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:
This is whatPharma 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 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.