Prescription drug personal importation bill fails in Senate. 'Do no Harm' to personal importation should be goal of policy-makers

Watching the ‘debate’ regarding the amendment by Senator John McCain (R-AZ) in support of his amendment to the Food and Drug Administration funding bill to establish astructure for personal importation of prescription medicines by individuals,one had to have a feeling of de javu.

There were so many  familiar faces.  Senator  McCain  showing his irritation and frustration at the continued success of Pharma in derailing any importation legislation…Senator Charles Grassley (R-IA) once again exhibiting the Midwestern Common Sense that has made him a favorite with Iowa voters…Senator Olympia Snowe (R-ME) in a last hurrah before retiring after this term, showing the passion and leadership that has made her name synonymous with personal importation through the bills that bore her and former Senator Byron Dorgan’s(D-ND) names. 

She even used the Lipitor example of the former Senator Dorgan and one could only wonder if Senator Dorgan, who retired from the Senate after his last valiant effort topass legislation favorable to personal importation—a failure which he laid at the doorstep of the White House, accusing the Obama Administration ofdeal-making with Pharma--would appear on the Floor and lend her his favorite prop, a bottle of Lipitor, the most profitable medicine ever developed. 

At the same time, one had to wonder why Senator Snowe used the Lipitor example since the drug no longer has its patent protection, and a flood of generics is expected to erode the market Lipitor enjoyed when it had such protection.

There were many of the same Pharma supporters of past debates, who pooh-poohed Senator McCain’s charges about Pharma influence, which is so obvious that to deny it is and of itself a self-proving action. 

But while the amendment went down in flames with 43 yeas, 54 nays (60 votes needed toadoption), there were other reasons that it failed, none of which has anything to do with the merits, benefits and record of personal importation.

Not the least of these was an old problem continues to be troublesome for  importation legislation and is an indication that since there likely will be no form of legislation passed, the goal should be to protect the right to personal importation.  Although the amendment has passed in the Senate many times, it has always had a challenge in even being called up for a vote.

Former Senate Majority Leader Bill Frist (R-TN), who has since returned to private medical practice, reneged on his commitment to bring the proposal up for a vote during the administration of George W. Bush.  This led to a running discussion throughout  that session of Congress and succeeding sessions of what strategy would be employed to identify a ‘vehicle’ to which to attach the legislation.

The problems continued with the election of President Barrack Obama. 

Supporters all believed Candidate Obama to be a proponent of personal importation, until an aide, Dora Hughes, said in September 2008 that Candidate Obama was not as strong a supporter of personal importation as had been presumed. 

Still, while at a hearing in St. Louis by Senator Claire McCaskill, when I asked the Senator   about the Obama position, she assured me that it would be the first bill he signed into law.

Alas, we were soon to discover when President Obama made a closed-door, back-room deal with Pharma to not support personal importation in return for a Pharma guarantee of not doing a ‘Harry and Louise-type attack’  upon the President’s healthcare proposal, that,alas, Ms. Hughes’  insights were better than Senator McCaskill’s.  And,  as noted earlier, Senator Dorgan  bemoaned the lack of leadership from the Obama Administration when his final effort also fell short of the 60-vote threshold,citing the deals made by Pharma with the Administration.

The simple truth:  The President early on determined that Healthcare Legislation was to be his legacy.  The economy and joblessness were set aside, as was prescription medicine importation .

Part of the closed-door negotiations including blocking personal importation was to strike a deal that supposedly was to reduce the costs of medicines for Seniors in the Doughnut Hole by $80 billion (but which because of the delay of enacting the cuts, and prescription price increases, has been one of the best investments Pharma ever made—even more lucrative than the multi-million investment in former Representative Billy Tauzin (D-LA) who engineered the passage of Part D,  and then resigned his post to immediatelybecame head of PhRMA, the industry’s trade association).

If anyone wonders why Senator McCain was so upset during the most recent claims by Pharma's Senators that healthcare policy is not/has not/and will not be influenced by Pharma—which Senator McCain described as the very type of thing that has eroded public confidence in Congres-- may I suggest it was not ‘anger’ or temper, it was righteous indignation.

Still, the amendment he offered and 41 other Senators supported was defined by situations that reflected the same, albeit , valid arguments made since Seniors were the first Americans to turn to personal importation of prescription medicines at the turn of the Century 12 years ago via bus trips to Canada to order their medicines at tremendous savings of as much as 60 percent.

Their actions were to give rise to a vigorous new industry—the establishment of certified, licensed, and registered pharmacies dispensing medications via the Internet, thereby allowing more than just the Americans located on the Northern US Border to have access to safe, affordable brand-name medicines at tremendous savings.

It also spurred many local groups, governments and others individual Americans to realize that they could attain fiscal relief through personal importation , all the while providing the  health benefits of  access to safe, affordable brand-name medicines.

Lower costs…improved health…fiscal savings…safety…a competitive alternative to the highest prescription medicine prices in the world…those are the drivers that make personal importation still the most viable option available to lowering US prescription medicine prices.

Personal importation validates that Americans can use their Common Sense in exercising their right and ability to make responsible healthcare decisions.  That native Common Sense is absent from the US Congress that has failed in developing solutions to the challenge of high prescription medicine prices that before the widespread use of personal importation forced millionsof citizens to do either without their vital medicines or without other  life-supporting services such as food andshelter.

And therein, I submit, lies the root of the ‘solution’ to the challenge of presentation and support of any legislation that might be presented in the future in support of personal importation—namely, illustrating how personal importation reflects the inherent Common Sense of the American people, similar to Rep. Ron Paul's (R-TX) proposal (HR 147) to basically, 'just do it,' which we have supported for sometime.

The McCain amendment was self-defeating with its emphasis upon restrictions of sourcing that limited personal importation to only medicines from Canadian internet-based pharmacies because the language had ambiguities that would have made the amendment ineffective.  Example: the medicines would by my reading have to be dispensed specifically by a Canadian Internet pharmacy,  restricting the ability to have medicines dispensed from licensed, registered pharmacies in other countries whose standards of oversight and efficacy meet or exceed  those of pharmacies in Canada or the U.S.

The legislation also called for the Secretary of Health and Human Services to ‘certify’ the involved pharmacies, although they have been approved by the appropriate provincial licensing authority in Canada.  In a touch of irony, previous forms of personal importation legislation that have passed the Senate have been turned aside by opponents of personal importation by the introduction of ‘poison pill’ amendments requiring ‘certification’ by the Secretary of Health and Human Services that any imported medicine is safe.

 It’s a ridiculous position, one that was first introduced at the same time that Ford F150’s were crashing and burning, causing me to suggest to then-Senator James Talent’s (R-MO) staff, that the ‘certification’ of the safety of ALL vehicles, tires, engines, etc.,  should be demanded of  the Secretary of Transportation, requiring that he or she ‘certify’ that there would be no recalls nor safety problems with the Ford vehicles at that time, or other situations that could affect the safety of a vehicle.

What will be next? 

Perhaps the Online Pharmacy Safety Act, introduced by Senator Diane Feinstein (D-CA) and Senator Jeff Sessions (R-AL)  that would empower the Secretary of HHS to utilize the VIPPS Certification Program of the NationalAssociation of Pharmacy Boards to ‘certify’ online pharmacies in the US, an authority it denies certification services such as PharmacyChecker.com andPharmacy Accreditation Services, designed specifically to provide oversight services for Internet pharmacies.

Senator Snowe described the McCain Amendment as a ‘first step.’  Actually, the first step was taken years ago by millions of Seniors  , followed by untold numbers of other Americans for whom personal importation of brand-name medicines has provided a lifeline to vital medicines that have contributed to their health, finances, and well-being.

By continuing the comparisons of price differences alone, without a greater emphasis upon the beneficial contribution and proven record of personal importation to providing fair and equitable pricing for vital medicines, and improved health, the proponents of personal importation, of whom I am one, continue to allow opponents to trot out the same old tired saws about rogue pharmacies, the claimed 'dangers ' of the Internet from even legitimate safe pharmacies, and the claimed negative impact upon R&D of new medicines.

Even after  Pharma’s stunning defeat in the Stop Online Pharmacy Act,  the latest vote is indicative that Senator McCain’s lament about the influence of Pharma inside the Beltway is ‘on spot.'

It is time for proponents of personal importation to shape their message and quit dribbling the basketball at Pharma’s 50-yard line and come forth with the proven merits and benefits already made possible by personal importation.   By developing such a message of what the past and future benefits will be, not merely for the purpose of passing legislation but to ensure Congress acts to block Pharma's continuing effort to scare the American people in such a way as to keep them using their Common Sense to continue exercising their right--and capability--to make responsible healthcare decisions, and to distinguish facts from Pharma-driven-fiction--the continued beneficial contribution of personal importation shall be ensured.

Stop Online Piracy Act endangers health of millions

The law of unintended consequences is a warning that an intervention in a complex system tends to create unanticipated and often undesirable outcomes

The Stop Online Piracy Act (SOPA) claimed by its sponsors to be the answer to protecting the intellectual property of Americans—an admirable goal—is the latest example that will without doubt lead to unintended consequences that will affect the health and well-being of millions of Americans by denying them access to safe, affordable medicines from reputable pharmacies in countries outside the U.S. .

Furthermore, the proposed legislation will not meet its goals, because it will create an unworkable and vague enforcement trigger that does not rely upon a system of law and courts, but instead that allows the Justice Department to cede to private entities the right to initiate action against individuals or websites, with such action carrying with it an assumption of guilt of the party being charged.

I shall leave it to Constitutional experts to illustrate the questionable constitutionality of SOPA. However, I believe it almost certainly will be used as a weapon against free speech and differences of opinion by some who will claim that a promotion of a product or service t violates the intellectual property right of the entity making the charge.

This includes, but is not limited to, the Pharmaceutical industry (Pharma)—an industry whose pricing practices have imposed the highest-cost drugs in the World upon Americans.

This has led to Americans using their common sense and exercising their right—and ability—to make personal health care decisions for more than a decade to purchase safe, affordable medicines. These are the very same ones that would cost at much as 60 percent more,if purchased in the U.S., rather than from reputable sources in other countries, countries whose standards of safety and efficacy meet or exceed those of the United States.

The passage of SOPA would endanger that capability by allowing Pharma to initiate actions against websites or individuals that Pharma could claim was promoting infringement upon its intellectual property rights.

I have mentioned unexpected consequences, Unfortunately, the stage for those consequences has been set by recognized consequences of the pricing of medicines in the U.S.

· As the skyrocketing costs of brand name drugs leave millions of Americans skipping doses or abandoning their prescriptions, investors representing 14 faith and health care organizations are petitioning the nation's top pharmaceutical companies to re-examine pricing for commonly used drugs like Lipitor, Plavix and Celebrex in an effort to make them more affordable;

· Cost of heart drugs makes patients skip pills, putting themselves at risk (Mayo Clinic);

· U.S. prescription drug spending will grow 93% during 2008-2018, exceeding all major categories of health expenditures (Centers for Medicare and Medicaid Services);

· Americans failing to fill prescriptions or not taking their medicines as prescribed because of costs of medicines (Consumer Reports);

· Bi-partisan identification of the problem of healthcare costs in resolving our fiscal crisis (Senator Richard Durbin (D-IL), former Senator John Danforth (R-MO);

· Reports of Seniors falling Into Doughnut Hole buying fewer drugs (Kaiser Family Foundation);

· As many as one in ten elderly people in the US, registered with Medicare, not have access to their prescribed medication because it is too expensive (Dr. Larissa Nekhlyudov and colleagues from Harvard Medical School);

It is staggering to consider the negative impact—an unexpected consequence--that will occur as millions of Americans who rely upon personal importation of their safe and affordable medicines find that they must now be without their vital medicines because of legislation supposedly designed to protect American intellectual propert without any consideration of its impact because of the proposal’s vague language.

Fortunately, there is also recognition of the beneficial role of personal importation of vital medicines in protecting the health of Americans:

· Recognition of the ‘safety valve’ function of personal importation in preventing prescription medicine prices from going even higher “Basically, what’s going on with Canada is a little bit of leakage, It’s a release valve so that American consumers don’t get more upset with the prices’’ ( Arthur A. Daemmrich, assistant professor of business administration at Harvard Business School);

· Formation of a Congressional Caucus by Representatives Joanne Emerson (R-MO) and Peter Welch (D-VT) to work to lower prescription drug prices (Representative Emerson is a long-time supporter of personal importation of prescription medicines);

· Adoption of a new policy by the FDA facilitating importation of ingredients for pharmaceutical manufacture in the U.S. to address drug shortages in this country via reciprocal agreements with regulatory agencies in other countries, validating a process of reciprocity long advocated by supporters of personal importation;

· Numerous private and government support systems exist to help ease the cost for America's poor, but there are still millions of patients who are uninsured, and many who can't find cheap medicines in the U.S. look abroad To avoid high prices at home, U.S. patients have trekked to Canada for decades to buy their medicines… pharma companies and myriad industry-funded groups have scared Americans into believing that drugs from overseas pharmacies are inherently dangerous (American Enterprise Institiute);

· Introduction of legislation by Senators Al Franken (D-MN) and Amy Klobuchar (D-MN) supporting personal importation to relieve the growing problem of shortages of medicines in the U.S..

So it is now up to the House of Representatives to act, aware that if they sow the wind of SOPA, they will reap the whirlwind of endangering the health of millions of Americans who rely upon personal importation of their prescriptions medicines.

Recent findings of two separate studies should nudge FDA to reciprocity

For some time, I have suggested that the U.S. Food and Drug Administration (FDA) has operated on a faulty premise regarding the personal importation of safe, affordable brand-name medicines from Tier One countries.

We havesupported our stance with numerous blogs athat illustrate thatpersonal importation is safe, that it offers tremendous savings, and should bea primary element of reducing the cost of prescription medicines for individuals and even of our nation’s fiscal crisis in which increased costs of healthcare are a major driver of our budgetary crisis, and the continued increased costs of prescription medicines are a major driver of healthcare costs.

That is why we—and other advocates across the country—support personal importation of brand-name medications from Tier One Countries, those that have standards of safety and efficacy that meet or exceed those of the United States.

We have suggested that the FDA itself enter into arrangements with the regulatory oversight agencies in those countries that would establish reciprocity that reflects that the majority of medicines taken by Americans are manufactured outside the U.S. , and that a growing volume of ingredients used in the manufacture of medicines, even those produced in the U.S., come from sources outside the U.S.

In effect, the FDA and the Pharmaceutical industry (Pharma) have engaged in a form ofimportation they would deny  to the more than one million U.S. citizens that have found relief from the prescription   medicine prices in the U.S. are the highest in the world. 

That is why we were encouraged by the decision by the FDA in mid-2011 to enter into ‘working agreements’  with regulatory agencies in other countries regarding ingredients used in the manufacture of prescription medicines.  Admittedly, the FDA’s intent was directed only towards ingredients, but many advocates of personal importation contend that if the working agreements (read, ‘reciprocity’) can be applied to particular agreements approving oversight of ingredients, it is only logical that such arrangements can be extended to those countries in the ‘approval’ and oversight of medicines imported from within their jurisdiction.

Now, two independent studies—one from a private source, the other, ironically from the FDA itself, lend further credence to this position.

The first,  ‘Unveiling the Mystery of Online Pharmacies:an Audit Study’,   is from the National Bureau of EconomicResearch (NBER)  validating the claims of supporters and advocates that personal importation of brand-name prescription medicines from reputable sources outside the U.S. is both safe and cost effective.

The other is a study of the Institute of Medicine (IOM), requested by the FDA itself, to study the question of improving the agency’s ability to work with regulatory agencies in developing and other countries to, as the title of the report states, ‘Ensuring Safe Foods

and Medical Products Through Stronger Regulatory Systems Abroad .”

Highlights from each of the reports reflect favorably upon the concept of personal importation, the former from the viewpoint of safety and cost, the latter from the viewpoint that the mechanisms are in place in ‘developed countries’  to ensure the safety and efficacy of ingredients—and, personal importation advocates would contend, that of imported medicines approved by the regulatory agencies in those countries, of personally imported medicines.

The NBER report notes: “Focusing on five brand-name prescription drugs, we acquire 370 drug samples from 41 online pharmacies and test their authenticity. Of the 41 websites, 8 are clearly US-based and verified by the National Association of Boards of Pharmacy (NABP) or LegitScript.com. We refer to them as tier 1. Another 23 websites – referred to as tier 2 – are not verified by NABP or LegitScript but verified by PharmacyChecker.com or the Canadian International Pharmacy Association (CIPA). ”

Significantly, the study found “… that according to our Raman spectrometry test, no failure of authenticity is found in drugs that came from verified websites, the only failures are Viagra from non-verified websites in tier 3. Second, within verified websites, tier 1 websites on average charge 52.5% more than tier 2 websites in final price (including shipping and handling) for the same drug and dosage.”

From a political perspective, one of the more significant aspects of the NBER report is that a major participant in the survey is Roger Bate, a well-respected free-market, Libertarian economist and contributor to the American Enterprise Institute.

I say significant because traditionally support of personal importation of prescription medicines has come from policy-makers considered more liberal, and who would rely upon governmental policy—such as the annual reincarnation of the failed (many times) Dorgan-Snowe bill establishing what supporters hoped would provide a mechanism to ‘ensure’ the safety of personally imported medicines. 

However, after many failures, and with the changing tide of politicalsentiment in the country, we and others suggested that it might actually be theconservative movement with its emphasis upon personal responsibility and afaith in the ability of the American people to make intelligent decisions aboutpurchases of safe medicines from outside the U.S.

In addition to Bate’s involvement, this stance is strengthened by the continued support of Rep. Ron Paul (R-TX) whose personal importation bill is a model of simplicity, especially when compared to the latest version of Dorgan-Snowe. Senator Byron Dorgan (D-ND), who retired from the Senate before the last election was a champion of personal importation. 

In the latest version of the legislation, Senator Olympia Snowe (R-ME) is again a co-sponsor, and Senator Debbie Stabenow (D-MI) has stepped forward as the co-sponsor.  

Senator Snowe’s announcement that she plansto retire after her term ends in this session makes it almost certain that there will be no legislation forthcoming this year.

While the NBER report validates the authenticity of and cost savings of brand-name medicines via personal importation, the findings of the IOM study can be construed as a validation of the concept of reciprocity because of its conclusions regarding cooperation with agencies in other developed countries.

 The reports notes that “… more than 80 percent of active pharmaceutical ingredients—the building blocks of medicines—are imported, and 40 percent of medicines are imported as finished products. Further, U.S. imports of medical devices quadrupled over the last 10 years…”

The significant conclusion reached by the IOM report, while supporting the FDA plans to strike reciprocal agreements to extend scarce resources also sets the stage for calls for partnerships with developed countries noting:

“The FDA should use partnerships to drive improvements in supply chain management…The committee recommends that the FDA work with strong regulators in other countries to plan inspections and pool data.”

“The FDA should use partnerships to drive improvements in supply chain management…The committee recommends that the FDA work with strong regulators in other countries to plan inspections and pool data. There is no need for American and European inspectors to duplicate each other’s work, especially when a vast number of facilities go uninspected.”

We contend that this meets at least one definition of reciprocity:  “…the relation or policy in commercial dealings between countries by which corresponding advantages or privileges are granted by each country to the citizens of the other.”

We also contend that such action will enhance the role of personal importation of safe, affordable brand-name medicines, providing enhanced health and contributing tothe physical and fiscal well-being of millions of Americans—perhaps as criticalan issue today as it has ever been as millions of Americans forego following aprescribed regimen of vital medicines because of the high costs, and as our country faces a Tsunami of healthcare costs, driven, in good measure , by thosesame high costs. 

Independent Study confirms safety and cost-effectiveness of personal importation

St. Louis, MO, April 2, 2012--The publisher of a leading informational website for America’s seniors, caregivers and policy-makers says that an independent study by the National Bureau of Economic Research validates the claims of supporters and advocates that personal importation of brand-name prescription medicines from reputable sources outside the U.S. is both safe and cost effective.

Daniel Hines, publisher of www.TodaysSeniorsNetwork.com, says the study, ‘Unveiling the Mystery of Online Pharmacies: an Audit Study ‘ should serve as a guide for policy-makers, including elected officials and the Food and Drug Administration (FDA), to ensure that facts about the safety, efficacy and cost-savings of personal importation of prescription medicines are not buried under the efforts by the Pharmaceutical industry (Pharma) attempts to ‘lump’ legitimate sources of safe, affordable medicines from outside the U.S. with bogus, illegitimate sources.

Legitimate sources of prescription medicines for personal importation of brand-name medicnes into the U.S. have established their own rigorous standards of safety and efficacy, Hines says.

“U.S. citizens pay the highest cost in the world for their prescription medicines, a reflection of the success of Pharma in influencing policy that has made the country a ‘safe haven’ for medicines,” Hines says.

In the study, the investigators purchased four top-selling brand name medicines from U.S. pharmacies and via personal importation. The medicines from the U.S. pharmacies cost an average of 52.4 percent more.

“The newly released study illustrates that the attempts by Pharma to impugn the safety, efficacy and savings of brand-name prescription medicines from such legitimate sources outside the U.S. by a more than decade-long effort to cast them in the same light as bogus operations that have no regard for safety or health, and that provide counterfeit medicines without prescriptions has been misdirected,” Hines says.

Industry, common sense illustrate why personal importation of prescriptions medicines is safe

· After more than a decade or working on behalf of providing Americans with access to safe, affordable brand-name medicines from licensed, registered pharmacies outside the U.S., in countries (usually referred to as Tier One countries) whose standards of safety and efficacy meet or exceed those of the United States, I feel compelled to present what I hope will clearly identify why the argument of Pharma and its trade association and many front groups that Americans turning to personal importation of vital medicines to protect their health is flawed.

• · There are virtually no prescription medicines sold in this country that are manufactured in the U.S.
• · It is a matter of record that prescription medicines personally imported from licensed, registered sources outside the U.S. are subject to the oversight of not one but many regulatory agencies and professional industry groups.
• · Significantly, the medicines from licensed registered pharmacies outside the U.S. have a ‘tacit’ endorsement since all are manufactured at U.S. Food and Drug Administration-approved facilities and are subject to FDA Oversight.
• · Additionally, the FDA has announced a new operating philosophy in which it will allow reciprocity of importation of ingredients for prescription medicine manufacture. For many years, supporters of personal importation have urged a series of reciprocal agreements with Tier One Countries, similar to that now adopted by the FDA for ingredients. It is only logical that such a concept of reciprocity be extended to personal importation of prescription medicines.
• · Brand-name medicines are identical to those offered in the U.S. although they may have additional or different labels applied because of the regulations of the countries in which they are manufactured or to meet requirements of pharmacy regulations within that country. This does not alter the safety, efficacy or authenticity of the medicines but is an indication of the extraordinary levels of oversight.
• · The FDA has stepped up its approval of generic medicines, and generics offered for personal importation should be only those already approved by the FDA and offered for sale by US pharmacies.
• · Additionally, there are additional levels of oversight offered by the countries in which the manufacturing of medicines must meet the standards of that country.
• · Safe medicines have been provided for more than 12 years to millions of Americans from licensed, reputable pharmacies in countries whose standards of oversight and safety meet or exceed those of the U.S., and this proven safety record provides yet another verification of the safety and efficacy of personal importation.
• · This includes Internet mail-order pharmacies and pharmacy fulfillment services located in Canada, which are the prime sources of personal importation of prescription medicines in the U.S. Health Canada is recognized as one of the stellar regulatory agencies in the world because of its professionalism and high standards and it has repeatedly noted that these services are in no way violating Canadian law.
• · Additionally, legitimate Canadian pharmacies must be licensed and registered by their provincial regulatory bodies, creating yet more impartial regulatory professional oversight to help ensure the safety and efficacy of the medicines and their handling and dispensing.
• · To provide additional oversight and assurance of safety and meeting professional standards, legitimate Canadian mail-order pharmacies have established the Canadian International Pharmacy Association (CIPA) to certify that a member pharmacy meets its high standards of safety and quality.
• · As an example of the commitment to safety and efficacy, Canadian Internet and mail-order pharmacies, and recognized pharmacy benefit services have also established their own internal oversight services—a Gold Standard so to speak—to be applied to pharmacies outside of Canada to ensure that standards meet or exceed those outlined in this statement and meet their own high standards of the individual entity’s procedures and emphasis upon safety and efficacy.

I submit that these extensive efforts by regulatory agencies, industry members, advocacy groups and policy-makers creates a climate where as one neutral observer has noted that such steps eliminate virtually any chance of a ‘bogus’ operation not being easily identified.

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New Congressional proposal is ‘third leg’ of Pharma-driven legislation designed to ensure ‘The United States of Pharma’ as a safe haven for highest

Publisher's Note: While Pharma and its allies have vast funding, there is still an opportunity for the average American to make his or her voice heard, and to pull the props out from the Pharma Stool. RxRights.org has mounted a vigorous citizen-based campaign by which citizens who know the benefits of personal importation can easily utilize state-of-the-art communications with their Senators or Representatives to make the case for Americans to not being denied continued access to safe, affordable medicines.

On September 27, 2010 and October 26, 2010, we warned that the Obama Administration and the Pharmaceutical Industry were engaged in a series of actions designed to end Americans’ access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries outside the U.S.—countries whose standards of safety and efficacy meet or exceed those of the U.S.—as a part of a strategy to ensure that citizens of ‘The United States of Pharma’ continued to pay the highest prices in the world for their medicines.

At that time, we paid special heed to a radical departure by Pharma from the traditional method of encouraging that FDA and Customs, acting in collusion, to deny access to vital medicines by seizures of prescription drugs from pharmacies outside the U.S. that they claimed were ‘illegal’ even though they were the very same medicines sold in the U.S. at prices of as much as 60 percent more.

Having had such strategy rejected by the U.S. Congress, which denied the use of governmental funding for such seizures, Pharma’s new technique was to co-opt legitimate legislation ostensibly designed for purposes not related to the goals of Pharma, but to address other concerns—specifically, the protection of intellectual property rights of U.S. individuals and companies by deterring the excessive counterfeiting made possible by their promulgation of sites specializing in infringement activities with bogus goods.

The first two ‘legs’ of the ‘legislative stool’ were the Protect IP Act (formerly Hatch-Leahy) and the Stop Online Piracy Act (SOPA), both of which we vigorously opposed with letters to Senate and House Judiciary Committee members and selected health care staff to point out how the law of unintended consequences—namely, the perverse effect of endangering the health and well-being of millions of Americans who could be denied access to vital medicines—would override any beneficial effects of the bills, solely because of the Pharma-influence.

The co-opt process was launched by a number of Pharma front groups that built upon the fact that there are admittedly ‘bogus’ pharmacies in many countries that produce unsafe, knock-off medicines and are able to utilize the Internet to attempt to deceive Americans, ironically because the predatory pricing practices of Pharma have made them so expensive as to be beyond the reach of untold numbers of Americans.

Now, in what can only be described as the ‘third leg’ of the ‘legislative stool’ policy of the Pharmaceutical Industry (Pharma) to attempt to co-opt the legislative process to its own ends, Senators Feinstein (D-CA), Schumer (D-NY), Sessions (R-AL) and Cornyn (R-TX) have introduced a proposal that they claim will help ‘protect’ Americans against being duped by bogus pharmacies doing business on the Internet.

The misnamed bill, ‘The Online Pharmacy Safety Act’, is actually nothing more than an attempt by which the U.S. government incorporates into Health and Human Services (HHS) programs a number of groups that have received funding over the years from Pharma in the industry’s efforts to deny millions of Americans access to safe, affordable prescription brand-name medicines from licensed, registered pharmacies outside the U.S.

The bill is misleading in both its title and the Pharma boilerplate language. It would be better named, ‘The U.S. Internet Pharmacy Act,’ and its attempts to ‘criminalize’ any and all pharmacies not verified by the new directory that the legislation would establish.

The new ‘directory’ is actually nothing more than the VIPPS verification service already promulgated by Pharma and the National Association of Boards of Pharmacy. Of course, no pharmacies from outside the U.S. would be allowed to be ‘registered’, which gives clue to the real reason for the legislation—to attempt to present U.S. Internet and mail-order pharmacies as the only source of safe prescription medicines via the Internet even though for more than a decade millions of Americans have purchased safe, affordable medicines from licensed, reputable pharmacies in other countries. Also, there is no requirement that all—or even any—U.S.-based Internet Pharmacy seek to be included in the registry.

Ironically, the Canadian International Pharmacy Association already has a ‘verification’ list of members, all approved by their provincial licensing authority, but none of those sites would be eligible for inclusion in the HHS site. Also, reputable sources for pharmacy services have established their own standards, including rigorous inspection of the licensed pharmacies that service millions of Americans.

But the goal of the legislation is to cast doubts about the safety and efficacy of those operations by ‘criminalizing’ them.

An example of the ‘boilerplate’ attempt to create an impression that by not being in the directory, those pharmacies are ‘criminal’ is to highlight the real problem of ‘bogus’ pharmacies, and to indicate that any source of personal medications from outside of the U.S. is, in and of itself ‘criminal’ because they are outside the U.S. Consider these excerpts from the proposed legislation (in the interest of space, I have used only segments pertaining to ‘criminality’ and the threat to health and life of the bill’s language. I have highlighted portions to illustrate how contrived and disingenuous is the attempt to ensnare all Internet pharmacies from outside the U.S. ). The bill’s rationalization follows, accompanied by my comments in bold face.

Bill Language: (2) illegal online drug sellers offer products that do not meet the safety standards established by United States laws, and recent reports from the National Association of Boards of Pharmacy show that 92 to 95 percent of Internet websites offering to sell prescription medications online are illegitimate and operate in clear violation of United States laws enacted to protect patients; …

(4) the World Health Organization estimates that 50 percent of the prescription medicines sold online by Internet websites that hide their physical address are counterfeit… research by The Partnership at Drugfree.org found that 1 in 6 consumers in the United States, a total of about 36,000,000 Americans, has bought or currently buys prescription medication online without a valid prescription…

The facts:

While the FDA has said personally importing prescription medicine is ‘illegal’, for years, the it has ‘allowed’ Americans to cross into Canada to purchase prescription medicines for their personal use in the U.S. To deny Americans who do not have proximity to the Canadian border the right to make similar purchases via the Internet from those same pharmacies or sources denies them the right of equal protection in the exercise of their right to make personal decisions regarding their health that are available to one group of U.S. citizens but not to them, merely because they lack proximity to the Canadian border. Also, while the FDA says that personal importation is not allowed, its own policies note:

"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country/area."

The Facts: Simply put, the medicine that is unaffordable is unavailable

.

More Bill Language: (6) the prevalence of illegal online drug sellers, and their sale of counterfeit or otherwise illegitimate

medicines, is a growing public health threat…

(7) people have been seriously injured or killed by products sold by illegal online drug sellers…

(8) the accessibility of controlled substances and other drugs without a valid prescription by

illegal online drug sellers contributes to a growing prescription drug abuse problem in the United States that is endangering teenagers and public health…

(9) the anonymous and unregulated nature of the Internet contributes to the counterfeit drug trade and enables counterfeit medicines to reach United States consumers through illegitimate online drug sellers posing as legitimate pharmacies;

(10) counterfeit drugs that are sold through illegal online drug sellers are manufactured by criminals who deliberately and fraudulently misrepresent the product in order to trick consumers into thinking they are purchasing a legitimate and safe medicine…

The Facts: As to Americans being seriously injured, in response to an inquiry about Canadian pharmacies and other legitimate pharmacies, “The FDA's Director of Pharmacy Affairs, Tom McGinnis, says, "I can't think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these.” And, As then-Governor Tim Pawlenty said in his famous response to claims by Pharma of the lack of safety and efficacy of those medicines : “Show me the dead Canadians”.

The facts about the benefits of personal importation are self-evident. We see them in the improved health and well-being of friends and neighbors. We see them in the savings afforded to individuals and groups for whom personal importation is the only (and best) alternative to either paying the highest drug prices in the world with is dire personal fiscal consequences, or depriving themselves of vital medicines with its drastic health consequences of being denied the health benefits of access to a regimen of safe, affordable and necessary medicines. The legislative initiative of Pharma threatens all of these.