Monday, August 22, 2016

PRESCRIPTION DRUG USE RISES, OUT-OF-POCKET SPENDING DROPS AMONG INDIVIDUALS NEWLY INSURED UNDER AFFORDABLE CARE ACT

Improved Access to Medicines Cuts Costs
Newswise August 22, 2016 — People who gained health coverage following the implementation of the federal Affordable Care Act's coverage expansion sharply increased their use of prescription drugs, while their out-of-pocket spending for medications dropped significantly, according to a new RAND Corporation study.

Studying the experiences of nearly 7 million prescription drug users nationally, researchers found that among those who gained private insurance there was a 28 percent increase in prescriptions filled and a 29 percent reduction in out-of-pocket spending per prescription compared to the previous year when they were uninsured.

Those gaining Medicaid — the government insurance program for low-income people — filled 79 percent more prescriptions and paid 58 less out-of-pocket per prescription after gaining coverage.

The effects were even larger for individuals with one of five chronic conditions such as diabetes and asthma that were tracked by researchers. The findings are published online by the journal Health Affairs.

“This is strong evidence that the Affordable Care Act has increased treatment rates while reducing out-of-pocket spending, particularly for people with chronic health conditions,” said Andrew W. Mulcahy, lead author of the study and a health policy researcher at RAND, a nonprofit research organization.

“Improving the treatment of people with chronic conditions is an important step in improving health outcomes.”

The study also tracked the drop in the uninsurance rate among the study population, which was adjusted to be representative of all prescription drug users nationally. Researchers found a 30 percent drop in the number of uninsured from 2013 to 2014.

In addition, states that opted to expand Medicaid by early 2014 had significantly larger declines in uninsurance rates (39 percent) when compared to states that had not (23 percent).

There is little research on the change in health care utilization caused by the ACA. RAND researchers examined changes in prescription use over a three-year period by analyzing prescription transactions for nearly 7 million individuals who had purchased medication from a retail pharmacy in January 2012 prior to the coverage expansion.

Researchers developed methods to assign individuals to insurance status categories by reviewing whether they paid for prescriptions with cash or using insurance coverage. Individuals' prescription purchase patterns were tracked from before the coverage expansion in 2013 through the end of 2014, after the ACA coverage expansion.

People who had one of five chronic condition categories studied — diabetes, high cholesterol, anxiety or depression, asthma or chronic obstructive pulmonary disease, and hormone therapy for breast cancer — sharply increased the number of prescriptions filled after gaining coverage, but had lower annual out-of-pocket expenses.

For example, individuals with high cholesterol who gained private coverage had $200 less in annual out-of-pocket spending while those newly covered under Medicaid had $359 less in out-of-pocket spending.

Support for the study was provided by the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. Other authors of the study are Christine Eibner of RAND and Kenneth Finegold of the Office of the Assistant Secretary for Planning and Evaluation.


RAND Health is the nation's largest independent health policy research program, with a broad research portfolio that focuses on population health, health care costs, quality and public health systems, among other topics.

AHF: Committee Sues Jon Husted, Ohio Secretary of State, Over Voter Signatures on Drug Price Ballot Measure

AHF sues to restore voter signatures in support of a ballot measure to lower drug prices for state programs in Ohio

Legal action, filed as a Complaint in Original Action in Mandamus with the Supreme Court of Ohio today over improper rejection of voter signatures by Secretary Husted, seeks to restore the signatures on a ballot measure intended to lower drug prices for state programs in Ohio.

The Court had previously dismissed, without prejudice, a lawsuit seeking restoration of the voter signatures, writing at the time that the lawsuit was “premature,” pending the resolution of a separate, but related OSC lawsuit brought by PhRMA seeking to invalidate voter signatures on the ballot measure.

The Supreme Court of Ohio issued a ruling in the PhRMA case denying most of PhRMA’s claims and objections on the signatures; however, one part of the ruling now compels backers of the Ohio Drug Price Relief Act to collect an additional 5,044 voter signatures by August 25th—making the backers’ prior legal action to restore the voter signatures urgent, and no longer “premature.”

August 22, 2016  --(BUSINESS WIRE)--Members of the citizens’ committee sponsoring the Ohio Drug Price Relief Act filed a new legal action (Case No. 2016-1235) today with the Supreme Court of Ohio against Ohio Secretary of State Jon Husted over voter signatures in support of a ballot measure to lower drug prices for state programs in Ohio that backers allege were unlawfully invalidated by Secretary Husted earlier this year.

The legal action was filed as a Complaint in Original Action in Mandamus with the Supreme Court of Ohio .

The Supreme Court of Ohio had previously dismissed (without prejudice) a lawsuit by members of the drug pricing ballot measure citizens’ committee that was seeking restoration of the voter signatures, writing at the time that the backers’ lawsuit was “premature,” pending the resolution of a separate, but related lawsuit brought in the SCO by PhRMA (the Pharmaceutical Research and Manufacturers Association, the lobbying association of large drug manufacturers) in conjunction with the Ohio Manufacturers’ Association seeking to invalidate voter signatures on the ballot measure.

On Monday, the Supreme Court of Ohio issued a ruling in the PhRMA case denying most of PhRMA’s claims and objections on the signatures; however, one part of the ruling now compels backers of the Ohio Drug Price Relief Act to collect an additional 5,044 voter signatures by August 25th—making the citizens’ committee’s prior legal action to restore the signatures urgent, and no longer “premature.”

In its lawsuit, the Ohio drug pricing advocates assert:
“The instant action is a re-filing of State ex rel. Tracy L. Jones, et al. v. Jon Husted, et al., Case No. 2016-455, but is more limited in scope based on the Court’s August 15, 2016 decision in Ohio Mfrs. Assn. v. Ohioans for Drug Price Relief Act, Slip Opinion No. 2016-Ohio-5377 which invalidated 10,303 signatures from the petition proposing the Ohio Drug Price Relief Act to the General Assembly (“the Petition”), leaving the Petition 5,044 signatures below the constitutionally required threshold. However, the Court in Ohio Mfrs. Assn. also held that it is improper to invalidate part-petitions because they contain signatures crossed out by someone other than the circulator, signer, or signer’s attorney-in-fact. The instant action seeks to recover such signatures that were rejected by Respondent and various county boards of elections. The recovery of these signatures would more than make up the deficiency and further would moot the portion of the Court’s decision that “[i]f the secretary certifies enough valid signatures, then he shall resubmit the initiative to the General Assembly, in accordance with the terms of the Ohio Constitution, Article ii, Section 1b.” Id. at ¶47.”

The Ohio Drug Price Relief Act will amend Ohio law to require state programs to pay the same or less for prescription medications as the U.S. Department of Veterans Affairs1.

Backers intended to have the initiative appear on Ohio’s November 2016 presidential election ballot, but obstructionist—and backers believe, illegal—moves by Secretary of State Husted have forced the ballot measure proponents to aim for the November 2017 Ohio ballot instead.

“Secretary of State Jon Husted rode roughshod over local County Board of Elections that twice certified voter signatures for the Ohio Drug Price Relief Act when he eliminated those signatures, an act that thwarted attempts to get this measure before voters and on the ballot in Ohio,” said Michael Weinstein, President, AIDS Healthcare Foundation, the sponsor and primary funder of the measure.

“Now, Monday’s Supreme Court ruling in the PhRMA case forces backers to gather an additional 5,044 signatures by August 25th in order to compel Secretary Husted to transmit the proposed law to the Ohio legislature, as legally required under the Ohio Constitution. However, the ruling also appears to overturn Husted’s invalidation of more than 20,000 signatures previously thrown out by him.

The committee is now suing to get further clarity from the court and restore those other signatures—which are more than enough to force Husted to advance this measure for consideration and possible action by the Ohio legislature as the next step in the process of ultimately bringing this drug pricing issue before Ohio voters in ballot measure form in November 2017.”

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 614,000 individuals in 36 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook:www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram:@aidshealthcare


1 V.A. pricing is generally believed to be 20% to 24% lower than for almost any other government program.

Tuesday, July 26, 2016

News Release: We Can’t Wait:Personal importation of prescription medicines offers lower costs, health benefits for Americans

Personal Importation of Brand-Name Drugs Primary Campaign Issue for Senators, Representatives

Election 2016 story about Congress and Personal Importation Prescription Drugs
The cost of illness and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution
— Daniel Hines
ST. LOUIS, MISSOURI, USA, July 26, 2016 /EINPresswire.com/ -- The publisher of RxforAmericanHealth says that Election 2016 is an opportunity to demand the next Congress make the enactment of personal importation of brand-name prescription medicines a legislative priority.

Daniel Hines explains that for more than a quarter-century, Americans have been victims of the predatory pricing practices of Pharma.
“It is time for a change! American patients can’t way any longer!,” he says, “especially when there is an answer—personal imporation can provide the touchstone for a bi-partisan approach to comprehensive legislation to allow Americans the health benefits of access to vital personally imported maintenance medicines that would otherwise be unaffordable.
“Such access could very well be a key to deterring the illness and physical deterioration that too often lead to more drastic devastating illness that will require specialty medicines,” Hines says.
“That is why AmericanRxBillofRights has submitted its Articles defining the rights of Americans to enjoy the health and personal well-being benefits of access to safe, affordable prescription brand-name medicines from licensed, registered pharmacies from Tier One Countries whose standards of efficacy and safety meet or exceed those of the U.S. before Representatives, Senators and even the Platform Committees of the Republican and Democratic parties, “ he continues.
Hines says the challenge lies with our political leadership. 
“The Presidential candidates have offered their support of many of the provisions laid out in the AmericanRxBillofRights. It is now the voters who must call out their Congressional candidates to demand answers about the harmful impacts of the predatory pricing practices of Pharma.”
He outlines the results of the failure of Congress to act:
Result #1—A denial for millions of Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line brand-name 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. 
He then suggests that voters demand answers to a series of questions from Representatives, Senators and candidates:
1. In light of the wide-spread bi-partisan support of personal importation for at least 16 years, sponsorship and support of legislation from the leadership of both political parties including the President, and the three major candidates of the Democratic and Republican Party this year, why has there been no adoption of personal importation;
2. If the answer is the ‘certification’ of the safety of the medicines by the Secretary of Health and Human Services, could you please provide the names and responsibilities of other Cabinet members who are legislatively made personally responsible for certifying the health impact of regulations, decisions, policies of their particular departments? 
3. There are many groups that are being formed to ‘study’ the harmful impacts of recent price increases such as the spike in generic drug costs, and, of specialty medicines. Many of you have exhibited leadership in hearings about these issues. Unfortunately, the new groups being formed will require time—perhaps more than a year—to develop a consensus on the scope of the problems. Strategies to address the challenge of high prices will take even longer, ironically, since enactment of legislation to allow personal importation can offer immediate relief.
4. And, this leads to a final set of questions:
a. If you are not a sponsor or co-sponsor of a bill to allow personal importation, why not? If you are a supporter of personal importation, why do you believe your efforts have not gained traction?
b. Have you received contributions from the Pharmaceutical industry?
c. Does the problem lie within Congress itself? For years, the Democrats controlled the House and Senate. Now, the Republicans have had control of the House and Senate for six years, and have failed to even bring the issue to a vote. Does this indicate that politics take precedence over the health of your constituents?
d. Irrespective of the cause, what is your strategy to advance the case for personal importation and lowering prescription drug costs? 
e. Are there stumbling blocks that public action by advocacy groups and the millions of Americans for whom personal importation is a vital lifeline, can help remove?
“Relief will come only when the American voter finally speaks up and takes the initiative to clearly demand that Congress act, “ Hines says. “Americans pay the highest costs for prescription medicines in the world. We truly Can’t Wait anymore. The cost in terms of illness, costs, and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution.”

We Can’t Wait: Making the case for Personal importation of prescription medicines as the primary immediate health care tool to lower costs and provide 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.

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

There is an answer, a strategy that can provide the touchstone for a bi-partisan approach to comprehensive legislation to allow Americans the health benefits of access to vital maintenance medicines, access that could very well be a key to deterring the illness and physical deterioration that too often lead to more drastic devastating illness that will require specialty medicines.

That answer is personal importation of 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.

That is why AmericanRxBillofRights submitted its Articles defining the rights of Americans to enjoy the health and personal well-being benefits of access to personally imported medicines to Representatives, Senators and even the Platform Committees of the Republican and Democratic parties.

We did this because the challenge lies with our political leadership.  The Presidential candidates have offered their support of many of the provisions laid out in the AmericanRxBillofRights, so it is now the voters who must call out their Congressional candidates to demand answers about the harmful impacts of the predatory pricing practices of Pharma.

The first step is to define the results of the failure of Congress to act, and why we can’t wait any longer. Consider the results of Congress’ failure:
  • Result #1—A denial for millions of Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line brand-name 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 the denial of vital personally imported maintenance medicines that could have benefited 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 Pharma continues to rake in obscene profits, and American patients continue to be denied their medicines.
  • Here is a series of questions to ask the candidates in your Congressional districts and U.S. Senate races:
  • 1.     In light of the wide-spread bi-partisan support of personal importation for at least 16 years, sponsorship and support of legislation from the leadership of both political parties including the President, and the three major candidates of the Democratic and Republican Party this year, why has there been no adoption of personal importation;
  • 2.    If the answer is the ‘certification’ of the safety of the medicines by the Secretary of Health and Human Services, could you please provide the names and responsibilities of other Cabinet members who are legislatively made personally responsible for certifying the health impact of regulations, decisions, policies of their particular departments?
  • 3.    There are many groups that are being formed to ‘study’ the harmful impacts of recent price increases such as the spike in generic drug costs, and, of specialty medicines.  Unfortunately, the new groups being formed will require time—perhaps more than a year—to develop a consensus on the scope of the problems. Strategies to address the challenge of high prices will take even longer, ironically, since enactment of legislation to allow personal importation can offer immediate relief.
  • 4.    And, this leads to a final set of questions:
  • a.    If you are not a sponsor or co-sponsor of a bill to allow personal importation, why not?  If you are a supporter of personal importation, why do you believe your efforts have not gained traction?
  • b.    Does the problem lie within Congress itself?  For years, the Democrats controlled the House and Senate. Now, the Republicans have had control of the House and Senate for six years, and have failed to even bring the issue to a vote.  Does this indicate that politics take precedence over the health of your constituents?
  • c.     Irrespective of the cause, what is your strategy to advance the case for personal importation and lowering prescription drug costs?
  • d.    Are there stumbling blocks that public action by advocacy groups and the millions of Americans for whom personal importation is a vital lifeline, can help remove?
Relief will come only when the American voter finally speaks up and takes the initiative to clearly demand that Congress act.  Americans pay the highest costs for prescription medicines in the world.  We truly Can’t Wait anymore.  The cost in terms of illness, costs, and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution.

Tuesday, July 19, 2016

Republican Platform Committee fails in healthcare plank with falsehood, ignoring the major issue of the past 16 months-- high prescription drug costs

By Daniel Hines
Publisher, RxforAmericanHealth

There is an old story about why an Ostrich sticks its head in the sand.  It is said that since it can’t see anyone, he thinks no one can see him. 

Now, the Republican Party Platform Committee has exhibited Ostrich-like behavior in its Healthcare plank, not even mentioning the cost of prescription medicines as an issue that demands immediate attention from elected officials except to claim that Obamacare is the cause, claiming that Obamacare “… through mandated price cuts for drugs under Medicare and Medicaid, forced pharmaceutical companies to raise prices for everyone else. Its “silver plans,” the most common option on the government insurance exchanges, limit people’s access to their own doctor through narrow networks and restrict drug coverage, forcing many patients to pay for extremely costly medicines for their chronic diseases…

This is an insult to the millions of Americans who can’t afford their medicines because of the predatory pricing practices of Pharma that have led to Americans paying the highest prices for their medicines in the world, making prescription drugs a major driver of total health care costs.

The truth is that Pharma charges what the traffic will bear. While the GOP Platform views Pharma as the ‘victim’ being forced to raise prescription drug prices by Obamacare, which ironically was passed because of the many behind-the-door deals made with Pharma, two hard truths remain: (1)  A prescription medicine that is unaffordable is, in and of itself, unavailable because of that unaffordability; (2)  And, As Stephen Schondelmeyer, Ph.D., drug pricing expert and head of the University of Minnesota Department of Pharmaceutical Care and Health Systems says, “A drug that’s not affordable is neither safe nor effective.”

The GOP cannot claim not to be aware of the public outcry abut high prescription drug prices. 

Most significantly, Candidate Donald Trump has expressed his support for personal importation of prescription medicines and price negotiation to lower prescription drug costs, only to be ignored by the Platform Committee.

Surely the Committee knows of the many bi-partisan Congressional investigations into the pricing abuses of Pharma, headlines among virtually all media, cost pressures that threaten the very stability of the Health Care system as prescription drugs are readily identifiable as a primary driver of costs,   and the demands by advocates that Congress take action to ensure that Americans have access to safe, affordable medicines that will enhance the health and well-being of Americans who cannot afford even their maintenance medicines, let alone the outrageous high costs of specialty medicines whose prices have soared simply because Pharma can charge what it wishes.

The failure to exhibit the leadership necessary to even acknowledge the problem cannot be construed as anything more than pandering to Pharma.  It is more disconcerting when the failure to present even a basic consideration of and reaction to the many bi-partisan proposals that have been brought forth over the years to lower prescription drug costs is put up against the Democrat Party Platform, which presents specific proposals to lower prescription drug prices. 

These include an end to pay-for-delay tactics of Pharma to keep lower-priced generics off the market; personal importation of safe, affordable prescription medicines from licensed, registered pharmacies in Canada and other ‘comparable’ (Tier One Countries) where the standards of Safety and Efficacy meet or exceed those of the U.S.; greater ‘stakeholder’ rights for the general public; and price negotiation for Medicare drugs.

For the record, we submitted a proposal to both the Democrat Platform Committee and to the GOP Platform Committee.  Both were based on the principles outlined in The American Rx Bill of Rights, but tailored to reflect the particular political philosophies of each Party,  in a manner showing how certain tenents of  what might seem to be differences actually could provide a basis from which to reach consensus.

From a strictly political viewpoint, it is imperative that Candidate Trump intervene to ensure that the Healthcare portion of the GOP platform reflect his stance, which has included a role for some sort of personal importation of brand-name medicines. 

But, instead of incorporating Trump’s stance into the document, the Platform Committee has instead included boilerplate  that sounds as though it has been written by Pharma spokespersons.

Candidate Trump had already shown his ability to shape the platform on other issues, such as trade,  moving the Committee closer to his stance on agreements such as NAFTA, TPP and future negotiations.

In light of that issue, the failure of the GOP Platform Committee to even acknowledge a basic understanding of the pricing philosophy of Pharma calls for immediate action by Candidate Trump to acknowledge that the cost of prescription drugs is nothing less than a national emergency.

The challenge now is for him to clearly identify his stance on healthcare and related-issues such as prescription drug costs.  If he acts to ensure the inclusion of his previously announced stance, it will be a welcomed sign of a commitment to making safe, affordable prescription medicines available to millions of Americans.

The alternative—signing-off on the GOP Platform Committee ill-founded reasoning of why prescription drug costs are high is unacceptable and likely could have severe political recriminations in Election 2016 since at one time or another in our lives, virtually every American of some member of their family will require medications.


A failure to act will be viewed as a repudiation of his previously announced stance, and would be an indication that the GOP is unresponsive to the major healthcare story of the past 16 months, e.g. the predatory pricing practices of Pharma.  If it is the latter, then the symbol of the GOP should be changed from the Elephant to the Ostrich.

Wednesday, July 13, 2016

WHY THE REPUBLICAN PARTY PLATFORM PLANNING COMMITTEE SHOULD INCLUDE THE TENANTS OF AN AMERICAN RX BILL OF RIGHTS TO LOWER PRESCRIPTION DRUG PRICES



·       Submitted by Daniel Hines, Publisher, Todays Seniors Network, American Rx Bill of Rights, RxFor American Health
53 Oak Hill Drive,
Ellisville, MO 63021

As an advocate working for 16 years on behalf of lowering prescription medicine prices, I am respectfully making this submission to the Republican Party Platform Planning Committee to address,  by incorporating into the Party platform  the Articles covered in an American Rx Bill of Rights,  a move that would lessen the damaging impact of rising prescription drug costs upon the health and well- being of millions of Americans
.
Unaffordable medicines deprive American patients of the health maintenance benefits made possible by access to a regimen of safe, affordable medicines, because unaffordable medicines are, in and of themselves, unavailable. 

The solution: the members of the committee will have a unique opportunity to illustrate its awareness of the sense of urgency that exists for millions of Americans who are unable to afford their prescription medicines. 
 
While higher-priced specialty medicines have captured most of the headlines in the recent outrage about the pricing abuses of Pharma, we also respectfully submit that cost relief can be made possible immediately by legislation allowing personal importation of vital maintenance brand-name medicines. 

As noted, (a) a medicine that is unaffordable is unavailable; (b) vital maintenance medicines are a ‘driver’ of health care costs both immediately and in the future with ensuing harmful effects upon the health of Americans who are denied those maintenance medicines simply because they are unaffordable. 

This can lead to future health complications requiring medications that cost thousands of dollars, claiming justification for their costs because, admittedly, they offer extensions of life-expectancy that would not be otherwise available.  However, if the patients had access to affordable maintenance medicines in the first place, possibly they would, in many instances, likely have avoided later complications.

An American Rx Bill of Rights should be included because it represents many of the prominent values of the Republican Party:

  • It reflects the extension of freedom of choice and competitive practices that are a touchstone for the Party;
  • It is an opportunity for the Party to take steps that will improve and enhance the health and well-being of a vast number of Americans who, because of the continuing recession, are the forgotten segment of America that is suffering economically from the longest-lasting economic ‘recovery’ in our history’;
  • In the instance of personal importation of brand-name medicines, it can embrace its confidence in the ability of Americans, acting with the assurance of safety and efficacy through reciprocal agreements and Memorandums of Understanding with Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S., to have an affordable and safe source of vital brand-name prescription medicines;
  • The presumptive nominee of the Party, Donald J. Trump, has called for support of policies, including personal importation;
  • It offers the Party a workable strategy to address the shortcoming of the Affordable Care Act under which premiums and related costs have accelerated too such a point that the structure of many parts of Medicare and other programs that were accomplishments of bi-partisan efforts and leadership is threatened;
  • It creates a ‘place at the table’ for ordinary Americans in policy development;
  • It opens an opportunity to address the rules promulgaters by ensuring a Congressional Oversight that will ensure that regulators remember that it is Congress not regulators that make laws, and not the function or responsibility of the unelected and faceless regulators.
The Basic Tenants of the Submission follow:

A basic right to good health; An unaffordable medicine is truly 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 validated source of medications for Americans.

An examination 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)
Because a prescription medicine that is unaffordable is unavailable, it qualifies within even the existing   'rules' of the FDA that such a medicine that is otherwise unavailable in the U.S. 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 only 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, and Congress should compel the Secretary of Health and Human Services to take action for the authority already passed by Congress to facilitate outreach with selected countries to establish such reciprocity and Memorandums of Understanding on Good Manufacturing Procedures.
(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

Specifics of the Platform Plank

Specifically then, the Platform Plank would call for Congressional and Presidential support and enactment of a comprehensive consensus-building strategy to lower prescription prices,  including but not limited to price negotiations;  Pharma patent protection revisions to reflect American taxpayer support of NIH-funded research and development;  an end-to-pay-to-delay tactics of Pharma to protect their markets while denying Americans access to lower-cost generics;  approval of the rights of Americans to personally import 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.; compelling the Secretary of Health and Human Services to facilitate agreements for implementation and, with reciprocal Memorandums of Understanding, to provide the framework for such personal importation.

We urge your serious consideration of this submission.
Respectfully submitted: