Friday, December 2, 2016

President-Elect Trump Urged: Act on Campaign Pledge to allow personal importation of safe, affordable medicines

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.
 “Personal importation 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.
An October Kaiser Health Tracking Poll found 74 percent of the American public believes high prescription drug prices are a priority issue. Prescription drug prices in the U.S. are the highest in the world. Americans often pay twice as much or more than 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 patient. 
·          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.
·          PhRMA has a proven record of undue and troubling influence in healthcare policy.
o   The lobbying group met with the President of the United States in closed-door meetings to influence prescription policy related to the Affordable Care Act.
o   PhRMA and its front groups influence the U.S. House of Representatives and the Senate through millions of dollars of campaign contributions.
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.
Sincerely,

Lee Graczyk,
Lead Organizer
RxRights.org

Daniel Hines
Publisher
TodaysSeniorsNetwork.com


Thursday, December 1, 2016

New Survey: Consumers Hold Drug Companies Responsible for High Prices and Out-of-Pocket Costs

WASHINGTON, 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 prescription drugs.

"Consumers 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.

North Star Opinion Research surveyed 1,000 registered voters nationwide.

Key findings from survey include:
By almost 3-to-1, voters blame high drug prices for increased cost-sharing.
Only 1-in-5 voters buy the drugmakers' "rebates cause high prices" message.
Three-quarters of voters say the cost of prescription drugs is too high.
More than 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.


SOURCE Pharmaceutical Care Management Association

Monday, October 17, 2016

Senator Grassley: Competition is key to controlling drug costs, including a role for personal importation of prescription meds

By Senator Chuck Grassley
Top of Form
Bottom of Form

Congress must act to use personal importation to lower drug prices
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. 

Paying 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. 

The 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. 

When 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 paying attention.

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 possible.


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.

Wednesday, October 5, 2016

ADVOCACY GROUPS LAUNCH JOINT EFFORT TO ENSURE PRESIDENTIAL CANDIDATES ADDRESS LOWER DRUG COSTS AT NEXT DEBATE

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 solutions.

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 (September, 2016).

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.

About TodaysSeniorsNetwork
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 todaysseniorsnet@sbcglobal.net. 

About RxRights
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: lee@rxrights.org or 1-866-703-5442.

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 info@personalimportation.org or 202.765.3290.

About PharmacyChecker.com
PharmacyChecker.com (www.pharmacychecker.com) 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.levitt@pharmacychecker.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 jodi@pjag.org.
 –

Daniel Hines
TodaysSeniorsNetwork
636-399-2849
email us here

Friday, September 30, 2016

Publisher Lauds Committee for Mylan investigation, says time for Congress to pass legislation cutting Drug Prices


It is time for the American voter to hold Congress accountable and demand the end to Pharma pricing abuses as exemplified--this time--by Mylan

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 Committee members.

“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 medicines.”

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' hands."

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 result?
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.

Daniel Hines
TodaysSeniorsNetwork
636-399-2849
email us here

Open Letter to Members of Congress.Asks: What will it take to get Congress to act to lower prescription dug prices?

 
The following letter was sent to members of the House Committee on Oversight and Government Reform by Publisher Daniel Hines



Daniel Hines, Publisher, TodaysSeniorsNetwork
Phone: 636-386-5234
Fax:  636-386-5904
Cell Phone: 636-399-2849
Email: TodaysSeniorsNet@sbcglobal.net

Dear Members of the U.S. House of Representatives Committee on Oversight and Government Reform:

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.

It is 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?

In conclusion, 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.

Respectfully submitted,
Daniel Hines
Daniel Hines

The Articles of the American Rx Bill of Rights
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.


BLUMENTHAL, GRASSLEY, KLOBUCHAR CALL FOR DEPARTMENT OF JUSTICE TO CONSIDER INVESTIGATING MYLAN

Mylan may have knowingly misclassified the EpiPen in order to reap huge profits at the expense of states and taxpayers

Mylan might be target of DOJ investigationWASHINGTON, 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:

We 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 Rebate Program.

Congress 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.

Pharmaceutical 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.[1]

Mylan 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.[2]

The 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.[3]” 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.


The 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.[4] During this timeframe, Mylan increased its prices dramatically, including a rise from $265 to $609 in the last three years.[5]