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- 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.
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.
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