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.

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.

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.

Has FDA reached its hubris with its disingenuous approach to justification of seizures of vital medicines, by thumbing its nose at Congress

Recent FDA seizures of individual purchases of vital, safe, affordable medicines from licensed, registered pharmacies in countries outside the U.S.—countries which have standards of oversight that meet or exceed those of the U.S. and our FDA—and statements made to justify such seizures illustrate that the agency has no appreciation or respect of the intent of Congress to end such seizures as well as engaging in disingenuous actions by claiming that any past Congressional actions do not apply to it. And, now, in an attempt to justify such seizures, it is evident that the Agency actually does not even know what actions Congress has taken in regard to personal importation of prescription medicines.

These are the inescapable conclusions after seizures recently started again. This prompted us to submit a series of inquiries to the FDA. The responses did not directly answer the questions. Now even more significantly, correspondence by the FDA to which we have gained access claims that "it is prohibited by congress (sic) to purchase prescription (sic) by mail."

Either the person making the statement is completely uninformed or is guilty of a deliberate falsehood.

As long ago as 2000, Congress approved the concept of 'reimportation', a misnomer since virtually no medicines are produced in the U.S. and the majority of prescriptions purchased in the U.S. is imported from other countries.

It was also passed in the last year of the Bush Administration, only to be turned away because it was attached to the FDA Reauthorization Bill, and President Bush had threatened a veto if the bill contained provisions for importation.

Added to this is the fact that for nearly a decade, personal importation has been supported by a huge number of sponsors in the House of Representatives and the Senate, only to be denied a vote because of parliamentary maneuvering by the highly effective pharmaceutical lobby.

That U.S. citizens should be denied access to vital, safe, affordable medicines via individual purchases for whatever reason best fits the moment for the FDA indicates that the agency, even in light of its failed record of safety for a number of products, is willing to allocate its limited resources to hindering personal importation.

One can only wonder whether such actions might actually do more harm to the people whose health it should be protecting by denying Americans access to personal importation as an integral part of their health regimen.

It is also reasonable to wonder whether or not seizing of safe, affordable medicines is done at the risk of detracting from seizures of counterfeit drugs from bogus pharmacies.
Some background is in order:

I have been and continue to be a strong supporter of personal importation. In that capacity I have worked—and continue to do so-- with seniors’ advocacy groups, policy-makers and as a communications consultant for companies that support importation of safe affordable medicines.

I have contacted and been in the offices of numerous Congressmen and Senators to make them aware of past actions by the FDA, Homeland Security and Customs in denying seniors and untold numbers of other Americans vital medicines that are important to the health and well-being of the persons ordering the medicines.

In 2006, we were successful in what, to that time, had been the to that time the most major abuse of power regarding seizures when elderly people across the country were not only having their medicines seized, but were receiving threatening letters from Customs officials telling the seniors that they were in violation of U.S. law.

This is, I and many others believe, a debatable point depending on one’s interpretation of the availability statement on the FDA’s own site saying that if a medicine or medical device is not available in this country, an individual may purchase it from outside the U.S.

My view is that if a medicine is unaffordable, it is certainly ‘unavailable’. Futher more, in an even more abusive attempt to scare America's elderly, in its letter, Customs went on to force the individuals to acknowledge that they knew they had violated U.S. law and were subject to prosecution if they continued to engage in such behavior, namely ordering medicines that helped keep them alive.

A sense of righteous indignation set in among elected officials. Then-Congressman Gil Gutknecht (R-MN) offered to file a friend of the court brief should supporters of importation decide that legal action be taken, his purpose being to illustrate how the FDA, Customs and Homeland Security were thumbing their nose at Congress. Senators Bill Nelson (D-FL) and David Vitter (R-LA) sponsored legislation to end the seizures, a clear signal that it did not approve of the actions of regulatory agencies designed to enforce the intent of the Legislative branch, not to design and interpret laws and make policy.

It was evident that the FDA was denying access to drugs that had not been tested for safety and efficacy. This is a crucial point since in the latest communications with FDA, the agency now (2009) says it does not have test results to affirm safety and efficacy. It does claim to have conduct tests and found ‘some drugs’ to not be authentic, but will not provide results from any tests it might have conducted on legitimate medicines. This leads to the inevitable conclusion that it has made its decisions whether to seize or not strictly upon country of origin rather than safety and efficacy

In 2006, the outrage over the seizures led to what was described as a ‘historic vote’ as the Senate took action, voting 68-32 to forbid such seizures. (And, herein lies the basis of the basis of the current disingenuous rationale of FDA…which now claims in verbatim statements that follow that the legislation was directed only towards Homeland Security, although the spokesperson for DHS at the time clearly states that the department was working in cooperation with FDA.
It is clear that the intent of the Congressional action—an intent which it clearly understood—was to defer seizures of specific medicines and pharmacies from acknowledged safe sources.

It was not aimed at hampering the seizures of counterfeit medicines from bogus pharmacies. Since the FDA, according to the comments of other agencies was cooperating in such seizures, this intent was directed equally towards all agencies involved in the seizures.

The issue seemed to be settled with the 2008 Presidential election. Both candidates supported importation of safe, affordable medicines from outside the U.S., and today, Senator John McCain (R-AZ) remains an outspoken advocate of importation.

Still, seizures have recently increased. This led us to make contacts with an FDA spokesperson to seek the rationale of the agency for the seizures. We had--and continue to have--several questions, including whether increased seizures might be a part of the deal struck by PhRMA to 'lower' the price and rate of increase of medicines in Medicare Part D's Doughnut Hole. That the claimed savings are illusionary and have been challenged by many policy-makers and advocates only adds to the suspicion that there might have been some 'quid pro quo' made by the Administration in return for PhRMA's 'cooperation.

But, it is an ill wind that blows now good. The responses to the series of inquiries and later statements made by other FDA officials in justifying seizures of personally imported medicines with a proven record of safety and efficacy, and absolutely no record of coming from bogus pharmacies or being counterfeit is illustrative of an agency that is suffering either from miscommunications in defense of its stance on such seizures, a complete lack of respect for the intent of the U.S. Congress, or a bias that indicates the unwillingness of the FDA to stick to its own guidelines as to its 'primary' reason for seizures--or all of the afore mentioned.

The FDA is a severely criticized agency. It has failed to protect American consumers from easily identifiable sources of potential contamination of on the medical front such as failure to identify defective medical devices from China. Even though it claims concern for drug safety, it failed to identify unsafe ingredients from China are blamed for deaths from Heparin, manufactured by Baxter.

It has also been criticized for failures in protecting the U.S. food supply for products ranging from domestically grown peanuts to imports of unsafe foods from China.

It is a matter of public record that the FDA has limited resources. So when we made our contact with a staffer assigned to deal with questions involving importation, our first question, submitted in writing was:

Knowing of admittedly limited resources of the FDA, how does the agency reconcile the seizure of proven safe medicines from legitimate pharmacies (albeit from outside the U.S.) with the possibility that dispersing those limited resources might actually increase the chances of counterfeit medicines from bogus pharmacies escaping seizures.

The answer such as it is follows:

"Because of limited resources the FDA uses a risk based approach to detention and actions related to imported drugs"

This is a typical Public Relations approach in which one answers a question that was not asked. It fails to address the question that was asked, and is nothing less than a tacit admission that the people making the seizures have no idea of the safety or efficacy of the medicines.

The agency has made a decision that it is doing more to promote drug safety by seizing individual purchases of medicines than to allocate its resources, which the FDA admits are limited, towards identifying bogus pharmacies and counterfeit drugs.

If the FDA needs help in identifying and distinguishing legitimate pharmacies from other countries, whose standards of quality meet or exceed those of the agency, surely a measured and more effective use of 'limited' resources could be expended in working for reciprocal arrangements to identify those pharmacies. If it needs help to identify bogus pharmacies, I suggest the agency cooperate with the Canadian International Pharmacy Association which has worked diligently to identify bogus pharmacies, or that it take advantage of several other sources that have done so.
Another question asked was about the 2006 vote:

Congress voted to end the seizure of prescription medicines from licensed, registered pharmacies via Canadian pharmacies. How does the FDA reconcile that intent of Congress with the broad brush approach that such imported medicines are subject to seizure? Does the FDA supersede the Congress in this instance?

The response follows:

“What you are referring to was directed to DHS authority. Under the FDA's current authorities, most of these drugs are illegal and unapproved.”

This is, as noted above, completely disingenuous. In a statement at the time of the vote, the following statement was issued:

A Department of Homeland Security spokesperson in a statement said, "While we are reversing this policy, (Customs and Border Protection) remains committed, in cooperation with the FDA, to protecting the American public from unsafe and ineffective medications. We will be focusing our resources to best protect the American public." An FDA spokesperson declined to comment on the decision to end the seizures.

This statement makes the record clear. Congress had a clear intention to end seizures. At the time, the FDA declined comment, buy its silence spoke volumes in light of the admission by DHS that the policy was conducted in cooperation with the FDA.

While the spokesperson for FDA provided written answers, most of them were as follows:

“Under current law, these products are illegal. Sometimes FDA does test products, and we have found substandard and counterfeit drugs.”

This led to yet another question:

Is the reason for such seizures continue based upon the point of origin, or has the FDA conducted any tests on the seized medicines from such pharmacies as described in (2) to determine the efficacy, quality, safety of the affected medicines? If so, what are the results of such testing? (For the record, (2) refers to “vital prescription medicines from licensed, registered pharmacies in other countries who standards of oversight meet or exceed those of the FDA?”

The response follows:

Under current law, these products are illegal. Sometimes FDA does test products, and we have found substandard and counterfeit drugs.

The response seems to indicate that the FDA has indeed tested and found problems with prescription medicines from the designated Tier One countries.

But the response to a specific request indicates that this is not the case.

The question follows:

This is a request for the specific findings of substandard and counterfeit drugs from any licensed registered pharmacy from outside the U.S.

The response follows:

FDA does not have that information to share. Testing typically performed by the FDA relates to the identity and content of the product, and not to the efficacy, quality and safety of those products.

And therein lies the self-imposed dilemma of the FDA.

It admits that it has not only has no reason for making seizures based on safety and efficacy of the legitimate vital medicines it has seized, but instead relies upon country of origin. Add to this, the attempts to twist the intent of Congress on forbidding such seizures, and the complete misstatement about Congress forbidding the purchase of prescriptions via mail. All lead to questions about the real intentions of the FDA.

And, we can only wonder if, while seizing vital medicines, how many shipments of counterfeit drugs from bogus pharmacies might have slipped past inspectors

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.

Dear Mr. President...an appeal to President Obama for his healthcare speech

Dear Mr. President:
Once again, you have been placed at the crossroads of history. Tonight (September 9) you will have an opportunity to regain the impetus of the need for real change that was delivered to you by the American people last November.

As one who foresaw you as the next President long before others had even thought of it, I urge you to use this chance to reclaim the mantle of leadership which, unfortunately and disappointingly, you gave to the Congress and the shrillness of the Town Hall Meetings in August.

As you prepare your remarks and as you reassume the mantle of leadership that is unique to the Presidency, remember some important points:

o You are the only elected official who has subjected himself to the extreme scrutiny of the American people.
o You are the leader of the Democrat Party, and alone have a national vision that will address a multitude of problems, including but not limited to healthcare.
o The people who disrupted the democratic process of Town Halls are a shrill minority. Yes, there were those who have legitimate concerns, but there are two things that abhor a vacuum--nature and communications. Something will always fill the vacuum, and in the Summer of 2009, it was, unfortunately a small, albeit loud and disruptive, number of people with a particular agenda aimed directly at usurping the results of the past three elections.

So, Mr. President, here is my suggestion. Speak plainly, not professorial. Tell people what you are going to tell them, tell them and then tell them what you have told them.

Take the playing field of the 2010 elections away from those GOP House and Senate members who are already envisioning their elevated roles in a new Congress by making it clear that you are willing to layout your proposals, that the Democrat Party stands ready (at least in large part) to stand with you and on behalf of the American people who need and deserve affordable healthcare.

Then, stake your position. Let it be known that your confidence in the correctness of what you and others are doing is such that you have full faith in the ability of a majority of the American people to do the right thing.

This will provide a voice for those of us whom have believed in your ability to provide the leadership to implement needed change. It will also reflect your confidence in the basic goodness of the American people. And, it will show that you realize that your ability to govern is based upon continuing to merit the trust and support of the country.

With all best wishes,
Daniel Hines

President should have known pharma was a snake when he picked it up

For the past three weeks, we have posted blogs wondering what the payback of the Obama Administration was to PhRMA in return for its 'support' of 'price cutting' for Medicare Part D Doughnut Hole prices, generating a claimed $80 billion savings.

We were among the first to suggest that the pattern of backroom dealing violated Candidate Obama's pledges of greater transparency and openness in government, and an end to the special relationship between industry groups and policy-makers. We noted with regret that the President had invited healthcare industry groups, including PhRMA, the trade association for the pharmaceutical industry, headed by Billy Tauzin, the former-Louisiana Congressman who not only engineered the restriction against price negotiation in Part D before resigning his elected post shortly afterward to accept a $2 million annual salary position as head of PhRMA. To some, including me, it appears that a case might be made that there could be a conflict between representing a Congressional district while leading a legislative effort that was going to reap billions of dollars in benefits for an industry that was soon going to offer you a $2 million salary. This was why we bemoaned the new found alliance of the Obama Administration with PhRMA.

We asked: What is the payback to the industry? It is an honored guest at The White House; it is praised by the President as he speaks to Seniors, praising pharma's largess in reducing their pain with the 'offer' to reduce the cost of medicines for those stuck in The Doughnut Hole; it negotiates with Senator Max Baucus, (D-MT), chair of the influential Senate Finance Committee (and the recipient of large contributions from the healthcare industry); it has the audacity to 'demand' that the White House 'clarify' its 'agreement' that the Administration will 'honor' its agreed-to commitment to not allow price negotiation--and it gets its way, as the White House quickly falls in line, even to the point of having Press Secretary Robert Gibbs flounder as he had to admit he really didn't know the details.

But then, in a complete flip-flop, the next day, a new stance emerges, largely due to opposition from House members such as Rep. Henry Waxman, chair of the influential House Energy and Commerce Committee, which included price negotiation in its markup of HR3200. Waxman put it bluntly--neither he nor the Committee were bound by the negotiations with the Administration or with Senator Baucus.

Apparently others had the same concerns at about the same time we started asking questions about the relationship of this Administration with the pharmaceutical industry. There is an increasing number of stories asking questions about details of the agreement.

This is a fortunate turn of events. During the campaign, Candidate Obama made two pledges regarding prescription medicines: (a) to lower prices for Medicare by removing the restriction on price negotiation and (b) to allow Americans to expand their freedom of choice by legislation that would allow personal importation of safe, affordable medicines from licensed, registered pharmacies in Tier One countries, those that have standards of safety and efficacy that meet or exceed those of the United States.

It is interesting to note that earlier this year--at about the time that the White House was starting its outreach with industry reps, including PhRMA, that seizures by the FDA of vital medicines from Tier One countries picked up. The question must be asked, was this another part of the deal being cut with PhRMA? It is well-known that in addition, the other monster under the bed for PhRMA is importation of medicines at affordable prices. Interestingly, these are the same medicines that the industry ships into this country at prices 60 to 70 percent higher.

After a concerted effort,including appeals directly to the President by publishers of leading websites for seniors, and news releases about the seizures, they declined.

The continued concern about seizures was the reason that we hailed the successful legislative maneuvering of Senator David Vitter (R-LA) for an amendment restricting such seizures, a stance that reaffirmed the banning of such seizures by Congress in 2006. Still, even the Senator has said that he is not confident that the Amendment will stick in conference, perhaps reflecting the feeling that many share that the reach of pharma is such that it can have its way.

And therein lies the moral of the dilemma that the President faces. Will legislation affecting the price and availability of vital medicines be conducted in the bright sunlight of openness and opportunity for total and equal participation by all? Or will we be subjected to the special interests of groups such as PhRMA?

If it should be the latter, we would like to remind our elected policy-makers of the old tale that so amply illustrates the consequences of bad decisions...the fable of the snake and the little girl:

A young girl was trudging along a mountain path, trying to reach her grandmother's house. It was bitter cold, and the wind cut like a knife. When she was within sight of her destination, she heard a rustle at her feet.

Looking down, she saw a snake. Before she could move, the snake spoke to her. He said, "I am about to die. It is too cold for me up here, and I am freezing. There is no food in these mountains, and I am starving. Please put me under your coat and take me with you."

"No," replied the girl. "I know your kind. You are a rattlesnake. If I pick you up, you will bite me, and your bite is poisonous.”

"No, no," said the snake. "If you help me, you will be my best friend. I will treat you differently."

The little girl sat down on a rock for a moment to rest and think things over. She looked at the beautiful markings on the snake and had to admit that it was the most beautiful snake she had ever seen.

Suddenly, she said, "I believe you. I will save you. All living things deserve to be treated with kindness."

The little girl reached over, put the snake gently under her coat and proceeded toward her grandmother's house.

Within a moment, she felt a sharp pain in her side. The snake had bitten her.

"How could you do this to me?" she cried. "You promised that you would not bite me, and I trusted you!"

"You knew what I was when you picked me up," hissed the snake as he slithered away.

The moral of the fable is that things are not always as the seem. PhRMA has not shed its skin. Americans pay the highest prices for prescription medicine in the world. The industry's predatory pricing has contributed to the costs that now are the biggest obstacle to necessary healthcare reform, and the 'savings' of the brokered arrangement carry a heavy price...we can only hope that it will not be a snakebite that creates a climate of an industry group dictating to the Administration and Congress, thereby throwing into question the need for and benefits of healthcare reform.