Monday, June 13, 2016

We The People

News Release: American Rx Bill of Rights submits Call for Bill of Rights in Democratic Party Platform (click here)

Why the Democratic Platform Committee should include an American Rx Bill of Rights (click here)

AMERICAN RX BILL OF RIGHTS URGES PUBLIC TO ASK SENATORS, REPS WHERE THEY STAND ON RX PRICES, POLICIES...(CLICK HERE)



Why We need an 
American Rx Bill of Rights

The elections of 2016 offer what may a once-in-a-lifetime opportunity to 
ensure that millions of Americans are no longer denied the health benefits made possible by access to vital medicines simply because of the predatory pricing practices of Pharma.  Simply put, a medicine that is unaffordable is, in and of itself unavailable, thereby putting the health and well-being of Americans at risk, contributing to rising health costs caused by complications that could have likely been avoided by access to safe, affordable medicines. 

The pricing practices of Pharma are made possible because of its influence with  their extensive lobbying efforts suppported by millions of dollars in campaign contributions to elected officials.  This gives Pharma extraordinary influence with the U.S. Congress, regulatory agencies such as the Food and Drug Administration as evidenced by a number of issues, policy development, and a 'place at the table' for hearings and other actions amd presence with policy makers denied to ordinary Americans. 

Citizens must have rights as stakeholders equal to that of Pharma in debate and discussions of health policy centered on pharmaceutical costs.  The 2016 elections and a citizen-oriented approach as exemplified in the Articles of the American Rx Bill of Rights offer that opportunity.


Article One—A Basic Right to Good Health

Article Two--An Unaffordable Medicine is Unavailable
Article Three--Citizens as Stakeholders in
Article Four—Due Process to Protect Unfair Confiscation of Authentic Medicines
Article Five—The Public Interest of an Rx Bill of Rights
Article Six—Reciprocity Agreements to Facilitate Personal Importation of and Access to Safe, Valid Medications


You can make a difference in the battle for Control of the U.S. Senate...Read our reviews of the 34 contested races and then ask your Senator where he or she stands on the need for the American Rx Bill of Rights call for comprehensive bi-partisan legislation to lower prescription medicine prices...(read more)

Stay informed and up-to-date on the abuses of Pharma pricing with our national coverage of stories form around the U.S... Pharma prices are a major driver of healthcare costs and endanger American patients lives with pricing strategies that make medicines unavailable because they are unaffordable...(read more)


Review and support legislative proposals on behalf of a role for 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....(read more)

How Pharma uses its funding of Senators to further its influence over the cost and accessibility of vital medicines!...(read more)

American Rx Bill of Rights publisher summits appeal for Democrat Platform Planning Committee: Include widely supported measures to lower prescription prices

June 13, 2016—The publisher of the American Rx Bill of Rights has submitted comments to the Democratic Platform Planning Committee urging that it incorporate measures designed to lower prescription medicine costs into the party platform. He said a similar submission will be made to the Republican Platform Committee.

Daniel Hines, who also publishes the blogs Todays Seniors Network and Rx for American Health, noted that, “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.”

He noted that Representative Elijah Cummings (D-MD 7), who is the chairman of the Platform Planning Committee, has been a long-standing supporter of moves to lower prescription prices, and that Committee member Representative Keith Ellison (D-MN 5) has introduced legislation on behalf of personal importation of prescription medicines.  He also notes that the campaigns of both the Democrat Presumptive nominee, Hillary Clinton, and Senator Bernie Sanders have announced strategies to lower prescription drug costs that are reflected in the Basic Tenants of the submission.

“All this is an indication of the support within the Democratic Party for inclusion into the Party Platform,” Hines says.

“By ensuring that this level of support is included in the Party Platform, 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.”
Hines notes that, “While higher-priced specialty medicines have captured most of the headlines in the recent outrage about the pricing abuses of Pharma, cost relief can be made possible immediately by legislation allowing personal importation of vital maintenance brand-name medicines.”

He cites the cause-effect impact of denied access to readily available lower-priced, safe, authentic vital maintenance medicines.

“Because these medicines are priced so high, they 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, “ Hines explains. “ However, if the patients had access to affordable maintenance medicines in the first place, possibly they would, in many instances, have avoided later complications.”

The basic tenants of the submission are

·       All Americans have 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 personally imported medications for Americans.

Hines says that the Platform Plank should 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.

“The inclusion of this plank in the Democratic Party would put the Party on the record that it truly does realize the urgent need for immediacy in dealing with the harmful health and economic impacts upon millions of Americans deprived of their medicines,“ Hines concludes.  “And that will make it accountable for its actions in the future to ensure such availability of and access to affordable vital medicines.”


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


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

As an advocate working for 16 years on behalf of lowering prescription medicine prices, I am respectfully making this submission to the Democratic 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 Chairman of the Drafting Committee, the Honorable Representative Elijah Cummings has been a leader in the continuing struggle to lower prescription drug prices; The Honorable Representative Keith Ellison has been a long-time champion of personal importation and sponsor of legislative initiatives to grant such access to American patients; the campaigns of both the Democrat Presumptive nominee, Ms. Hillary Clinton, and the Honorable Senator Bernie Sanders have announced strategies to lower prescription drug costs that are reflected in the Basic Tenants of this Submission (see below)—all these are indications of the support within the Democratic Party for inclusion into the Party Platform.
Now, by ensuring that this level of support is included in the Party Platform, 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.

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:


Thursday, May 5, 2016

Pharma Price Abuses In The News



Stay informed and up-to-date on the abuses of Pharma pricing with our national coverage of stories form around the U.S... Pharma prices are a major driver of healthcare costs and endanger American patients lives with pricing strategies that make medicines unavailable because they are unaffordable.  Keep up with the growing news coverage of the struggle for fair prices for American patients:




Drug Companies Pony Up in Illegal Marketing Cases, But Critics Wonder if Penalties are Enough…If you make truck deliveries in the overcrowded downtown streets of a big city, parking tickets might simply be a cost of doing business…For top drug companies, critics say, there’s an equivalent expense — the billions of dollars paid out to settle criminal and civil charges of illegal marketing practices, Medicaid overcharges and kickbacks…Big Pharma has written more than $30 billion in checks in the last 10 years to resolve the government allegations, according to statistics compiled by the consumer watchdog group Public Citizen. Nine drug manufacturers each forked over at least $900 million from 2006 through 2015…(read more


Bill aimed to limit the pain of prescription drug prices for Ohioans… ABC6 is On Your Side, trying to get to the bottom of sky rocketing prescription drug prices…A Hilliard man reached out to us after the price of his medication went through the roof. Like many people, Larry Farrow takes a prescription medication for his health. A recent price change almost gave him a heart attack."In 2015, I ordered the drug and it was $80 plus a $100 deductible," he said…(read more)

Wyden introduces bill to cap drug costs under Medicare…Sen. Ron Wyden (Ore.), the top Democrat on the Senate Finance Committee, on Wednesday introduced a bill aimed at protecting seniors from high drug costs, an issue that has attracted growing scrutiny…Wyden’s measure would cap drug cost-sharing for Medicare enrollees so that seniors would not have to pay out of pocket costs above a roughly $7,500 cap…(read more)

While patients in Massachusetts await affordable doses of the blockbuster hepatitis C drug Sovaldi, Rep. Joseph Kennedy III has financially benefited from the success of the drug’s manufacturer, Gilead Sciences, according to public financial disclosures and campaign finance records...And he’s not the only lawmaker profiting from investments in a company that has drawn unwelcome attention for the sky-high price of a lifesaving medication it produces. Kennedy held the largest stake, but 23 other members of the House and Senate held stock in the company in 2014, the most recent year for which disclosure statements are available...(read more)


 Survey on Prescription Drugs: Insights of Patients over 50, What Can be done to reduce prescription drug costs…This AARP survey was fielded to better understand consumers’ prescription drug use and any struggles consumers face with regard to the cost of their prescription drugs…(read more)

Wednesday, May 4, 2016

Current Legislation for Personal Importation of Medicines


Status of Personal Importation of Prescription Medicine Bills in Congress


S.122 - Safe and Affordable Drugs from Canada Act of 2015114th Congress (2015-2016)
BILL
Sponsor:
Sen. McCain, John [R-AZ] (Introduced 01/08/2015)
Committees:
Senate - Health, Education, Labor, and Pensions
Latest Action:
01/08/2015 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.  (All Actions)
Tracker:
This bill has the status Introduced
Here are the steps for Status of Legislation:
1.    Introduced
2.    Passed Senate
3.    Passed House
4.    To President
5.    Became Law
More on This Bill
Subject — Policy Area:
Summary: S.122 — 114th Congress (2015-2016)All Bill Information (Except Text)
There is one summary for S.122. Bill summaries are authored by CRS.
Shown Here:
Introduced in Senate (01/08/2015)
Safe and Affordable Drugs from Canada Act of 2015
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:
  • is dispensed by a pharmacist licensed in Canada;
  • is purchased for personal use in quantities not greater than a 90-day supply;
  • is filled using a valid prescription issued by a physician licensed to practice in the United States; and
  • has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA.
Sets forth exceptions, including for controlled substances and biological products.
Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.

S.2023 - Prescription Drug Affordability Act of 2015 114th Congress (2015-2016) Get alerts
BILL
Sponsor:
Sen. Sanders, Bernard [I-VT] (Introduced 09/10/2015)
Committees:
Senate - Finance
Latest Action:
09/10/2015 Read twice and referred to the Committee on Finance.  (All Actions)

Introduced in Senate (09/10/2015)
  • requires the Centers for Medicare & Medicaid to negotiate lower prices on behalf of beneficiaries for drugs covered under Medicare Part D;
  • accelerates closure of the Medicare Part D coverage gap known as the "donut hole," under which beneficiaries who have reached a certain level of yearly drug costs become fully responsible for any additional drug costs up to a certain limit;
  • requires drug manufacturers to issue rebates for prescription drugs dispensed to eligible low-income individuals under Medicare or Medicaid; and
  • expands the application of certain prescription drug rebate requirements under Medicaid to include rebates for generic drugs.

The bill also requires drug manufacturers to produce and share annual reports containing specified information related to domestic and foreign sales.

Tracker:
This bill has the status Introduced
Here are the steps for Status of Legislation:
1.    Introduced
2.    Passed Senate
3.    Passed House
4.    To President
5.    Became Law
More on This Bill
Subject — Policy Area:
Summary: S.2023 — 114th Congress (2015-2016)All Bill Information (Except Text)
There is one summary for S.2023. Bill summaries are authored by CRS.
Shown Here:
Prescription Drug Affordability Act of 2015
This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions related to the affordability of prescription drugs under the Medicare and Medicaid programs. Specifically, the bill:
The bill also amends the Federal Food, Drug, and Cosmetic Act to: (1) allow the importation by individuals of prescription drugs from Canada and, potentially, other countries; and (2) establish certain conditions on the award of market exclusivity with respect to drugs. Specifically, a drug manufacturer's market exclusivity shall be terminated if the manufacturer commits, or fails to report, a drug-related violation such as misbranding, illegal marketing, or fraud.
In addition, the bill amends the Federal Trade Commission Act to: (1) establish restrictions on certain anticompetitive patent settlements known as "pay-for-delay" agreements, which effectively block generic drug competition; and (2) allow the Federal Trade Commission to initiate proceedings to enforce these restrictions against any parties to such a settlement.

H.R.2623 - Personal Drug Importation Fairness Act of 2015114th Congress (2015-2016) | Get alerts
BILL

Sponsor:
Rep. Ellison, Keith [D-MN-5] (Introduced 06/03/2015)
Committees:
House - Energy and Commerce
Latest Action:
06/05/2015 Referred to the Subcommittee on Health.  (All Actions)
Tracker:
This bill has the status Introduced
Here are the steps for Status of Legislation:
1.    Introduced
2.    Passed House
3.    Passed Senate
4.    To President
5.    Became Law
More on This Bill
Subject — Policy Area:
Summary: H.R.2623 — 114th Congress (2015-2016)All Bill Information (Except Text)
There is one summary for H.R.2623. Bill summaries are authored by CRS.
Shown Here:
Introduced in House (06/03/2015)
Personal Drug Importation Fairness Act of 2015
This bill allows a drug to be imported by a person other than the drug's manufacturer if the drug: (1) has the same active ingredients, route of administration, and strength as an approved drug; (2) may be lawfully marketed in, and is imported or reimported from, a country included on a list in this Act that the Food and Drug Administration determines has standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer; (5) is shipped or imported in quantities that do not exceed a 90-day supply; (6) is accompanied by a copy of a valid prescription; and (7) is not a controlled substance.