Pharma practices ‘disingenuous connectivity’ in attacks upon personal importation

 Pharma, and its trade group PhRMA, are employing a strategy that is best described as ‘disingenuous connectivity’ in its latest strategies against personal importation of prescription medicines.

The strategy-- attempting to remove itself as the focus of attacks upon personal importation of safe, affordable medicines, from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy for prescription medicines meet or exceed those of the US. 

Why does this constitute being disingeous?  Let's look at the Dictionary definition:

‘Witholding known information or giving a false impression of sincerity or simplicity’’. 

 This is what Pharma is doing in establishing relationships and connections with  erstwhile and commendable interest groups to persuade them to adopt the admirable goal of  prescription drug safety as a part of their mission, but one in which any imported medicines are by definition of being imported are, in and of themselves, ‘unsafe’.

 Some examples:  The Institute of Medicine,   a national Non-Governmental Organization designed to provide national advice on health and medical issues and to develop programs for  patient safety, have, in response to a request from the Food and Drug Administration  for a study on drug safety issued a statement calling for increased tracking and tracing of the worldwide pharmaceutical chain of custody.

 The IOM statement does base its appeal on recognition of the problems of admittedly bogus pharmacies and counterfeit medicines.  It is disturbing in other ways, however,  not the least of which is that  IOM has dropped the use of the word ‘counterfeit’ to describe fake medicines, choosing instead to restrict the term to encroachment of intellectual property rights, a Pharma goal in its failed PIPA and SOPA pushes. 

 Another  example:  In a recent article in the Journal of Nursing, the nurse community is urged to assist in counseling patients on drug safety, using standards that limit the application of a ‘safe pharmacy’ or source of personally imported medicines to only those in the US.

 The FDA is a major player in this effort.  Its new web site ‘identifying’  what it describes as ‘unsafe’ pharmacies uses the VIPPS program as a resource, an embrace that reflects the success  of the  National Boards of Pharmacy Verified Internet Pharmacy Practice Sites (VIPPS) program and opponents of personal importation to provide what might be a ‘gateway’ service designed to allow FDA and Pharma to claim, because there continues to be legislation empowering the FDA to contract selected services to privately sourced, third-party groups in the private sector to conduct safety oversight that normally would be a part of the FDA responsibility within the limits determined by Congress.

 As to prove the case, the Journal of Nursing refers nurses and patients to the FDA site and the VIPPS program as the ‘standards’ for safety.

  To imply that all medicines from licensed, registered pharmacies outside the US are unsafe does not stand in the light of facts. Many countries, especially those in Tier One Countries do have excellent standards of safety.  Add to this that virtually all prescription medicines sold in the US are manufactured at plants outside this country, meaning that even those medicines sold in NABP pharmacies, are likely imported into the US.

 The target of these programs is not prescription medicines that might be ordered from clearly identifiable bogus pharmacies on the Internet, but those safe sources from outside the US that provide as many as two million Americans access to safe, affordable prescription medicines that would otherwise be denied to them because of the predatory pricing practices of Pharma that have made the US a safe haven for the highest prescription drug prices in the industrialized world.

 No one disputes the need to ensure that Americans are made aware of the potential danger of bogus pharmacies, and providing Americans with the tools to identify such pharmacies. There are ample guidelines on identifying guidelines to ensure safety based on more than a decade of safe use of personally imported prescription medicines.

  For more than 12 years, seniors’ advocacy groups and others have made the case that access to safe, affordable medicines via personal importation is a matter of fact.

  Supporters of personal importation have published stories, guidelines, and have developed materials to help identify the validity of a pharmacy. The US Congress has repeatedly passed legislation in support of personal importation only to see it turned aside by ‘poison pill’ amendments brought forth by Congressional supporters of Pharma. 

 Even the FDA has taken actions that validate the claims of supporters of personal importation that the regulatory agencies of Tier One Countries meet or exceed those of the US and should therefore be the basis of approval for personally imported medicines, by moving to allow a form of reciprocity in the oversight and manufacture of ingredients for prescription medicines by regulatory agencies in countries outside the US.

 This leads to the simple question:  If reciprocity is ‘doable’ in the case of ingredient manufacture, why is it not able to be extended to personal importation? 

 The answer:  this just another example of the disingenuous strategies of Pharma and others.

 There are more:

 PhRMA has launched a series of efforts to attain goals that it was denied by the legislative process, including what is cited as patent and trademark protection but really was nothing more than attempting to co-opt legislation by shaping it in a manner that reflected its goals of deterring personal importation. 

 The examples below amplify the case that Pharma is indeed engaged in a full scale attack upon personal importation with no concern for the vital lifeline it provides to untold numbers of Americans, or the fiscal impact to citizens being denied access to affordable medicines:

·         The drafting of a bill by the Senate Health Committee and House Energy and Commerce Committee in October 2012, written by staff members, free of any input from stakeholders. The ‘draft’ established the framework for the empowering of the FDA to enter into third-party relationships with the private sector granting the authority mentioned in the paragraph above.  The 118-page draft was not even submitted for consideration.  The question must be asked: Why not?  Is it still in someone’s desk drawer waiting to be pulled out for introduction in the 113^th Congress, free of any opportunity for input from stakeholders? The language also focuses on ‘potentially’ unsafe medicines, a particularly troublesome term since there are no standards of what constitutes ‘potentially’ except for several mentions of ‘misbranded’ (read personally imported) medicines.

·         The FDA Reauthorization bill (PDUFA) calls for Rules Promulgation in the next two years.  Section 708 empowers the seizure of medicines dispensed by pharmacies in countries outside the US for Americans’ use by granting the power of seizure to Customs, Homeland Security, and Border Agents. Questions that must be asked and answered include but are not limited to:

o     When will FDA communicate the schedule on Rules Promulgation;

o    How will it ensure that all persons and groups desiring to make comments are notified?

o      The challenge:  the language as written gives authority for the Secretaries of HHS and Homeland Security to make seizures by Customs  and destroy them.  In a disturbing aside, Senator Bill Nelson (D-FL) , chair of the Senate Select Committee on Aging, and a supporter of personal importation, tells a senior advocate in Florida that he believes the action in 2007 when he and Senator David Vitter (R-LA) led legislation that ended FDA-Customs collusion resulting in seizures of personally imported medicines , is a precedent that will preclude such action now.  Unfortunately, he is incorrect.

·         FDA launches a website in an effort to ‘identify’ what it describes as ‘safe pharmacies’,  all within the US, again using the VIPPS model;

·         The Center for Safe Internet Pharmacies ‘launches’, a year after its founding.  The timing of the launch seems to be a part of a communications effort to attain a critical mass to determine the ‘message’ that the definition of safe pharmacies of safe pharmacies is applicable only to those in the US.  Again, the VIPPS model comes into play;

·         FDA issues a series of news releases, including statements from FDA Commission Margaret Hamburg, about the need for new initiatives in the chain of custody to guarantee the safety of the prescription medicine supply.  This comes only months after more than 60 people dying from unsafe medicines from a Massachusetts compounding pharmacy.

·         The problem with the counterfeit Avastin (bogus?) continues to be a mainstay of FDA releases.  The identification of potentially dangerous medicines is a commendable goal and important to protecting Americans, but there is no record of anyone becoming ill of dying from taking the Avastin.  The Federal government has commendably been diligent in its prosecution of offenders, many of whom are physicians.

·         The President of Eli Lily, angered by the refusal of Canadian authorities to approve a patent, suggests in a prepared statement that Lily is granted a degree of sovereignty equal to that of Canada due to the North American Free Trade Agreement, and , that companies such as Lily (and other Pharma companies?) have such a standing in not only NAFTA, but future trade agreements. What does this say about the sovereignty of a country like Canada...or even the US...and its authority to conduct its governmental functions?

·         PhRMA apparently has returned to the issue of controlling the Internet. But, apparently burned by its SOPA debacle, this time,  Pharma has the NABP acting on its behalf as it seeks a new domain designation for .pharmacy.  The .pharmacy designation would be specific for US-based pharmacies only, would disable Americans from having access to Internet pharmacies in other countries (including Canada), and would utilize, yes, the VIPPS list to determine approved pharmacies, in effect granting PhRMA the victory it was denied in the PIPA and SOPA battles.  Of interest, in its application for the .pharmacy designation, NABP declares that FDA, Pharma, other groups will conduct a vigorous communications and educational campaign on the significance of the new domain designation.  This is a move to encroach upon the freedom of the Internet and to attempt to utilize  .pharmacy for the special interests of NABP and Pharma.  It should receive the same vigorous opposition as the SOPA boycott.

Look for the pattern to hold true. The FDA is faced with budget cuts, plus Sequestration, Pharma is desperate to circumvent the openness of the legislative process with its demands for hearings, testimony, and, public statements from stake holders.  

 The goal is the silencing of seniors’ advocates and others who support the benefits that access to such a vital lifeline and savings from prescription medicines offered by personal importation. 

 

Pharma and its allies are opting for passage of administrative rules that the rules makers will adopt citing that they either has the power to make such decisions, and which it will attempt to validate through the passage of vaguely written ‘drafts’ crafted behind closed doors.

  It provides us with a new phrase to describe what we are witnessing:  disingenuous connectivity.  It is time for Congress to pull the plug.