Making the case for personal importation of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One Countries. Rx for American Health is published by Daniel Hines, an international award-winning communicator with five decades of experience, and the publisher of www.TodaysSeniorsNetwork.com and www.BoomersNewsOnline.com. He also works with progressive senior advocacy groups across the nation to promote the health and well-being of America’s aging population.
Minneapolis, MN, (December 2, 2016)—President-elect Donald
Trump is being urged to act
immediately upon assuming office to explicitly legalize
the personal importation of medicine from licensed registered pharmacies in
(Tier One) countries whose standards of safety and efficacy meet or exceed
those of the U.S.
In an open letter to the President-elect from Lee Graczyk,
lead organizer of RxRights, and Daniel Hines, publisher of
TodaysSeniorsNetwork, RxforAmericanHealth and the American Rx Bill of Rights blogs,
cite his campaign pledge to support the importation of safe prescription
medicines from other countries, and that the U.S. pharmaceutical industry has
been instrumental in blocking legal importation even though untold numbers of
Americans already safely rely upon personal importation which is subject to
seizure and possible destruction, even of authentic medicines.
The letter is based upon a long-standing mantra of
supporters that a medicine that is unaffordable is, in and of itself, unavailable,
thereby leading to harm to the health and well-being the medicines are
developed to prevent.
The letter notes that “ Virtually all medicines the FDA
would deny access to are identical to those manufactured in FDA-approved
facilities outside the U.S.—the only difference being the label, which reflects
requirements of the medicine’s country of origin.”
The letter points out that hours of Congressional hearings
about the pricing abuses of Pharma have had no impact on the costs of
prescription medicines, all the while that
an October Kaiser
Health Tracking Poll found 74 percent of the American public believes high
prescription drug prices are a priority issue.
is an immediate strategy to allow competition and access to safe affordable
medications,” the letter says.
A copy of the letter follows:
An Open Letter to President-Elect Donald Trump:
Dear Mr. President-Elect:
The nation anxiously looks to you for leadership on the many
challenges our country faces in the months and years ahead. One major challenge
is access to affordable medicine.
Before the 2016 election, you made a number of statements
regarding Americans' need for affordable prescription drugs. In particular:
·You noted the U.S. pharmaceutical industry has
been instrumental in blocking importation legislation (even though untold
numbers of Americans already rely on importation).
·You said you would support the importation of
safe prescription drugs from other countries.
Hours of Congressional hearings on outrageous prescription
medicine prices have not yielded a speedy solution for citizens struggling to
afford medicine. Personal importation is an immediate strategy to allow
competition and access to safe affordable medications.
Consider these points:
·The Food and Drug Administration currently
allows personal importation of prescription medicines if they are unavailable
in this country or if they’re carried across the border in person by the
·Virtually all medicines the FDA would deny
access to are identical to those manufactured in FDA-approved facilities
outside the U.S.—the only difference being the label, which reflects
requirements of the medicine’s country of origin.
Your administration has the authority
to address the public health crisis created by out of control drug prices. We
urge you to act to explicitly legalize the personal importation of medicine
from licensed registered pharmacies in (Tier One) countries whose standards of
safety and efficacy meet or exceed those of the U.S.
Nov. 30, 2016 /PRNewswire-USNewswire/ -- A new national survey finds most
voters blame drug companies not only for high drug prices, but also for
out-of-pocket costs. The findings undermine the drug industry's $100 million PR
campaign to blame higher costs on employers, unions, health plans and the
pharmacy benefit managers (PBMs) they use to negotiate discounts on
are well aware drug companies set drug prices and they know higher prices mean
higher out-of-pocket costs. No one's buying the drug companies' campaign to
shift blame to employers, unions, plans, or the PBMs that negotiate discounts
on their behalf," said Pharmaceutical Care Management Association (PCMA)
President and CEO Mark Merritt.
Opinion Research surveyed 1,000 registered voters nationwide.
from survey include:
3-to-1, voters blame high drug prices for increased cost-sharing.
voters buy the drugmakers' "rebates cause high prices" message.
of voters say the cost of prescription drugs is too high.
4-of-5 voters with prescription drug coverage are satisfied with it.
PCMA is the
national association representing America's pharmacy benefit managers (PBMs).
PBMs administer prescription drug plans for more than 266 million Americans who
have health insurance from a variety of sponsors including: commercial health
plans, self-insured employer plans, union plans, Medicare Part D plans, the
Federal Employees Health Benefits Program (FEHBP), state government employee
plans, managed Medicaid plans, and others.
Back to school shopping this year brought sticker shock for
families in Iowa and elsewhere. This wasn’t over pencils and notebooks but a
life-saving device that kids with severe allergies have to have available at
all times. The EpiPen cost has jumped more than 400 percent since 2007.
as much as $600 per product is a lot of money, especially considering families
like one in Polk City, Iowa, with four kids who need EpiPens.
The shelf life is
about a year, so the EpiPen needs to be replaced, and parents try to stock the
item in multiple places, like grandma’s house, in case of emergency.
The price increases brought scrutiny on the company, Mylan,
that sells EpiPens. Iowans asked me to find out what was going on, and I
started asking questions.
Soon afterward, Mylan announced steps to help
patients afford the product: more patient discount coupons and an authorized
generic version. Still, the company won’t lower the price, and daily headlines
tell us the EpiPen is only one of many prescription medicines busting budgets.
So what can and should be done to hold down drug costs?
One of the best ways is to increase competition, where drug
companies are encouraged to innovate and produce new products and the
marketplace works to drive down prices.
Driving down prices also requires
making sure drug companies are playing fair and not gaming the rules. The
Department of Justice and the Federal Trade Commission enforce the antitrust
laws and investigate anti-competitive behavior.
Companies aren’t allowed to
engage in unfair or deceptive practices that end up harming consumers. The
agencies need to be assertive in enforcing these laws.
I’m a co-sponsor of two bipartisan bills that would help
address drug company practices that have delayed the availability of generic
drugs and kept drug costs high for patients. One is the Creating and Restoring
Equal Access to Equivalent Samples (CREATES) Act.
This bill would deter brand
name pharmaceutical companies from blocking less expensive generic alternatives
from entering the market. The brand companies do this by denying access to the
drug samples that generic makers need to develop their generic versions.
second bill is the Preserve Access to Affordable Generics Act. It would help
end the practice of brand name and generic manufacturers’ using anti-competitive
pay-off agreements to keep more affordable generic equivalents off the market.
Another way to lower costs is making sure drug companies
aren’t gaming taxpayer-funded public health care programs. Medicare and
Medicaid are big customers for prescription drugs and medical devices.
they overpay, the taxpayers overpay, and so do the beneficiaries who face out
of pocket copayments. My office found that Mylan relies heavily on Medicare and
Medicaid for its EpiPen revenue. Meanwhile, the federal agency that runs those
health care programs says Mylan has been overcharging Medicaid for EpiPens.
This might have cost the taxpayers hundreds of millions of dollars. Where was
the federal agency while this was going on?
The taxpayers are getting short
shrift, and the Obama Administration has not done its job here. I’m continuing
to ask questions. The Justice Department, and other agencies, now seem to be
Yet another way to drive down drug costs is the reimportation
of prescription drugs from other countries where product safety and
effectiveness can be assured.
The Food and Drug Administration already has the
power to certify the safety of such drugs. The agency hasn’t wanted to use this
power for reasons that are unclear.
The FDA also needs to continue to make progress on its backlog
of generic drug applications. When a company has submitted an application for a
generic product, consumers deserve a timely answer on whether that product is
ready for the marketplace.
And while the FDA’s no. 1 job is protecting public
safety, the agency also needs to make sure not to impose unneeded regulations
that prevent patients from getting new alterative or generic drugs as soon as
There may be other steps that would ease the sticker shock of
sky-high prescription drug prices. In the meantime, I’m working on legislation
and oversight efforts that will make a big difference for consumers and the
people of Iowa.
Effort will give voice to millions of Americans who support
access to personal importation of safe, affordable prescriptions
WASHINGTON, D.C., USA, October 5, 2016 /EINPresswire.com/-- A group of patient advocates and businesses
representing the right of Americans to engage in the importation of
prescription medications from safe, credentialed international pharmacies,
today announced joint support of an unprecedented initiative to ensure
presidential candidates Hillary Clinton and Donald Trump address the issue of
prescription importation at the second presidential debate.
The group includes Daniel Hines, the publisher of TodaysSeniorsNetwork;
RxRights.org; the Campaign for Personal Prescription Importation,
PharmacyChecker.com, and the Prescription Justice Action Group. Together, these
organizations represent more than four million Americans who import medication
for personal use each year.
A 500 percent increase in the price of the EpiPen® has elevated the issue of
high drug prices to the public’s attention and resulted in Congressional
hearings on high drug costs in the U.S. The discussion surrounding unaffordable
drug prices, however, has focused almost exclusively on long term
Americans cannot wait for long term solutions. The Commonwealth Fund reports at
least 35 million Americans failed to adhere to their prescribed drug regimens
in 2014 due to the high cost of their medications. This non-adherence is estimated
to cost $100-$300 billion in avoidable healthcare costs in the U.S. annually,
according to a study in Risk Management and Healthcare Policy (2014).
Meanwhile, the Kaiser Family Foundation found that 71 percent of Americans
support access to safe, affordable medications through prescription importation
The group is asking Americans to support the issue by voting for its
importation question through the Open Debate Coalition forum, at https://presidentialopenquestions.com/questions/12064/vote/.
It is also encouraging supporters to share their stories on social media and
let the moderators of the October 9 presidential debate, Anderson Cooper and
Martha Raddatz, know that Americans want the presidential candidates to explain
how they will provide immediate relief on drug prices and how they’ll fight to
increase access to safe, affordable medications through prescription
importation. Supporters should use the hashtags #RxAccess and #RxImportation to
participate in the discussion.
TodaysSeniorsNetwork , which includes RxforAmericanHealth and
the AmericanRxBillofRights, is America's leading information source for seniors
an issues facing an aging America. Publisher Daniel Hines, an international
award-winning communicator brings his unique perspective to a host of issues
based on his extensive work with policy-makers at the local, state and Federal
levels, elected officials, seniors' and other advocacy groups, and who has
worked extensively on behalf of personal importation of safe, affordable
prescription medicines for 15 years. For the official blog, visithttp://www.todaysseniorsnetwork.com and
for more information, contact Daniel Hines at 636.399.2849 or firstname.lastname@example.org.
RxRights is a national nonprofit coalition of individuals and organizations
dedicated to raising awareness and spurring action around issues related to
U.S. prescription drug pricing. We support the right of Americans to import
medicine from legitimate, licensed online and mail order international
pharmacies. RxRights.org serves as a forum for individuals to share experiences
and voice opinions regarding Americans’ need for affordable prescription drugs.
We encourage participation and discussion through our website. For more
information visit www.rxrights.org or
contact Lee Graczyk: email@example.com or
About Campaign for Personal Prescription Importation
Campaign for Personal Prescription Importation (CPPI) is a national nonprofit
patient advocacy organization that advocates for Americans’ access to safe,
affordable prescription medications from Canada for personal use. Tens of
millions of Americans – especially the elderly and others on fixed incomes –
struggle to pay the extremely high price of prescription medications in the
U.S. We are here to be a voice for them. For more information visit www.personalimportation.org or
contact Rebecca Kelley at firstname.lastname@example.org
is the only independent company that verifies U.S. and international online
pharmacies and compares prescription drug prices. Our verifications and price
comparisons have been referenced by AARP Magazine, the New York Times, the Wall
Street Journal, and many others. We were formed in 2002 when our founder, Tod
Cooperman, M.D., saw that increasing numbers of Americans were looking on the
Internet to save money on medication but did not have adequate information to
protect their health. We are a stakeholder in the online consumer-driven
healthcare community, seeking an open Internet environment that promotes
innovation and new business models, especially those that serve the public
health. For more information, contact Gabriel Levitt at 718.387.4526 or Gabriel.email@example.com.
About Prescription Justice Action Group Prescription Justice Action Group is a not-for-profit organization that is
dedicated to providing relief and protection for American patients.
Prescription Justice Action Group brings together doctors, lawyers, public
health advocates, and companies dedicated to helping people afford medication.
For more information, contact Jodi Dart at 217.306.5823 or firstname.lastname@example.org.
It is time for the American voter to hold Congress
accountable and demand the end to Pharma pricing abuses as exemplified--this
ST. LOUIS, MISSOURI, USA, September 29, 2016 /EINPresswire.com/ --
The publisher of TodaysSeniorsNetwork, which includes RxforAmericanHealth and
the AmericanRxBillofRights, has lauded the members of the House of
Representatives Oversight Committee for its vigorous questioning of both Mylan
Chief Executive Officer Heather Bresch and Dr. Douglas Throckmorton, Deputy
Center Director for Regulatory Programs of the Food and Drug Administration, in
recent hearings about the continuing EpiPen price scandal, but says Congress
must ask itself about its failure to end Pharma pricing abuses.
“It is gratifying to see bi-partisan consensus on the dramatic, undesirable
consequences affecting the health and well-being of American citizens because
of the predatory pricing practices of Pharma,” Daniel Hines said in a letter to
“Hopefully the expressions of outrage and indignation by the members are a
prelude to Congressional action to end Pharma’s charging not just what the
traffic will bear but what it determines to be necessary to inflated profits
despite the harmful consequences to patients that simply cannot afford their
But, Hines notes, there are questions that remain unanswered, and must be
directed to not Pharma but to Congress.
“The questions should be asked by voters across the country as Congress
prepares to recess before the elections,” he says. "It's in the voters'
The questions include, When will Congress act? What will it take to make it
act? Why has it not acted before, choosing instead to hold what seem to be
endless ‘investigations? How does the FDA ignore previous Congressional
Direction? What penalties are there other than fines for Pharma’s errant
actions and misleading Congress? What is the harmful effect of unaffordable
maintenance medicines that are a vital lifeline to patient? Why has Congress
not implemented allowed personal importation of brand-name medicines from Tier
One Countries to ensure that Americans have access to such a vital life-line?
In his letter to Committee members, Hines asked the following questions:
1. Throughout the hearing, Committee members noted that ‘they had been here
before’, charges were leveled against Ms. Bresch’s statements calling them
‘rope-a-dope,’ ‘a shell game,’ and suggesting that perhaps this will be the
impetus that will finally lead to Congressional action. But, If this latest
example of Pharma abuse does not lead to Congressional action, what will it
take? When will Congress act? Why is there a delay?
2. The testimony of Dr. Throckmorton, M.D., and his non-responsive answers to
requests from the Committee, were appalling. His refusal to share information
with the Chair of the Committee was particularly troublesome, and is indicative
of the FDA, an agency ostensibly designed to protect the health and well-being
of Americans, claiming equal status with Congress. Another example of such a
blatant rejection of Congressional oversight is its refusal to implement ‘march
in’ rights for more than 35 years, even in light of a recent bi-partisan
Congressional request from 51 members of Congress. ‘Why does Congress allow the
FDA to act in such an authoritative manner, refusing to acknowledge
Congressional oversight?’ Also, why did the FDA reportedly deny the application
of Teva for a competitive product to EpiPen on the basis of patent exclusivity
of the design of the Mylan product?
3. The Wall Street Journal and others report that Ms. Bresch “underreported”
Mylan profits by 60 percent, manipulating tax payment claims that, according to
the WSJ did not apply to Mylan. Senators Amy Klobuchar (D-MN), Chuck Grassley
(R-IA) and Richard Blumenthal (D-CT) have asked the Department of Justice to
investigate whether Mylan has committed fraud. Will this claim be investigated
further by Congress or DOJ? If the charge is found to be true, what will be the
4. There was a consensus on the Committee that a medicine that is unaffordable
is, in and of itself, unavailable. You can’t buy what you can’t afford. But,
millions of Americans have for years been denied the health benefits of access
to a regimen of their prescribed medicines. It is virtually impossible to
estimate the adverse impact to the health of individuals and society that have
occurred simply because they can’t afford their medicines, due to Pharma and
the FDA ignoring previously adopted directives to the FDA and HHS to explore
and facilitate what is a readily available, affordable and safe resolution to
the fact that Americans pay the highest prescription prices in the world—i.e., the
personal importation of safe, affordable brand-name prescription medicines from
licensed, registered pharmacies in Tier One Countries whose standards of safety
and efficacy meet or exceed those of the U.S.
5. Congress has introduced legislation that would allow personal importation
many times over the past 15 years. Millions of Americans have personally
imported their medicines for years despite by FDA and Pharma opposition. Both
current Presidential candidates support some form of personal importation of
prescriptions from Canada and Tier One Countries as a means to lower
prescription costs. There are bi-partisan bills for personal importation that
have been introduced in the current Congress. But the FDA claims it cannot
verify the safety and efficacy of drugs produced outside this country and that
are personally imported , although it works with Pharma to provide oversight of
the more that 80 percent of the prescription ingredients that are produced
outside the U.S., and has stated that it is seeking greater cooperation with
counterpart oversight agencies outside the U.S. Added to this is that while
millions of Americans have been denied access to affordable medicine because of
Pharma pricing practices, millions more have turned to personal importation of
safe, affordable medicines for years, leading to the question, why does
Congress fail to enact enabling legislation for personal importation?
Hines concludes, “One can only hope that the Mylan hearings will lead to a
consensus-building initiative that will result in comprehensive legislation as
outlined in the American Rx Bill of Rights and finally ending the ‘be damned’
attitude of Pharma.
of the U.S. House of Representatives Committee on Oversight and Government
I am writing
in my capacity of publisher of the TodaysSeniorsNetwork series of blogs dealing
with issues facing an aging America and the need for policies to lower the
costs of prescription medicines in the U.S. to applaud your intensive questioning
of Mylan CEO Heather Bresch during your recent hearings.
gratifying to see such bi-partisan consensus on the potential of the dramatic,
undesirable consequences affecting the health and well-being of American
citizens because of the predatory pricing practices of Pharma. The many
expressions of outrage and indignation are, hopefully, welcomed preludes to
Congressional action to end Pharma’s attitude of charging not just what the traffic
will bear but what it determines to be necessary to inflated profits despite
the consequences to patients that simply cannot afford their medicines.
But there are
questions that remain unanswered, and must be directed to not Pharma but to Congress:
1.Throughout the hearing, members of the Committee noted that ‘they had
been here before’, charges were leveled against Ms. Bresch’s statements calling
them ‘rope-a-dope,’ ‘a shell game,’ and suggestions that perhaps this will be
the impetus that will finally lead to Congressional action. While such comments are welcomed, question
must be asked: “If this latest example of Pharma abuse does not lead to
Congressional action, what will it take?
When will Congress act? Why is
there even a delay?
2.The testimony of Douglas Throckmorton, M.D., Deputy Center Director for
Regulatory Programs of the Food and Drug Administration, and his non-responsive
answers to requests from the Committee, while not surprising, were appalling. His refusal to share information with the
Chair of the Committee was particularly troublesome, but is indicative of the FDA,
an agency ostensibly designed to protect the health and well-being of Americans,
claiming an equal status with Congress.
Another example of such a blatant rejection of Congressional oversight was
its refusal to implement ‘march in’ rights for more than 35 years, even in
light of a recent bi-partisan Congressional request from 51 members of Congress
for such action. A question that must be
addressed is ‘Why does Congress allow the FDA to act in such an authoritative
manner, and to basically refuse to acknowledge Congressional oversight?’ Also, why did the FDA reportedly deny the
application of Teva for a competitive product to EpiPen on the basis of patent
exclusivity of the design of the Mylan product?
3.As I write this letter, the Wall Street Journal is reporting that Ms.
Bresch “underreported” Mylan profits by 60 percent, manipulating tax payment claims
that, according to the WSJ did not apply to Mylan. This leads to two questions: Will this claim
be investigated further by the Committee? If the charge is found to be true, will that
lead to the possibility of a perjury charge?
4.It was especially gratifying to note that there was a consensus among
many members of the Committee that a medicine that is unaffordable is, in and
of itself, unavailable. You can’t buy
what you can’t afford. But, millions of
Americans have for years been denied the health benefits made possible by
access to a regimen of their prescribed medicines. It is virtually impossible to estimate the
adverse impact to the health of individuals and society that have occurred
simply because they can’t afford their medicines. This is due to Pharma and the
FDA ignoring previously adopted directives to the FDA and HHS to explore and
facilitate what is a readily available, affordable and safe resolution to the
fact that Americans pay the highest prescription prices in the world—i.e., the
personal importation of safe, affordable brand-name prescription medicines from
licensed, registered pharmacies in Tier One Countries whose standards of safety
and efficacy meet or exceed those of the U.S.
5.Ironically, for many years, Congress has introduced legislation that
would allow such personal importation.
Both Presidential candidates support some form of personal importation
of prescriptions from Canada and Tier One Countries as a means to lower
prescription costs. There are
bi-partisan bills for personal importation that have been introduced in the
current Congress. But the FDA claims it
cannot verify the safety and efficacy of drugs produced outside this country,
although it works with Pharma to provide oversight of the more that 80 percent
of the prescription ingredients that are produced outside the U.S., and has
stated that it is seeking greater cooperation with counterpart oversight
agencies outside the U.S. Added to this
is that while millions of Americans have been denied access to affordable
medicine because of Pharma pricing practices, millions more have turned to personal
importation of safe, affordable medicines for years, leading to the question, why
does Congress fail to enact enabling legislation for personal importation?
it, one can only hope that the Mylan headings will lead to a consensus-building
initiative that will result in comprehensive legislation as outlined in the
American Rx Bill of Rights included with this letter. Thank you for your
consideration of the issues presented.
We respectfully urge action to finally address the harmful impacts of
the predatory pricing practices of Pharma, resulting in improved health and
well-being of Americans.
Daniel Hines Daniel Hines
The Articles of the American Rx Bill of
It is time to call out the harmful
effects of the undue influence of Pharma upon public health policy. It is
time for an Rx Bill of Rights on behalf of All Americans
Article One (A Basic Right to Good Health)
The impact of millions of Americans being denied the health
benefits of access to a regimen of safe, affordable medicines because of cost
is a national health issue that has yet-to-be-recognized consequences.
That is why the ability of American Citizens to make health care
decisions in concert with their physicians such as the purchase of
personally imported safe, affordable prescription medicines should not be
hampered by any actions by government or private entities as a policy to
restrict Americans' access to authentic medicines.
Article Two (An Unaffordable Medicine is Unavailable)
A prescription medicine that is unaffordable is unavailable,
thereby meeting the 'rules' of the FDA that such a medicine that is otherwise
unavailable is indeed eligible to be personally imported by an American
patient, Arbitrary denial by the FDA to such access is detrimental to the
health of the patient by denying him or her access to vital maintenance
medicines. This is a violation of the purpose of the FDA which is ostensibly
designed to protect the health and well-being of American citizens.
Article Three (Citizens as Stakeholders)
The relationship between the FDA, elected
officials, and Pharma has led to numerous abuses, access by Pharma to
legislators and other elected officials based on the contribution of millions
of dollars, favored status for Pharma representatives and their front groups as
the primary representative at public hearings to determine the health care
policy for Federal, State and Local Governments, thereby skewering the
decision-making process. That why it is incumbent upon Congress that it
act to ensure that ordinary American citizens whose health and finances are
adversely affected by Pharma pricing practices, advocacy groups other than
those of Pharma, are given a 'stakeholder' status equal to that of Pharma.
Article Four (Due Process)
Americans who purchase safe, affordable medicines from licensed,
registered pharmacies in Tier One Countries whose standards meet or exceed
those of the U.S., are the legitimate owners of their authentic medicines and
are entitled to exercise their due process rights to have their personal
property free from undue and unjustified seizure oar destruction by any
governmental agency unless the seizing authority can demonstrate via
established judicial processes and to courts that such seizures are of bogus,
counterfeit or unsafe prescription medicines.
Article Five (Public Interest)
Americans are significant contributors to the development of
research and development costs of new medicines through their tax dollars in
support of grants to the National Institutes of Health (NIH), and, as such,
should be protected from unfair or questionable patent protection granted to
Pharma that fails to recognize the rights of American citizens. Abuses in
pricing, illegal business activities, or undue influence upon policy-making by
the FDA or elected officials should result in a reduction of the patent
protection afforded Pharma to the detriment of untold numbers of Americans who
must be able to pay what Pharma believes the traffic will bear.
Article Six (Reciprocity)
The FDA should extend reciprocity to other Tier One countries in
the interests of the health of American citizens. The majority of brand name
prescription medicines sold to Americans is manufactured at plants outside the
U.S., under FDA supervision, or at plants licensed by Pharma members to produce
medicines under a license granted by a particular company, a validation that
medicines produced outside the U.S. and sold in this country are indeed capable
of being safe. Also, the FDA has entered into agreements with regulatory
agencies in many countries to assume the task of overseeing ingredients
manufacture of ingredients for brand name medicines. Added to that is
that many countries (excluding the U.S and the FDA) have reciprocal agreements
(Memorandums of Understanding) that one country will accept the medications
produced in another country as safe and authentic.
may have knowingly misclassified the EpiPen in order to reap huge profits at
the expense of states and taxpayers
WASHINGTON, D.C., September 30,
2016 – U.S. Senators Richard Blumenthal (D-CT), member of the Judiciary
Committee, Chuck Grassley (R-IA), chairman of the Judiciary Committee, and Amy
Klobuchar (D-MN), ranking member of the Judiciary Subcommittee on Antitrust,
Competition Policy, and Consumer Rights, have called on the Department of
Justice (DOJ) to consider investigating whether Mylan Pharmaceuticals violated
the law when it apparently misclassified its EpiPen product in order to pay a
lower rebate to states and reap huge profits at the expense of taxpayers.
“The American people have been rightly outraged as Mylan
engaged in substantial price increases that resulted in billions of dollars
paid by U.S. consumers,” the Senators wrote. “They deserve to know whether the
company also violated the False Claims Act and diverted millions of dollars
from U.S. taxpayers.”
More than ten years ago, Mylan classified EpiPen as a
“Non-Innovator Multiple Source Drug,” or generic drug, for purposes of the
Medicaid Drug Rebate Program. In order to protect states from high pharmaceutical
prices, the Medicaid Drug Rebate Program requires drug companies to pay a
percentage of their revenues to states in the form of rebates. Under this
program, companies like Mylan are required to pay a higher rebate for
brand-name drugs than for generic drugs. In a letter to the DOJ today, the
Senators cited evidence that Mylan may have knowingly misclassified EpiPens,
potentially in violation of the False Claims Act and other statutes.
The text of the letter is available here and below.
Dear Attorney General Lynch:
write to inquire whether the Department of Justice has considered an
investigation into whether Mylan Pharmaceuticals violated the law when it
apparently misclassified its EpiPen product for purposes of the Medicaid Drug
created the Medicaid Drug Rebate Program to protect states from high pharmaceutical
prices by requiring drug companies to pay a percentage of their revenues to
states in the form of rebates. Crucially, the Medicaid Drug Rebate Program
distinguishes between “innovator drugs”—new products that are generally
insulated from generic competition by patents—and “non-innovator multiple
source” (NIMS) drugs—older products that are available from multiple sellers.
Companies pay a rebate of 13 percent of the price of non-innovator drugs. For
innovator drugs, sellers pay a minimum rebate of 23.1 percent, but they can pay
far more for drugs that experience large price hikes.
companies are responsible for determining whether their products are innovator
or NIMS drugs. Companies can reap huge profits, at the expense of the states
and taxpayers, by misclassifying innovator drugs as NIMS drugs. In the past,
the Department has secured settlements against drug companies under the False
Claims Act for such practices—including against Mylan Pharmaceuticals.
has classified the EpiPen as a NIMS drug since acquiring the product license in
2007. According to press reports, however, the Center for Medicare and Medicaid
Services (CMS) has stated publicly that this is incorrect.
first indicator that the EpiPen should not be classified as a NIMS drug is the
plain text of the relevant statute. Under section 1927(k)(7)(A) of the Social
Security Act, for a drug to be classified as a NIMS there must be “at least 1
other drug product which . . . is rated as therapeutically equivalent.”
In other words, the NIMS drug must face an FDA-approved competitor. The EpiPen
faces no such competitor, and it has not since Mylan began selling the product.
second indicator comes from Mylan’s own behavior. The Medicaid Drug Rebate
Program imposes a higher rebate on innovator drugs because innovator drugs are
generally protected by patents. Shortly after Mylan began marketing the EpiPen,
it sued Teva Pharmaceuticals for patent infringement, leading to a settlement
that kept Teva out of the EpiPen market until late 2015. During this
timeframe, Mylan increased its prices dramatically, including a rise from $265
to $609 in the last three years.