use have
also seen similar price increases. As the statistics
demonstrate, addressing the consequences of these price
increases is no mere academic matter. It is beyond the dispute
that such price increases have had a devastating impact on
patients, their families, insures, first responders, and
healthcare providers.
In addition, I would like the witnesses to consider the
current law whether the current law strikes a proper balance
between incentivizing investment in new pharmaceutical products
and ensuring vigorous competition.
Under both our patent and regulatory systems manufactures
of brand name drugs are entitled to temporary exclusivity
periods for their products, during which other firms are
prevented from offering competing products. These exclusivity
periods are designed to provide an economic incentive for
manufacturers to invest in developing new products. But the
result is that prices for brand name drugs remain high. After
the exclusivity periods end, competition in the form of the
introduction of generic versions of the brand name drug is
supposed to lead to decreases in drug prices.
Indeed, the availability of generics is the primary means
of insuring competition in low prices in pharmaceutical
markets. Nevertheless, there is a concern that some brand name
manufacturers have manipulated the current patent and
regulatory regimes to extend what our supposed to be their
time-limited monopolies. We ought to explore whether there
should be a better balance.
And finally, the witnesses should, if they can, address the
factors responsible for the skyrocketing cost of generic opioid
addiction drugs and the actions that Congress should take in
response. Prices for almost all opioid addiction medicines have
risen, not just for those for brand name products. This
situation undermines the competition based rational for
encouraging generics to enter the market in the first place. We
and Congress need to focus on constructive ways to respond to
this problem.
And so accordingly I look forward to hearing the thoughtful
suggestions that I know will come from our witnesses today.
Thank them for their participation and thank the Chairman.
Mr. Marino. Thank you. The Chairman of the full Committee,
Mr. Goodlatte, will be here shortly so we will reserve time for
his opening statement. But without objection, other Members'
opening statements will be made part of the record.
I will begin by swearing in our witnesses before
introducing them. Would you please stand and raise your right
hand?
Do you swear that the testimony that you are about to give
before this Committee is the truth, the whole truth, and
nothing but the truth, so help you God? Let the record reflect
that the witnesses have responded in the affirmative. Please be
seated.
Dr. Anne McDonald Pritchett is the vice president of Policy
and Research at the Pharmaceutical Research Manufacturers of
America. Prior to joining PhRMA, she worked in the Office of
National Drug Control Policy for almost 8 years.
Dr. Pritchett earned her bachelor's degree in English and
Graphic Design from Virginia Tech, her master's in Public
Policy from George Mason University, and her doctorate in
Public Policy and Public Affairs from Virginia Tech. Welcome,
doctor.
Mr. David Gaugh is the senior vice president of Science and
Regulatory Affairs for the Generic Pharmaceutical Association.
Prior to joining GPhA, Mr. Gaugh was the vice president and
general manager of Bedford Laboratories and has otherwise been
engaged in the pharmaceutical industry for years. Mr. Gaugh is
a registered pharmacist and a graduate of the University of
Wyoming School of Pharmacy. Welcome.
Mr. Mark Merritt has served as the president and CEO of the
Pharmaceutical Care Management Association, PCMA, since 2003,
which is the National Association representing America's
Pharmacy Benefit Managers, or known as PBMs, that collective
administrative prescription drug plan for more than 266 million
Americans.
Prior to joining PCMA Mr. Merritt served as a senior
strategist with America's Health Insurance Plan and PhRMA. Mr.
Merritt received both his bachelor's degree and his master's
degree from Georgetown University. Welcome, sir.
Dr. Eric Ketcham, M.D., is the current president of the New
Mexico Chapter of the American College of Emergency Physicians.
Dr. Ketcham is also the medical director of the Emergency
Department and Urgent Care and the Co-Medical Director of the
EMS at the San Juan Regional Medical Center in New Mexico.
Dr. Ketcham also served our country in the U.S. Navy as a
second-class petty officer, aviation ordnanceman in the Strike
Fighter Squadron 11 and later in the Naval Reserve as a first-
class petty officer.
Dr. Ketcham earned his bachelor's degree in economics and
Russian studies from the University of Colorado; his MBA from
the University of Texas at Dallas; and his medical degree from
the University of Colorado School of Medicine. He completed his
residency at the University of Michigan Hospital and Saint
Joseph's Mercy Hospital. Welcome, sir.
Professor Robin Feldman holds the Harry and Lillian
Hastings chair and is also the director of the UC Hastings
Institute for Innovation Law. Professor Feldman is a prolific
author on among other things, intellectual property, antitrust
and pharmaceutical issues. She has provided testimony and
commentary for other congressional Committees, the Federal
Trade Commission, the Department of Justice, the Patent and
Trademark Office, and the National Academy of Sciences.
Professor Feldman earned her bachelor's degree from
Stanford University and her J.D. from Stanford Law School where
she graduated Order of the Coif. Welcome.
Each of the witnesses' statements will be entered into the
record in its entirety. I ask that each witness summarize his
or her testimony in the 5 minutes or less. And to help you stay
within that time, there is a timing light in front of you. The
light will switch from green to yellow indicating that you have
1 minute to conclude your testimony. When the light turns red,
it indicates that the witness' 5 minutes have expired.
Again, I want to thank you for being here and I
diplomatically will pick up the gavel here if you are running
over your 5 minutes. I will not hit anything; it is just a
little polite indication to you, would you please wrap up
because I do not look at the lights when I know I have 5
minutes. I am thinking about what I am asking or saying, and I
know you may do the same thing. So there will just be a polite
little gesture. I have not thrown this yet. Dr. Pritchett, will
you please make your opening statement?
TESTIMONY OF ANNE McDONALD PRITCHETT, Ph.D, VICE PRESIDENT,
POLICY AND RESEARCH, PHARMACEUTICAL RESEARCH AND MANUFACTURERS
OF AMERICA (PhRMA)
Ms. Pritchett. Good afternoon Chairman Marino, Ranking
Member Johnson, and Members of the Subcommittee. As mentioned,
my name is Anne Pritchett. I am the vice president of Policy
and Research at the Pharmaceutical Research and Manufacturers
of America, also known as PhRMA. We represent the Nation's
leading biopharmaceutical research companies which are
dedicated to making new treatment and cures for some of the
most of our most challenging diseases. Our members have
invested half a trillion dollars in R&D since 2000 alone, and
about $58.8 billion in the last year alone.
PhRMA is committed to supporting the appropriate use of
prescription medicines and to making the R&D investments needed
to develop new therapies including new medications to treat
addiction and overdose reversal agents. Before speaking
specifically to addiction treatments, I wanted to give a sense
of what we see as the key policies necessary to address this
overall epidemic.
First, we feel that prescribers immediately undergo ongoing
education and training on the appropriate prescribing of
controlled substances and effective pain management. They need
training on how to identify those at risk for prescription drug
abuse, for overdose, and those in need of treatment. We need
more prescribers to be using evidence based clinical guidelines
to inform opioid selection dosage and duration of treatment.
Second, we feel that State prescription drug monitoring
programs have been demonstrated through peer review research to
be one of the most effective tools in detecting potential
doctor shoppers.
But, they are only useful if their being used. We need to
mandate training in the use of PDMPs and we need to adjust
those barriers to their use. Third, we need to encourage the
development of abuse to current formulations not opioid pain
medications and medications to treat addictions and prevent
overdose.
Given more than 90 percent of the most abused medicines are
generic opioids; we think it is critically important that the
FDA finalize its guidance to assist generic manufactures in the
development of abuse deterrent formulations products as well.
And we need coverage and access polices that reflect the public
health benefits of these products.
And finally, we need to expand access to the full range of
treatment and recovery services needed to break the cycle of
addiction. A couple of key points. Despite the fact that a
large body of research is documented the cost effectiveness of
medication assisted treatments for addictions, and despite the
fact that opioid abuse is widely recognized as a chronic
disease, prescription drug benefit designs often include prior
off step therapy, or as I call it, fail first.
The consequences of which in this case can be deadly and a
number of State Medicaid programs impose lifetime limits on the
use of addiction treatments. These polices are in direct
conflict with the public health goal of expanding access and
breaking the cycle of addiction.
Now, I wanted to take just a moment to talk about the
nature of competition in the biopharmaceutical market, overall.
I would say in contrast to Mr. Kesselheim, respectfully, the
competitive market is structured to take maximum advantage of
savings from brand competition.
We have brand medicines facing competition before they come
to market. About 88 percent of medicines that are deemed first
in class had competitors in development at the time of launch.
In Hepatitis C, we saw multiple competitors within less than a
year with payers negotiating discounts between 40 and 65
percent. We do to continue, though, to have challenges related
to coverage and access to these critical medicines.
In following generic entry, payers quickly shift
utilization to generics. The reality is, more than 90 percent
of all medicines prescribed in the U.S. are generics, and once
a drug loses its exclusivity, within less than a year 93
percent of market share is generic based. But, we have a drug
cycle that balances the need for incentives innovation with a
desire for increased competition.
I would note that with the coming loss of IP protection
between now and 2020, were going to have about 93 billion U.S.
brand sales that will be facing generic competition. In the
case of addiction treatments, we have a substantial number of
generic medicines available in these well-established classes.
But we have also seen a number of new drug applications that
are providing significant medical advances for addressing
opioid abuse and addiction in terms of more convenient delivery
systems.
In recent years, the market has signaled a need for new
treatment options in this space that can improve patient
adherence and quality of life by providing more convenient
dosing and delivery methods. And companies are beginning to
respond as we have seen from the recent approvals, and from
what we have seen in the pipeline.
When you look at the pipeline we have 31 abuse deterrent
determinations in development of pain so that we avoid ever
getting to this point. There are 35 addiction medicines in
development and 49 opioid pain medications in development
potentially providing important treatment alternatives to what
is currently on the market. But the demand for treatment in the
addiction spaces has dramatically increased. It has increased
unfortunately because opioid overdose rates have increased the
growing burden on communities and families around the country.
On the positive, we have seen increased awareness in
education removing some of the stigma related to addiction. In
addition, we have seen State and Federal policy changes, the
Care Act was mentioned as critical to expanding access. I would
say that we think there is robust competition in this space one
of the key barriers we have seen when we look at products in
this space is the challenges related to ensuring coverage and
access to these. When we have lifetime limits and we have Fail
First, that creates tremendous challenges and one of our
concerns is how the dynamics of coverage and access policies
impact incentives to enter the market. Thank you.
[The prepared statement of Ms. Pritchett follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
__________
Mr. Marino. Thank you. Mr. Gaugh.
TESTIMONY OF DAVID R. GAUGH, R.Ph., SENIOR VICE PRESIDENT FOR
SCIENCE AND REGULATORY AFFAIRS, GENERIC PHARMACEUTICAL
ASSOCIATION
Mr. Gaugh. Thank you. Good morning, Chairman Marino--
afternoon excuse me--Ranking Member Johnson, and Members of the
Subcommittee. I would like to first begin by commending the
Committee for your continued focus on these important issues
that we are going to discuss today. The Generic Pharmaceutical
Association is the Nation's leading trade association for
manufactures and distributors of generic medicines.
GPhA's mission is to improve the lives of patients in the
U.S. healthcare system through access to affordable generic
medicines. Eighty-eight percent of all prescriptions dispensed
in the United States are generic; however, generics account for
only 28 percent of the totals of drugs span. GPhA is strongly
committed to addressing the improving treatment options for
patients suffering from addiction. This includes combating drug
abuse by supporting community anti-drug coalitions, encouraging
safe disposal of unused drugs, and through the development of
abuse deterrent drug formulations.
As part of this response, including ensuring the
availability of high quality low cost generics. I am here to
discuss the GPhA conviction that the best way to achieve the
goals of patient access to use lifesaving treatments is through
the development of policies to promote robust competitive
markets. As GPhA represents multiple competing generic
manufactures, we are not privileged to member company
information about individual products or any pricing decisions
around those projects.
We can; however, provide some insight to what we believe is
a proven solution to rapidly inflating drug prices.
Competition. Competition from generic drugs savings is access
and not cost. In fact, a variety of healthcare stakeholders
have found a trend of overall price decreases for generics.
Last week, the government accountability office publishes a
report examining drugs in Medicare, part D. That report echoes
the findings of multiple previous independent reports. That
generic drug prices continue to decrease.
Specifically, the GAO report that between 2010 and 2015,
drug prices for Medicare part D declined by 59 percent. In
January 2016, the Department of Health and Human Services
released a comprehensive study which concluded, and I quote,
``Our view of evidence strongly supports the conclusion that
generic drug prices are not an important part of the drug cost
problem facing the Nation.'' Taken with other important
studies, these data show the competition in pharmaceutical
markets is effective. The Drug Price Competition and Patent
Term Restoration Act, commonly known as the Hatch-Waxman Act,
created the abbreviated regulatory approval pathway for
generics, while simultaneously providing lucrative incentives
for brand manufactures to continue to bring new treatments to
the market.
The overwhelming success of Hatch-Waxman led to the
approval of over 14,000 generic applications. But, that
incredible volume brought complications in the FDA's ability to
effectively and efficiently review them. By 2011, there where
over 2.700 generic applications pending at the FDA and the
average approval time for these products or these applications
exceeded 30 months. To alleviate the burden on FDA and expedite
generic approvals, the Generic Drug User Fee Program, or GDUFA,
was improved and implemented in 2012.
Unfortunately, 4 years later the number of pending generic
applications has ballooned to over 4,000 while the median
approval time now exceeds over 45 months. Nonetheless, FDA has,
under GDUFA, hired and trained over a 1,000 new employees and
increased its efficiency in reviewing applications. As these
are important steps forward, we will continue to work with the
FDA to ensure it meets its GDUFA goals.
Generic manufacturers make complex and highly confidential
analysis when selecting which products to pursue. This analysis
can include assessing the complexity of reverse engineering,
the state of the intellectual property, the size of the market,
the likely number of competitors, the product development and
manufacturing capabilities and costs.
Once the generic manufacturers make the decision to develop
a product, they often face significant delay tactics from brand
manufacturers, including the Risk Evaluation Mitigation
Strategies or REMS program. And exempting themselves from
scrutiny or their intellectual property covered by the U.S.
Patent and Trade Office.
While current law forbids brand companies from using REMS
to delay competition, they are nonetheless denying generic
manufacturers access to samples of their products. These
samples are required to conduct the bioequivalent studies
necessary for FDA approval of the generic application. They
have even begun applying restricted access programs to drugs
for which FDA has not required a REMS program in order to delay
generic entry.
Presently, two pieces of legislation are pending before
Congress that would address this situation. The Fast Generic
Act and the CREATES Act. The GPhA has encouraged that each of
these addresses the barriers to success.
This Committee has also played a key role in recognizing
The Interim Parties Review, the IPR, as a critical consumer
protection against abusive patens. The IPR holds great promise
in reducing anti-competitive evergreening practices that drive-
up healthcare costs.
In conclusion, Mr. Chairman, GPhA believes that the best
way to control drug costs, generally, whether in the drug
addiction treatment market or otherwise is through policies
that incentivize competition. Thank you very much.
[The prepared statement of Mr. Gaugh follows:]
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Mr. Marino. Thank you. Mr. Merritt.
TESTIMONY OF MARK MERRITT, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION
Mr. Merritt. Good afternoon Chairman Marino, Ranking Member
Johnson, other Members of the Subcommittee. My name is Mark
Merritt, president and CEO of the Pharmaceutical Care
Management Association. I appreciate this opportunity to appear
before the Committee examining sudden price spikes in opioid
antagonists.
PCMA is a national trade association representing America's
Pharmacy benefits managers which administer prescription drug
plans for more than 266 million Americans with health care
provided by Fortune 500 companies, health insurers, labor
unions, Medicare part D, Medicaid, FEHPB, ACA, and other
arenas. PBM's offer a wide variety of services aimed at making
prescription drug benefit programs offered safely, efficiently,
and affordably for their clients. PBM's are projected to save
$654 billion on drug benefit costs over the next decade alone.
For today's discussion, we have seen far too many
heartbreaking stories come out of nearly every corner of
America about the destruction of lives due to opioid addiction.
According to the Centers for Disease Control and Prevention
overdose deaths involving prescription opioids have quadrupled
since 1999. Over the last 15 years, more than a 165,000 people
have died in the U.S. from overdoses related to opioids. The
same period has seen a quadrupling of deaths due to overdoses
specifically of illicit heroin including over 10,500 deaths in
2014 alone.
Addiction treatments and recovery medications are critical,
but an important first step is overall prevention. That is why
we commend Congress for passing the Comprehensive Addiction and
Recovery Act, CARA. PCMA and its member company supported this
legislation which among other provisions created a Medicare
part D Lock in Program to curb substance abuse at the pharmacy
counter.
The legislation will help stop drugstore shopping by
allowing Medicare part D Plans to restrict known abusers to
select pharmacies for certain medications, such as opioids. The
law also expands the availability of Naloxone to law
enforcement agencies and other first responders to reverse
overdoses and save lives.
Unfortunately, as opioid antagonists have gotten more
widely available, there have also been unprecedented price
spikes. We encourage policy makers to consider the following
recommendations to stem the rising tide of abuse and reduce
cost.
First, we think it should be mandatory that prescribers use
E-prescribing for controlled substances. Second, State
governments should make their prescription drug management
program databases more easily accessible, more user friendly,
and better integrated across the country to make that data
accurate and in real time. Medicare part D Plans should be
allowed to suspend payments of suspicious claims just as is
allowed throughout the rest of Medicare. This would effectively
eliminate pay and chase activities which increase cost and make
fraud detection more difficult.
We also recommend the following policy changes to enhance
competition and reduce drug costs. First, address the generic
drug backlog at FDA. As has been mentioned before me,
improvements have been made but much more needs to be done.
Second, accelerate FDA approval of drugs with little or no
competition. Third, limit delaying tactics and patent abuses
that prevent competitors from coming to market. Fourth, unlock
more innovative value based pricing arrangements by removing
the existing barriers such as the Medicaid best price
requirement. While this is certainly well intended, it acts as
an artificial price war that discourages drug companies from
steeper discounts in a commercial market. And finally,
eliminate any or all Medicare part D protective classes which
significantly weakens the power of PBM's to negotiate rebates
and lower prices. Again, I appreciate this opportunity to be
here today and look forward to answering any questions you
might have.
[The prepared statement of Mr. Merritt follows:]
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Mr. Marino. Thank you. Dr. Ketcham.
TESTIMONY OF ERIC KETCHAM, M.D., AMERICAN COLLEGE OF EMERGENCY
PHYSICIANS (ACEP), MEDICAL DIRECTOR, EMERGENCY DEPARTMENT AND
URGENT CARE, CO-MEDICAL DIRECTOR, EMS SAN JUAN REGIONAL MEDICAL
CENTER
Dr. Ketcham. Thank you, Mr. Chairman. My name is Dr. Eric
Ketcham. I am an emergency department medical director and EMS
Medical Director and a medical director for an Opioid Addiction
Treatment Clinic. On behalf of the 37,000 members of the
American College of Emergency Physicians, I would like to thank
you for this opportunity to testify today about this important
issue.
The unnecessarily high price of these medications obstructs
access to treatment for opioid addiction and overdose in
America. And thus prolongs the scourge of heroin prescription
opioid addiction and puts American lives at risk. Access to
Buprenorphine, which should be a low cost medication, must be
expanded so that more Americans can be successfully treated for
the affliction of opioid dependence.
Secondly, access to Naloxone which also should be a low
cost medication, must be increased. This is truly a lifesaving
drug that when used properly can reverse opioid overdoses and
save lives. In its current, most commonly used form,
Buprenorphine has been FDA approved for 30 years. Because of
its unique properties it produces much less euphoria and
respiratory depression than traditional opioids, such as
oxycodone, heroin, and methadone.
When properly prescribed, this medication is a very safe
alternative to Methadone and thus can be effectively utilized
to treat opioid abuse and addiction by a variety of physicians
in a variety of settings, as opposed to Methadone which must be
administered in a licensed opioid addiction treatment clinic,
such as one that I run.
One would think that a lifesaving and life transforming
medication such as Buprenorphine, which has a well-established
safety profile, would be accessible to hundreds of thousands
more opioid dependent patients. Unfortunately, that is not the
case. In my written testimony, I provide specific examples of
the rising prices associated with Buprenorphine and the related
Buprenorphine Naloxone combination medications, including their
generic counterparts.
For example, based on surveys I have conducted of local
pharmacies affiliated with national chains in my region, the
cost for a 30-day supply of Buprenorphine--that is two 8 mg
tablets per day, the usual dose, is now $334 compared to a $142
just 6 months ago. And a month of the Suboxone brand name
Buprenorphine Naloxone combination filmstrips, is $532.
Shockingly, the generic version of the combination tablets is
even more than the brand name prescription film strips this
week and cost $625 for a 30-day supply.
The critical medication we use to treat acute opioid
overdose is Naloxone. It has been utilized in hospitals and by
fire EMS personal for decades. More recently, there has been an
organized effort expand direct access to Naloxone and in some
regions it can already be purchased from a pharmacy even
without a prescription. However, these efforts to expand
availability of Naloxone have surprisingly not caused the price
of this medication to decrease. In fact, the price of Naloxone
in nearly all forms of packaging has been steadily climbing.
In my community, the cost of a one-millimeter syringe of
0.4 milligrams of Naloxone went from about $12 in 2012 to $30
in 2016. Without a hospital or municipal volume discount for
fire or EMS service, the preloaded two milligram syringe used
by many first responders is now priced at approximately $49 a
dose. That same dose was $17 in 2014 and reportedly as low as a
$1 in 2001.
The consequence of these rising prices may force Naloxone
out of the budget for the rural fire or EMS service that does
not have the buying power of a hospital or a larger municipal
agency. Furthermore, in my region, Naloxone products designed
for the layperson are the most expensive of all.
For example, the cash price for the four-milligram nasal
spray has increased to a $150 for the package of two doses.
This simple device does not present a form of revolutionary
technology, and it includes a generic, and until recently, very
inexpensive medication. What is truly astounding is the price
for the single dose Naloxone autoinjector, which can be more
than $2,200 and is often not a sufficient rescue dose.
Another topic not yet addressed on this greater topic is
the expanding Good Samaritan Laws are an important aspect of
increasing Naloxone availability. These efforts must be paired
with legislation that would make healthcare providers and lay
users immune from liability for failure or misuse of the
product by bystanders.
Moreover, administration of Naloxone is often not as simple
as providing a single dose for various reasons. That is why
ASEP strongly recommends that whenever Naloxone is administered
by a bystander, to treat an opioid overdose, EMS must be
called, and ideally, that patient would then be transported to
the nearest emergency department for evaluation.
In conclusion, we urge Congress to help make Buprenorphine
and Naloxone more readily available to those suffering from
opioid addiction. These critical drugs cannot only save
countless lives, but help alleviate a great burden on society
by reducing crime, incarceration, and healthcare expenses
including complications from intravenous drug use such as
spreading HIV and Hepatitis C. Most important, access to
Buprenorphine and Naloxone means potentially deadly overdose
deaths could be avoided.
If Congress wants to help increase access to these drugs,
then something must be done to curtail the cost of these
lifesaving medications. Thank you, and I look forward to
answering any questions you may have.
[The prepared statement of Dr. Ketcham follows:]
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Mr. Marino. Thank you. Professor Feldman.
TESTIMONY OF ROBIN FELDMAN, ESQ., HARRY AND LILLIAN HASTINGS
PROFESSOR OF LAW, DIRECTOR OF THE INSTITUTE FOR INNOVATION LAW,
UC HASTINGS COLLEGE OF THE LAW
Ms. Feldman. Mr. Chairman and esteemed Subcommittee
members, I am honored to address competition issues in the
market for addiction medicine. Open and vigorous competition is
the backbone of U.S. markets, but we are not seeing that in the
market for addiction medicine. Rather, drug companies are
engaging in regulatory games, stringing these out one after
another while competition languishes on the sidelines.
These games come in two baskets. One set involves
manipulating Hatch-Waxman, which is the system for quick
approval of generic drugs when the patents on the main drug
expires. The other basket of games relates to the system for
non-patent exclusivities known as regulatory exclusivities.
Some of these games just blatantly delay entry of
competition. With addiction medicine, for example, we have seen
petitions asking the FDA to deny approval of any generic
versions. Among many of the demands, one addiction medicine
company asked the FDA to require things for generic Suboxone
that the FDA did not have the authority to do and that we would
not want them to do in the first place. Now, the agency denies
80 percent of these petitions, as it denied this one, but the
process takes time, even for silly petitions. In the case of
the Suboxone petition, the FDA was so disturbed by the
petitioning behavior that it referred the company's behavior to
the Federal Trade Commission.
In other games, companies block competitors from getting
access to the samples they need to get approval. Generics have
to show that their drug is the same as the branded, and some
brand companies just flatly refuse to sell samples to generic
companies or to cooperate with generic companies to write
safety plans. With addiction medicine, the FDA so despaired of
getting one brand name company to cooperate that it took the
unprecedented step of granting a waiver so that the generic
company could just go forward on its own. Again, competition
languished for another stretch in the addiction medicine
market.
In other games, companies make slight modifications to the
dosage or the delivery systems, and then encourage doctors to
prescribe the new version, or even withdraw the old version
completely. If that is successful, there is no market for the
old version. There is just a new market for the new version
that is protected by shiny new patents. We have seen this in
the addiction medicine market as well where a company switched
from tablets to meltaways just before the patents expired.
Now these modification patents are quite weak. And in fact,
when generics challenge these patents, they win three quarters
of the time. But again, these challenges can take years and
competition is thwarted, and prices stay high.
In addition to gaming, Hatch-Waxman companies carve out
competition free zones in ways that have nothing to do with
patents. There are 13 forms of regulatory exclusivities that
companies can obtain by doing things like new clinical studies
or pediatric studies. And with these, companies can keep
competitors out even if the patent has expired.
Now these zones were created for very appealing reasons,
but they are being exploited now to block competition in ways
that were never intended. As a side note, the key drug in the
addiction medicine market came through the most powerful of
these, the orphan drug exclusivity.
The spotlight today is on the market for addiction
medicine, but the game playing is epidemic throughout the
pharmaceutical industry. Companies pile these games on, one
after another, exploiting the laws and regulations that are in
place. As always, society pays the price with higher taxes to
pay for soaring Medicare costs, higher insurance premiums,
higher treatment costs, and more suffering for those who cannot
afford treatment. Nowhere is this terrible combination more
apparent than in the market for addiction medicine. Thank you
very much.
[The prepared statement of Ms. Feldman follows:]
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Mr. Marino. Thank you. Now, as I stated earlier, the Chair
now recognizes the Chairman of the full Judiciary Committee,
Mr. Bob Goodlatte from Virginia.
Mr. Goodlatte. Thank you Mr. Chairman, and I apologize for
stepping out of turn. It has been a very busy day, and I was
held up in the last meeting; also I am going to have to leave
for another one pretty soon. But I do want to offer some
thoughts on this important subject. Today's preceding marks the
fourth in our series of hearings focused on competition in the
healthcare marketplace. Now, the Committee turns its attention
to the pharmaceutical industry and the drugs that are used in
the treatment of opioid overdose and addiction.
Competition in the addiction medicine markets, like the
pharmaceutical market as a whole, involves a delicate balance.
On the one hand, we want to encourage pharmaceutical companies
to invest in expensive research and development in order to
bring innovative and life-saving drugs to market. On the other
hand, we also want to encourage sufficient competition to
ensure that there is an appropriate check on consumer prices.
Today's hearing will explore what polices help to maintain this
balance and whether it has been upset.
Like other drugs in the market, addiction medicine has been
the subject of media reports detailing steady and sometimes
dramatic price increases. Oftentimes, however, these reports
can be misleading, glossing over nuance to achieve a
sensational headline. Today's hearing will allow us to explore
whether prices have indeed increased material, and what
competitive factors impact the ultimate cost to consumers.
The issues that have been raised in connection with the
addiction medicine market parallel the issues facing the
pharmaceutical market at large. For example, two of the most
predominant drugs used in the treatment of the opioid epidemic
have existed for over 50 years. Yet, new variations of these
old drugs and increasingly inventive applications to administer
the drugs continue to come to market often accompanied by high
prices tags. Persistent innovation is one of the hallmarks of a
free market and should be celebrated.
However, there have been allegations that some companies
may be using this innovation as a disguise to cover-up the
manipulation of regulations to preclude competitors from coming
to market. Clearly, this is anti-competitive conduct that
should be swiftly and harshly punished. I look forward to
hearing the witnesses' views on this issue and whether our
existing antitrust laws are equipped to address any such
behavior.
I also look forward to hearing what policies influence
competition in the addiction medicine market including the
impact on competition on regulatory oversight by the Drug
Enforcement Agency, the Food and Drug Administration, and the
Department of Health and Human Services. To the extent
regulation is necessary, we should ensure that the addiction
medicine market and the entire pharmaceutical market includes
proper incentives that foster a competitive environment.
No one wishes for a friend, family member, or a loved one
to succumb to addiction. For those that are forced to face the
opioid epidemic head on, we should strive to encourage a
competitive market for the drugs that can help them back on the
path toward recovery.
I also want to mention that I think the government plays a
role in this that needs to be examined more closely. We, I
think, invited the Drug Enforcement Administration to
participate in this hearing, and for various reasons they are
not here today. But a number of issues related to their work
need to be addressed as a part of making sure that our
consumers, our physicians, and our first pharmaceutical
companies, are able to operate in a manner that effectively
brings the drugs to the right people at the right time and I
think sometimes government regulations are interfering with
that.
Therefore, we should continue to expect further public
examination of this, and have the DEA here before us in the
future to address this and some other of their regulatory
issues.
So, thank you Mr. Chairman for your forbearance, and I look
forward to hearing the questions of the other Members of the
Committee.
Mr. Marino. Thank you. We will now move into the
questioning of the panel. The panel did such a good job in
keeping within their 5 minutes, now we will see how well we
Congress Members do.
Dr. Pritchett, I am especially interested in innovative new
options to treat overdose. As an 18-year prosecutor, I have
seen hundreds if not thousands. When I think of this space, I
look to the loved ones and first responders who are often the
first to address addiction and potential overdose. Your
testimony mentions that there are innovative drugs in new
therapeutic areas.
My two questions are, would you expand on this and explain
how branded pharmaceuticals are investing and researching new
ways to address increase need in recent years, as well as
different applications that would be used by first responders,
emergency medical personal, and family? And anytime you want me
to repeat these, please ask me.
Ms. Pritchett. In terms of looking at the Naloxone space,
yes, there has been a substantial range of generic products
available for a long period of time. As I mentioned in my
testimony, what we have seen change in the past couple of years
is the market has sent different signals to our industry. So
what we have seen is a need for expanded options in terms of
convenient delivery forms, and we have seen a substantial
change in State laws, making Naloxone more widely available.
One of the key dynamics here is that now most States have
changed their laws allowing Naloxone to be available at the
retail level via standing orders, meaning without a
prescription. So, it is hard to say in terms of the pricing
issues, what is occurring there in terms of whether in
different elements as a supply chain how that is affecting
pricing at the retail level. But, in terms of the fact that
these products are being made more readily available to first
responders and others, that speaks to the increased demand for
convenient delivery systems.
And what we have seen over the past few years, we have seen
the introduction of an autoinjector but we have also seen most
recently the approval of a nasal spray. At the same time,
another nasal spray was in development that was not approved by
the FDA. But in terms of our review of the pipeline, there are
about 35 drugs in development to treat addiction treatment.
Some of them are in this space, some of them are in the
Buprenorphine space, but I think what is critically important
though is that the market has to send signals that there is an
incentive to enter this market.
So, when a company is looking at entering this space, they
are looking at is there going to be demand, are they going to
be able to make a significant benefit to patients compared to
existing therapies? And, in this case, that is what driving the
introduction of new brand competition in this area.
Mr. Marino. Thank you. Mr. Gaugh, Dr. Ketcham states in his
written testimony that the cost of the generic version of
Buprenorphine had doubled despite a number of competitors in
the market. Can you explain why that is the case concerning the
BUP market, and why prices increase generally in the market
with a number of generic competitors?0
Mr. Gaugh. Thank you. So, to your question, there are a
number of different situations that a company has to look at
and face when they are in a market, and I am assuming in this
case these companies are already in the market. So, you have
API sources that can change and go up in price. You have
mergers and acquisitions that occur, as I think you well know
throughout the supply chain.
So, when API companies merge, a lot of times that takes one
or two of the players out of the market and that may increase
the price of the API. The components that the products use
whether it is an injectable, tablet, capsule, inhalation, or
autoinjector, those components have a price point to them as
well. And so these many factors are taken into account into
what causes the price to go up. Why a specific company made
that decision, I do not know the answer to that.
Mr. Marino. Then in 35 seconds, Dr. Ketcham, your testimony
lays out that there are many barriers experienced by first
responders and medical professionals in an effort to respond to
these overdoses. Can you speak to the belief within the medical
community as the best methods and science to approach?
Dr. Ketcham. I want to make sure I understand your
question. So, barriers to getting addiction treatment or
treatment for overdose?
Mr. Marino. Treatment for overdose.
Dr. Ketcham. So, right now, the issue with getting a timely
treatment for overdose is really having access to Naloxone and
the people who are around the patient. Just remember that a
patient never treats himself for an overdose. So, unlike an
autoinjector such as an EpiPen, where somebody will treat
themselves for their allergic reaction, getting treatment for
your opioid overdose requires there is a bystander who is ready
to administer that medication and or a prompt response from law
enforcement who hopefully can be able to carry that medication
which is not necessarily done by all law enforcement agencies.
This is becoming a bigger part of law enforcement's budgets
now, as well, of course traditional EMS and fire agencies.
Mr. Marino. Thank you. Time is expired. The Chair now
recognizes the Ranking Member, Mr. Johnson.
Mr. Johnson. Thank you, Dr. Pritchett. Professor Feldman
testified that drug companies have engaged in legal and
regulatory games to block entry into the market for opioid
addiction treatments, including the practice of evergreening
and product hopping, brand products whose patents are about to
expire. What is your response?
Ms. Pritchett. I do not particularly care for the terms
``product hopping'' or ``evergreening.'' I think when we are
looking particularly at the addiction medications base and we
look at the new delivery reforms that have been introduced,
these are significant medical advances in this very challenging
area. One of the most challenging aspects of successfully
treating addiction is compliant patient compliance. And it is
not a minimal tweak to develop a new delivery system to conduct
a relevant clinical trials and make the case to the FDA that
this is a significant benefit and that this should be approved
and that it can be easily used.
So, I think that the innovations that we have seen have
been incredibly valuable in increasing our arsenal in the
treatment of addiction. If you think about these two spaces
what we have seen is, we have had standard care in Naloxone has
been in vial form for decades. And we have had standard
treatments in Buprenorphine in pill form for decades. But what
we are seeing now is a great expansion in the use of the
delivery methods.
Mr. Johnson. Okay, all right, thank you. Mr. Gaugh, in your
written testimony you state that Senate bill 3056, The CREATES
Act would address abuses of patient safety programs like the
Risk, Evaluation, and Mitigation Strategies Program. And in a
letter opposing the CREATES Act, PhRMA president, Stephen Ubl,
recently argued that it provides considerable incentives for
generic manufactures to litigate, rather than arrive at
agreements with innovators. What is your response?
Mr. Gaugh. Under the current situation, as a company comes
to the market dynamic and the market decision, when they come
to market, the first thing they have to do is get samples so
they can develop that product. The only way they can get that
sample in a REM situation is from the company, directly. So, we
do this all the time but in a non-REM situation you go to a
wholesaler distributor to buy that product. Under REMs, it is
in a strict distribution and you cannot do that.
So you have to go to the company and once we supply a
letter to the FDA saying that we want to develop this product,
the FDA has to determine that we are a company in good
standing, they will present a letter to us on that, we present
that letter to the innovator company and they are to sale the
products. But there is no factor today that requires them to do
that. Other than, we can take them to court under antitrust
laws.
Mr. Johnson. All right, I understand. Thank you. Mr.
Merritt, in your written testimony you state that the generic
approval backlog is currently at 36 months, undermining
competition in the brand drug market. What recommendations do
you have for reducing the backlog?
Mr. Merritt. Well, we would ask for better staffing, better
resources there; not better staffing because of quality, but
more staffing and so forth. It is a very serious issue and if
there is a backlog there needs to be maybe better capacity
there. We would also ask for the FDA to look at situations
where for instance there is a generic that does not have
competition or an off patent brand that does not have
competition and accelerate approvals for drugs that can compete
in those spaces too.
Representing the payers for these medicines, the unions,
lawyers, insurers, and so forth, obviously we just want lower
costs. But, lower costs only happen when there is competition.
And the more competition there is, the lower the costs that
there are. And the FDA, I think, is doing a good job they have
a lot of volume but they need to do more. And I think the
situation in America is changing where they may need to ramp
things up maybe than they anticipated.
Mr. Johnson. Thank you. Dr. Ketcham, have other areas of
treatment suffered as the result of the necessary response and
the expense associated with that response to opioid overdoses
and addiction treatment?
Dr. Ketcham. I am trying to make sure I understand the
question.
Mr. Johnson. Yeah, because of the costs associated or the
increased costs associated with opioid overdoses and addiction
treatment, have other areas of treatment suffered?
Dr. Ketcham. So, specifically, many patients that I would
see in the emergency department who are wanting to get started
on treatment for their addiction: Their single most common
barrier is being able to afford the medication; the same thing
upon release of prisoners, of those incarcerated upon reentry
into society, which is a very important time to begin
treatment. The cost of medication is the single biggest
barrier.
Therefore, it is the process, even when working with social
workers in the emergency department, to try to help the patient
now get onto Medicaid. There is a time delay between when they
can get Medicaid acceptance, then to submit and get preapproval
for Buprenorphine. I can give them a dose in the emergency
department to get them started, but really getting a
prescription filled and then have a place for them to follow
up, that is the significant barrier for addiction.
Mr. Johnson. All right, thank you. Mr. Chairman, I would
ask that a letter dated September 22, 2016 from Consumers Union
on this issue be admitted into the record, without objection.
Mr. Marino. Without objection, so ordered.
[The information referred to follows:]
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Mr. Johnson. Thank you.
Mr. Marino. The Chair now recognizes the Chairman, Mr.
Goodlatte.
Mr. Goodlatte. Thank you, Mr. Chairman. Dr. Ketcham, there
have been allegations that threats by the Drug Enforcement
Administration, the DEA, have resulted in pharmacies removing
Buprenorphine products from their inventory. Are you familiar
with these allegations, and can you comment on the alleged
conduct?
Dr. Ketcham. I cannot verify that that is necessarily the
case. I do know that pharmacies in my region try to keep only a
limited amount of Buprenorphine in stock, try to preserve that
for when a patient shows up with a prescription in hand.
I will say, however, that, regarding the DEA, and I think
their general view of treating addiction with Buprenorphine and
office-based practice; that after you have been a licensed
Buprenorphine prescriber for 3 years, at some point you are
supposed to have a random meeting with the DEA, in which they
are going to interview you, go over your patient logs, your
prescriptions, et cetera.
When they do this, they do interrogate you and make you
feel like you are a criminal, and this really is a significant
factor that causes physicians not to want to participate in
addiction treatment.
Let me also add that there is, however, a significant
amount of diversion of Buprenorphine, you know, in almost every
community, and I believe that the DEA has a very founded
interest in why there is such a tremendous amount of diversion
of Buprenorphine in most communities.
Mr. Goodlatte. But do you think that if that is indeed
leading to local pharmacies carrying limited supplies, is that
leading to the inconsistency that patients are finding? They
will get a prescription. They will go get it filled, and then
the next month or whenever they go back again, that pharmacy
does not honor their prescription?
Dr. Ketcham. I think the issue is that the cost of the
medication is high, and in pharmacies that I have spoken to,
when working with Medicaid, for example, they are selling the
Buprenorphine to patients at the same cost for which they are
paying for the medication, and usually they pay through a
wholesaler such as McKesson, let's say.
So, if your pharmacy is buying it at that price, that is
exactly the price they are turning around and selling it to
patients for, with usually a minimal fee of about a dollar or
so for packaging. So there is no market. There is no, you know,
profit for them anywhere in this.
Mr. Goodlatte. I get the profit side of it.
Dr. Ketcham. Yeah.
Mr. Goodlatte. We definitely want to hear more about why
these prices cannot be lowered through competition, but I also
would suspect that if you are treating a patient for addiction,
consistency and being able to stay on the regimen prescribed by
the physician would be extremely important, and the
inconsistency with which that physician can rely on local
pharmacies to have the product available would make a big
difference in the success of treating the patients.
Dr. Ketcham. I completely agree, and that is definitely a
problem that our patients face. I will also add to that that
there appears to be varying quality amongst the generic
product, and when the generic product changes within a
pharmacy, patients then are often trying to look for a
different pharmacy that carries a different generic version of
the drug.
Mr. Goodlatte. So the physician wants them to take a
specific formulation, and expect that it is going to be at the
same place where that patient is used to going. This
consistency of carrying the same product over a period of time
is very important, and pharmacies should work with the DEA and
work with their suppliers to make sure that they can be more
consistent than they are in some areas.
Dr. Ketcham. Absolutely.
Mr. Goodlatte. Thank you. Dr. Pritchett, your testimony
outlines what appears to be a relatively competitive market for
both Buprenorphine and Naloxone products. Given its competitive
state, can you explain the media accounts and testimony today
that suggests rising prices in each of these markets?
Ms. Pritchett. So I would just say that I represent a trade
association. My representative from GPhA is not privy to actual
pricing information of any of these products. We did have IMS
just take a look at the overall trends and, for example, for
Buprenorphine related medications IMS data shows that pricing
for both the generic and innovator products have similar
pricing; that it has remained generally stable since 2011.
Now, one of the challenges related to Naloxone, as I
mentioned in my testimony, is that we have had a shift in that
now many States are having standing orders where Naloxone
products are available without a prescription at the pharmacy
level. We do not have insight into what pricing may be
occurring at the retail level. So, that is one of the
challenges inherent there.
But I would say what we have seen in terms of--not looking
at sales, but looking at volume, is that in both of these
spaces that you have substantial generic competition. We have
recently had an influx of innovative products. If you look at
Naloxone, we have had an autoinjector form that has been
introduced, and then we have had a nasal form introduced, and I
think now you have two brands competing on the delivery system
method, so that is a sign of positive competition and, given
what we are seeing in the pipeline, we expect to see more
competition there. But, again, I cannot speak to the price
reports that have been reported in the media.
Mr. Goodlatte. Let me just say----
Ms. Pritchett. IMS data just does not seem to be bearing
that out.
Mr. Goodlatte [continuing]. As a member of the trade
association that many pharmaceutical companies belong to, I
hope you will convey back to them our concern, that the
Congress has just passed CARA legislation, designed to try to
deal with the addiction epidemic in our country, and that one
of the aspects of being successful--we passed about 17 bills,
some out of this Committee, some out of the Energy and Commerce
Committee, that are going to help, I think, a lot in this area,
but they are not going to help as much as they could unless the
product, for people who obviously are not, taken as a whole,
the most likely to be able to pay whatever the market demands.
They are going to need to be able to have an affordable
product; that that is an important thing for your industry to
consider, as we take on this national challenge of dealing with
addiction.
Ms. Pritchett. Thank you for that. One thing I would note,
IMS just released a report this morning that found that the
annual growth rates in the number of prescriptions for
Buprenorphine medicines slowed from 22 percent in 2012 to about
6.4 percent in 2016, and IMS found that the states with the
highest rates of heroin and other opioid use had below average
levels of Buprenorphine use and public funding, suggesting a
disconnect between the need for treatment and access and
coverage of treatment. And what we have seen is that a lot of
these medications require, as mentioned by Dr. Ketcham, require
a step therapy. So, you have to fail on multiple other options
before you get to some of these medications.
Some of these are not even covered. For example, Vivitrol,
which is an innovative medication in terms of it is a once
monthly injectable that just does not just treat withdrawal
symptoms, but treats opioid dependence; that you have three
State Medicaid programs that require substantial step therapy
and prior auth before you can even have an opportunity for
that. And the Arkansas State Medicaid program does not even
allow access to it.
So, agree that we need more competition, but we also need
to ensure that, as we are introducing competition, that there
is the potential that there is going to be uptake of these
products. As innovators are looking at entering a market, they
do need to know that this is going to be valued by payers and
patients. So that is an important dynamic as well, but
appreciate the thoughts.
Mr. Goodlatte. Well, thank you, and if you would submit
that study to the Committee, we would be more than anxious to
have the benefit of it.
Ms. Pritchett. Certainly, will do so.
Mr. Goodlatte. Thank you. Mr. Chairman, my time has long
since expired.
Mr. Marino. Thank you. The Chair now recognizes Mr.
Conyers, the Ranking Member of the full Judiciary Committee.
Mr. Conyers. Thank you very much. I thank the witnesses.
Professor Feldman, what are some of the ways that drug
manufacturers manipulate the existing patent and regulatory
schemes to extend their monopolies on brand drugs?
Ms. Feldman. Understanding the life cycle in the
pharmaceutical industry is a matter of understanding how the
games get piled on one after each other. With each of them,
they got a small amount of additional exclusivity; 5 months
here, 6 months there, a couple of years. But you add them
together and they add up. So, a 5-month extension in a
blockbuster drug can be worth half a billion dollars or more.
You add a billion here, a billion there, that adds up to real
money, and the taxpayers are paying. So it is not the
individual game. It is the way that games are strung out, one
after another.
Mr. Conyers. Is this true of generic manufacturers as well?
Ms. Feldman. The best and most competitive market is when
you have lots of competitors directly in that market. When
there is only one generic competitor, the price generally drops
by only about 15 percent. When you have multiple generics, you
often see price drops in the 85 to 90 percent. So there are
definitely incentives for first generics, also who wish to keep
others out as well.
Mr. Conyers. Thank you. Do you support S3056, the CREATES
Act, which, as you know, among other things, allows a generic
drug developer to sue a brand manufacturer to obtain the
necessary samples to create a bio-equivalent product?
Ms. Feldman. I had the honor of testifying on the Senate
side about the CREATES Act a couple of months ago. I do support
that type of approach, particularly taking the competition
policing out of the FDA, and into agencies and courts that are
better at doing that. The FDA is great at policing safety; not
so great at policing competition.
Mr. Conyers. Thank you. Mr. Merritt, you suggest that one
of the factors keeping the price of the Naloxone high is the
fact that many States require insurance coverage for it,
hampering the ability of pharmacy benefit managers to negotiate
discounts and rebates. Do you support that?
Mr. Merritt. Well, insurance does cover that, just to
clarify that, sir. Insurance and insurers generally cover these
products. The challenge is when there is a mandate to cover one
particular generic, if there are competitors available, or one
particular brand, for that matter. Because when there is a
mandate to cover that, it gives all the pricing power back to
PhRMA because they do not need to compete on price to get on a
formulary or to get on a formulary with a lower co-pay.
So that was the intent of that particular statement, but
these are broadly covered, although I will add that many, many
times, although I do not have the percentage in front of me,
these are not processed through insurance. They are products
that have been given away. Different drugs have been given
away. People come and sometimes they do not want to process it
through insurance, sometimes they are uninsured themselves, and
so that is just another clarifying factor.
Mr. Conyers. Dr. Ketcham, what is the impact of the spiking
price of opioid addiction treatments on the ability of
healthcare providers to address addiction long term?
Dr. Ketcham. Sir, the rising price essentially means that
patients will not fill their prescriptions, and without filling
the prescription, it means they discontinue getting their
addiction treatment. What invariably often happens in this
situation, which is very unfortunate, is that patients, when
they cannot afford the medication, will often do their own sort
of self-tapering.
Many patients are self-managing with Buprenorphine; either
that they have been prescribed for that they are running out
of, or that they are obtaining in a secondary market, and very
often when we see them tapering very quickly, much faster than
we would recommend that they do, there is a very high rate of
relapse, and then proceeding back to using heroin or other
black-market opiates.
Mr. Conyers. Thank you, Mr. Chairman, for permitting me to
ask these questions.
Mr. Marino. Mr. Ranking Member, you came under everyone
else today. So, kudos. The Chair now recognizes the gentleman
from Georgia, Congressman Collins.
Mr. Collins. Thank you Mr. Chairman, and the Ranking Member
said I could have his time, his extra. There you go. We will
split it; that is what we will do. No, I appreciate the time,
Mr. Chairman. We will be submitting questions for four of the
witnesses today on different wells, but I have some other
issues that I would like to address because I do not get the
opportunity often to do so. Mr. Merritt, thank you for being
here today.
I have an opportunity to say something here that, for many
in this room, is going to find they may fall out of their
chairs because I am going to agree with you on some parts of
your testimony. I agree that opioid epidemic and opioid
addiction is heartbreaking. I have seen it tragically up close
and personal, and agree that the Comprehensive Addiction
Recovery Act was a good first step toward combating this
problem. That is why I was a part of that act.
I think we can agree there needs to be competition in the
addiction medication market, but when we talk about general
pricing, there are some points that I want to raise that
concern me, and I think you know we have a different opinion on
the value of PBMs to the healthcare marketplace. You say in
your written testimony that PBMs help bring down prices of
prescription drugs across the market by harnessing competition
and among manufacturers. You go on to say that the one way the
PBM lower prices for prescription drugs is through taking
advantage of all the efficiency of mail service pharmacies.
Mr. Merritt, is there not an inherent conflict of interest
when a PBM mandates or heavily incentivizes patients to use
their own specialty or mail order pharmacy? Can you please
explain how steering patients to a PBM owned specialty or mail
channel allows for greater competition in the marketplace?
Also, help me understand how it is beneficial for a patient
to obtain expensive, complex medications, some of which need to
be self-injected, in the mail, where they have zero opportunity
to show in-person how to properly use the medication for
maximum benefit?
Mr. Merritt. Sure, well, first of all, the Federal Trade
Commission has looked into this, in terms of the mail and if
there is a conflict of interest, and found that there is not.
And I think probably the way to think about it----
Mr. Collins. That is not a real helpful analogy, given
their track record in some of the trade.
Mr. Merritt. No, I have----
Mr. Collins. We are going down a wrong road to start with
here.
Mr. Merritt. Okay, well, I think the FTC is a respected
agency, but we can disagree on that. I would say this. Maybe a
simpler way to think about it, because all this is so complex,
with so many different layers, even for people who really know
a lot about health care. Think about it like Amazon.com. They
have Prime, which a lot of us use for home delivery. Amazon is
its own deliverer.
Would it be smart to force them to use Federal Express or
UPS or some other higher cost carrier to deliver their goods?
Would that be better for consumers? Would that take advantage
of scale? No, I think it would cost more. It would not add any
value to consumers, and the fact that we work with mail service
pharmacies often that we partner with or own adds value because
we can deliver those products cheaply and more effectively to
consumers.
Mr. Collins. Well, I think that is even under question
because even a study was done from TRICARE says that you are 83
percent higher than most community pharmacies serving through
mail order. So I mean, these are the problems that I have. I
understand the PBMs will usually pay the pharmacy one amount
for dispensing a drug, but charge a payer a different amount,
referring to this as the spread.
CMS is aware of this and have changed part of the rules to
account for this practice, which is inflating patient costs.
Can you explain to me, and the rest, the often large
differential in the spread between what PBMs reimburse
pharmacies, versus what you charge health plans, and could you
not save the system dollars, which is actually what your own
website says that you supposedly do by lowering that spread?
Mr. Merritt. Well, first of all, we do not work for the
pharmacies. We work for the employers and the consumers who go
there, right?
Mr. Collins. Most of your members own pharmacies.
Mr. Merritt. No, but we do not work----
Mr. Collins. Let's at least get this straight.
Mr. Merritt. We do not work for drugstores. Our job is
negotiating----
Mr. Collins. No, you own them.
Mr. Merritt. No, that is a different story. We----
Mr. Collins. Yeah, we do not want to talk about that story.
It is vertical integration that is a problem here.
Mr. Merritt. Well, if you give me just a second, I will
talk about it and answer your question. PBMs are hired by
employers to negotiate against and with drug companies and
drugstores to make sure that people get access to the
medications and drugstores they need, but that we also use the
competition in those spaces, for instance, where there are
numerous brands or brands and generics that treat the same
conditions. We want to encourage people to use the least
expensive one. The same is true with drugstores. Some local
drugstores are more expensive than others. We want to encourage
people to use the more affordable drugstores.
In terms of spread pricing and so forth, that is something
that the plan designs. That is something that the employer
decides. They are fully aware of that, and if they want to
provide incentives for us to get better deals with drugstores
by doing that, they will go ahead and do that but, as you said,
Medicare and a lot of other programs and payers do not want
that. That is fine too. It is totally up to the payer.
Mr. Collins. Look, TRICARE's own study said if they got rid
of PBMs, they would save $1.3 billion in 2013. You cannot tell
me, and sit here and tell me that your groups, which you
represent, many of which have testified before this Committee
and been untruthful with this Committee can say----
Mr. Merritt. No.
Mr. Collins [continuing]. No, I would not go there with me
on that one. You did not testify. One of your members did.
Mr. Merritt. Okay.
Mr. Collins. And this is the problem we have. And do you
want to look at it over all, not only the opioid addiction
issues we have got here, but the pharmacy prescription. I have
one more Mr. Chairman, because this is out of his own
testimony. It says, ``Allow them stronger measures to remove
disciplined or rogue pharmacies from plan networks,'' as one of
your solutions.
I do not think you need any more power because right now
you are removing pharmacies that actually try to compete in
their marketplace and serve on regular means. You do not need
more power to go after them. You have got plenty right now,
controlling 83 percent of the market. Your business model that
suffers and forces customers to have problems; not the other
way around. The last thing we need to do is give PBMs more
power. Thank you, Mr. Chairman, I yield back.
Mr. Marino. Mr. Merritt, you can respond if you choose to.
Mr. Merritt. Well, I would just say that, as Dr. Ketcham
pointed out, there is a problem with diversion. There is a
problem with fraud in health care, in general. We see it at the
pharmacies. We see it in other places in health care as well.
Some drugstores are better than others, and so we want to make
sure the highest quality, most affordable drugstores are ones
that people are encouraged to go to. We may have a disagreement
on this, but this is the way that we see it, and I think facts
back that up.
Mr. Collins. Mr. Chairman, all that is in these pharmacies
were actually doing something----
Mr. Marino. Gentleman----
Mr. Collins. Are we going to get a second round, because
that statement right there is false.
Mr. Marino. No, we are not, because before I got here
because of votes and not keeping this panel, you certainly can
submit written questions too. This the business to be answered.
The Chair now recognizes the gentlelady from the State of
Washington, Congresswoman DelBene.
Ms. DelBene. Thank you, Mr. Chairman, and thanks to all the
witnesses for being with us today. Today, we are considering
the intersection of two important policy priorities; addressing
the cost of prescription drugs, and combatting the opioid
crisis. As everyone knows, the epidemic of opioid abuse is
having a devastating effect on Americans' health and safety,
both in my home State of Washington, and across the country.
With more than 120 deaths occurring from drug overdoses every
day, more than half from prescription drugs, it is clearer than
ever that Congress must take action to treat addiction and save
lives.
Addressing this epidemic will require a multi-pronged
approach, and one piece of the solution must be ensuring access
to addiction treatment medicines, and overdose reversal drugs.
That is why the Comprehensive Addiction and Recovery Act, or
CARA, authorized important new funding for the expansion of
medication assisted treatment. But that support could be
severely diminished if our constituents cannot afford the cost
of these medications, not to mention law enforcement agencies
and State, local, and tribal governments. And CARA cannot solve
this crisis alone. We are also going to depend on the
manufacturers of addiction medicines, and the regulatory
structure that governs them.
So, as someone who started her career in the life sciences,
I know how important it is to strike the right balance between
incentivizing medical innovation, and ensuring access to
affordable medicines. But some companies have rightfully drawn
criticism for increasing drug prices to generate profits,
rather than support the development of life-saving therapies,
and I have heard from hundreds of constituents who are outraged
by what they have heard on the news.
So, as we work together to fight the opioid crisis, it is
appropriate to examine the state of this marketplace, and
ensure that it is working as it was intended.
Dr. Ketcham, in negotiations over CARA, Congress failed to
provide the President's request for $1.1 billion in emergency
funding to immediately fund new addiction treatment efforts.
Instead, funding decisions were left to the annual
appropriations process, and now we hear there might be $37
million in a continuing resolution.
So, do you believe that emergency funding would have helped
Americans with the substance use disorder; help them to seek
treatment, complete treatment, or sustain their recovery?
Dr. Ketcham. Well, absolutely. In any way that funding
filters down to the patient being able to obtain that
medication, as well as in any path that funding proceeds to
help keep open and open more addiction treatment centers or
other mental health centers, where addiction medicine is
handled.
Ms. DelBene. How do you believe those funds would best be
used to help first responders and healthcare providers fight
the opioid epidemic. I mean, you have talked a little bit about
keeping treatment centers open, but where do you think those
funds are most critically needed?
Dr. Ketcham. I do think that a multi-pronged approach is
necessary. I am worried that, particularly as I stated earlier,
the smaller fire departments, EMS agencies that are starting to
really look at the price of Naloxone as a significant budget
item in their pharmaceuticals. I think this needs to be
addressed, and this is one area where I think funding should be
directed.
However, funding can be used to lower the overall price and
evaluate the whole competition issue. That would, I think, go a
long way as well. But also, again, we certainly need more
access by patients, you know, to the mental health care so they
can start getting their addiction treatment.
Ms. DelBene. Thank you. Regarding competition, Professor
Feldman, we talked a little bit about the competitive
marketplace in this area. Are there other factors we have not
talked about yet today that you think are critical that we
should be aware of that are impacting pricing?
Ms. Feldman. I think I would put it this way. In a well-
functioning market, if someone charges eye-popping prices, a
bright young company will come in and compete and the price
will come down. So if we are not seeing that--and we are not
seeing that--then we have to ask, ``What is going on, and what
is functioning improperly in the market?'' We have lots of
carving out of little territories there, but we do not have the
type of robust competition that we would like to see in this
market.
Ms. DelBene. Thank you. Thank you, Mr. Chair, and I yield
back.
Mr. Marino. Thank you. Seeing no other Members, this
concludes today's hearing. I really want to take the time to
thank you for being here. I am glad we did not have to hold you
over, nor would I have held you over, but I appreciate what you
had to tell us today. We have learned from it, and all of us in
this room, from the family members, to the businesses, to
Congress. We have to pay particular attention to this and
react, because it is only going to get worse. Without
objection, all Members will have 5 legislative days to submit
additional written questions for the witnesses or additional
materials for the record. This hearing is adjourned.
[Whereupon, at 3:29 p.m., the Subcommittee adjourned
subject to the call of the Chair.]
A P P E N D I X
----------
Material Submitted for the Hearing Record
Response to Questions for the Record from Anne McDonald Pritchett,
Ph.D, Vice President, Policy and Research, Pharmaceutical Research and
Manufacturers of America (PhRMA)
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
__________
Response to Questions for the Record from David R. Gaugh, R.Ph., Senior
Vice President for Science and Regulatory Affairs, Generic
Pharmaceutical Association
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
___________
Response to Questions for the Record from Mark Merritt, President and
Chief Executive Officer, Pharmaceutical Care Management Association
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
___________
Response to Questions for the Record from Robin Feldman, Esq., Harry
and Lillian Hastings Professor of Law, Director of the Institute for
Innovation Law, UC Hastings College of the Law
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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