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.’ 

RxforAmericanHealth Publisher: Time for Action to Lower Prescription Prices, Stop Pharma Abuses

August 31, 2016--Daniel Hines, publisher of RxforAmericanHealth has written and sent the following letter to Senators calling for an investigation of the pricing abuses of Mylan's EpiPen:

I am writing in my capacity as the publisher of the TodaysSeniorsNetwork blog sites that include TodaysSeniorsNetwork, RxforAmericanHealth, and AmericanRxBillofRights.

I applaud your efforts in calling for investigations into the outrageous pricing practices of Mylan’s EpiPen Auto-Injector.

Hopefully, this or some series of the many investigations that have occurred as a result of public outrage over not just this instance, but a  of pattern of Pharma pricing abuses, will somehow finally lead to true reform.

However, it is undeniable that Pharma has a philosophy of charging what the traffic will bear, irrespective of how many investigations are launched.  Regrettably, the investigations have a familiar outcome:  A group of ‘experts’ testify, questions are asked, statements made, and within weeks, Pharma once again not merely raises prices, but does so to such a level as to threaten the very health and well-being of Americans.

The major problem is that,  as in the old country saying, the horse is out of the barn by the time the investigations are held,  and investigations in and of themselves are brushed aside by Pharma, which continues with its abusive pricing practices.

The EpiPen price increases also illustrate the willingness of Pharma to attack the most vulnerable members of our society.  Its long-standing opposition to Personal Importation became and remains a major issue even with Part D passage as an attack upon America’s Elderly.  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.’’

Those  comments underlie the attitude that Pharma practices today, more than a decade later.  It acts, Congress reacts, hearings are held, statements issued—and we all brace for Pharma’s next abuse.

The EpiPen price increases were an attack upon the parents and children of America, and those others for whom allergies are not merely a ‘seasonal’ nuisance, but actually potentially life-threatening conditions.

Because of that, rather than merely attempting to find out why or how such predatory pricing occurs, it is time for Congress to take action to introduce and pass comprehensive legislation that will make prescription medicines readily available and affordable for the literally millions of Americans that are denied access to the health benefits possible only through access to a regiment of such safe, effective and affordable medicines.

It is time to face the truth:  irrespective of the potential health benefits from a medicine, an unaffordable medicine is unavailable in and of itself because of its price, and a medicine that is not available and is not taken, is ‘ineffective.’

With that in mind, I am including the articles of the RxBillofRights with this letter.  It includes a series of proposals, many of which you have supported. It is time for a new approach which will have a synergistic favorable impact upon availability, access, price and health benefits.

For the record, I am a long-time supporter of and communications consultant of the  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 US.

 

I support immediate favorable action by Congress to allow personal importation as a part of the comprehensive strategy of the AmericanRxBillofRights, since even with investigations, study groups being formed, and the reliance upon generics (which have also undergone outrageous price increases), personal importation offers the only immediate relief to millions of Americans who simply cannot afford their medicines.

The EpiPen issue illustrates that personal importation is the only immediate relief for Pharma pricing practices is, even with the questionable ‘staging’ of the introduction of price reduction certificates and a ‘new’ generic EpiPen, the cost of Epi Pen from Canada is still as much as two-thirds less that the exact authentic product in the U.S.

This and other examples of the benefits of access to safe, authentic medicines show why it  is time to take a new approach towards drug pricing legislation that offer solutions to the  challenges to Americans’  health and well-being from pricing abuses of Pharma.

Thank you for your consideration of this letter. I  look forward to your response, and the opportunity to share it with the many visitors to our sites.

Respectfully,

Daniel Hines

Daniel Hines

Iowa has opportunity to direct National Attention to Pharma pricing abuses

January 19, 2016--Iowa voters have a unique opportunity to help shape policy to end the price abuses of Pharma which have moved the high cost of vital prescription medicines to the national spotlight by demanding that candidates in the upcoming caucuses explain their programs to lower prices,   and to disclose what donations they have received from Pharma-related industries or front groups that might have an impact on their stands, says the publisher of a blog dedicated to prescription drug issues of cost and Pharma’s undue influence upon policy-makers.

In a blog posted on RxforAmericanHealth, Daniel Hines says that while much of the national attention focus on Iowa deals with the candidate matchups, the focus should instead be on real issues such as the unfavorable impact of Pharma’s ‘charge what the traffic will bear’ philosophy.

In his blog, Hines points out the extent of Pharma influence, noting Pharma-related contributions of thousands of dollars to virtually all of the leading candidates. He also lists specific contributions made by Pharma to candidates, and examines the relationships of the candidates with Pharma.

He calls the silence on the issue, especially in Iowa among Republican contenders as “ironic” since long-time Senator and Chair of the Senate Judiciary Committee Charles Grassley is a ‘long-time supporter of personal importation of prescription medicines’ as a strategy to lower the cost of vital prescription medicines.

“As Chair of the Senate Judiciary Committee, he has joined Senator John McCain (R-AZ) in appealing to Health and Human Services Secretary Burwell requesting waivers to permit personal importation of prescription medicines under the provisions of 21 U.S. Code § 384,” Hines notes.

“Iowa offers a chance to remind the American public of the impact that Pharma has on elections and politicians, and that it (Pharma) has the deep pockets to protect its goal of making the U.S. into its ‘safe haven’ for the highest drug prices in the world,” he continues.

“Let’s hope that the voters of Iowa use these last weeks before the caucus to call out the candidates and demand answers as to where they stand on prescription drug costs, as well as defining their relationships with Pharma. And, let’s hope that the rest of the election will demand more of the candidates of both political parties…and the people of Iowa can say that it all started with them, “  he concludes.

Ohio’s Senator Brown introduces Medicare Drug Negotiation Bill

October 14, 2015– As more companies buy the rights to old, existing drugs then raise prices overnight, U.S. Sen. Sherrod Brown (D-OH) unveiled a plan to save taxpayer dollars and lower drug prices for seniors. A recent report from the Plain Dealer revealed that price increases have cost the Cleveland Clinic $11 million and University Hospitals $3.6 million – impacting costs for everything from cancer care to emergency medicine.

“Seniors on Medicare face skyrocketing bills for lifesaving drugs that they can’t afford and some insurance companies have stopped covering their drugs altogether,” Brown said. “This isn’t right, and it must stop. That’s why I helped introduce the Medicare Prescription Drug Savings and Choice Act. Giving Medicare the authority to negotiate with pharmaceutical companies will help seniors get the best prices for these critical prescription drugs. Seniors should be able to get drug coverage directly through Medicare – not be forced to buy from a middle man.”

During a press conference in Cleveland today, Brown was joined by Charmaine Szanyi-Hrusch, a retired teacher from North Ridgeville whose prescription drug prices have recently tripled and Ernest Boyd, a pharmacist who discussed how Brown’s legislation would help keep costs under control.

“Senator Brown is attacking an issue that impacts older Americans’ health very directly,” Boyd said. “Pharmacists are having hundreds of patients tell them that they cannot afford the drug or the copayment. It is critical we get this problem under control.”

Brown outlined legislation he cosponsored that would help rein in costs by allowing Medicare to negotiate the best prescription medication prices, lowering drug prices for seniors enrolled in Medicare prescription drug coverage. The Medicare Prescription Drug Savings and Choice Act would help keep costs down for Americans enrolled in Medicare Part D by requiring the Secretary of the U.S. Department of Health and Human Services (HHS) to negotiate the best prescription medication prices for seniors.

Current law only allows for bargaining by pharmaceutical companies and bans Medicare from doing so. The bill would require the HHS Secretary to directly negotiate with drug companies for price discounts for the Medicare Prescription Drug Program, eliminating the “non-interference” clause that expressly bans Medicare from negotiating for the best possible prices even though the government can often negotiate bigger discounts than private insurance companies.

Publisher of Blog on High Drug Costs calls for adoption of American Rx Bill of Rights into party platforms

Daniel Hines, publisher of RxforAmericanHealth urges support of American Rx Bill of Rights

...rising costs of medicines will lead to unwelcome consequences in terms of increased price of medicines that will act as a major driver of medical costs overall...

— Daniel Hines

ST. LOUIS, MISSOURI, USA, September 3, 2015 /EINPresswire.com/ -- The publisher of RxforAmericanHealth has called for both the Democrats and Republicans to address the issue the impact of rising prescription drug costs by incorporating into their Party platforms an American Rx Bill of Rights.
Daniel Hines says that rising costs of medicines will lead to unwelcome consequences in terms of increased price of medicines that will act as a major driver of medical costs overall and force many Americans to forego needed medical care.
He also points to the potential for abuse of Congressional intent with the announcement schedule for September 30, 2015 of the rules regarding Section 708, that could lead to the seizure and destruction of safe, authentic personally brand-name medicines from licensed, registered pharmacies subject to oversight and regulation equal to or exceeding that of US agencies.

“We have called for a Congressional Caucus to use the reservoir of good will and support of many members of Congress to protect against such abuse,” Hines notes. 

“Now, it is also time to articulate the issues caused by the pricing practices of Pharma that can threaten the ability of Americans to enjoy the health benefits offered by access to a regimen of safe, authentic medicines.

“That is why as we listed the Articles of the Rx Bill of Rights, we included an explanation of each article,” he explains.


The Articles are: 

A basic right to good health; An unaffordable medicine is unavailable; Citizens must have rights as stakeholders in debate and discussions of health policy centered on pharmaceutical costs equal to that of Pharma; The rights of Americans to due process in the protection of their rights and ability to make valid medical decisions must be protected; It is in the public interest to recognize the 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; the FDA should enter into reciprocal agreements and Memorandums of Understanding (MOU) in recognition of its many agreements already in place with authorities in other countries to help ensure a safe and easily validate source of medications for Americans.

Hines cited the following explanations of the Articles:


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)
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.
(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.)


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

Daniel Hines
RxforAmericanHealth
636-399-2849
email us here

Why High Drug Prices require an Rx Bill of Rights for Americans

Senator Bernie Sanders (I-VT) is the first Presidential candidate to announce that, if elected, he will introduce legislation that will reduce prescription medicine prices.  

One leg of his three-legged stool deals with the rights of Americans to have access to safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One countries of whose standards of safety and efficacy meet or exceed those of the USA.  The other two legs of the platform deal with abuses of the regulatory process by Pharma, acting in collusion with FDA.  

We applaud Senator Sanders for his leadership.  He has been a long-standing advocate of the detrimental impact upon the health care system of the US created by the comfortable relationship between Pharma and the FDA, and the predatory pricing practices of Pharma that have made the US a 'safe haven' for its charging what the traffic will bear for medicines. 

It is time for an American Rx Bill of Rights that confers the right of participation in vital health decisions for Americans. Following are the first six articles of such an Rx Bill of Rights, based upon the most pertinent issues affecting prescription drug costs. 

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)

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.

(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.)

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.)