As any visitor to this blog or our website knows we have been a long-standing supporter of importation legislation that provides the greatest access for Americans to purchase physician-prescribed prescription medicines produced at FDA-Approved facilities from licensed, registered pharmacies in Tier One Countries (those with oversight standards of safety and efficacy that meet or exceed those of the U.S.).
It has been a long-standing goal of most supporters of importation that Americans be able to continue to make such purchases directly from those pharmacies, formalizing the movement that was spurred by American seniors, who have demonstrated over the past 10 years that, when presented with pertinent facts about vital medicines and pharmacies in Tier One countries, they are able to make decisions that have enabled them to enjoy safe, effective medicines at tremendous savings that simply would not be available otherwise.
In the many incarnations of prescription medicine importation legislation proposed since 1999,while the primary language, under the sponsorship of Senator Byron Dorgan (D-ND) and Senator Olympia Snowe (R-ME)has called for direct purchases from Canadian pharmacies, their bill, popularly called Dorgan-Snowe has limited the rights of Americans to directly purchase physician-prescribed medicines from other Tier One country pharmacies in countries such as Australia and New Zealand,
Yet, while limiting such direct purchases, Americans would be able to purchase those same medicines from Australia and New Zealand at any U.S. pharmacy that might choose to purchase those same medicines for resale from a wholesaler or pharmacy based in either Australia or New Zealand. The result: The U.S. pharmacy becomes a middle-man supplier, unable to provide the savings that would otherwise be generated by direct purchases. And,there is no guarantee that ANY of the savings might be passed along to U.S. consumers.
Still, I and others supported the importation push because there were those who supported the right of individual purchase, and it was hoped that such provisions could be incorporated into any legislation that might be adopted.
With the change in Administrations in Washington, and the overwhelmingly Democrat majorities in the House, plus the bi-partisan support for importation as a tactic to lower prescription medicine prices in this country, it was hoped by many advocates that any legislation proposed would reflect the fact that the safety and efficacy, as well as the savings possible from access to pharmacies in Tier One countries have been adequately demonstrated, and that those responsible for drafting the proposed language would make sure that it reflected policy that would take full advantage of the benefits of access to safe, affordable medicines for the greatest number of Americans--including no restrictions on the right of Americans to purchase medicines directly from licensed, registered pharmacies in Tier One countries.
Instead, the new proposed language for the Dorgan-Snowe bill imposes such limitations while at the same time, telling Americans that if they want those same medicines from the same countries to which they are otherwise being denied access, they must purchase them from U.S. pharmacies, with no guarantees of savings.
For those thousands of Americans who have come to rely upon purchases of their medicines from those countries, this is a unacceptable situation because it threatens the health of U.S. citizens, and creates a situation which likely will only add to the costs of their medicines at a time when increasing numbers are facing dire economic times. Also, the fact is that the safety record of prescription medicines from licensed, registered pharmacies is exemplary.
Added to this is the fact that there are many other questions about the scope of the bill's proposed language and its impact upon mail-order and Internet-based pharmacies based in Canada that we believe require that the time be taken by the writers of the bill to seek additional input for consideration in the shaping of the final proposed language.
The new Administration of President Obama has pledged to bring a new openness and transparency to Washington and policy-making. The sponsors of importation have garnered many allies and friends over the years, and, I consider myself among those. But the fact is that this is not only an opportunity to ensure that any legislation will reflect the positive influence that can come from inclusion, but will address many concerns that are arising even among supporters. The fact is that this is as one supporter said,"not an ideal bill", but that he was willing to accept it because he believes it reflects several items that supporters have sought. While that might be true, the passage of a bill is not, in and of itself, the ultimate goal. Rather it is the health and cost benefits that can be provided to Americans across the country. The current proposal is fraught with many challenges.
We have written to staff of Senators Snowe and Dorgan, as well as staff in Congressman Marion Berry's (D-AR) office and Congresswoman Joanne Emerson's (R-MO) office to offer a list of considerations and questions that many feel need to be addressed in any legislation. Representatives Berry and Emerson will provide the leadership in the U.S. House, as Senators Dorgan and Snowe will do in the U.S. Senate. We hope that they will respond favorably to the request for seeking input from a number of sources.
In the next few posts, we will examine each of the points/questions presented to staff.
Note: For the record, in the interest of transparency, I have worked on this issue with senior advocacy groups across the nation for the past seven years. I also have been a communications consultant with Canadian pharmacies and others whose products and services are of benefit to the health and well-being of American citizens.
2 comments:
I'm all for healthcare cost savings. I wiggle & squirm under the high healthcare costs & clench my jaw at the inefficiency & incompetence at least as much as any other American, (very likely much more) believe me! I'm also for high quality, efficient, effective, & user-friendly healthcare. Sometimes we can't have both without one compromising the other. There is a limit on what is possible & a balance to be found.
With inadequate resources, the FDA is having a very difficult time inspecting all those foreign drug manufacturers. If we rush to legalize importation by individuals of drugs manufactured in foreign countries by companies on which the FDA is unable to keep tabs by proper & timely inspection, we risk our lives. Reference an AP article dated Apr 24, 2008 on this subject available as a cached page at:
http://cc.msnscache.com/cache.aspx?q=fda+inspections+of+foreign+drug+manufacturers&d=75591607783843&mkt=en-US&setlang=en-US&w=4efb73df,8d7a2e65.
Also of interest:
“Statement of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, before House Subcommittee on Health, "Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Drug Safety"
May 01, 2008 at http://www.fda.gov/ola/2008/fdaglobalact050108.html
I agree that prescription drugs are sometimes outrageously priced. We consumers are too often contributors to that when we ask for, or even insist on the latest “designer” drug when a tried & true “oldie but goodie” will serve the purpose just fine. This is why drug manufacturers spend billions every year on advertisement of prescription drugs, & why their advertisement expenses are increasing exponentially faster than their research & development expenses are. And you bet they pass that cost on to we consumers!
Besides New Zealand, the U. S. is the only developed country that even allows direct-to-consumer advertising (DTCA) of prescription drugs. Details & stats are available at http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising and http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising_in_the_United_States. (See more in “Truth in Advertising: Rx Drug Ads Come of Age” at http://www.fda.gov/fdac/features/2004/404_ads.html
Before we all yell “Hurray! Cheap drugs!” & flock in droves across the borders after these bargain meds, ask yourselves, “Precisely how effective do I truly believe a once in every two or three years (or less) pre-announced inspection could possibly be?” and “How far do I really trust that the unknown person who filled my order in XYZ country for this medicine is even remotely qualified to do so & is completely careful? Is this medicine really as safe as it should be?” Think very seriously about these questions before you pop your next pill into your mouth. What is your safety worth to you?
We MUST proceed with caution in fixing our healthcare system & make certain we make decisions based on accurate facts, not personal or political agenda, lest we make it worse instead of better.
Let’s do the right things right!
Concerned RN, CPHQ (Registered Nurse X 35 years, Certified Professional in Healthcare Quality X 15 years)
Related Information: FDA’s current “Guide to International Inspections and Travel” linked from the FDA Inspection Reference page at http://www.fda.gov/ora/inspect_ref/default.htm
Be well, fellow seniors!
I am not aware of anyone asking for designer pills, which are actually produced not to meet a particular medical need but merely to extend patent protection. Also, recognized authorities have long recognized that the standards of oversight and protection in Tier One countries meet or exceed those in the U.S. And, as Senator Bernie Sanders says, 'Show me the dead Canadians'...also the R&D of pharma is financed in large part by U.S. taxpayers...the biggest contributor to expenses is lobbying.
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