Open Letter to Members of Congress.Asks: What will it take to get Congress to act to lower prescription dug prices?

 

The following letter was sent to members of the House Committee on Oversight and Government Reform by Publisher Daniel Hines

Daniel Hines, Publisher, TodaysSeniorsNetwork

Phone: 636-386-5234
Fax:  636-386-5904
Cell Phone: 636-399-2849
Email: TodaysSeniorsNet@sbcglobal.net

Dear Members of the U.S. House of Representatives Committee on Oversight and Government Reform:

I am writing in my capacity of publisher of the TodaysSeniorsNetwork series of blogs dealing with issues facing an aging America and the need for policies to lower the costs of prescription medicines in the U.S. to applaud your intensive questioning of Mylan CEO Heather Bresch during your recent hearings.

It is gratifying to see such bi-partisan consensus on the potential of the dramatic, undesirable consequences affecting the health and well-being of American citizens because of the predatory pricing practices of Pharma. The many expressions of outrage and indignation are, hopefully, welcomed preludes to Congressional action to end Pharma’s attitude of charging not just what the traffic will bear but what it determines to be necessary to inflated profits despite the consequences to patients that simply cannot afford their medicines.

But there are questions that remain unanswered, and must be directed to not Pharma but to Congress:

1.     Throughout the hearing, members of the Committee noted that ‘they had been here before’, charges were leveled against Ms. Bresch’s statements calling them ‘rope-a-dope,’ ‘a shell game,’ and suggestions that perhaps this will be the impetus that will finally lead to Congressional action.  While such comments are welcomed, question must be asked: “If this latest example of Pharma abuse does not lead to Congressional action, what will it take?  When will Congress act?  Why is there even a delay?

2.     The testimony of Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs of the Food and Drug Administration, and his non-responsive answers to requests from the Committee, while not surprising, were appalling.  His refusal to share information with the Chair of the Committee was particularly troublesome, but is indicative of the FDA, an agency ostensibly designed to protect the health and well-being of Americans, claiming an equal status with Congress.  Another example of such a blatant rejection of Congressional oversight was its refusal to implement ‘march in’ rights for more than 35 years, even in light of a recent bi-partisan Congressional request from 51 members of Congress for such action.  A question that must be addressed is ‘Why does Congress allow the FDA to act in such an authoritative manner, and to basically refuse to acknowledge Congressional oversight?’  Also, why did the FDA reportedly deny the application of Teva for a competitive product to EpiPen on the basis of patent exclusivity of the design of the Mylan product?

3.     As I write this letter, the Wall Street Journal is reporting that Ms. Bresch “underreported” Mylan profits by 60 percent, manipulating tax payment claims that, according to the WSJ did not apply to Mylan.  This leads to two questions: Will this claim be investigated further by the Committee?  If the charge is found to be true, will that lead to the possibility of a perjury charge?

4.     It was especially gratifying to note that there was a consensus among many members of the Committee that a medicine that is unaffordable is, in and of itself, unavailable.  You can’t buy what you can’t afford.  But, millions of Americans have for years been denied the health benefits made possible by access to a regimen of their prescribed medicines.  It is virtually impossible to estimate the adverse impact to the health of individuals and society that have occurred simply because they can’t afford their medicines. This is due to Pharma and the FDA ignoring previously adopted directives to the FDA and HHS to explore and facilitate what is a readily available, affordable and safe resolution to the fact that Americans pay the highest prescription prices in the world—i.e., the personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S.

5.     Ironically, for many years, Congress has introduced legislation that would allow such personal importation.  Both Presidential candidates support some form of personal importation of prescriptions from Canada and Tier One Countries as a means to lower prescription costs.  There are bi-partisan bills for personal importation that have been introduced in the current Congress.  But the FDA claims it cannot verify the safety and efficacy of drugs produced outside this country, although it works with Pharma to provide oversight of the more that 80 percent of the prescription ingredients that are produced outside the U.S., and has stated that it is seeking greater cooperation with counterpart oversight agencies outside the U.S.  Added to this is that while millions of Americans have been denied access to affordable medicine because of Pharma pricing practices, millions more have turned to personal importation of safe, affordable medicines for years, leading to the question, why does Congress fail to enact enabling legislation for personal importation?

In conclusion, it, one can only hope that the Mylan headings will lead to a consensus-building initiative that will result in comprehensive legislation as outlined in the American Rx Bill of Rights included with this letter. Thank you for your consideration of the issues presented.  We respectfully urge action to finally address the harmful impacts of the predatory pricing practices of Pharma, resulting in improved health and well-being of Americans.

Respectfully submitted,

Daniel Hines
Daniel Hines

The Articles of the American Rx Bill of Rights

It is time to call out the harmful effects of the undue influence of Pharma upon public health policy.  It is time for an Rx Bill of Rights on behalf of All Americans

Article One (A Basic Right to Good Health)

The impact of millions of Americans being denied the health benefits of access to a regimen of safe, affordable medicines because of cost is a national health issue that has yet-to-be-recognized consequences.  That is why the ability of American Citizens to make health care decisions in concert with their physicians such as the purchase of personally imported safe, affordable prescription medicines should not be hampered by any actions by government or private entities as a policy to restrict Americans' access to authentic medicines. 

Article Two (An Unaffordable Medicine is Unavailable)

A prescription medicine that is unaffordable is unavailable, thereby meeting the 'rules' of the FDA that such a medicine that is otherwise unavailable is indeed eligible to be personally imported by an American patient, Arbitrary denial by the FDA to such access is detrimental to the health of the patient  by denying him or her access to vital maintenance medicines. This is a violation of the purpose of the FDA which is ostensibly designed to protect the health and well-being of American citizens.

Article Three (Citizens as Stakeholders)

The relationship between the FDA, elected officials, and Pharma has led to numerous abuses, access by Pharma to legislators and other elected officials based on the contribution of millions of dollars, favored status for Pharma representatives and their front groups as the primary representative at public hearings to determine the health care policy for Federal, State and Local Governments, thereby skewering the decision-making process.  That why it is incumbent upon Congress that it act to ensure that ordinary American citizens whose health and finances are adversely affected by Pharma pricing practices, advocacy groups other than those of Pharma, are given a 'stakeholder' status equal to that of Pharma.

Article Four (Due Process)

Americans who purchase safe, affordable medicines from licensed, registered pharmacies in Tier One Countries whose standards meet or exceed those of the U.S., are the legitimate owners of their authentic medicines and are entitled to exercise their due process rights to have their personal property free from undue and unjustified seizure oar destruction by any governmental agency unless the seizing authority can demonstrate via established judicial processes and to courts that such seizures are of bogus, counterfeit or unsafe prescription medicines.

Article Five (Public Interest)

Americans are significant contributors to the development of research and development costs of new medicines through their tax dollars in support of grants to the National Institutes of Health (NIH), and, as such, should be protected from unfair or questionable patent protection granted to Pharma that fails to recognize the rights of American citizens. Abuses in pricing, illegal business activities, or undue influence upon policy-making by the FDA or elected officials should result in a reduction of the patent protection afforded Pharma to the detriment of untold numbers of Americans who must be able to pay what Pharma believes the traffic will bear.

 Article Six (Reciprocity)

The FDA should extend reciprocity to other Tier One countries in the interests of the health of American citizens. The majority of brand name prescription medicines sold to Americans is manufactured at plants outside the U.S., under FDA supervision, or at plants licensed by Pharma members to produce medicines under a license granted by a particular company, a validation that medicines produced outside the U.S. and sold in this country are indeed capable of being safe.  Also, the FDA has entered into agreements with regulatory agencies in many countries to assume the task of overseeing ingredients manufacture of ingredients for brand name medicines.  Added to that is that many countries (excluding the U.S and the FDA) have reciprocal agreements (Memorandums of Understanding) that one country will accept the medications produced in another country as safe and authentic.