Making the case for Personal Importation as a tool to lower drug costs—an open appeal to President Trump as he formulates executive orders

(Part 1 of 2-parts: )

President Donald Trump, whose administration has been hamstrung in keeping one of his most significant campaign pledges—to lower the cost of prescription medicines--, now has apparently decided to take the course of issuing executive orders to end the tragedy  that continues to plague American patients, namely living in the country with the highest costs prescription medicines of any industrialized nation in the world and being denied access to vital medicines.

We have issued news releases and blogs urging that the President take such action, and move it out of the purview of members of the U.S. Congress who receive millions of dollars from Pharma in campaign contributions. 

At the same time, we believe the President must accept some of the burden of the blame for the inaction.  He has appointed a Health and Human Services Secretary, former Representative Tom Price, who is decidedly pro-Pharma, and who, many believe, even profited from stock purchases of a Pharma stock that increased tremendously in value based upon inside knowledge.

Also, the President’s appointee (Scott Gottlieb) as Commissioner of the Food and Drug Administration (FDA), apparently believes that the ‘free market’ is the primary tool to lower the costs of over-priced medicines, and opposes personal importation of safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S. He also opposes negotiation by the government with Pharma, choosing instead to look to stepped-up introduction of generics as the primary route to lowering the costs of medicines.

As for Congress, it continues to stumble along with plan after plan, proposed legislation, including the fatally flawed S. 469, hailed by many Democrats as the save-all concept to lower prescription drug costs.  The bill is based upon an equally flawed effort of 2003 when it was first introduced. The legislation has already raised vigorous opposition among groups not only in the U.S. but also in Canada because it would impose U.S. oversight on Canadian-based operations such as provincial licensing authorities in Canada, and even Health Canada.

This is more than unfortunate, it is tragic because it illustrates what can only be considered the politicalization of an important American healthcare issues, e.g., the beneficial impact upon the health and well-being of American patients from access to adherence to a regimen of authentic prescription medicines.

The estimates vary, but the undeniable fact is that millions of American patients forego such adherence simply because the medicines themselves are so high-priced that they are unaffordable, making them, in and of themselves, unavailable.

While we are faced with the spectacle of an ineffective response from Congress, which continues to offer narrowly defined proposals ranging from personal importation to transparency to more generics to penalties for Pharma price gouging , and conducting time-consuming hearings that result in nothing, while Pharma continues to thumb its collective nose to the American people and set prices beyond the reach of patients.

At the same time, a score of group and organizations issue periodic statements, collective letters and develop positions that address the costs and availability of medicines that costs thousands of dollars, all the while ignoring the fact that these commendable efforts are not mutually exclusive from the inclusion as part of recognition of the harmful impact of lack of access to any medicine, and that an unaffordable maintenance medicine is just as unavailable to untold numbers of patients  as a medicine that costs $120,000 a year.

As an advocate for role for Personal Importation of brand-name prescription medicines, and as a supporter of a comprehensive approach to address all elements of the negative impact of Pharma pricing abuses, and the rapidly evolving record of abuses by huge pharmacy benefit managers, I believe it is tragic that the discussion about the costs and availability of any medicine has become so highly segmented. 

That is why it is incumbent upon the President to provide  leadership by creating policies that will result in a truly comprehensive solution with personal importation being recognized as not only a part of his strategies, but as the only offering a degree of immediate relief to the dilemma of 55 million Americans not being able to afford their medications.

While many of the challenges of new medicines, value, and prices will be met in the future, the fact is that personal importation is a readily, safe available strategy that has already been embraced by millions of Americans, and has received support from policy-makers at local, state and Federal levels, even in the face of Pharma opposition and Congressional inaction!

Why then, has the personal importation of safe, brand-name medicines from licensed registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S. not become a part of the solution when an examination of the facts makes the case for such a strategy from to allow personal importation of prescription and offer benefits to the health and well-being of Americans.

For more than a quarter-century, Americans have been victims of the predatory pricing practices of Pharma. 

•        Americans pay the highest prescription prices in the industrial world

•        This is based upon a national policy of allowing the industry to ‘charge what the traffic will bear’

•        The Pharmaceutical Industry has created alliances, influenced governmental policy, colluded with regulatory agencies designed to ensure prices are affordable, and literally ‘bought’ overwhelmed the U.S. Congress with the most contributions of any industry segment in the U.S.

•        Result #1—A denial for an estimated 55 million Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line medicines, simply because they are unaffordable

•        Result # 2—The ‘hoped-for’ answer to the scourge of unaffordable medicines—generic medicines—have seen price spikes that have made many of them equally unavailable to American patients.

•        Result # 3—Literally millions of Americans suffer from diseases—many of them life-threatening—raising the question of a possible link to the cause-effect impact of unaffordable but vital maintenance medicines that could have benefitted patients  and deterred the harmful effects of their disease.

•        Result # 4—Pharma raises prices, on specialty medicines to thousands of dollars for treatments, even though many of the costly medicines are older, lower-cost medicines, and manufacturers are simply taking advantage of the illness of Americans.

•        Result # 5—Congress becomes indignant, holds hearings, witness testify, advocacy groups coalesce to ‘address’ price challenges, but…prices remain high, Congress continues with more hearings…and Americans continue to pay the highest prices in the world…WHY?

•        RESULT #6--Because Pharma and its allies in the House of Representatives and the U.S. Senate who are the beneficiaries of Pharma’s extensive contributions have controlled the discussion on how to lower prescription and health care costs while Pharma continues to rake in obscene profits, and American patients continue to be denied their medicines.

It is time for a change!  American patients can’t wait any longer!

Brand Name Drug Prices Increase Nearly 130 Times Faster Than Inflation

New AARP report shows fourth straight year of double-digit price average annual increases for widely used brand name drugs

Washington/PRNewswire-USNewswire/, December 2016-- Retail prices for brand name prescription drugs widely used by older Americans rose by an average of 15.5% in 2015—almost 130 times faster than the 0.1% general inflation rate—according to a new AARP Public Policy Institute (PPI) report 

AARP's Rx Price Watch Report: Trends in Retail Prices of Brand Name Prescription Drugs Widely Used by Older Americans, 2006-2015, shows that the average annual cost for one brand name drug used on a chronic basis now exceeds $5,800.

For the average older American taking 4.5 prescription drugs per month, this translates into an average annual cost of therapy of $26,000*. This amount exceeds the median income of $24,150 for Medicare beneficiaries.   

Retail Prices for 6 Brand Name Drugs Increased by 500%+ from 2006-2015

"This new report once again highlights the high and unrelenting price increases that are shockingly common in the pharmaceutical market," said AARP Chief Public Policy Officer Debra Whitman.

"What's particularly remarkable is that these incredibly high price increases are still occurring in the face of the intense public and congressional criticism of prescription drug pricing practices."

Highlights of the Rx Price Watch Report

• The average annual retail price increase for widely used brand name prescription drugs was more than two and a half times higher in 2015 (15.5%) than in 2006 (5.9%).
• Brand name drug prices increased almost 130 times faster than general inflation in 2015 (15.5% vs 0.1%).
• In 2015, the average annual retail cost of one brand name medication used to treat a chronic health condition more than $5,800, compared with nearly $1,800 in 2006.
• Retail prices increased for 97% of the 268 brand name prescription drugs in the study's market basket.
• Seven widely used brand name drugs had average annual retail price increases of over 50% in 2015.
• Five of the six drugs with the highest cumulative price increases over the study period were marketed by Valeant Pharmaceuticals. The retail price of Valeant's anti-anxiety drug, Ativan 1 mg tablets, increased by 2,873% between 2006 and 2015.

"Prescription drug therapy is not affordable when its cost exceeds the patient's entire income," said Leigh Purvis, Director of Health Services Research, AARP Public Policy Institute, and co-author of the report.

 "Even if patients are fortunate enough to have good health care coverage, high prescription drug costs translate into higher out-of-pocket costs—especially for those who pay a percentage of drug costs rather than a fixed copayment—as well as higher premiums, deductibles, and other forms of cost-sharing."

Rx Price Watch Report Methodology

AARP's Public Policy Institute, in collaboration with the PRIME Institute at the University of Minnesota, developed a market basket of 268 brand name prescription drug products widely used by older Americans.

Using data from the Truven Health MarketScan® Research Databases, the report analyzed retail price changes between 2006 and 2015 for the drug products in the market basket.

The medications include products in 49 therapeutic categories used to treat common and often chronic health conditions, including high cholesterol, diabetes, and hypertension.

This report is the latest in the AARP Public Policy Institute's Rx Price Watch series. Separate reports analyze price changes for widely used generic and specialty drug products.

The series also analyzes the price changes for an overall market basket (i.e., brand name, generic, and specialty drug products combined) to reflect the overall market impact of drug price changes.

The full report can be found here: http://www.aarp.org/rxpricewatch

*These prices reflect the total costs for specific prescriptions and may not reflect the actual out-of-pocket costs (such as a copay) that a consumer would pay at the pharmacy.

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

By Senator Chuck Grassley

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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.

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

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

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:

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]

Candidate call for temporary importation of meds proves FDA can and should work to review personally imported brand-name prescriptions from Tier One Countries

ST. LOUIS, MISSOURI, USA, September 7, 2016 /EINPresswire.com/ -- The publisher of RxforAmericanHealth says Hillary Clinton’s plans to lower prescription prices proves that the Food and Drug Administration, Pharma and Pharma supporters have misled the American Public about the ability to ascertain authenticity and safety of personally imported medicines!

Daniel Hines notes that Ms. Clinton’s plan calls for importing medicines when drug prices are ‘threatening’ the health of Americans because the drugs are unaffordable.

“This should be extended to unaffordable ‘maintenance’ brand-name drugs that millions of Americans rely upon as a vital health link,” Hines says.

He suggests that while her plan calls for ‘temporary’ personal importation, she likely would have to use executive orders to implement ‘temporary ’importation because of Congress’ failure to even vote on bills allowing personal importation of brand-name medicines from licensed, registered pharmacies in Tier One Countries.

“Congress should end its seemingly endless delays, investigations, statements, and business as usual,” Hines says.

As to being able to validate the safety and authenticity of imported medicines which the FDA and Pharma have said is not possible, Hines notes that:

• The Clinton stance clearly relies upon medicines from what can only be construed at Tier One Countries with proven standards of safety and efficacy;

• She points out that the FDA has previously allowed such ‘emergency’ importation;

• This illustrates that, contrary to repeated claims of the Food and Drug Administration regarding personal importation that :

o It is possible to monitor and certify the safety, authenticity of brand name medicines ‘imported’ to the U.S.;

o Since such ‘importation’ would have to be implemented quickly to be of benefit indicates that the FDA is capable of validating the sourcing, manufacture, packaging, safety and efficacy of such medicines. It has for years cooperated with foreign sources for ingredients’ oversight, and has certainly worked with regulatory agencies in other countries during previous ‘emergency’ importation;

o The implementation of ‘temporary importation’ is proof of the safety and efficacy of imported medicines as well as their immediate economic benefit, and, their favorable impact upon Americans’ health.

o The lie to claims by Pharma and the FDA that a medicine allowed to be imported from a Tier One Country cannot be validated would be repudiated.

“A medicine that is imported in an ‘emergency’ situation that is safe and authentic does not become fraudulent after the ‘emergency’ is over, Hines says.

“When a medicine—any medicine—is unaffordable, it is unavailable, and that unavailability creates a health crisis for the individual denied access to vital medicines.”

Hines explains that a ‘temporary importation’ would illustrate the contradiction of a policy that raises questions about the ‘legality’ of personal importation, since it clearly shows that the Federal Government is willing to consider importation as a part of a national policy to lower prescription drug costs to protect the health of Americans;

“It is time that that recognition of the potential benefit to fair pricing of medicines and the right to importation should be extended to the millions of Americans who are unable to afford not only their specialty medicines, but their highly important maintenance medicines that have been proven in the Rand study of enrollees in the Affordable Care Act to improve patient health and lower drug spending”

Hines notes that the Clinton plan calls for consumer involvement and representation in an oversight group to monitor and determine when price abuses by Pharma have occurred, one of the key articles of the American Rx Bill of Rights.

He explains however that the key to the effectiveness of such a group will be based on a determination of the members of the ‘consumer’ advocacy segment and how they will be selected.

“The concept is a valid approach, but only if implemented in such a fashion as to include truly representative advocacy groups that represent patients’ rights and needs,” he notes.

He also says that the strong emphasis in the Clinton plan on the role of generics may be misplaced.

“In what is can only be construed as an admission of the failure of reliance upon generics to lower drug costs because of their being co-opted for many of the price increases in the past 18 months, the Clinton place calls for fines and penalties to be assessed against Pharma and generic industry firms that are found to profit from excessive price increases,” Hines says.

He lauds the plan calling for an end to several key elements of Pharma strategies: One is ending pay-to-delay, a tactic to delay the introduction of generics to replace brand-name drugs scheduled to lose patent protection; another is a call for negotiating Medicare Drug prices; The plan would also call for an end to the backlog of generic applications awaiting approval at the FDA; and, in one of the most dramatic recommendations, it calls for an end to direct-to-consumer (DTC) advertising by Pharma, with the money spent on DTC being redirected to Research and Development.

Hines says that Pharma has, because of its extensive lobbying and financial support of candidates at the state and Federal levels, been able to turn aside any effort to erode its ability to engage in a ‘what the traffic will bear’ pricing approach.

“ If any strategy—be it that of Ms. Clinton or Candidate Trump—is to succeed in lowering prescription drug prices, both candidates would be well-served to remember that years ago, at a press conference after a Pfizer Board meeting, then-CEO Henry McKinnell commenting on remarks by Minnesota Governor Tim Pawlenty said that efforts to lower prescription prices were nothing more than “a Prairie Fire that breaks about every four years as an election issue and then burns out.’’

“It is time to end the pricing abuses of Pharma and to implement policies that will lead to the health benefits that only access to safe, affordable prescription medicines can provide. Failure to do so will once relegate the rights of Americans to enjoy the benefits of good health such access can provide in the ‘ashes of yet another Prairie Fire.’

Clinton recommendations to end Pharma pricing abuses, including a role for ‘emergency’ importation of medicines, proving that the FDA, Pharma and Pharma supporters have misled the American Public on the ability to ascertain the authenticity and safety of personally imported medicines

by Daniel Hines, Publisher

Hillary Clinton’s strategy to deal with lowering prescription prices is the most comprehensive approach employing several action steps that have previously been introduced only as individual actions reliant upon reaction to a series of Pharma price abuses.

As such, it represents hopefully an end to Pharma’s actions that have been based on its confidence that it can charge what the traffic will bear, thumbing its Collective nose at Congress and the American public.

Most importantly, its stand on imported medicines proves that the Food and Drug Administration Pharma and Pharma supporters have misled the American Public on the ability to ascertain the authenticity and safety of personally imported medicines!

 While GOP Candidate Donald Trump has indicated his support for strategies to lower prescription drug costs, he has yet to come forth with specifics to lower prescription drug prices.

Also, while the Democratic Party Platform specifically endorsed and supported a role for Personal Importation, an end-to-pay to delay and other steps to lower prescription drug prices, the GOP Platform had no mention of healthcare except for a call for repeal of the Affordable Care Act (ACA).

Additionally, former GOP Speaker of the House Newt Gingrich recently touted the GOP Platform as supporting ‘Pharma innovation and research and development’.  Gingrich specifically attacked the role of Personal Importation of brand-name medicines from Tier One Countries, asking only that the American public adopt a ‘trust us’ attitude towards Pharma.

An examination of Ms. Clinton’s proposal is triggered by a realization of the fact that unaffordable medicines are, in and of themselves, unavailable because of their unaffordability. 

At the same time, it is limited because it deals with ‘emergency-like’ crises that continue to occur with a disturbing frequency as Pharma continue its pricing abuses.  That’s why it is time that the Presidential candidates take a strong stand to enact permanent—not just temporary or emergency-related incidents.  Some thoughts on her plan follow:

• ·       Her plan calls for implementation when drug prices are ‘threatening’ the health of Americans because the drugs are unavailable due to their price. This should be extended to unaffordable ‘maintenance’ brand-name drugs that millions of Americans rely upon as a vital link to their health and well-being;
• ·       While her plan calls for ‘temporary,’ personal importation,  if she were elected, she likely would have to use executive orders to implement and utilize such a ‘temporary’ role for importation. That’s why Congress should end its seemingly endless delays,  investigations, statements, and business as usual;
• ·       Her stance clearly calls upon medicines from what can only be construed as a reliance upon Tier One Countries with proven standards of safety and efficacy that meet of extend those of the U.S.;
• ·       She points out that the Food and Drug Administration has in the past allowed such ‘emergency’ importation;
• ·       This is a tacit admission and recognition of the fact that, contrary to repeated claims of the Food and Drug Administration regarding personal importation that :
• o   It is indeed possible to monitor and certify the safety, authenticity of brand name medicines ‘imported’ to the U.S.;

o   The fact that such ‘importation’ would have to be implemented quickly to be of benefit indicates that the FDA also is capable of such validation of the sourcing, manufacture, packaging, safety and efficacy of imported medicines, particularly since it has for years cooperated with foreign sources for ingredients' oversight, and it has worked with regulatory agencies in other countries during previous ‘emergency’ importation;

o   The implementation of even a temporary importation’ program would be proof positive of the safety and efficacy of imported medicines as well as their immediate economic benefit, and, in the long-term, their favorable impact upon American’s health.  The lie to claims by Pharma and the FDA that a medicine allowed to be imported from a Tier One Country cannot be validated would be repudiated. A medicine that is imported in an ‘emergency’ situation that is safe and authentic cannot become fraudulent after the ‘emergency’ is over.  Simply put, when a medicine—any medicine—is unaffordable, it is unavailable, and that unavailability creates a crisis and emergency situation for the individual denied access to vital medicines;

o   A ‘temporary importation’ would illustrate the contradiction of a policy that raises questions about the ‘legality’ of personal importation, since it clearly illustrates that the Federal Government is willing to consider importation as a part of a national policy to lower prescription drug costs to protect the health of Americans;

o   That benefit to medicines and the right to purchase them via personal importation should be extended to the millions of Americans who are unable to afford not only their specialty medicines, but their highly important maintenance medicines—maintenance medicines that have been proven in the Rand study of enrollees in the Affordable Care Act to improve patient health and lower total drug spending;

o   The Clinton plan calls for consumer involvement and representation in an oversight group to monitor and determine when price abuses by Pharma have occurred, one of the key articles of the American Rx Bill of Rights.  The key to the effectiveness of such a group will be based on a determination of the members of the ‘consumer’ advocacy segment and how they will be selected. The concept is a valid approach, but only if implemented in such a fashion as to include truly representative advocacy groups that represent patients’ rights and needs;

o   There is a strong emphasis in the Clinton plan on the role of generics.  But, in what is can only be construed as an admission of the failure of such a previous reliance upon generics to lower drug costs because of their being co-opted for many of the price increases in the past 18 months, the Clinton plan calls for fines and penalties to be assessed against Pharma and generic industry firms that are found to profit from excessive price increases;

o   The plan calls for an end to several key elements of Pharma strategies:  One is  pay-to-delay, a tactic to delay the introduction of generics to replace brand-name drugs scheduled to lose patent protection; another is a call for negotiating Medicare Drug prices; The plan would also call for an end to the backlog of generic applications awaiting approval at the FDA; and, in one of the most dramatic recommendations, it calls for an end to direct-to-consumer (DTC) advertising  by Pharma, with the money spent on DTC being redirected to Research and Development.

If any strategy—be it that of Ms. Clinton or Candidate Trump—is to succeed, both candidates would be well-served to remember that years ago, at a press conference after a Pfizer Board meeting, then CEO Henry McKinnell commenting on remarks by Minnesota Governor Tim Pawlenty said that efforts to lower prescription prices were nothing more than  “a Prairie Fire that breaks about every four years as an election issue and then burns out.’’

Such a statement shows the contempt that Pharma has long held for the American political process—a contempt based upon Pharma’s extensive lobbying and millions of dollars in campaign contributions, including to Ms. Clinton.

It is time to end the pricing abuses of Pharma and to implement policies that will lead to the health benefits that only access to safe, affordable prescription medicines can provide.  Failure to do so will once again leave the rights of Americans to enjoy the benefits of good health such access can provide in the ‘ashes of yet another Prairie Fire.’