Thursday, November 5, 2015
Call for Congressional Coalition effort to draft consensus, comprehensive legislation combining elements of proposals, for 2016 conventing of Congress
In what may be one of the biggest news stories of 2015, and one with the potential for long-range health and financial benefits for untold numbers of Americans is that the harmful effects of Pharma pricing strategies has seemingly become an issue of primary importance to the U.S. Congress.
But, after the many hearings are held, after the Forums are over, after the Task Forces disband, after Pharma and its front groups launch their counterattack using the vast financial support of literally dozens of members of Congress and the army of lobbyists that will be turned loose on Capitol Hill, the question remains:
Will this be, as Henry A. McKinnell,, the then-chairman of Pfizer scolded then-Governor Tim Pawlenty of Minnesota in a press conference following a shareholders’ meeting in St. Louis, the seeming outrage would be nothing more than a ‘Prairie Fire that comes along every four years as a product of the elections and then ‘burns itself out.’
That is why it is crucial that Congress acts to ensure that the U.S. joins the rest of the industrialized world to ensure that our citizens have access to affordable, safe, and innovative medicines that will enhance the health and well-being of all Americans.
As a long-time supporter and advocate for personal importation of brand name medicines, acting as a consultant on personal importation issues, I have previously expressed my support for a Congressional Caucus of Congressional supporters of personally imported brand name medications.
Now, the furor over the Pharma practice of ‘charging what the traffic will bear’ has led to a number of Senators and members of the House of Representatives of both political parties supporting legislation on behalf of a range of issues such as ‘pay to delay’; personal importation; patent rights of U.S. citizens as ‘stakeholders’ because of their dual role as patients and as major providers of the fiscal support of Research and Development costs of developing new medicines; and, measures to allow negotiation of prices for Medicare and Medicaid, a practice already in place for the Veterans’ Administration.
While all of these initiatives are encouraging, we believe it is time for a coalition of Senators and Representatives and their staffs to come together to reach consensus on a single comprehensive bill incorporating all of the points listed above, and to be prepared to offer their bill immediately with the reconvening of the 114th Congress in January 2015.
By so doing, Congress will assume its rightful role as the determinant of policies affecting prescription medicine safety, cost and availability with a bill that will favorably provide physical and fiscal benefits to untold numbers of Americans. It will also end the ‘Safe Haven’ that Pharma has created in the U.S. for its predatory pricing practices.
It was in August 2014 that I wrote how Pharma was developing ‘The Perfect Storm” to advance its agenda employing a number of techniques to ensure that America remained its ‘Safe Haven’.
An exploration of the many aspects of Pharma’s strategy led us to “…The conclusion is that whereas previous Pharma efforts had been characterized as admittedly potentially harmful, they were ‘individual’ in nature and lacked what can be determined in the present circumstance to be ‘cumulative’…”
We noted that “The current Pharma effort on a number of fronts reflects a comprehensive, coordinated strategy that by its breadth threatens the health and fiscal interests of the American patient/client…”
We cited the strong support of Pharma’s agenda by members of Congress who received millions of dollars of contributions from Pharma, noting that there existed “…An attitude inside the Beltway by elected Senators and Representatives who are beneficiaries of huge donations from Pharma interests that is described as a ‘By Invitation Only’ (BIO) attitude. The BIO-approach limits the opportunity for advocates of personal importation to testify before Congressional hearings on issues that affect the role of personal importation while including only Pharma interest spokespersons.”
The situation was bleak, but at the same time, I observed to colleagues that there were always certain things that we could count on from Pharma.
The first was the arrogance of the industry which had led over many years and instances to a hubris that exposed Pharma’s primary motive, i.e. to charge the highest prices possible and whatever ‘the traffic will bear’.
I followed that with the observation that perhaps Pharma was not as smart as we gave them credit for being, noting the comment of a Pharma lawyer during the submission of comments on Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA) in which she called for the criminalization of individuals who were personally importing their authentic medicines from Tier One Countries, a policy move that was contrary to all previous FDA actions.
I have always hoped that the public, policy makers and media would someday recognize the merits of the mantra published so many times in these blogs: A medicine that is unaffordable is equally unavailable, and, by extension, a medicine that is unavailable is equally incapable of providing any health benefit.
Now, that day has come, and it is Pharma that is attempting a pushback to overcome the wrath of the public and policy makers by claims that treatments that cost $80,000 to $100,000 are ‘worth it’ when compared to the alternative of dying.
But the highly expensive, overly priced specialty medicines were only the tip of the iceberg. One need to only consider the spike in Generic prices in the last year.
There is finally a recognition of the problem of the predatory pricing policies at a national level as the two Democrat candidates for President have offered comprehensive legislation that for the first time combines all the elements that have contributed to Pharma abuse in proposed legislation.
The proposals include dealing with ‘pay to delay’ tactics that keep lower-cost medications from being introduced; a recognition of the ‘stakeholder’ role of U.S. citizens and taxpayers who provide much of the funding for Pharmaceutical research in the U.S. through their support of the National Institute of Health; a call for changes in the prosecution of criminal activity by Pharma members that would hold not merely the companies liable, but would subject the offending officers of the firms to criminal action; and, a strategy that would allow the ending of patent protections with the ‘ownership’ of the patents ‘returning’ to American citizens; finally, there are many bi-partisan bills in the U.S. Congress dealing with one or another aspect of Pharma practices including ‘pay to delay’, personal importation of Brand Name medicines from Tier One Countries, promotion of the broader use of generics,
The result is that whereas a year ago, Pharma was creating ‘The Perfect Storm’, it today is in an unprecedented situation in which it is not the determiner of the debate, but is instead is engaged in the middle of the storm with lightning bolts directed at them by hospitals, insurance companies, patients, Presidential candidates, and Congressional investigations.
This creates a climate of opportunity for long-suffering Americans who have paid steadily increasing prices for their medications. It creates a climate of opportunity to end Pharma actions that create costly—and too often unaffordable medicines—that are a major driver of health care costs. It creates a climate of opportunity to recognize the role of the American patient, caregiver, family member as having ‘stakeholder’ rights that merit a seat at the table in the form of ordinary citizens and/or their advocates.
Most importantly, it creates a climate in which the totality of the harmful effects of Pharma pricing strategies has been exposed.
The challenge: Will Congress exercise leadership to take the steps that will ensure success, or, will we witness another Prairie Fire burning out?