Common Sense approach can lower drug prices, improve fiscal and personal health

St. Louis, MO, October 3, 2011--In response to many stories identifying cost-related challenges created by high prescription medicine prices, the publisher of a leading informational web site dealing with issues of an aging America, has issued a statement that a ‘Common Sense’ approach to personal importation of prescription medicines offers the most immediate and viable option to the problems created by prescription drug prices in the U.S., the highest in the world:

Daniel Hines, publisher of www.TodaysSeniorsNetwork.com notes that:

“For more than a decade, we and other advocates and groups have worked both individually and collectively to provide Americans relief from the highest prescription medicine prices in the world by supporting their right and recognizing their capability to make responsible decisions in their purchases of safe, affordable medicines from proven reputable sources outside the U.S

“Concurrently, we were among the first to identify the potential of the detrimental fiscal impact for both citizens and government of high prescription medicine prices, when, nearly four years ago, we first called for the U.S. government to ‘just do it’ in regards to lowering prescription drug costs

“Now, with the continuing fiscal crisis facing local, state and Federal governments, and with millions of Americans unemployed, there is a finally a growing consensus among a growing number of groups and policy-makers that healthcare costs are indeed a primary driver of our budgetary crisis, and, significantly, that prescription medicine prices are a major contributor to healthcare costs.

“The problem calls for a ‘Common Sense’ resolution such as presented again in a statement we made in August of this year , namely that ‘Common Sense’ recognizes the beneficial contribution of personal importation to addressing recent reports that define the extent of the crisis caused by healthcare and prescription drugs costs:

· 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);

· 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);

· 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);

· 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..

“These actions/situations from diverse groups reflect the extent of the problems and challenges caused by the pricing practices of Pharma that have made the cost of medicines in the U.S. the highest in the world, Hines says.

“ The most immediate and viable solution to these challenges is a ‘Common Sense’ approach protecting the right of Americans to purchase their safe and affordable medicines from reputable sources outside the U.S.

“The FDA’s actions for reciprocal agreements with other countries regarding ingredients for pharmaceutical manufacture can be a model for addressing questions of safety and efficacy.

“And, last but not least, we believe that for more than a decade, the safety and efficacy of personally imported medicines has been demonstrated by millions of Americans utilizing their ‘Common Sense’ validating that they are capable of acting in a responsible manner in making prescription drug purchases.”

A call for a common sense approach to personal importation of prescription medicines and access to safety, savings, and improved health

The publisher of a leading informational website on aging issues says that personal importation by Americans of safe, affordable brand-name prescription medicines from Tier One countries remains a primary option to reduce the cost of medicines in the U.S.

Tier One countries are those defined as having standards of safety, efficacy and quality, of prescription medicines and pharmacies and oversight that meets or exceeds those of the U.S.

“The U.S. Food and Drug Administration ( FDA) has recently launched a series of initiatives that call for greater cooperation with regulatory agencies in other countries regarding importation of ingredients into the U.S. for pharmaceutical manufacture,” says Daniel Hines, Publisher of www.TodaysSeniorsNetwork.com and a series of related websites on aging and health issues.

“This indicates the FDA is both willing , and has the power to act to enact such agreements."

He also points to the role of personal importation in reducing the crushing burden of prescription medicine costs in the U.S.

“In a recent interview with Kaiser Health Report, former Senator John Danforth (R-MO) cited the cost of health care as the major problem facing the newly formed ‘Super Committee’ of Representatives and Senators as they must consider recommendations to address the country’s fiscal crisis,” he says.

“The pricing practices of Pharma have been major drivers of the governmental and personal fiscal crises facing the country by spurring the cost of healthcare by raising prescription medicine prices at a rate exceeding inflation and have likely led to bogus internet sources springing up as Americans seek relief from excessive prices ,” Hines says.

“That’s why personal importation of safe, affordable brand-name prescription medicines has passed the U.S. Congress under two administrations over the past 10 years, but the bills which would have established additional safety procedures were made inoperable by the extensive lobbying of Pharma that imposed ‘poison pill’ amendments.

“Deterring the activities of bogus sourcing of prescription medicines and to protect the safety of Americans is commendable and is reflected in the operating credo of those services that have created and adhere to standards of safety, efficacy and quality.

“Americans should not confuse the ability for safe implementation of personal importation that might exist in light of the recent Google settlement regarding internet pharmacy advertising.

”We call on the FDA to extend its new approach towards possible reciprocity and cooperative agreements with agencies, especially those in Tier One Countries, as a means to lower prescription medicine prices in the U.S., thereby contributing to the already proven record of safety, efficacy and quality from medicines being personally imported into the U.S.”

New Consumer-based organization in support of personal importation of prescription medicines launches national campaign

New Consumer-based organization in support of personal importation of prescription medicines launches national campaign

The RxRights Coalition, comprised of advocacy organizations around the country that are concerned about the high cost of pharmaceuticals in the U.S., has launched an outreach and communications program to ensure that Americans are able to exercise their right to access to safe, affordable medicines from licensed and registered pharmacies in Tier One Countries who standards of oversight and efficacy meet or exceed those of the U.S.

Lee Graczyk, acting director of Mature Voices Minnesota, the lead organizer for the Coalition, explains that that vital medications are often too expensive for American consumers because of the predatory pricing practices of the Pharmaceutical industry.

“Personal importation not enhances the health and physical well-being of huge numbers of Americans by allowing them to benefit from the access to vital medicines, and provides financial relief for Americans with prices that are as much as 60 percent less for the very same medicines,” Graczyk explains.

Graczyk points out that Congress has repeatedly passed legislation favoring personal importation, only to see it turned back by extensive lobbying by unmanageable amendments promoted by Pharma.

Now, even though it has made agreements with the current Administration, Pharma continues to raise prices at a pace exceeding the inflation rate, Graczyk explains.

Graczyk also points to the record of safety and efficacy of personal importation of medicines.

“We believe that Americans have the capability to act responsibly in exercising their right to purchase their medicines,” Gracyzk says. “There are many ways of verifying legitimate pharmacies, and one of the most important is their record of providing safe medicines.”

Graczyk himself can point a more than decade-long-history of working on behalf of safe, affordable medicines.

In his role as public policy director of the Minnesota Senior Federation, starting in 1999 he organized monthly bus trips to Canada to ensure that seniors could obtain affordable prescription drugs. The Federation collaborated with then-Senator Mark Dayton to fund this project. For six years, Senator Dayton donated his entire senatorial salary to the cause.

The bus trips helped bring national public attention to all Americans’ need for access to safe and affordable prescriptions, and the Federation soon realized that more than the bus trips were needed to provide access to the medicines. What was required was providing them with the ability to order prescription drugs online, bringing greater convenience and savings to even more Americans.

Graczyk was instrumental in establishing a prescription drug importation program for the Federation. He scrutinized more than 20 Canadian companies, and approved those with the highest standards for the program. All met the standards of Health Canada, the Canadian equivalent of the U.S. FDA

The program is now maintained by Mature Voices Minnesota and currently has 2,200 members. Participants save anywhere from 20 to 80 percent on their prescription drugs by using the service.

Additionally, Internet importation has become a “virtual lifeline” for millions of Americans—a lifeline the RxRights consumer coalition is working to protect to allow continued access to safe and affordable prescription prescription medicines.

The Coalition is a partnership of organizations throughout the country that support reimportation in order to expand this influence. The Coalition’s goal is to inform and educate both the public and elected officials on the issues surrounding prescription drug sales in this country.

Reasons to Join this Effort:

The prices that Americans pay for prescription medicines are the highest in the world.

A prescription drug one cannot afford is neither safe nor effective.

Every American is entitled to enjoy the health benefits made possible by prescription medicines.

Access to safe, affordable prescription medicines from licensed, regulated pharmacies outside the U.S. will reduce the costs of medications and improve the health of U.S. citizens.

Lack of competition in the U.S. allows pharmaceutical companies to fix prices and overcharge Americans.

The Coalition Pledges to:

Present the truth about the safety, efficacy, and cost-savings of prescription medicines from outside the U.S.

Support policies allowing U.S. citizens to exercise their right of freedom of choice in determining where they purchase their prescription medicines.

What You Can Do:

Join the coalition

Sign the petition

Tell your friends about the website

Contact your Senators and Representatives and let them know that you support prescription drug importation

Follow RxRights on Twitter, Facebook and YouTube

The Coalition holds regular teleconferences to discuss safe and affordable drug importation. Contact Lee Graczyk to join the Coalition or for more information.

List of Coalition Members

Stop Pharma from denying access for Americans to safe, affordable prescriptions

If you agree with this position, write your Congressman or Senator to let them know of your support of the right of Americans to purchase safe, affordable—and vital—medicines from licensed, registered pharmacies in Tier One countries.

· Personal Importation of safe, affordable prescription medicines from countries outside the U.S was spurred more than a decade ago as a reaction to the fact that the U.S. has the highest prescription drug prices in the world.

· Personal importation of prescription medicines is the only option available to provide lower-cost brand name medicines for Americans.

· These medicines—from licensed, registered pharmacies in Canada and other countries with standards of oversight that meet or exceed those of the U.S.—have provided health benefits and financial relief to hundreds of thousands of Americans.

· The U.S. Congress has through repeated votes in the House and Senate expressed its support of the concept of making personally imported medicines available to U.S. citizens from pharmacies in Canada and 22 other countries whose standards of oversight for safety and efficacy equal or exceed those of the U.S.

· While a rash of bogus pharmacies and counterfeit medicines has arisen on the Internet, legitimate on-line pharmacies have taken extraordinary steps to distinguish them from bogus pharmacies.

· The pharmaceutical industry and its trade group (PhRMA) have targeted the right of personal importation of prescription medicines, which , ironically, they themselves have manufactured.

· The latest attempt to curtail access to personal importation is to define any online pharmacy from outside the U.S. as ‘bogus’ , even if an online pharmacy has met the standards of safety and efficacy of its practice required by the appropriate regulatory agency of its government.

· Opponents of personal importation have taken steps that indicate they hope to use the anti-counterfeiting intent of S 3804 as a rationale to claim that even licensed, registered pharmacies would be guilty of infringement of Copyright and Intellectual property rights.

· This would make the pharmacy liable to enforcement provisions of S 3804 which include, but are not limited to, the shutting down of domains and websites not only of the pharmacy, but could be extended to the sites of advocacy groups and individuals that support personal importation.

· Because of that, specific legislative language should be included in S 3804 to ensure that the legislation meets its intended purpose, and cannot be co-opted by special interest groups that would utilize the bill to meet their own narrow interests.

· Without the inclusion of language to more carefully define the intent of S 3804, the stage would be set for the pharmaceutical industry to take actions to restrict the right of Americans to enjoy the health benefits provided by safe, vital medicines that they otherwise could not afford.

· We believe that Americans have the right to make personal healthcare decisions including the right to purchase safe, affordable medicines from licensed, registered pharmacies, and that they have the capability to make such informed decisions in a responsible manner, free of governmental interference, and that current efforts to define legitimate pharmacies as bogus is an attempt by the pharmaceutical industry to extend its influence to impose its predatory pricing practices upon American citizens with regard only for industry profits, not the health and well-being of American citizens.

If you agree with this position, write your Congressman or Senator to let them know of your support of the right of Americans to purchase safe, affordable—and vital—medicines from licensed, registered pharmacies in Tier One countries. We will be posting email addresses for the new session of Congress in early January 2011.

Pharma Interests attack Open Web in attempt to deter importation

Publisher of leading seniors’ web sites urges Congress clarify language of Anti-Counterfeiting proposal to prevent co-opting of Intent by pharmaceutical industry

The publisher of a leading informational site for America’s seniors, says that Congress must clarify the language of S. 3804, which is ostensibly designed to deal with the issue of intellectual property rights and counterfeit products sold in the U.S., to deter attempts by special interest organizations of the Pharmaceutical industry to co-opt the legislation to their own limited purposes and the detriment to health and savings for Americans.

Daniel Hines,. Publisher of www.TodaysSeniorsNetwork.com and http://RxforAmericanhealth.blogspot.com , says that the pharmaceutical industry is attempting to utilize the open-ended language of S.3804 as part of its latest tactics to prevent Americans from utilizing personal importation of vital and safe, affordable prescription medicines from licensed, registered pharmacies in countries whose standards meet or exceed those of the U.S. and the FDA.

Additionally, a growing number of legal sources is coming to view the enforcement provisions of S.3804 as an attempt to empower the Federal government to extend its ‘enforcement’ of ‘infringements’ upon intellectual property rights to web sites that the AG believes might contain materials that constitute such an ‘infringement’ by the shutting down of those domains.

“Pharma has long attempted to deny Seniors and other Americans access to these medicines through its extensive lobbying among elected officials and with appointed policy-makers, “ Hines says. “The many health and cost-saving benefits of Americans having the capability to exercise their right to make personal health care decisions through the purchase of safe, affordable medicines from licensed, registered pharmacies from 22 Tier One Countries, are evident and a matter of record.”

The reason for Pharma’s opposition to personal importation—ironically, importation of the very same medicines that they produce under FDA oversight and themselves sell in the U.S. —is that the imported medicines are priced at 40 to 60 percent less that the identical medicine in the U.S., Hines says.

“This record of savings, efficacy and health benefits, has been validated by the U.S. Congress on many votes in favor of personal importation, only to be turned aside because of parliamentary maneuvering of the interests of the pharmaceutical industry with the addition of a ‘personal certification’ requirement of the safety of imported medicines by the Secretary of Health and Human Services (HHS). No other Cabinet member is required to make such certification of products that are within their department’s jurisdiction.

Ironically, even though HHS Secretary Sebelius indicated her support of personal importation while Governor of Kansas by announcing the state’s affiliation with the ISaveRx program, the current FDA policy has been to not even consider how a policy favored by the President during his election campaign and the Secretary when she was Kansas Governor might be implemented. Instead, the emphasis has been upon policies supported by Pharma to focus on means of deterring Americans access to legitimate, vital medicines, especially through restrictions on the Internet.

Hines noted that “Pharma has spared no expense to create a series of ‘front groups’ to create the specter of ‘bogus pharmacies’ flooding the country with unsafe prescriptions.

“But it has shown no interest in directing its vast resources to establishing a mechanism and framework that could address the best means of identifying legitimate, licensed pharmacies in Tier One countries and how to distinguish those legitimate on-line pharmacies from bogus operations.

He says that the legislation was approved by the Judiciary Committee during the Lame Duck Session of Congress. “The opportunity still exists for members of the Committee and Congress to allow public comment and hearings that would provide transparency into the deliberative process, thereby ensuring that S 3804 meets its stated purpose rather than rewarding the false claims of Pharma about the safety and efficacy of personal importation of prescription medicines.

“We urge the Committee members and other Senators and members of Congress to pay special attention to ensuring that the language in S.3804 encompasses the real goals of deterring copyright and intellectual property theft, as well as counterfeiting and that there be specific and clearly defined restrictions upon efforts by Pharma’s special interest groups to co-opt the intent of the bill.

“The health interests of large numbers of Americans should be of utmost consideration and Pharma interests must be restricted from utilizing the legislation to attain its long-standing goal of limiting the access of Americans to vital medicines, “ he concluded.

American Public has common sense answer to lowering drug prices…just do it!

The failed vote in the U.S. Senate on the Dorgan Amendment to ‘allow’ lower-cost prescription medicines from licensed, registered pharmacies located in countries that have standards of oversight that meet or exceed those of the U.S. was both tragic and unnecessary.

It was tragic to watch the tremendous courage of Senator Byron Dorgan (D-ND), a man whom I greatly admire, who has been a champion of lowering prescription drug prices through ‘reimportation’ for nearly a decade, as he pleaded, cajoled and passionately made the point that the amendment was truly the only one that would have the effect of providing savings.

It was equally tragic to see him victimized by the deal-making of the Obama Administration with PhRMA. The snake that the President has decided to pick up may still bite him, as we warned in a previous entry.

At the same time, the spectacle was unnecessary. There are several reasons:
• As we have noted before, and even though we strongly support the right of personal importation, the bill, popularly called Dorgan-Snowe, was unworkable. It relied upon assumptions that simply were not possible to achieve:
• The first-year limitation upon medicines coming only from Canadian mail-order pharmacies was naive.
• There simply are not enough mail-order pharmacies left in Canada to provide the hoped-for funding;
• By restricting the ability to purchase medicines immediately from Australia, New Zealand and Great Britain for one year, and then limiting even those purchases to U.S.-based wholesalers and pharmacies, the bill’s supporters failed to acknowledge that as much as 80 percent of the sourcing for the Canadian mail-order pharmacies comes from Australia, New Zealand, and Great Britain.
• This was not the case when ‘reimportation’ first became an issue, but while the situation has changed, the language of the amendment reflected a situation that simply no longer exists, that of several years ago. It appears that the hoped-for impact was that since President Obama had co-sponsored a bill with virtually the same language two years ago, as had his Chief of Staff Rahm Emanuel on the House side, that they would be so flattered as to support the reincarnation of ‘their’ bill, a surprising bit of naivete.
• There was no opportunity for public input into the formation of the language. Supporters were given a ‘love it or Lump it’ choice. Some accepted this direction. I never did, not because I did not support the concept of importation, but because after years of hard work and support for personal importation, my responsibility remains the health benefits and savings that personal importation generates for seniors, workers, and others, not the mere passage of a bill.
• Many of the supporters of importation failed to ask themselves a very basic question: Why should Canada, which is a sovereign nation, and which through Health Canada has standards of oversight that meet or exceed those of the U.S. FDA, allow its pharmacies, operating completely within the laws of Canada and the provinces to be subject to U.S. inspections. Rather, why was there not a move made for reciprocal agreements?

But, in addition to being unworkable, there is another reason the amendment as written and the punishment heaped upon importation supporters was unnecessary: Importation of safe,affordable medicines is well-established through the common sense of the American public.

As the pharmaceutical industry continues to raise its prices, making deals with the Obama Administration that will lead to even greater costs for Medicare Part D payments by the government, growing numbers of Americans will be able to make wise, independent evaluations of safety and efficacy, as well as costs of medicines from safe, easily identifiable sources, not only from Canadian pharmacies, but through other pharmacies in Tier One Countries.

This is yet another example that all wisdom does not generate from within The Beltway but lies with the common sense of the American people.

For years, we have contended that individual, personal importation is allowed because the FDA itself has stated that a medicine that is not available in this country may be ordered in 90-day supplies for personal use, and any medicine that is not affordable is equally unavailable.

Also, that same common sense, enables Americans to evaluate the sources of their medicines for safety and efficacy as well as price. Those who believe that the FDA is the sole source of drug or product safety need to only look at the sorry record of the agency on a number of fronts ranging from Peanuts to Heparin.

As one who supported President Obama during his Presidential quest, I must admit to a deep sense of chagrin on a number of fronts. The deals with PhRMA are just the latest in a series of failed pledges for transparency and openness in government.

If Senator Dorgan wants to proceed with his quest, I encouraged him take actions that reflect the realities of the moment, rather than a bill with language that, while deserving support in a different time, is no longer relevant…irrespective, we shall increase our efforts to help the American people have the information to make informed, wise decisions, step forward, and exercise their common sense with the selection of safe, affordable medicines from pharmacies in other countries that meet or exceed the standards of those in the U.S.

Perhaps the President can then redeem himself by directing HHS to take steps to lead to reciprocal agreements with those countries for the benefit of the health care needs of untold numbers of people in this country. But, it is not necessary to wait for him or others within The Beltway to take action.

The American people have already spoken and as they are faced with the tremendous price increases initiated by pharma, we urge advocates of lower drug prices to help provide them with the information that will help them make the purchase decisions that will solidify the role of vital medicines in their healthcare regimen.

Questions arise about motives of Senator Vitter regarding stance on prohibiting seizures of imported medicines

The motives of Senator David Vitter (R-LA), one of the traditional supporters of importation of prescription medicines from outside the U.S., have come into question because of the Senator’s response to a question from a participant in a Town Hall meeting and the lack of response to inquiries made to the Senator’s office about reports of stepped-up activity of seizures of vital medicines from legitimate, registered pharmacies in Tier One countries—medicines intended for individual purchase by U.S. citizens.

That this should occur involving the Louisiana Senator is somewhat of a surprise, since he has been a supporter of importation legislation, even introducing his own version of bills in past sessions of Congress.

Also, he has a record of supporting the rights of individual purchases of safe, affordable prescription medicines, and was a leader along with Senator Bill Nelson (D-FL) in passing legislation forbidding the seizure of prescription medicines in 2007. We worked closely with the staff on board at that time to support the legislation. He was known as being friendly to issues involving not only individual access to imported medicines but those affecting the elderly as well, serving on the Senate Select Committee on Aging. And, to add to his credentials, he was successful in pushing through Senate approval of legislation to prohibit funding being used to seize prescription medicines in the next budget year.

An admirable record, indeed. So what is the problem?

With his answer to a constituent’s question at a Town Hall meeting in which the questioner suggested that by supporting such legislation to prohibit seizures, the Senator was actually saying that because of lower-priced medicines being available from Canadian pharmacies (an issue we’ll discuss shortly because it does not reflect the realities of the current situation involving sourcing for legitimate Internet-based and mail order pharmacies), the Senator was actually commending the Canadian Healthcare System.

Senator Vitter’s replay was disingenuous, to say the least. Instead of reaffirming his support of the rights of individuals to make such purchases, he retreated to pandering to his audience, saying that his real goal was to force prices in Canada to increase, so that the pharmaceutical industry could lower prices in this country. He actually went so far as to suggest that his legislation could cause the collapse of the pricing methodology not only in Canada, but to create a worldwide collapse of pricing structures of other countries, and that they would be forced to increase their prices and the drug companies would show a charitable side to the American public, which has been besieged by predatory pricing of the pharmaceutical industry for decades

Oh yeah, and I have some beachfront property in Arizona to sell you.

Perhaps the reason the Senator believes that even though he pushed his bill through the Senate that the real reason that it would not be in any final bill coming out of the Senate-House conference was that his colleagues know that his real motive is not to lower drug prices in this country by ensuring the right of access for individual purchases and increasing the options available, but is merely an unworkable attempt to walk on both sides of this issue.

This is disappointing because several years ago, we worked with previous staff in the Senator’s office, and enjoyed such an amiable relationship that we were invited to participate in a Senate Aging Committee hearing that the Senator was planning in New Orleans. Unfortunately, a series of events forced the cancellation of the planned hearing.

Still, because of the Senator's record as a supporter of personal importation of safe, affordable medicines, we extended an invitation to current staff to respond to questions about the seizure ban legislation and related issues. The staff has declined to respond, creating additional questions about the Senator’s commitment to importation, and even of his commitment to presenting his views to America’s seniors. This is especially disheartening in light of his position on the Senate Select Committee on Aging.

Perhaps it is just as well. The Senator’s anti-seizure bill is unlikely to gain any traction and will not be a part of any Conference Committee agreement. This is unfortunate, especially in light of questions about what PhRMA received in return for its decision to cut prices for seniors in the Doughnut Hole. Did it ‘negotiate’ that there would be no price negotiation for Part D? Did it receive an understanding that there would be increased seizures of individual, personal orders of prescription medicines from outside the U.S.?

A final note: Earlier, we mentioned that the Senator’s bill to halt funding for seizures of medicines is flawed. In that regard, it shares with the Dorgan-Snowe bill for importation of personal medicines a fatal fault because the language of both reflects reliance upon importation of prescription medicines from Canada as well as not comprehending how the landscape for importation has changed over the years.

The problems

(a) Where at one time there were more than 140 mail-order or internet pharmacies in Canada, today the membership of the Canadian International Pharmacy Association is 31 pharmacies;

(b) The primary souring for the medicines dispensed by these is not Canada, but from licensed, registered pharmacies in other countries with which the Canadian pharmacies have established relationships and oversight that complements the standards of the country in which the pharmacies are located. The Senator’s bill limits the seizure ban to medicines from Canada;

(c) Finally, the Senator’s response to the question from the Town Hall meeting raises serious questions about his commitment to the role of importation as a part of a strategy to lower prescription medicine prices in this country. Canada has made it clear that it will not become America’s drugstore and will take whatever steps are necessary to protect its citizens and keep prices low.

(d) His belief that his stance will destroy not only the Canadian Health Care pricing structure but that of the rest of the world by forcing other countries to raise their drug prices, and that pharma will respond by lowering prices in the U.S. because it is able to charge more in other countries would be laughable were it not yet another example of the inability of many of our elected officials to understand the role that personal importation of prescription medicines could play in reducing prices and healthcare reform.

Importation bill has chance to offer example of concern for ALL U.S. citizens, leadership, innovation

The news hit with the suddenness of a surprise attack early Saturday, June 20—the Pharmaceutical industry had made a late night call to Senator Max Baucus (D-MT) to tell him that is was willing to cooperate by pledging $80 billion over the next decade in resolving one of the biggest problems (and resulting criticisms) of Medicare Part D, The Infamous Doughnut Hole.

The facts surfaced by Monday afternoon however, as it became evident that pharma’s move really was nothing more than a carefully crafted and possibly successful attempt to circumvent several challenges facing it—the possibility of price negotiation for Part D medicines, and the potential contribution that could be provided by allowing personal importation of safe, affordable medicines from licensed, registered pharmacies in Tier One designated countries.
The Doughnut Hole should have been called ‘The Black Hole.’ Seniors were forced to continue paying their premiums, but their coverage was ‘suspended’ when drug costs reached $2250. They had entered The Doughnut Hole, where they would pay 100 percent of their prescriptions for the next $3600—even though they still had to pay for their premiums (a windfall for insurance companies). After paying the $3600, the ‘catastrophic’ level was reached, and the seniors who had survived The Doughnut Hole, were eligible for renewed coverage with low cost co-pays.

The fiscal and medical hit upon the elderly was immediate. Many seniors simply quit taking their medicines or began ‘splitting’ pills. Either action not only derailed the claimed hoped-for goals of Medicare Part D, it caused untold numbers of elderly to gamble their health, well-being and perhaps even their lives by the self-denial of vital medicines that had been forced on them by a pharmaceutical-influenced Congress that enacted Part D. Billy Tauzin, the former Congressman from New Orleans who was instrumental for many of the 11th hour (and 59 minute) changes that shaped Part D was rewarded with a multi-million-dollar position by PhRMA, the influential and well-heeled trade group for the drug companies.

A proposed solution to relieving the burden of The Doughnut Hole dilemma—price negotiation for drugs-- soon became a favorite of politicians, and repeated calls were made from untold numbers of stumps, town hall meetings, and locales where the pols could promise the elderly that help was on the way.

With the election of President Barack Obama, a Democratic House and a Democratic Senate, negotiation seemed ready to be moved from stump speeches to reality.

But, it is said that politics makes strange bedfellows. And, the push for healthcare reform soon created a lot of odd sleeping arrangements. Many of us winced when PhRMA joined with FamiliesUSA, a leading progressive, hard-working and well-respected advocacy group, to work for ‘healthcare reform.’ What, we asked, was the industry looking for? Images of the Fox in the Henhouse, the camel with his nose under the tent, flashed though our minds.

Added to this was the White House meeting President Obama arranged with industry groups representing insurance companies, PhRMA, hospitals, and other healthcare industry groups. Our concerns were quickly validated when a White House statement about pledges to cut the growth of health care costs was actually nothing more than a pledge to reduce the rate of growth by not increasing prices as much as before. The President needs to remember what John Kennedy said about big business special interest groups and what a bunch of SOBs they were.

The fact is that the ‘pledge’ was actually not a true savings. It would be a bit like buying your groceries at a store that has raised its prices 20 percent for the past few years. But, to ‘save money’, it says it will raise its prices only 10 percent next year, so instead of groceries that cost $100 per week in year one, the next year they would cost $110 instead of $120. The store owner could then tell consumers that each had saved $10 in year two, even though they were paying more for the same groceries. Only the rate of the increase was less than in previous years.

This type of math should have been the tip-off that the pharma ‘commitment’ to aiding seniors in The Doughnut Hole isn’t what it at first seemed to be.

On Sunday, President Obama issued the following statement about the agreement with the drug companies:

"I am pleased to announce that an agreement has been reached between Senator Max Baucus and the nation’s pharmaceutical companies that will bring down health care costs and reduce the price of prescription drugs for millions of America’s seniors. As part of the health reform legislation that I expect Congress to enact this year, pharmaceutical companies will extend discounts on prescription drugs to millions of seniors who currently are subjected to crushing out-of-pocket expenses when the yearly amounts they pay for medication fall within the doughnut hole any payments by seniors not covered by Medicare that fall between $2700 and $6153.75 per year. The existence of this gap in coverage has been a continuing injustice that has placed a great burden on many seniors. This deal will provide significant relief from that burden for millions of American seniors.

"The agreement by pharmaceutical companies to contribute to the health reform effort comes on the heels of the landmark pledge many health industry leaders made to me last month, when they offered to do their part to reduce health spending $2 trillion over the next decade. We are at a turning point in America’s journey toward health care reform. Key sectors of the health care industry acknowledge what American families and businesses already know - that the status quo is no longer sustainable. The agreement reached today to lower prescription drug costs for seniors will be an important part of the legislation I expect to sign into law in October. I want to commend House chairmen Henry Waxman, George Miller and Charles Rangel for addressing this issue in the health reform legislation they unveiled this week. This is a tangible example of the type of reform that will lower costs while assuring quality health care for every American."
It was to be Monday before the facts began to surface. Simply put, PhRMA had negotiated an arrangement that would become law only if Congress enacted comprehensive healthcare reform, a part of which would include expanded coverage for more Americans, creating new, additional and profitable markets for the pharmaceutical industry. It is distressing to once again witness the ability of pharma to define issues to its advantage. Perhaps I need a refresher course in civics, but why does the industry have to ‘agree’ to cuts that are intended to be a part of the governing legislation enacted by the U.S. Congress? What option do they have?

Also, why is the Obama Administration so ready to heap praises upon the drug companies, all of which have reaped whirlwind, virtually ensured profits at the expense of the American public that has been denied access to the health benefits provided by access to vital medicines because it must pay the highest cost in the world for its prescription medicines?

But, it is an ill-wind that blows no good. Last Fall, before the elections, a group of advocates for senior advocacy groups from areas across the country, met in Washington, DC to shape support for personal importation of prescription medicines from Tier One countries. At that time, the participants reached a consensus that the importation concept should be included as a part of discussion about comprehensive healthcare reform, a ‘third-leg’ of the stool, because such access to vital medicines is essential to the health and well-being of Americans. It also urged consideration of the beneficial budgetary impact that could be provided though the inclusion of personal importation of prescription medicines into Part D thereby remedying plan shortcomings while saving money for the elderly, protecting their health and creating real savings for the Plan.

Sources tell us that moves have made recently by supporters of importation to define a stronger argument for importation of prescription medicines within the framework of the healthcare debate. We applaud such action. Now, there is an additional opportunity to address the benefits of improved health and savings by fine-tuning the healthcare debate to explore other opportunities for personal importation and defining a role for personal importation in Medicare Part D. Senators Dorgan and Snowe, the two legislators most identified with importation, have issued a statement that reflects their realization that the pharma 'offer' really does not address the challenge of lowering prescription drug prices. And, already, there is a growing realization that the pharmaceutical industry's motives are self-serving.

It is time to call out the pharmaceutical industry. There are legitimate questions that deserve answers about the motives of pharma. It has reaped the benefits of guaranteed pricing for Part D that has led to windfall profits. The claimed or hoped-for savings,while beneficial to individuals, is too little-too late for many elderly. As to the claimed savings to be scored by the Congressional Budget Office, there is a growing realization that possible trade-offs to gain pharma support might actually lead to increased--and virtually guaranteed--sales and earnings.

There is a role for personal importation in helping provide a solution to providing safe, affordable prescription medicines for all Americans. We believe the pharma moves should lead to increased discussion of creating such access, free of what we believe to be unnecessary delays by empowering Secretary Sebelius to designate Tier One countries whose standards of oversight, safety, and efficacy meet of exceed those of the U.S.

A pivotal year

Although we have not posted for sometime, the upcoming and much anticipated inauguration of President-elect Obama and a new Congress means that healthcare certainly will become a major national issue and it is time to restore a sense of urgency to activities.

In the 'lapse', much has already been accomplished:
--Advocates of importation of prescription medicines have regrouped and are planning strategies in support of importation, likely under the auspices of a revised Dorgan-Snowe impetus led by Senator Olympia Snowe (R-ME) and Senator Byron Dorgan (D-ND) . The National Council of Consumer Organizations, a part of the National Council on Aging, is leading the effort with respected senior advocacy leaders Peter Wyckoff, the former executive director of the Minnesota Senior Federation, and Paul Severance, founder of United Senior Action of Indiana, as co-chairs.
--The importance of access to prescription medicines as part of a regimen of critical health care is gaining increased attention from media. Reports are that the Associated Press is preparing a feature on the savings that could be provided for seniors if the Obama Administration acts to provide not only price negotiation for prescription medicines, but would support importation to provide even more options for America's elderly and additional competitive pressures that would lower prices.
--Hard-pressed local governments, facing fiscal crises are finding that there are alternatives to layoffs, cutting services or attempting to increase taxes through significant savings. One example is Montgomery County, NY which has saved more than half-a-million dollars since using the services of CanaRx, an internationally based prescription medicine plan developer and administrator offering access to maintenance medicines from Tier One Countries.
--A number of advocates to reduce prescription medicine prices through importation will assemble during the FamiliesUSA annual meeting in Washington, DC January 28-31. At that time, a number of meetings will be held with Congressmen and Congresswomen, and staffers.
--A number of contacts have already been made with staffs and Congressional-Senate offices to evaluate the support for co-sponsorships. With the new Democratic majority, odds of Pharma success in poison-pill provisions regarding certification by the Secretary of Health and Human Services, is lessened. Also, former Senator Tom Daschle (D-SD), selected by the Obama Administration for the Secretary of HHS, has been a suppporter of importation.
--Additionally, a number of contacts has been made with groups that have supported importation and access to safe, affordable prescription medicines in the past, as part of the Coalition building to work for success in the 111th Congress.