While Pharma and its allies have vast funding, there is still an opportunity for the average American to make his or her voice heard, and to pull the props out from the Pharma Stool. RxRights.org has mounted a vigorous citizen-based campaign by which citizens who know the benefits of personal importation can easily utilize state-of-the-art communications with their Senators or Representatives to make the case for Americans to not being denied continued access to safe, affordable medicines.
ans’ access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries outside the U.S.—countries whose standards of safety and efficacy meet or exceed those of the U.S.—as a part of a strategy to ensure that citizens of ‘The United States of Pharma’ continued to pay the highest prices in the world for their medicines.
At that time, we paid special heed to a radical departure by Pharma from the traditional method of encouraging that FDA and Customs, acting in collusion, to deny access to vital medicines by seizures of prescription drugs from pharmacies outside the U.S. that they claimed were ‘illegal’ even though they were the very same medicines sold in the U.S. at prices of as much as 60 percent more.
Having had such strategy rejected by the U.S. Congress, which denied the use of governmental funding for such seizures, Pharma’s new technique was to co-opt legitimate legislation ostensibly designed for purposes not related to the goals of Pharma, but to address other concerns—specifically, the protection of intellectual property rights of U.S. individuals and companies by deterring the excessive counterfeiting made possible by their promulgation of sites specializing in infringement activities with bogus goods.
The first two ‘legs’ of the ‘legislative stool’ were the Protect IP Act (formerly Hatch-Leahy) and the Stop Online Piracy Act (SOPA), both of which we vigorously opposed with letters to Senate and House Judiciary Committee members and selected health care staff to point out how the law of unintended consequences—namely, the perverse effect of endangering the health and well-being of millions of Americans who could be denied access to vital medicines—would override any beneficial effects of the bills, solely because of the Pharma-influence.
The co-opt process was launched by a number of Pharma front groups that built upon the fact that there are admittedly ‘bogus’ pharmacies in many countries that produce unsafe, knock-off medicines and are able to utilize the Internet to attempt to deceive Americans, ironically because the predatory pricing practices of Pharma have made them so expensive as to be beyond the reach of untold numbers of Americans.
Now, in what can only be described as the ‘third leg’ of the ‘legislative stool’ policy of the Pharmaceutical Industry (Pharma) to attempt to co-opt the legislative process to its own ends, Senators Feinstein (D-CA), Schumer (D-NY), Sessions (R-AL) and Cornyn (R-TX) have introduced a proposal that they claim will help ‘protect’ Americans against being duped by bogus pharmacies doing business on the Internet.
The misnamed bill, ‘The Online Pharmacy Safety Act’, is actually nothing more than an attempt by which the U.S. government incorporates into Health and Human Services (HHS) programs a number of groups that have received funding over the years from Pharma in the industry’s efforts to deny millions of Americans access to safe, affordable prescription brand-name medicines from licensed, registered pharmacies outside the U.S.
The bill is misleading in both its title and the Pharma boilerplate language. It would be better named, ‘The U.S. Internet Pharmacy Act,’ and its attempts to ‘criminalize’ any and all pharmacies not verified by the new directory that the legislation would establish.
The new ‘directory’ is actually nothing more than the VIPPS verification service already promulgated by Pharma and the National Association of Boards of Pharmacy. Of course, no pharmacies from outside the U.S. would be allowed to be ‘registered’, which gives clue to the real reason for the legislation—to attempt to present U.S. Internet and mail-order pharmacies as the only source of safe prescription medicines via the Internet even though for more than a decade millions of Americans have purchased safe, affordable medicines from licensed, reputable pharmacies in other countries. Also, there is no requirement that all—or even any—U.S.-based Internet Pharmacy seek to be included in the registry.
Ironically, the Canadian International Pharmacy Association already has a ‘verification’ list of members, all approved by their provincial licensing authority, but none of those sites would be eligible for inclusion in the HHS site. Also, reputable sources for pharmacy services have established their own standards, including rigorous inspection of the licensed pharmacies that service millions of Americans.
But the goal of the legislation is to cast doubts about the safety and efficacy of those operations by ‘criminalizing’ them.
An example of the ‘boilerplate’ attempt to create an impression that by not being in the directory, those pharmacies are ‘criminal’ is to highlight the real problem of ‘bogus’ pharmacies, and to indicate that any source of personal medications from outside of the U.S. is, in and of itself ‘criminal’ because they are outside the U.S. Consider these excerpts from the proposed legislation (in the interest of space, I have used only segments pertaining to ‘criminality’ and the threat to health and life of the bill’s language. I have highlighted portions to illustrate how contrived and disingenuous is the attempt to ensnare all Internet pharmacies from outside the U.S. ). The bill’s rationalization follows, accompanied by my comments in bold face.
Bill Language: (2) illegal online drug sellers offer products that do not meet the safety standards established by United States laws, and recent reports from the National Association of Boards of Pharmacy show that 92 to 95 percent of Internet websites offering to sell prescription medications online are illegitimate and operate in clear violation of United States laws enacted to protect patients; …
(4) the World Health Organization estimates that 50 percent of the prescription medicines sold online by Internet websites that hide their physical address are counterfeit… research by The Partnership at Drugfree.org found that 1 in 6 consumers in the United States, a total of about 36,000,000 Americans, has bought or currently buys prescription medication online without a valid prescription…
While the FDA has said personally importing prescription medicine is ‘illegal’, for years, the it has ‘allowed’ Americans to cross into Canada to purchase prescription medicines for their personal use in the U.S. To deny Americans who do not have proximity to the Canadian border the right to make similar purchases via the Internet from those same pharmacies or sources denies them the right of equal protection in the exercise of their right to make personal decisions regarding their health that are available to one group of U.S. citizens but not to them, merely because they lack proximity to the Canadian border. Also, while the FDA says that personal importation is not allowed, its own policies note:
"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country/area."
The Facts: Simply put, the medicine that is unaffordable is unavailable
More Bill Language: (6) the prevalence of illegal online drug sellers, and their sale of counterfeit or otherwise illegitimate
medicines, is a growing public health threat…
(7) people have been seriously injured or killed by products sold by illegal online drug sellers…
(8) the accessibility of controlled substances and other drugs without a valid prescription by
illegal online drug sellers contributes to a growing prescription drug abuse problem in the United States that is endangering teenagers and public health…
(9) the anonymous and unregulated nature of the Internet contributes to the counterfeit drug trade and enables counterfeit medicines to reach United States consumers through illegitimate online drug sellers posing as legitimate pharmacies;
(10) counterfeit drugs that are sold through illegal online drug sellers are manufactured by criminals who deliberately and fraudulently misrepresent the product in order to trick consumers into thinking they are purchasing a legitimate and safe medicine…
The Facts: As to Americans being seriously injured, in response to an inquiry about Canadian pharmacies and other legitimate pharmacies, “The FDA's Director of Pharmacy Affairs, Tom McGinnis, says, "I can't think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these.” And, As then-Governor Tim Pawlenty said in his famous response to claims by Pharma of the lack of safety and efficacy of those medicines : “Show me the dead Canadians”.
The facts about the benefits of personal importation are self-evident. We see them in the improved health and well-being of friends and neighbors. We see them in the savings afforded to individuals and groups for whom personal importation is the only (and best) alternative to either paying the highest drug prices in the world with is dire personal fiscal consequences, or depriving themselves of vital medicines with its drastic health consequences of being denied the health benefits of access to a regimen of safe, affordable and necessary medicines. The legislative initiative of Pharma threatens all of these.