Thursday, November 15, 2012
As the 112th Congress concludes its business and we prepare for the launch of the 113th Congress, it is appropriate to call attention to one of the continuing major drivers of healthcare costs—the fact that Americans pay the highest prices for prescription medicines in the world.
It is these prices that have led millions of Americans to turn to personal importation of safe, affordable medicines from licensed, reputable pharmacies in Tier One Countries that have standards of efficacy and safety that meet or exceed those of the United States.
Many members of Congress have repeatedly recognized the importance of this lifeline to vital medicines for Americans by its support of personal importation. Unfortunately, even when legislation to facilitate personal importation was passed, Pharma-backed groups of Senators and Representatives thwarted the will of Congress and the American public by the addition of ‘poison pill’ amendments requiring ‘certification’ of each and every imported medicine by the Secretary of Health and Human Services (HHS).
In 2012, Pharma stepped up its activities to curtail the right and ability of Americans to engage in personal importation of their medicines with such legislation as the Protect Intellectual Property Act (PIPA) and the Stop Online Piracy Act (SOPA) , both of which would have given Pharma intellectual property rights that would have branded all imports as ‘counterfeit—ironically, including some of the very same medicines manufactured by Pharma members outside the United States and sold in this country.
Fortunately, these bills were turned aside , the SOPA bill being particularly significant because it actually led to an Internet ‘blackout,’ a recognition of the onerous provisions of the legislation that would infringe upon a number of American rights.
However, with the passage of the PDUFA legislation—considered a ‘must pass’ piece of legislation to allow the Food and Drug Administration (FDA) to conduct its operations, Pharma again saw an opportunity—Section 708 which unfairly and inaccurately portrays personal importation of medicines from reputable pharmacies as being one and the same with the many bogus pharmacies selling unsafe, counterfeit medicines. A summary of our concerns follows:
a. In 2006, a bi-partisan effort stopped Customs from seizing vital medicines personally imported by Seniors and others. Seniors personally importing their medicines had been coerced to sign letters acknowledging their guilt in violating US law, and agreeing that the letter could be used against them in criminal prosecution if they (the Seniors) continued to practice personal importation. Congress found this unacceptable.
b. We fear there may be some confusion about the actions taken in 2006 to block arbitrary seizures in response to such an abuse of power by Customs and the FDA. It has come to our attention that there are those supporters of personal importation in Congress who seem to believe that the previous legislation will prevent such arbitrary seizures. To them, we voice our gratitude for their past support. However, we must caution that they do not confuse actions taken in 2006 as being binding upon Section 708.
c. Section 708 is different. It allows the Secretaries of HHS and Homeland Security to arbitrarily make seizures of medicines valued at $2500 or less if they are deemed to be potentially dangerous to Americans’ health. Unfortunately, this highly commendable goal has been co-opted by Pharma to be likely construed to extend to seizures of legitimate, safe medications.
d. While the House version of PDUFA did not include any process for due process review, the Senate Leadership was able to get such a provision in the final bill. The following describes our understanding of the provisions:
i. From the viewpoint of personal importation the structure of the review is based upon an individual initiating a request for a review within 30 days.
ii. If there is no appeal, the seized medicines are subject to destruction.
iii. If there is an appeal, and it is not upheld, the individual making the appeal is liable for any costs incurred by the Government during the appeal process.
e. The authority to make seizures is granted to a wide number of individual Customs agents.
f. The reasons for seizures include, but are not limited to : Safety, unregistered medicine, new non-approved medicine lacking FDA review/approval (this would immediately make all personally imported medicines subject to seizure since they are approved by the regulatory agency of the country of origin), misbranding (this could include medicines identical to those sold in the US being subject to seizure because of labeling requirements of the country of origin.)
II. It is our belief that the intent of the legislation as written is evident, creating an authority to grant seizure powers not only of bogus , dangerous and counterfeit drugs, but to expand the scope to seize vital medicines personally imported from sources outside the United States that have a proven record of safety and efficacy.
III. When the bill was being considered, we made contact with staff on the Senate Health Committee, and were told by Majority Staff that this was not the ‘intent’ of the bill, and that Senate Majority leadership, notably Senator Harkin, was committed to the concept of personal importation of vital medicines, seeking assurances from the FDA that personally imported medicines were not the ‘target’ of the Section.
a. Significantly, however, when asked further, Staff said that the assurances given to the Senator by FDA were adequate. We fear this might be the impression given to Congressional supporters
b. Our review of Section 708 has not given us any reason to believe that such good will or intent without being addressed specifically in the legislative language, will prevent unwarranted seizures from occurring, or that individuals—especially seniors—will be able to navigate the complexities of the appeals process and face the risk of the potential costs of an appeal.
In summary, we believe that (a) Section 708 is written in such a manner as to enable arbitrary seizures of legitimate, safe, affordable , and vital medicines that provide a life-line to untold numbers of Americans (b) that even with the stated intent of supporters of personal importation that such seizures will not occur, without specific language excluding such seizures, and that the section , as written, leaves no room for interpretation to the contrary (c) our understanding of the provision is that there is not such exception in the bill.
The result will be that untold numbers of Americans will be forced to either pay higher costs for the very same medicines denied by the seizures, or more tragically imperil their health and well-being by not purchasing vital medicines. The consequences will be tragic.
That is why we call upon Congress to be alert to what will admittedly be unintended consequences of actions that, on the surface, appear to have merit, but really are nothing more than yet another effort by Pharma-driven forces to solidify the United States as a safe haven for the highest prescription medicine prices in the world, and a major driver of the continuing rise in healthcare costs.
Thank you for your consideration of this letter.
TodaysSeniorsNetwork is comprised of www.TodaysSeniorsNetwork.com, a leading informational website for the challenges and opportunities of dealing with issues facing an Aging America attracting more than two million visitors annually across the nation, http://RxforAmericanHealth.blogspot.com, www.BoomersNewsOnline.com, and www.RxforAmericanHealth.com .
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