Tuesday, December 28, 2010

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.

Thursday, December 16, 2010

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.

Tuesday, October 26, 2010

United States of Pharma (C): How Drug Companies abuse system, prevent us from getting safe, affordable medicines

Prescription medicine costs re-emerge as issue—The past few weeks have seen a rush of activity regarding prescription drug costs generally and moves within the Obama Administration and FDA with the pharmaceutical industry specifically.

Most troublesome are strategies to restrict access to imported medicines by the imposition of new legislation that would limit ‘infringement’ of claimed intellectual property rights of Pharma, even to the extent of shutting down Internet operations/web sites that support ‘activities’ that the government finds have aided such ‘infringement’ with support of a contrary position such as support of importation.

At the same time, there is an increasing realization that the price increases of Pharma are prompting increasing numbers of Americans to cut back on their prescriptions.

To gain a perspective on the breadth of the emerging debate, here are the issues in thumbnail:

· What is the impact of PhRMA’s ‘cost-cutting’ on its revenues? Bloomberg reports that the industry will see its revenues from the deal drop by less than one-half of one percent, and because it will receive as much as 32 million new customers under the provisions of Obamacare, the ‘deal’ was a significant win for Pharma. The article also points out that the deal helped Pharma avoid other actions such as importation of prescription drugs and Part D price negotiation.

· The failure of cutting the costs of the Part D Doughnut Hole—Because Pharma’s part of the deal with the Administration does not take effect until next year, it was able to initiate price increases of as much as 10 percent (reported on in earlier wraps) on brand name drugs—increases that are being paid for by Seniors and other Medicare beneficiaries. One perspective of the scope of the problem is offered in a NY Daily News story on how to cut costs for those in the Doughnut Hole.

· There is growing suspicion of the impact of the deal made with Pharma—The Washington Post reports many believe that Pharma will skirt the deal with the Administration with price increases.

· The Heritage Foundation reports that the Administration deal with Pharma might actually provide an excuse for Pharma to raise prices.

· Stories are beginning to appear about Americans turning to Canadian pharmacies to cut drug costs. The Dallas News reports on one Senior’s plight.

· The New York Times offers an indication of Pharma’s willingness to act with total disregard for law and ‘deals’ by its willingness to “…flout a federal law that requires them to provide the government with pricing data needed to calculate discounts on medications prescribed for poor people…”

· There are other ongoing examples of Pharma’s disregard for fairness and obeying the law:

o New Jersey Pharmaceutical Company Settles Medicaid Fraud Allegations for $2M

o In Hawaii, a leading newspaper is calling for making the terms of a settlement with Pharma public, saying that the public has a “strong interest” in making the terms public. A lawyer for an unnamed pharmaceutical company is saying they should be kept confidential.

· Increasing numbers of Americans are skimping on their prescription drugs due not only to drug costs, but because of moves by insurance companies to reduce costs—The Wall Street Journal reports on the impact of insurance companies increasing co-pays and higher deductibles—steps aimed at decreasing costs—leading to an increase of 55 percent of ‘abandonment’ of prescriptions—drugs ordered but not picked up by consumers.

· States continue to struggle with the impact of high drug prices—In North Dakota, the question of who should own a pharmacy is debated. The state statute reads that an in-state pharmacy must be majority-owned by licensed pharmacists, but some claim this restriction leads to higher prices.

· In light of stepped-up seizure activity by the FDA of imported medicines,, we entered a blog on the FDA actions and Pharma’s attempt to make the U.S. a safe haven for its predatory pricing. We also issued a release criticizing the seizures (The Inspectors making the seizures said Lipitor was a new, unregistered drug and was unsafe...so much for the rationale for seizures when the world's largest selling drug is seized on such a false claim..)

FDA in Pharma’s Pocket—Despite the record of Pharma misdeeds, of which only some are included above, the FDA actions with the Partnership for Safe Medicines , a PhRMA front group (reference blog mentioned above to understand PhRMA control of PSM) on a number of fronts is troublesome:

· FDA Commission Margaret Hamburg is the new Poster Girl for PhRMA. She spoke at the meeting sponsored by PSM on counterfeit medicines, then in a display that made her look more like a spokesperson for PhRMA than an FDA Commissioner, she conducted a Q-A session before a backdrop emblazoned with the logos of all of PhRMA’s members. A video of the Q-A session is available on the C-Span site.

Earlier I mentioned copyright ‘infringement’ as a new tactic by PhRMA and the FDA to attack importation:

o The Hatch-Leahy Act (proposed) is seemingly aimed primarily at counterfeit items such as music, movies, CDs, etc. But, it also includes the capability of being applied to a rationale for halting of personal importation, I believe.

o The White House ‘summoned’ a by-invitation only meeting for ICANN and other internet-related domain services to discuss ‘counterfeit’ products and sites that promote them, including ‘rogue pharmacies’ In an act of political courage, ICANN refused to attend the meeting..

o This did not stop Attorney General Eric Holder from ‘touching’ on ‘illegal web-based pharmacies; in a speech on opiate abuse. Note the linked article is on the PSM web site.

o Concurrently, stories are beginning to appear again about the lack of safety of ‘Canadian pharmacies.’ These are, of course, totally inaccurate since the safety and efficacy of prescription medicines from licensed, registered pharmacies in Tier One countries is based upon meeting standards that meet or exceed those of the U.S.

· In a bitter irony, Commissioner Hamburg, whose primary responsibility if the safety of foods and medicines, approves and supports the continued use of Avandia, making the U.S. the only country in the world where the sale of the drug is approved. Her rationale: It’s the only alternative for people with Type 2 Diabetes, so we are witnessing the spectacle of an FDA official who says that proven safe, affordable medicines from Tier One Countries are dangerous and the government must take actions to protect Americans from these ‘unsafe’ medicines, it is quite OK to put Diabetics at risk of heart attack or stroke. I shall be writing a blog on this.

Monday, September 27, 2010

How Pharma attempts to turn U.S. into ‘safe haven’—The United States of Pharma ©-- for predatory prescription prices by reducing rights of Americans

Publisher’s Note: Rights, Responsibility, Capability: For nearly eight years, I have been involved in work to promote the right of Americans to make personal health decisions to protect their health with the purchase of safe, affordable medicines from Tier One Countries. I believe that Americans have the right to make such decisions, while exercising their personal responsibility for good health, coupled with the inherent capability of Americans to make such decisions, free of artificial and incorrect ‘concerns’ about safety and efficacy that are really nothing more than a cover to protect the predatory pricing practices of the pharmaceutical industry, practices that unfortunately continue to be protected by elected officials and policy makers whose primary interest should be the protection of the health and well-being of American citizens. Instead, they unfortunately demonstrate their lack of faith in the capability of Americans to make decisions about their health. Because of that, in the next few weeks, I shall be presenting behind-the-scenes activities that almost certainly have adversely affected the health of untold numbers of Americans and made the country a ‘safe haven’ for Pharma pricing and practices. This first in the series is a broad look at the issue and how the pharmaceutical industry has co-opted the political process of this healthcare issue. The next post will deal with a failed attempt at cooperation with a major drug manufacturer to enlarge the discussion to focus on the healthcare benefits of a regimen of access to vital medicines—irrespective of source—as a crucial part of reducing healthcare costs.


Ever since the advent of the Internet helped make Americans aware that they were paying the highest prices in the world for their medications and that they could exercise their common sense to make responsible decisions about vital medicines to both save money and protect their health with purchases from mail order pharmacies via the Internet, the pharmaceutical industry has conducted what may be the most vigorous campaign by any industry group in our history to deny Americans their right to make their own health care decisions.


Its campaign—conducted by PhRMA, the industry trade group, an, d an untold number of the many fancifully name front groups it has funded (such as the Partnership for Safe Medications, LegitScripts, United Seniors Association, 60Plus, Center for Medicine in the Public Interest, to name a few)-- is a tragic textbook case study of how an industry whose primary concern should be the advancement of the health and well-being of Americans rather than profit, has spent millions of dollars to establish questionable relationships with policy makers and elected officials to set policies that ensure strategies that have denied large numbers of Americans access to the health benefits that could be made possible through access to safe, affordable medicines.


Ironically, the industry has been able to do this while it has been involved in massive wrong-doing of overpricing its medicines and defrauding millions upon millions of dollars from government programs such as Medicaid and Medicare. It has also spent millions upon millions of dollars for direct to consumer marketing (the U.S. is one of only two countries that allow such advertising).


It’s ‘gifts’ to physicians has, thankfully, been recognized as an attempt to ‘persuade’ what should be decisions based upon the needs of patients, not the value of the ‘gift’. It has foisted unsafe drugs upon an unsuspecting public. Merck recently was found liable for $250 million for the death of a patient in TX in 2001 after taking Vioxx, and that's only one example.


One would think that this record of misdeeds would generate a sense of righteous indignation among our Congressmen, Senators and the President.


Instead, pharmaceutical industry representatives are embraced by our President and Congressmen for ‘agreeing’ to charge 50 percent less for vital medicines sold to Seniors in the dreaded ‘Doughnut Hole’ within a year of the enactment of the Obama-Baucus healthcare legislation, afterwhich they embark upon a series of price increases that virtually ensure that the claimed savings will not only not exist for the Elderly in 2011, but that Pharma profits will be protected.


The latest example of how the pharmaceutical industry co-opts groups comes with the push for ‘safe prescription medicines’ by using antii-counterfeiting sentiment as included in the Hatch-Leahy legislation regarding ‘infringement’ of intellectual property rights.


Under the proposed bill, the U.S. Department of Justice would be empowered to initiate in rem civil action ( In rem specifies an action against a thing, property, or right, rather than a person) and is claime “… to protect the investment American companies make in developing brands and creating content and will protect the jobs associated with those investments.”


This is highly admirable. The theft of intellectual property is of serious concern. And, not surprisingly, I have received messages from music industry representatives who have urged that we express our support on various web sites.


The problem is that the proposed legislation might be seen as opening the door for infringement upon other claimed forms of intellectual property rights such as claiming that pharmaceutical manufacturers having the right to claim ‘infringement’ upon their ‘intellellctual property’ if a pharmacy from outside the U.S. sells a company’s medicines to someone in the U.S., even if it is the same medicine sold in the U.S. (at prices of as much as 60 to 80 percent more).


There is also the possibility that there could be grounds against a web site that practices its right of free speech in support of a position that is contrary to the Justice Department stance. Already the debate has begun with President Obama pledging support of free speech on the Internet, although there are many who question if this support is for domestic speech or if it is more of a statement directed to an international audience since the comments were made at a United Nations session .


While it might seem a ‘stretch’ from CDs and books or articles to prescription medicines, the pharmaceutical industry (Merck) did sue several Canadian pharmacies about five to six years ago on the grounds that its intellectual property rights had been violated claiming it has the exclusive right to determine where and how its products could be sold even though it had already sold the medicines to licensed, registered pharmacies.


While all of this is occurring, PhRMA and its front groups such as PSM , engage in a classic example of misdirection under the umbrella of the very real concern of counterfeit medicines, which we vigorously oppose.


I say ‘misdirection’ because PSM attempts to create a linkage between pharmacies in other countries that must meet or exceed the standards for U.S.-based pharmacies and those in Kenyna or other third-world countries that lack such oversight.


If PSM, and the FDA, which periodically seizes vital prescription medicines that have come from pharmacies in Tier One countries, with their high standards of oversight, and are the identical product to that sold at the corner pharmacy, are concerned that such medicines are either not safe or counterfeit, they should provide the evidence that would validate their claims and actions. If they fail to do so, the FDA should stop the seizures and follow the will of the U.S. Senate when it voted overwhelmingly to halt seizures by Homeland Security. The FDA denied any role in the seizures, although Homeland Security said it was acting in collusion with the FDA.


They should answer the question about how many of the counterfeit drugs being seized are from licensed, legitimate pharmacies in Tier One Countries, and provide evidence of what it is that make the medicines ‘counterfeit’.


It is not adequate merely to point to a labeling difference that is based upon the requirements of the country of origin when the medicines are the same brand-name medicines produced at FDA-inspected sites. And, someone should let FDA inspectors and the U.S. Post Office know that Liptor is not a new, unregistered drug.


It is ironic that an Administration that said, if elected, it would support the rights of Americans to purchase medicines from outside the U.S. should now say there are difficulties in ensuring safety.


Perhaps the statement is more understandable as a reflection of the capability of the FDA than the safety and efficacy of imported medicines from Tier One countries since this is an agency that hasn’t been able to protect Americans from domestic products such as contaminated peanuts, eggs and, in a case that illustrates its gap in applying protect standards as compared to other countries, continues to allow the sale of Avandia, a drug for Diabetes that has been banned in the European Community.


The FDA solution: limit the use of Avandia only to new US patients with type 2 diabetes only if they are unable to control their glucose levels through other medications.”


Ironically, FDA Commissioner Margaret Hamburg, who has claimed that there are ‘difficulties’ in ensuring the safety of legitimate and safe, effective medicines imported into the U.S. has apparently found a way to determine that Avandia can be justified, saying "The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,"


If only she would apply the same standards to the needs of Americans to access to vital medicines about which there is no question of safety, efficacy or price.

Tuesday, September 21, 2010

Seizures of prescriptions represent broken promise of Obama Administration to support of personal importation of prescription medicines

A rash of seizures by the Food and Drug Administration of vital medicines from licensed, registered pharmacies in Tier One Countries is threatening the health of Americans by denying them their right to purchase safe, affordable medicines that are identical to those sold in the U.S., but at prices as much as 60 percent lower.

The FDA action breaks the promise made during the 2008 Presidential campaign by then-candidate Obama to provide access through personal importation of these medicines as a part a strategy of lowering prescription drug costs in the U.S.

When Obama was seeking the votes of America’s Seniors, their caregivers and families, he and others spoke frequently and with great conviction about their support of the right of individuals to purchase safe, affordable medicines from sources outside the U.S.

But, in September 2008, Dora Hughes of the Obama Campaign Staff sent up the first signals that the support was not as strong as Candidate Obama would have people believe when she was quoted as saying that there were problems with what is called reimportation.

(The term reimportation is misleading. Personal importation is more accurate as it best describes American citizens exercising their right to purchase the very same medicines that are priced at as much as 60 percent more in the U.S. than from pharmacies in Tier One Countries that meet or exceed standards of oversight of those in this country.)

Since then, the Obama Administration has engaged in a series of actions that indicate that it not only has no intention of carrying out its campaign pledge, but has even made arrangements and deals with the pharmaceutical industry that have helped boost the cost of medicines to such an extent that a growing number of Americans are finding drug prices to be a deterrent to their being able to buy and take their prescriptions.

· The deal with PhRMA in which the drug industry ‘agreed’ to lower prescription drug prices for drugs in the dreaded Doughnut Hole of Medicare Part D, only to raise prices at rates far exceeding inflation during the year before the price drop was to take place, is the prime example of the willingness of the Administration to sacrifice principle for process. Actually, PhRMA limited its ‘financial hit’ to $80 billion over ten years, a ‘hit’ that will almost certainly be outstripped by the industry’s price increases. The price increases are already eating up the $250 stipend paid to Seniors in the Doughnut Hole. In return, PhRMA pledged not to oppose the President’s signature legislation, the Patient Protection and Affordable Care Act.

· As a part of what many consider the quid pro quo for PhRMA’s pledge, the Administration kicked ‘reimportation’ of prescription medicines—and its primary supporter for many years, Senator Byron Dorgan (D-ND)—under the bus when FDA Commissioner Margaret A. Hamburg, in a letter to the Senate, warned that her agency was not able to guarantee that drug imports would not be counterfeited or contaminated. The Administration was silent about Commissioner Hamburg’s statement.

· There was speculation that the Administration had also pledged to continue to oppose personal importation as a part of the PhRMA deal. The stepped-up seizures and the Administration's coziness with a PhRMA-backed group, the Partnership for Safe Medicines (PSM), lends credibility to that concern. Consider this timeline:


05/2009: PSM opposes Reimportation... 09/18/2009: PSM says Search Engines promote illicit drugs...12/08//2009 : Commission Hamburg says ‘difficulties exist’ for safe reimportation , Dorgan Amendment fails...02/10/2010 : PSM applauds Google position on stopping Internet pay per click for Canadian pharmacies...06/22/: PSM applauds Administration position on ‘protection’ of intellectual property rights including drug manufacture...06/2010 : Commissioner Hamburg restates position about ‘difficulties’ with reimportation...06/2010: Senator Dorgan announces plans to introduce reimportation amendment to food safety legislation...07/29/2010: National Association of Chain Stores sends letter objecting to Dorgan amendment...09/14/2010: Generic group joins PSM...09/2010: PSM announces that Commissioner Hamburg to speak at Inaugural Conference on Counterfeit Medicines , sponsored by PSM...SEIZURES ACTIVITY PICKS UP IN AUGUST


PSM, which purports to seek an end to the danger of counterfeit medicines, a goal which we all share, is the proverbial sheep in wolf’s clothing—a PhRMA- backed organization with interlinking relationships to PhRMA among its Board members. Consider these links of the Board members:


Marvin D. Shepherd, Ph.D , Director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas-Austin , long-time record of opposition to personal importation, PhRMA links covered in previous blogs. http://rxforamericanhealth.blogspot.com/2009/07/time-for-critics-of-importation-to-look.html

Bryan A. Liang, Ph.D, M.D., J.D. , Executive Director, Institute of Health Law Studies, California Western School of Law Co-Director, San Diego Center for Patient Safety. See linkage to James N. Class, below

James N. Class, Ph.D Director, Global Public Policy, Merck & Co, Inc , Class is a member of the Institute of Health Law Studies at Case Western headed by Liang

Thomas T. Kubic , President and CEO, Pharmaceutical Security Institute, Composed of the security directors from 26 pharmaceutical manufacturers with business operations in more than 160 countries.

Scott A. LaGanga , Senior Director, Pharmaceutical Research and Manufacturers of America,

· While the latest round of seizures reflect a lesson learned by the FDA as it ‘softens’ its approach by posturing as the ‘protector’ of the patient that has ordered the medicine , it apparently doesn’t know much about formularies as one of the primary drugs seized is Lipitor, manufactured by Pfizer in Ireland for distribution and sale world-wide. But the highest-selling drug in the world is, according to the FDA, apparently a new drug with its safety and effectiveness in question (an excerpt from the FDA letter follows);

o ”According to the FDA’s ‘Procedures for Human Pharmaceutical Products Shipped through International Mail Facilities, it is a new drug because it is not generally recognized as safe and effective by experts and requires a prescription. It is an unapproved drug because there is no FDA approval of a new drug application on file for the product…” (emphasis mine)


· There is, of course, a prescription for the seized medicine. The FDA has admitted that it does not test the seized medications. The new letter says that the agency is not accusing the patient of a crime. What then is the basis of the seizure? The claim of acting as a protective measure simply dissipates in the light of the fact that by its action, the FDA is actually endangering the finances of the patient at best by denying them the right to purchase safe, affordable medicines.


At worst, by the denial of a vital medicine designed to protect the health of the patient, the FDA is endangering the health and well-being of the patient—this by an agency that is supposed to serve the public good. The Obama Administration should act on its election pledge to lower the prices of prescription medicines with a number of strategies, including the right of personal importation, and direct its appointees to act to stop the possible health-threatening seizures of vital medicines.


Commissioner Hamburg is widely recognized as a talented, intelligent professional with high standing in the medical community. Surely she can apply some of those talents to addressing what she perceives as ‘difficulties’ and work to deal with a problem that affects the very heart of our health care system—the highest drug prices in the world.

Sunday, January 17, 2010

2010…New Year offers chance for President Obama to take steps to keep pledge on ‘reimportation’

Even before the much-hailed (by Senator Max Baucus (D-MT and the Obama Administration) deal with PhRMA, the trade association for the pharmaceutical industry,in the Senate Health Care bill draws its first breath, it is obvious that the savings claimed for Medicare Part D were nothing more than a Magic Lantern Show.

The deal called for pharma to reduce its prices for Seniors in the Doughnut Hole by $80 billion by cutting prices paid by Seniors in half, but with the full price being credited by Administrators towards satisfying the individual Doughnut Hole requirement. The idea was that Seniors would pay less but because of the full credit to satisfying Doughnut Hole requirements, they would move more quickly from the Hole to Catastrophic Coverage.

Never mind that would require that the Government would then have to pay 93 percent of all future drug coverage for the duration of the plan that year, adding untold millions of dollars to the cost of Part D.

As for the claimed savings: After entering into the agreement, pharma began a series of price increases that has prompted an investigation by the U.S. House of Representatives (whose Health Care Reform bill does not include the deal struck by the Obama Administration and the Senate). It is suspected that the price increases not only eliminate the ‘savings’ to Seniors but also will add to the overall Part D costs.

Furthermore, as a part of the quid pro quo for agreeing to the price cuts, phama received pledges that the Senate bill would not include nor would the Administration push for drug price negotiation which would have offered real savings to all Part D enrollees and to the cost of Part D overall.

Also, there was obviously a deal struck that the Administration would not honor its election campaign pledge to support ‘reimportation’ of prescription medicines. And, while the Administration reneged on its pledge to voters, it kept its deal with pharma and PhRMA, the industry trade association, by effectively sabotaging Senator Dorgan in his efforts to make importation a fact.

Ironically., on the surface, this lack of support might actually have the opposite impact of what pharma was hoping for, providing an opportunity for the Obama Administration to keep its pledge to allow all Americans access to safe, affordable medications from licensed, registered phamacies outside the U.S. which are subject to oversight that meets or exceeds those of pharmacies in this country.

The oppportunity is created because, as noted in earlier posts, the vehicle introduced in the Senate by Senator Dorgan was virtually the same legislation that had been introduced in previous sessions of Congress, starting nearly a decade ago, when Canadian-based Internet Mail Order phamacies first began meeting the very real need of America’s Elderly for access to vital medicines at an affordable price.

At that time, the vast majority of the prescriptions was filled by those pharmacies—licensed and registgered in their respective provinces and subject to the oversight of Health Canada, which has proven, exceedingly high standards that meet or exceed those of the FDA.

The language then—and in its most recent incarnation—called for additional oversight by the U.S. Food and Drug Administration, which would be allowed to inspect pharmacies in Canada, to ensure that they met the U.S. standards.

At the time, this was perfectly logical. There were numberous Canadian mail-order pharmacies—some estimate as many as 140—but there were also bogus pharmacies in other countries springing up claiming to be Canadian pharmacies.

The bill, popularly called the Dorgan-Snowe Bill seemed a logical way to ensure safety as millions of Americans, some not familiar with the then relative ease with which a ‘web presence’ could be made to seem to be offering legitimate services.

This was before Medicare Part D. The pharmaceutical industry reacted to the loss of markets as, even without any U.S. interference, increasing numbers of Americans joined the country’s Seniors in ordering an estimated $140 billion in prescription medicines from legitimate Canadian-based pharmacies, by (a) expensive law suits against the mail order pharmacies, using ‘intellectural property rights’ arguments granted by U.S. law that allow the companies to determine where their products can be sold and by whom; (b) working in collusion with the FDA and U.S. Customs to seize vital prescription medicines in spite of U.S. Congressional action calling for an end to such seizures; and (c) using Senate lackies to thwart repeated votes of Congress to provide a domestic structure for oversight (Dorgan-Snowe) to provide a poison pill amendment for ‘certification,’ requiring that the Secretary of Health and Human Services certify that each and every drug from a pharmacy outside the U.S. was ‘safe’, even when the drug itself was manufactured at a plant with oversight and approval of the FDA, ironically an agency under the jurisdiction of the Secretary.

But, the Silver Lining was that was that for the first time ever, Americans were recognizing that the prices they had been paying for their medicines were the highest in the world even though as U.S. taxpayers, they paid for much of the research and development of new medicines which are then licensed for manufacture and sale by pharmaceutical companies—and manufactured not in the U.S. but solely at lower-cost FDA-supervised facilities in other countries only to be brought back into this country.

The result: Pharma claimed the right of ‘reimportation’ for itself, but wanted it denied for personal importation, even through there are specific references that personal importation is allowable in up to 90-day supplies if a drug is unavailable in this country. In light of today’s terrible economy, it is truer today than any time in recent memory that if a drug is unaffordable, it is unavailable.

That was then. This is now. There were many reasons that Dorgan-Snowe would not have worked, and we have outlined them many times before. But this should not be construed as a criticism of personal importation, nor of the commitment of Senator Dorgan and others who, even while not recognizing that many of the assumptions on which the implementation of Dorgan-Snowe was based (financing, sourcing, etc.) made the legislation unworkable, were driven by their desire to bring lower prescription medicine prices to Americans.

While it is time to ‘retire’ the language of past reimportation bills, it is also time to work to establish a policy that will bring to fruition the potential contribution of personal importation to lower prescription medicine prices. This requires that vital prescription drugs from safe, affordable sources, including outside the U.S, are available to and affordable for the largest number possible of U.S. citizens, irrespective of age.

Even with the harassment and collusion of the FDA with pharma, large numbers of Americans regularly turn to safe, affordable mail order sources from outside the U.S. to fufill their prescription drug requirements. Importation—a much more accurate term than ‘reimportation’ is a fact of life in in healthcare for untold numbers of Americans. And, even such a highly conservative source as The American Enterprise Institute has noted, one would have to be ‘an idiot’ to be able not to identify legitimate mail-order pharmacies (including those outside the U.S.) and to order their medicines safely because the 'safety risks' are overstated. (unless the individual was seeking a prescription for a controlled substance or for satisfying some sort of addiction with a source that does not require a prescription from a physician. Significantly, legitimate mail order pharmacies to not deal in controlled substances, nor will they fill an order without a verifiable prescription).

Here then are some steps that the Obama Administration should take to meet its election campaign pledges of support of importation as well as the statement by Obama advisor David Axelrod following the Senate rejection of the Dorgan-Snowe amendment,that the Administration would continue to work to create a role for personal importation in lowering prescription medicine prices:

1. Instruct the Secretary of Health and Human Services to identify those countries that have standards of oversight, efficacy and safety that meet or exceed those in this country. These are commonly referred to as Tier One Countries and include but are not limited to Great Britain, Australia, New Zealand and numerous other European Community countries.

2. Support the Vitter Amendment proposed by Senator David Vitter (R-LA) to prohibit the use of Homeland Security funds for seizures of vital medicines imported into this country for personal use. Expand the restriction to include banning any Federal agency from making such seizures, or if such seizures are made, that the prescriptions be released to the individual making the order upon verification with the individual that the medicine is for personal use.

3. If any seizures are made and not released to the individual making the order, require that tests be done on the unreleased medicine by the agency making the seizure and that the results be available under Freedom of Information (FOI) rights. The FDA has not responded to requests to make the results of such testing, nor even to verify that it does any tests.

4. If any medicine is found to meet the requirements of being imported for personal use and is not for resale, is manufactured at an FDA-inspected facility (irrespective of country of origin) and is identical in ingredients and efficacy to the same drug packaged for direct sale to consumers in the U.S., it shall not be seized because of irrelevant differences in packaging or labels.

5. The Secretary of HHS should be instructed to enter into reciprocal agreements with counterparts in designated countries for the purposes of lowering drug prices, safety and efficacy through personal importation.

6. HHS should provide information on its website and through other informational sources to help U.S. consumers best identify sources for safe, affordable prescription medinces from licensed, registered pharmacies in countries other the the U.S.

7. No individual certification of safety and efficacy should be required from the HHS Secretary. (If such certification is required, the concept should be extended to other Cabinet members—the Secretary of Transporation for the safety of vehicles and accessories; the Secretary of Agriculture for stopping agricultural pollution such as the Dead Zone in the Gulf of Mexico caused by run-off of ag chemicals. Obviously, these requirements are not practical nor needed, but neither is any certification requirement by the HHS Secretary).

8. The inclusion of imported medicines in Part D plans should be the subject of an immediate study. Congressman Dennis Kucinich (D-OH) has proposed such a concept, and the Administration should support such a plan.,

If the President keeps his pledge, steps to lower prescription drug prices in 2010 by promoting importation, will be not only a fact, but might actually be remembered as the most significant element of health care reform, bringing about tremendous savings, all the while protecting and improving the health of untold numbers of Americans, which would undoubtedly help avoid costly health problems in the future.