U.S. SENATOR PATRICK LEAHY

Leahy And Sanders Call For Greater Access
To Reimported Prescription Drugs

Sanders And Dr. Elizabeth Wennar Of United Health Alliance Of Bennington
Tell Panel Reimportation Safe And Necessary

Leahy, the ranking Democratic member of the Senate Judiciary Committee, invited Wennar and Sanders to testify before the panel to share their first-hand experience helping Vermonters reimport prescription drugs from Canada.  The hearing was called by Chairman of the Senate Judiciary Committee Orrin Hatch in light of Bush Administration claims that drug reimportation poses heath risks to the American public. 

Sanders said, "This issue is not just about whether Americans will be forced to pay the highest prices in the world for prescription drugs - it is about whether Congress will turn its back on tens of millions of Americans who desperately need lower prices for the medicines they rely on each day to survive. The United States Congress must have the courage to do what the rest of the industrialized world has done and tell the industry that they may no longer corner our sick and dying into an isolated, monopolized market and force them to pay outrageous prices for their medicines."

"Americans pay some of the highest prices for prescription drugs of any country in the world - despite the fact that many of these drugs are made right here, and they are often made with the benefit of taxpayer supported research," said Leahy.  "Prescription drugs are a lifeline, not a luxury.  Faced with this dilemma, and with Washington's unwillingness to help, many Vermonters, like Dr. Wennar, were among the first to take matters into their own hands."

Dr. Elizabeth Wennar is the CEO and Executive Director of United Health Alliance of Bennington, Vermont.  Her organization, which is made up of community physicians, a rural hospital, a nursing home and a home health agency in Southwestern Vermont, was a pioneer in importing prescription drugs from Canada by mail.  She has also done extensive research on prescription drug importation and has previously testified before Congress on the issue.

Leahy's opening statement, Sanders' opening statement and Wennar's testimony are available below:

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Statement Of Senator Patrick Leahy
“Examining The Implications Of Drug Importation”
Senate Judiciary Committee
July 14, 2004

Mr. Chairman, I agree that this is an issue with profound implications for the American public.  Vermonters were among the first to throw a spotlight on the issue of prescription drug importation, and we have followed this issue closely for many years and have pushed for consumer-friendly solutions.  I am pleased that now, we in this Committee, have the opportunity to restate the very compelling case for the establishment of a safe, legal system to import affordable drugs into the United States.  I regret that the Senate Republican leadership has obstructed the path to a solution for so long.   

A Lifeline, Not A Luxury

Americans pay some of the highest prices for prescription drugs of any country in the world – despite the fact that many of these drugs are made right here, and they are often made with the benefit of taxpayer supported research.  Prescription drugs are a lifeline, not a luxury.  Faced with this dilemma, and with Washington’s unwillingness to help, many Vermonters and other Northern Border citizens were among the first to take matters into their own hands.  On buses, Congressman Sanders started leading trips to Canada five years ago to let Vermonters safely buy affordable medicines on the other side of the border, where struggling seniors are able to find savings of anywhere from 50 percent to 70 percent.  Buses like this were powerful early symbols in opening this debate.  And they have been effective, much like Senator Dorgan’s use of his famous orange rubber pylon in demonstrating the lack of security along the Northern Border.

Voting With Their Bus Tickets

American consumers didn’t take long to figure out that the deck is heavily stacked against them, and they have found ways like this to vote with their pocketbooks and with their bus tickets.  Meanwhile, the White House, big drug companies and many in Congress have done all they can to thwart each consumer breakthrough.

Those trips worked for awhile, but for seniors who couldn’t easily make the trek across the border, there had to be another option.  That is where mail order entered this equation, and by now mail order has drastically transformed the importation of medicine, and it has also become a powerful new catalyst for reform.  The fact is a bus trip across the border is not the way Americans should have to get affordable medicine prescribed by their doctors.  And the fact that American consumers have had to resort to creative solutions like this long ago should have shamed Congress and the White House into action.

In my home state of Vermont, our Republican Governor, our Democratic Attorney General and the Mayor of our largest city have all spoken out on the unmet needs of the people of our state, and to offer their help to the federal government in designing workable systems for prescription drug importation.  But their pleas, and those of state and local government officials all across the country, have been met with obstinate resistance. 

Raw Deals, Life-And-Death Choices

At the same time, American consumers are moving ahead with or without us.  They know when they have been dealt a raw deal.  They see this raw deal in black and white each month when they sit down at their kitchen tables to pay the bills.  The issue boils down to access:  A prescription drug is neither safe nor effective if you cannot afford to buy it. 

We have to recognize that this imposes real dangers on American consumers when they cannot follow their doctor’s treatment plan because they can’t afford their medicine.  While we must do more to bring affordable healthcare to the millions of Americans who are currently uninsured or who do not have good coverage, we cannot continue to deny them this immediate market-based solution. 

For many Vermonters, purchasing drugs from Canada literally means the difference between following their doctors’ orders or having to throw the dice with their health and sometimes even with their lives by doing without their prescription medicines.  It makes the difference for the woman who has maxed out her health plan’s annual prescription drug benefit only three months into the year and is then faced with purchasing the other nine months worth of medicine at U.S. prices on her own.  It makes the difference for the elderly man on a fixed income who is unable to afford both the heart medicine he needs to live, and the gas bill he needs to keep warm.  As regulators and policymakers sit idly by in Washington, the pharmaceutical industry is moving to cut off supplies to Canadian pharmacies in order to prevent Americans from purchasing their drugs at affordable prices.  Are we prepared to tell those in dire need that they must go back to choosing between paying gas, food, and heating bills, or their medicine? 

We owe it to American consumers to stop asking whether we can set up a system to provide safe and affordable prescription drugs from Canada and to promptly devise a system that answers the question of how we do that.  Fortunately, we can do it and we have a bill before us that will do it.  It comes down to a matter of political will.  American consumers were ahead of their Government.  They have already proven that importation works.  We should be coming together without further delay to establish a self-financed system that will give FDA and Customs the resources they need to afford Vermonters and all Americans access to legally imported safe, FDA-approved prescription drugs from Canada.

We in Congress have put our stamp of approval on allowing American consumers to purchase prescription drugs from Canada three times over the past four years and yet each time those efforts have come up short because of the objections by many in the Executive Branch and their friends in the drug industry.   I am hopeful that this hearing and the long awaited markup before the Senate HELP Committee scheduled for next week will finally move us toward a workable solution.

Leverage For Average Consumers

At every turn, American consumers are finding that the big pharmaceutical firms have all the leverage.  The Bush Administration fought every effort we made during debate on the Medicare prescription drug bill to give some leverage to consumers and taxpayers.  And the critical issues of safe and reasonable drug importation are not being played out just at the FDA and in Congress.  Now the White House’s trade negotiators have become involved, and I am concerned that they have not acted to improve the situation. 

New Trouble In A Trade Agreement

In the last few days, some very troubling – and unpublicized – provisions in the proposed free trade agreement with Australia have come to light.  That agreement, as negotiated by the Administration, seems to pose real threats to drug importation.  It contains new provisions, not found in earlier agreements with other countries, that would appear to give new rights to pharmaceutical companies at the expense of American families.  It may also allow for the creation of new barriers to the importation of low-cost prescription drugs.  And it gives giant drug companies the opportunity to delay the availability of generic alternatives to their patented products.  These provisions raise serious concerns, and they threaten new and more dangerous precedents for subsequent trade agreements regarding prescription drugs being negotiated by this Administration.  On behalf of America’s consumers, we need to fight for the availability of low-cost generic drugs and for the importation of low-cost prescription drugs -- in the Senate, before administrative agencies and in this Administration’s trade negotiations.

We have a number of capable witnesses this morning.  I welcome Senator Dorgan and Senator Breaux.  We appreciate your leadership Senator Dorgan on this issue and the work you have done with Senator Stabenow, and we are always delighted to hear from the senior Senator from Louisiana.   It should be no surprise that I am a cosponsor of Senator Dorgan’s legislation on drug importation, as are a number of this Committee’s members and, I believe, a large portion of the Senate.  I look forward to hearing from a leader on this important issue in the House of Representatives, the distinguished Congressman from the State of Vermont, my friend Bernie Sanders.  Those of you on the Committee who have not had the pleasure of working with Congressman Sanders are in for a treat. 

Mr. Hubbard, Mr. Taylor, and Ms. Durant, thank you for coming up to the Hill today.  Mr. Mayor, welcome, it is good to see you again.  I also look forward to hearing from Mr. Catizone and Ms. Jaeger and I am pleased that Ms. Disch of AARP and Professor Schondelmeyer could be here with us this morning as well.   

Finally, I want to extend a particularly warm welcome to a fellow Vermonter who is here to testify on our third panel.  Dr. Elizabeth Wennar is the CEO and Executive Director of United Health Alliance of Bennington, Vermont.  Her organization, which is made up of community physicians, a rural hospital, a nursing home and a home health agency in Southwestern Vermont, was a pioneer in importing prescription drugs from Canada by mail.  She has also done extensive research on prescription drug importation and has previously testified before Congress on this issue.  Dr. Wennar, I appreciate your coming to Washington today to share your considerable expertise.     

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Testimony Of Representative Bernard Sanders
Before The Senate Committee On The Judiciary
Wednesday, July 14, 2004

Mr. Chairman, thank you for welcoming me to address this very timely and important hearing.  As the first member of Congress to take constituents over the Canadian border to purchase prescription drugs at a fraction of the price charged in the U.S. and as the Representative of a state in which large numbers of seniors regularly purchase prescription drugs from Canada, this issue is obviously of huge importance to me.  This issue is not just about whether Americans will be forced to pay the highest prices in the world for prescription drugs - it is about whether Congress will turn its back on tens of millions of Americans who desperately need lower prices for the medicines they rely on each day to survive and instead succumb to the hundreds of millions of dollars spent by the industry on campaign contributions, political advertising and relentless lobbying. 

This is not just a health issue - it is one about whether Congress represents the interests of the people of this country.  The pharmaceutical industry year after year is the most profitable industry in the world - by far - and has paid its CEOs as much as $150 million in a given year.  And, year after year, our people are forced to pay two and three and sometimes even ten times what Canadians are charged for the exact same prescription drugs.  I will not ever forget the trip I took to Montreal in 1999, where women who were struggling with breast cancer were able to buy Tamoxifen, a widely prescribed breast cancer dug, at one tenth the price they were forced to pay at home.  This, Mr. Chairman, is nothing short of a moral outrage and if the industry had any shame whatsoever it would have discontinued such egregious price-gouging on its own years ago.

Yet it hasn't - and it is the responsibility of Congress to reign in the insatiable greed that consumes this runaway industry.  American prescription drug prices - already outrageous - rise at roughly fifteen percent every year and, without action from us, there is no end in sight.  Meanwhile, according to a Kaiser Family Foundation report, almost twenty-five percent of seniors do not fill or skip doses of their prescription drugs in order to make their medicines last longer, and, for those without drug coverage, that number goes up to over thirty-three percent. 

The simple truth is that the pharmaceutical industry lies a lot.  They set up phony seniors' organizations and they have over 800 well-pad lobbyists from both parties who are prepared to descend on Congress at any given hour to protect the profits of the drug giants.  The two big issues they repeatedly harp on in opposition to drug importation are the supposed safety threat presented by a reimportation system and the threat such a system would pose to the research and development of new prescription drugs.  Let me briefly respond to both of these common charges.

Last year, William Hubbard, a senior official with the FDA and one of the leading critics of reimportation, testified before a Government Reform subcommittee on which I serve.  When asked if he could cite one example of an American consumer who had been harmed by a prescription drug purchased on the Canadian market, he responded, and I quote, "I know of none."  Then, as now, the industry and, pathetically, the FDA, were spending huge amounts of money talking about safety threats while they could not even name one individual who had been harmed by such purchases - despite that more than one million Americans are regularly buying on the Canadian market.  Some safety threat.

Also last year, I requested a report from CRS that confirmed that the drug markets in the United States and Canada are regulated in virtually identical ways from manufacturing and importation to labeling, distribution and sales.  Every prescription drug manufacturer, wholesaler, and distributor in Canada must be licensed by the federal government, and every pharmacy and pharmacist must be licensed by their provincial government.  All Canadian prescription drug manufacturing facilities and distribution facilities must meet strict Good Manufacturing Practices and Canada maintains strict chain of custody requirements.  All prescription drugs on the Canadian market must be approved for sale to Canadian consumers and must include contact information of every company that has handled the product along the chain of distribution.  Again, I say some safety threat!

Reimportation or its equivalent, "parallel trade" in pharmaceuticals, has taken place regularly in Europe and many other parts of the industrialized world for over 25 years with none of the problems conjured up in the scare campaign of the industry.  Further, I would simply add the safety argument represents the ultimate in hypocrisy.  Only in an institution so thoroughly corrupted and dominated by big money interests could those who swear on the altar of free trade tell us regularly how great it is that we can safely purchase fruits and vegetables from tens of thousands of farmers in dozens of countries and safely purchase beef and pork and poultry from farms all over the world, while simultaneously maintaining that the FDA cannot effectively regulate the flow of drugs from a handful of well-regulated pharmaceutical markets in the developed world.  Nobody seriously believes this transparent pharmaceutical industry lie, Mr. Chairman, and I urge your committee to reject it.

In terms of the "threat to research and development" argument, the industry is lying once again.  The taxpayers of this country regularly fund the most fruitful pharmaceutical research and development in the world and simply hand it over to the drug giants for free.  Our taxpayers directly fund nearly all R&D conducted in the U.S., both through our financing of the National Institutes of Health as well as through generous tax breaks given to the industry for the research it conducts on its own.  In return, the industry charges these very taxpayers anything they well please for desperately needed life-saving drugs. 

The industry often claims that it costs an average of $800 million to bring a product to market, though they refuse to produce documentation of such expenses.  Others who watch the industry closely estimate that the true cost is closer to $200 million.  Why must our citizens be gouged at every turn when this same industry manages to turn sufficient enough profit in European countries - where governments put reasonable limits on drug prices - to continue to conduct significant levels of research and development there?  This industry refuses to make clear to Congress or anyone else how much they really spend on research and development for drugs we need for cancer and heart disease and high blood pressure.  Yet the suspicion is that much of their so-called R&D dollars go to developing  "me-too" drugs that make minor changes - often merely cosmetic changes - to existing drugs in order solely to give one drug maker or another a bigger share of the market. 

In short, I hope the Senate will reject the scare tactics of the pharmaceutical industry and instead stand up for the interest of regular Americans who are struggling to afford their medicines.  Let the United States Congress have the courage to do what the rest of the industrialized world has done and tell the industry that they may no longer corner our sick and dying into an isolated, monopolized market and force them to pay "whatever the market will bear" for medicines they need to simply survive. 

Mr. Chairman, thank you again for this opportunity to share my views.

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Testimony Of Dr. Elizabeth A. Wennar,
President And CEO, United Health Alliance, Bennington, Vermont
Principle, HealthInova, Manchester, Vermont
July 14, 2004

Mr. Chairman, and Members of the Committee:

Thank you for inviting me to discuss (re)importation of prescription drugs.  

Today's healthcare market presents many challenges.  None is more controversial than that of technology in the form of a "pill".   Pharmaceutical spending has almost doubled in less than a decade.  More often than ever, our policymakers and physician providers are being queried as to why it is that Americans must pay many times more for their medications than their counterparts in other countries?   As you know, over the past few years many of your constituents have been purchasing their medications from Canada.   For these individuals, these medications are now affordable and even more importantly safe. From a pure medical standpoint, the most important part of a treatment plan that is intended to produce the best possible outcome for a patient, is the patients ability to comply with what 's prescribed by their provider/physician. Any medication, as part of a prescribed treatment plan, that is not affordable and therefore not accessible, is neither safe nor effective.  

Quality and Compliance

Many of the recent conversations around (re)importation have focused on quality and safety issues.   As providers of care, no one knows better than physicians and pharmacists how important quality is in the process of providing care.   Quality can be defined in many ways, in this instance I want to discuss the importance of compliance for an individual/patient.   When a physician/provider prescribes a medication as part of a treatment plan, they assume that the individual will have access.   Many do so because they [the provider] have used samples provided to them at no costs to give to their patients.   So, when they have a patient that responds well to a particular medication provided as a sample, they do naturally what comes next in the process…write a prescription for the medication.   Unfortunately, medications supplied as samples, in general, are the very ones that are not affordable.  

Clearly as a provider network, our major concern is the ability of patients to comply with a given treatment plan.   When a patient cannot afford their medications it is costly for all of us.   Are physicians concerned about quality?  Absolutely.  And there is a quality issue and exist on this side of the border.   When a patient cannot take their medications, they most definitely will consume services elsewhere in our system, such as the emergency room or by being admitted to the hospital.   That simply is not rational.   This is not about people that won't comply with a treatment plan, this about individuals that can't afford to purchase prescription drugs in the country they live in.   Also, let's keep in mind that we are talking about Canada not some third world country.  Having said this, these individuals are willing to take the risk associated with accessing their medications across the border.   Many of them have told us that there is certainly no more risk in doing this than they are at by not taking their medications as prescribed or not at all.   

Let's talk about quality and safety.   I would ask you to reflect on when the last time was that you witnessed an armored vehicle delivering medications from manufacturer to the community pharmacy in this country.  This is an extreme example, but I would like to make a point about safety under the guise of quality.  Much propaganda has surfaced over (re)importation of medications from other countries, particularly Canada.  This attempt to frighten individuals that are already terrified of compromising their health by not being able to take their medications, creates a form of terrorism that is inexcusable.   Some would have you believe that Canada's pharmaceutical supply is unsafe and of inferior quality.  Ads placing pills side by side and questioning which one is the counterfeit drug and poisonous snakes around medication bottles, is a poor use of valuable resources and intended to produce fear (Exhibit A,B, C).  It does nothing to help address the problems associated with access.

Facts/Observations: 

ü      Parallel trade has existed safely in the EU for years.  There is no evidence that parallel trade promotes counterfeiting when the appropriate controls and regulatory processes are established.  (Exhibit D )

ü      (Re)importation from Canada exist.  The U.S. consumer has taken upon themselves to demonstrate it works.  Millions are currently utilizing as a means to comply with their treatment plans.  (See Map displayed during testimony)

ü      The Canadian system is well regulated and safe (Exhibits E,F,G)

ü      Canada (as does) other countries) has the equivalent of the FDA with regard to oversight

ü      Customer satisfaction and compliance for those using (re)importation from Canada appears high

ü      Physicians engaged in the process. Compliance results in better outcomes and potentially lower costs to the overall system.

ü      Guidelines and standards can be [and have been] established for the oversight of mail-order.  Accreditation process must be much broader than just the marketing via the internet (Exhibit H  )

ü      U.S. Consumer created the mail-order industry in Canada.  Legitimate mail-order in Canada welcomes standards and the regulatory process needed to provide safety controls for U.S. citizens protection from unscrupulous providers via mail-order. Particularly for "lifestyle, me-too" medications and controlled substances (Exhibit I )

ü       The community-based pharmacists must be re-integrated into the health management plan (mail-order has carved the community-based pharmacist out as a provider of quality oversight)

ü      Recent reports surface that make reasonable arguments for legislation to be passed (Exhibit J,K,l GAO,AARP and Sagar)

ü      Legislation is necessary to provide standards and oversight  for what already exist

Background on United Health Alliance

United Health Alliance is a nonprofit physician-health system organization located in Southwestern Vermont.   Our partners include a rural hospital, nursing home, home health agency and just over one hundred (120) community physicians.  We serve residents of Vermont, New York and Massachusetts.   Our mission is to promote a physician-driven organization whose principle services are to provide advocacy and leadership in the areas of care management, contracting, performance improvement and educational programs to maximize value for our physician-hospital membership and customers [patients].   Although we have committed to ten (10) guiding principles, none is more important to us than assisting the communities we serve at becoming the healthiest in the nation.   Several years ago we found that although admirable, this objective was going to be very difficult to achieve given the circumstances that existed for some of our elderly and uninsured/underinsured.  Very simply, they did not have access to affordable prescription drugs, therefore they were not able to comply with the treatment plans prescribed by their physicians.  Although we had individuals that were seeking affordable medications via bus trips to Canada, we knew that this was not an option for the majority of the communities we serve by virtue of their medical condition and/or their limited resources.  One of our physicians came to us and requested our assistance at investigating how we could help a patient of his with breast cancer from Massachusetts access her medications from Canada without having to get on a bus.    Today that patient takes her medications because she can afford them.   It cost her ninety (90) percent less in Canada.  We compared the costs for 145 seniors for the first six months to see if what we had heard about the differences in pricing was in fact true.   While these individuals would have had to pay just over $81,000 in the U.S., they paid approximately $22,000 for their medications in Canada (see Exhibit M ).   Our understanding is that there were no substitutions for the medications they were currently on.   All medications accessed were for the treatment of chronic diseases such diabetes, heart disease and cancer.   A price comparison of some of the more commonly prescribed medications for the treatment of these diseases has been provided along with this testimony.   Although there is minor variation with some pricing in Canada, the savings are still significant and have been reported anywhere from thirty (30%) to (95%) percent (see Exhibit N )[Note:  These prices have changed since supply has been cut to some pharmacies and wholesalers).  Although the majority of the individuals that accessed their medication from Canada were the elderly on fixed incomes, with no prescription coverage, many individuals that have depleted their pharmacy benefits also are now accessing their medications from Canada.   As we have conversations with employers located in the communities we serve about benefits and coverage for their employees we find many are concerned about how to continue the level of coverage they currently provide, particularly with the growth in their expenditures for prescription drugs.   The implications are frightening for all of us. 

 Compliance: Physicians assume that when they prescribe a medication

 (write a script) that the patient will take their medication as prescribed. They

don't have any interest in where you get it filled.  This is not to say that they

would not be concerned if they thought there was a safety or cost issue.  They

are concerned about compliance with regard to a prescribed treatment plan.

FDA Site Visit: The FDA completed a site visit/audit of the UHA  initiative on July 22, 2002.   No notice to cease and desist was issued.  Additional information can be provided to the Committee upon request.      

Conclusion/Recommendations

Personal re-importation has for all intensive purposes, been implemented by the American consumer.   It may or may not be a long-term solution, but it does provide an option until we can provide appropriate levels of coverage (access).   Long-term viability will depend on the development of a program that can be implemented not just signed into law [as evidence by MEDSA 2000].

 Barriers to access are unacceptable.   (Re)importation of prescription drugs is working as a mechanism for access of affordable prescription drugs.  Should the current process be improved upon …absolutely!   Should there be controls in place to monitor quality of those involved…absolutely!

Clearly, there is no simple answer with regard to the issues we are discussing.  Barring any type of regulation of the pharmaceutical industry on this side of the border, personal (re)importation from Canada under controlled circumstances can provide an interim solution for those in need of access to affordable prescription drugs.  

The passage of S2328 (The Pharmaceutical Market Access and Safety Act of 2004) with the incorporation of standards requirements for participation is essential to protect what has already been established by the U.S. consumer.  I believe that all the intent of S2464 (Internet Pharmacy Consumer Protection Act) can be achieved by including language on standards requirements.  The marriage of these two pieces of legislation is essential to the establishment of a "good health policy".  

Epilogue

FDA Oversight 

From the perspective of safety and oversight clearly the FDA [and other agencies] must be concerned as to how any initiative that would involve re-importation of prescription drugs would be maintained under their current charge.  Although challenging, it can be done.  With regard to Canada it would not be that difficult to do. The following could/should be considered:

1.                  In order to maintain and provide an efficient means of oversight by the FDA, all participating pharmacies would be registered with the FDA.  In order to do so, they would have to be accredited, much the same as the Joint Commission (JCAHO) accredits hospitals and other health institutions here in the United States.   After meeting a set of quality standards the mail-order pharmacy would be awarded accreditation and allowed to register with the FDA.  They would then be listed as approved as foreign participating mail-order.   Once all requirements are met, the FDA or another entity, would issue non-counterfeitable seals/emblems for these pharmacies to use when shipping packages into the US (through Custom).   No seal, no entry in to the U.S.  (suggest the system currently used by the U>S. Treasury to protect U.S, currency)

Note:   Flex Products is a world leader in the development of optically variable technology for counterfeit deterrence.  Their Optically Variable Pigment (OVP) security technology is currently utilized by over 87 countries, including the US and the newly designed $10, $20, $50 and $100 bills.

2.                  With regard to monitoring of the quality of drugs being shipped, a proxy with the country (Canada) could be established.  There is no reason that we can not accept the standards that are equal or higher established by another country.   No country should be allowed to participate that does not have at the very least a set of standards equal to ours regulatory agency [FDA}.  Additionally provider whether mail-order or wholesale should be able to meet standards of U.S.-based oversight organizations similar to JCAHO (The Joint Commission on Accreditation of Healthcare Organizations) 

3.                  The role of US and Canadian physicians and pharmacists could/should  be worked out through the development of a cross-border professional associations association (licensure/registration and protocol development).

4.                  Private/Public partnerships should be developed in order to reduce the costs at the Federal level [while maintaining the oversight and input of the FDA]. 

Major/Potential Barriers to Access from Canada:

1.                  Major pharmaceutical manufacturers recent actions to discontinue supplies to wholesalers and pharmacists in Canada for export.   Although they accuse others of breaking the law, what they are doing although legal, is very unethical.  Many individuals have complying with their treatment plans for almost three years and now they propose to take away their medications.  All in the name of quality and safety...their answer… a prescription drug benefit under Medicare.   With no costs controls put in place on the front end.

2.                  No one central clearinghouse to manage the process on this side of the border exists currently. His should be the FDA's responsibility.

3.                  Personal (re)importation is still considered illegal and therefore puts agencies such as the FDA in a very awkward position [actually impossible position until the law is changed and implemented].   They are charged with enforcing what currently exists and it's almost impossible to do so.   Their recent threats to prosecute those of us that aid and that we may "be found civilly and criminally liable" was expected at some point, but is such an incredible waste of time and resources.  This will serve to accomplish only one thing and that to hurt the very individuals that we profess to serve.  Those individuals that are currently complying with their treatment plans.  All of this in the name of quality and safety.  [a drug that is not accessible because it is not affordable is neither safe or effective]

Final Note:

In reality the economic model regarding sales for the pharmaceutical industry actually improves: 1) they now get inconsistent sales (unstable purchasing currently exist).  Although the new sales would be a lower price, it would result in stability of purchasing and consistent compliance would result, which according to their own mission is their objective.   2) data reported by the Canadian pharmacies to the FDA could be very beneficial to research and development efforts and the development of a meaningful Medicare prescription drug benefit.       

This concludes my prepared remarks.    Thank you again for this opportunity and I would be happy to try to address your questions.

Respectfully submitted,

Elizabeth A. Wennar, M.P.H., D.H.A.

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