Why High Drug Prices require an RxBill of Rights for Americans (Part One)

Why High Drug Prices require an RxBill of Rights for Americans (Part One)

Publisher’s note:  This is the first of a three part series on why Americans need an RxBill of Rights that will guarantee their access to 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.  In Part Two, we will examine the abuse of the public policy process by Pharma to exercise undue influence that makes the US a safe haven for predatory pricing practices of Pharma, and what the potential public health care consequences are of that influence.  In Part Three, we will explore examples of the pricing policies of Pharma, including the concerns over the costs of ‘specialty’ medicines and the spike in Generics.  We will also present our case for an RxBill of Rights for Americans based on a role for the American public as a part of the stakeholder community with a specific interest in the costs of medicines, and having a role in the deliberative process of legislation, policy making and implementation of health care policy as it involves the benefit, savings and overall well-being, happiness and health of American citizens.

Imagine that you lived in a country where as many as 55 million people were denied access to vitalprescription medicines simply because their cost puts were the highest in theworld...

Then, imagine that when people who are supposed to represent your interests in an elective body turn instead to the very entities that are offered a ‘safe haven’in that country for those prices as ‘stakeholders’ to ‘invitation only’ opportunities to shape that country’s public health policy.

But wait!  Generic drugs can offer relief for the battered pocketbooks of people of this country, supposedly offering medicines at a fraction of the cost of the more expensive brand-name medicines...can't they?

Unfortunately, no...instead, these supposedly less-expensive alternatives are recognized as opportunities for immense profits merely by raising the prices by as much as nearly 1000 percent. 

And, imagine that when miraculous cures are found for diseases, that instead of a Jonas Salk model in which the founder of the vaccine to eliminate polio said that the rights to the cure were those of people around the world, the drug company that develops the medicine charges $1,000 a pill, putting the total cost to each individual (in this instance, Hepatitis C) a staggering $100,000, allowing the company making it to register 2nd Quarter profits of $3.67 billion.

Finally, imagine that this fictitious country had the capability to provide lower drug costs for all its citizens by allowing them to personally import valid, brand-name prescription medicines, from licensed registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of those in the U.S., and could offer those medicines at prices at as much as 60 to 80 percent less that the overly-expensive medicines currently protected.

Then imagine that those who oppose lower medicine prices use their vast funds, political contributions, front groups to deter the rights of the citizens of that country to purchase these medicines.

Unfortunately,  you don't have to imagine.  The country is very real.  It is the United States.

But there is a solution.  It rests with the United States Congress. Ironically,  a recent decision by a District Court Judge in Maine which opponents of personal importation hailed, might offer a road map to bold actions that could lead to lower prescription medicine prices.

While Pharma may believe that it has gained a victory in the ruling by Judge Nancy Torresen, Chief Judge of the United States District Court for the District of Maine, determining the right of the state of Maine to allow its citizens to personally import their medicines, it may want to pause before taking a victory lap.

Yes, the Judge’s decision did set aside the Maine law, passed by the state’s Legislature allowing Maine citizens to purchase brand-name medications from licensed, registered pharmacies based in Canada, the United Kingdom, Australia and New Zealand. 

The Legislature passed the law after the then-Attorney General, acting at the bequest of the state’s Pharmacy Board and the Maine Pharmacy Association, banned the sale of such pharmaceuticals because the pharmacies dispensing the medicines were not registered with the Main Pharmacy Board.

The Attorney General’s action occurred even though Maine Citizens utilizing the state’s proximity to Canada, have travelled across the border to purchase their medications for years, while others were purchasing their medicines through plans offered by businesses acting to make such safe, affordable prescriptions available to their employees through employee benefit plans.

The Legislature quickly stepped in, passing “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies.” 

The opponents to personal importation immediately initiated legal action based upon the contention of ‘Federal Supremacy’.  The issue for the courts was to determine federal law preempts state law when it comes to prescription drug imports.  She decided that it does.

Therein lies the basis of what has been a debate about the American process since our country’s founding—state rights and authority vs. that of the Federal Government over state actions.

Undoubtedly, the interest of PhRMA, acting on behalf of its members—and affiliated front groups—was based on fear that if the Maine legislation were to be upheld by the District Court, it would set the stage for other states to recognize what the American public has known for more than 15 years—that personal importation of safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety or efficacy meet or exceed those of the United States has increasingly over the history of personal importation become the only safe, affordable counter to the ‘Safe Haven” provided to Pharma  in the US for the highest prescription drug prices in the Industrial World.

So, it is no surprise that PhRMA Counsel John Murphy immediately jumped on the bandwagon with a statement that was an attempt to position the Maine Decision as a major decision regarding the legality of personal importation.  

He mentioned only in passing that PhRMA itself had been dismissed from the suit by Judge Torresen as having no standing because there was no evidence of ‘harm’ that might have been done to PhRMA. 

He continued his disingenuous stance by noting that: ““Last night, a federal judge in Maine agreed with our position. In short, the Court invalidated the importation law in Maine by ruling that, along with specific authority vested in the Food and Drug Administration (FDA) to regulate drug importation, the ‘FDCA’s drug approval, labeling, and packaging provisions demonstrate a clear Congressional intent to tightly control prescription drug importation, - See more at: http://www.phrma.org/media-releases/phrma-statement-on-court-ruling-on-maine-importation-law#sthash.Aqsyn1Rh.dpuf

The fact is that the FDCA reflects only the judge’s opinion that Congress indeed does have the jurisdiction to pass laws regarding the status of personal importation.  There is no reference to denying Americans access to their right to personally import medicines if Congress deems to act to allowing such access.

The ruling points out that the FDA itself has, as a matter of practice, allowed personal importation of prescription medicines as expressed in public statements, saying that it does not criminally prosecute individuals who personally imported up to 90-day supplies of their medicines.

Proponents of personal importation cite this as a de facto acceptance of personal importation.

The ruling also points out that Congress itself has passed legislation allowing personal importation with a caveat of ‘certification’ of safety by the Secretary of Health and Human Services. 

Unfortunately, this caveat has not been accompanied by Congress compelling the HHS Secretary to take steps to implement such certification, allowing instead, the option for the Secretary to exercise his or her own discretion as to whether to undertake such certification or even to offer Congress a reason for failure to act.

All of this masks the fact that brand-name medicines personally imported by American citizens from Tier One Countries are both valid and authentic medicines that of equivalent quality, safety and efficacy as their the same medicines sold in the US, at prices as much as 60 percent higher than the same medicine personally imported from a Tier One Country.

Equally, important, Mr. Murphy’s words may come back to haunt him if legislation in the form of S.122 – The Safe and Affordable Drugs from Canada Act of 2015 introduced by long-time allies of personal importation, Senators Amy Klobuchar (D-MN) and John McCain (R-AZ).

The bi-partisan legislation would allow the personal importation of brand-name medicines from Canadian sources, but, most importantly,  would require the HHS Secretary to undertake steps to implement the provisions of the bill, rather than making it an option for the Secretary.

It will be interesting to see if Mr. Murphy is as steadfast in his stand of support for Congress clear intent to control personal importation or will he join a fellow PhRMA attorney  Sarah A. Spurgeon, Assistant General Counsel of PhRMA,   who urges that FDA take action against individuals importing drugs in violation of the law, including use of its new destruction authority once FDA has finalized this proposed rule (for Section 708).”

This is a blatant appeal for the FDA to criminalize personal importation with actions against individuals for whom personal importation is a lifeline to vital medicines. 

An examination of the reactions of others who were party to the ruling indicate that they will attempt to distort in a way that Judge Torresen never intended:

·        Kenneth McCall of the Maine Pharmacy Association says, as a pharmacist, he sees first hand that cost is an issue for consumers - it's just that Maine's drug importation law is not the way to solve it.  "I think we can continue to look for better options," he says.

The obvious response is for McCall to deal first hand with an explanation of what he believes ‘better options’ might be.  We contend that Judge Torresen has laid it out—Congressional action such as S.122 setting a standard that ensures that the FDA finally fulfills the intent of Congress.

·        The problem, says Curtis Picard of the Retail Association of Maine, one of the plaintiffs in the case, is that it violated federal law. "The contention of our lawsuit was that the federal government regulates what can and cannot come into the United States," Picard says. "There's a lot of reasons for that...”

Really, Mr. Picard.  Other than the question of Federal supremacy, cite where the Judge presented any other reasons.

Interestingly, at the time of this post of this blog, PhRMA front groups such as The Center for Safe Online Pharmacies and the Alliance for Safe Online Pharmacies have not made a statement about the judgment.

Where does all this go?  The case might be appealed.  There is no guarantee it will be upheld.  Congress might pick up the cue from Judge Torresen and say, ‘Yes, we do have authority, and now, by God, we are doing to exercise it to (a) ensure that the FDA, HHS and unelected bureaucrats finally enact what we have said in many votes in the past, namely that personal importation of brand name medicines from Tier One Countries is safe—and affordable. “

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