Since the late 1990's, Internet Pharmacies have been providing drugs through the Internet to people around the world. The practice has been heavily scrutinized by regulatory authorities from many countries, but not to the same degree as those in the United States. As the vast majority of sales are likely coming from consumers in the U.S., the FDA and other Federal bodies have had increasing difficulty tracking where these drugs (many unapproved and therefore illegal under U.S. law) are coming from and to whom they are being sold.
While Canada and most European Union countries have price controls in place to make the cost of drugs affordable both for the individual consumer, and the governments that offer their citizens health plans, the U.S. has nothing of that kind. In fact, an article from Internetweek.com from November of 2004 showed that just under 40% of American seniors visited an Internet Website during a 12-week survey ending September 11, 2004.1 This suggests that those with the least earning power will be most in need of affordable medicine under the current U.S. healthcare system.
Though figures are difficult to determine due to the unorganized nature of the Internet, some people estimate that Internet Pharmacies have the potential to generate over $150,000,000,000 USD a year.2 Other sources, such as the firm Panagaea, estimate that Canadian Internet Pharmacies made an estimated $200,000,000 CDN in 2002, selling mostly to American customers, many of whom had no health plans.3 The popularity of these sites shows that they are not going away any time soon, and so the reality of a newly emerged industry must be dealt with. At the present time, however, authorities in the U.S. are not prepared to even begin to confront the mounting problems of illegal prescription drugs.
What seems to make an openly underground industry like this possible are the sometimes confusing loopholes of FDA law concerning the importing of small amounts of drugs into the U.S. The FDA allows what is called the Personal Importation Policy, which allows a person to bring a 90-day supply of any prescription drug into the U.S. if they are able to show that it was prescribed by a doctor.4
This has made the issue even cloudier, creating an environment in which the law, in the words of an October 2000 report from the United States General Accounting Office (hereafter referred to as the GAO), "has been inconsistently applied."5 At the time of the GAO report in October 2000, they estimated that there were at least 200 Internet Pharmacies operating in the U.S. alone. At that point, Americans were already spending an estimated $160 million USD on prescription drugs.6 Of course, that number has risen as the Internet has become an even more familiar part of our lives.
This paper will argue that Internet Pharmacies are essentially a good thing, though, as demonstrated in the U.S. at present, they are not being properly monitored, managed or regulated. It is important to recognize that, regardless of the one's opinion of Internet Pharmacies, they are as uncontrollable as any other aspect of the Internet, and will remain so until technology and laws to censor illegal online action catches up with the technology to hide behind illegal sites, or sites that promote illegal activity. As every Government report used in this paper says, it is very difficult to find reliable information about rogue Internet Pharmacies unless they provide the information on the website itself, making it difficult to prevent consumers from being hurt by them. Obviously, a company that does not want its actions easily reviewed by legal authorities will not provide that information.
The main documents used in this paper are the following:
From the GAO -
From The Library of Congress Congressional Research Service (hereafter referred to as CRS) -
As well, I will draw on newspaper and industry magazine articles.
The dangers of ordering drugs through the Internet as opposed to going to a local drugstore are vast. While the person going to a local pharmacy needs to do very little work and generally trusts that the pharmacist is distributing reliable drugs, ordering drugs from an Internet Pharmacy requires extra vigilance on the part of the consumer. This means that extra work must be done to educate the customer as to what things they should look out for when ordering from an Internet Pharmacy. This is not an easily introduced idea, especially after decades of simply trusting a pharmacist to correctly dispense the appropriate drug. Reports have shown that, time and time again, many Internet Pharmacies do not take care to deliver their product in a safe manner. As changes in light, heat and moisture can affect the strength of a drug, sometimes rendering it useless, packaging for delivery must be appropriate. The manner in which the drug is shipped to the distributor must also be taken into consideration. Extreme heat or cold en route to a distribution centre can also affect the drug. Drugs can be very fragile, but unless the consumer takes this into consideration, they could be ordering a dangerous or useless product and then expecting results that could prove fatal, depending on what the specific drug they require is to be used for.
When the GAO decided to conduct an experiment by ordering a large shipment of drugs from various Internet Pharmacies around the world, the results were concerning. After ordering more than 70 different drugs from various on-line companies in 12 different countries, they received only 68 of the items they paid for, raising the obvious issue of lost money to the consumer. Frighteningly, many of the drugs they received were obtained without the use of a prescription from a doctor. They were simply asked to fill out a questionnaire or, in some cases, simply pay for the item in order to have the prescription product approved for their use.
The drugs they targeted were among the most popular on the internet: OxyContin, Viagra, Lipitor, Accutane, Celebrex, etc. Many of the drugs they targeted were able to be purchased without a doctor's involvement. In 5 of the U.S. and all 18 of the Canadian sites the GAO targeted, a prescription was required from the patient, which then had to be verified by a doctor working for the pharmacy.
In the remaining 24 U.S. sites, and all of the non-North-American sites, a questionnaire was sometimes required, but not always. Some sites said that a licensed physician would review the questionnaire and issue a prescription. However, some companies still allowed a 30-day supply to be sent to the consumer without a prescription, ostensibly, so that the customer could have immediate relief while the physician has time to adequately review the prescription. It seems doubtful that a physician always reviewed the questionnaires, given the packaging condition of some of the samples the GAO received in its investigation.
The issue of packaging the product and sending it through the mail may likely become the greatest issue in the debate as to the benefits of Internet Pharmacies. The GAO found many discrepancies in the packaging and labelling practices of foreign pharmacies. In some cases this meant that both labelling and inserts were not approved by the FDA. This was a major issue for some of the Canadian drugs they obtained, basically rendering the drugs illegal for sale in the U.S.
Yet, the more egregious issues came in the form of packages from foreign Internet Pharmacies that seemed to be trying to disguise the item they were sending. In one case, a plastic bag of OxyContin was sent in a CD case that had been taped up to hide its contents. In another, a bottle of Crixivan (an AIDS treatment) was sent inside a sealed metal can, placed inside a box reading `Gold Dye & Stain Remover.' It seems fairly obvious that the senders were trying to slip the items past authorities, which the GAO proved they did by receiving the items unopened.
It is in cases like these that most lawmakers see the problem with Internet Pharmacies. There are packages being sent illegally through the mail everyday, and though the FDA's job is to monitor and punish these kinds of actions, there are many impediments that stand between them and a successful program of convictions for offenders. The issues for the FDA don't just come in the form of the invisibility of the world of the internet, although, it is definitely one of the biggest ones.
Most of the reports used for this paper noted that many of the businesses they tried to contact in the U.S. and in other foreign countries, except Canada, were virtually impossible to contact. Making the company available to the customer is a very important requirement of both Canadian and U.S. drug regulations. In some cases, they had reason to suspect that the pharmacy was actually operating out of a private residence, which clearly does not meet GMP (Good Manufacturing Practice) guidelines, and casts serious doubt as to the quality of the drugs being distributed. Yet, if the consumer is ignorant about these issues and their importance, then they are unlikely to care where the drugs come from and will continue to use them.
The dangers are obvious, then. It is easy to obtain powerful and addictive drugs through the Internet, and they are being sent in packaging that is equally dangerous and illegal. Yet, what can authorities do except redirect millions of dollars of resources to the tracking down of these kinds of crimes? This is not likely to happen until the issue itself becomes so grave that the public outcry demands action. At present, the public outcry is instead demanding a loosening of the rules, as was seen in many debates and news stories during the last Presidential election in the U.S. A loosening of the rules is more likely to let in as much a flood of illegal drugs as it is to make life easier on those with less money and no health plans to find cheap relief. This places governmental authorities in a difficult situation.
One of the more difficult issues in the cross-border sales of drugs are the laws surrounding what can and cannot be done in the importation of foreign drugs. This lies at the centre of the many problems inherent to the Internet Pharmacy issue.
The first problem is that Internet Pharmacies operate from a central location, but sell directly to various states across the U.S. This makes convicting a particular pharmacy difficult since each state makes its own laws and governs its own pharmacy practices. What might be legal in one state may not be legal in another. Individual states must decide how, and on what basis, to convict a company. Though the FDA has federal rights to convict Internet Pharmacies that would supersede the individual states' rights (in some instances), they often do not bother, as it takes away from the already stretched resources within the bureau itself. Instead, they must determine who is the biggest fish to catch and let the rest off the hook.
This fractured system of government creates a perfect world for Internet Pharmacies to thrive in. For a single pharmacy to be shut down completely, it would require all 50 states in the U.S. to file suit against the company and then win. The time alone it would take to carry this through to completion would almost make the final outcome useless, beyond sending a message to other illegal pharmacies. But, as there are always limited resources for issues that are not at the top of the public's list of concerns, nothing can really be done on the level of the individual companies. (Unfortunately, all 5 reports used in this paper implied this over and over again.) Internet Pharmacies that do not comply with the law are generally free to go about their business without interference from the law.
Added to the confusion of this kind is the practice of stopping these drugs at borders and ports of entry. When a drug is sent through the mail to a customer in the U.S., it is not the FDA's job to find and detain the packages though they have jurisdiction over them. This job is left up to U.S. Customs and Border Patrol, and it is only a part of their job, not the main focus.7 They will detain a package they think is suspicious and then do what ever the FDA says they should do with it after consultation. Given the massive influx of packages like these for private citizens, and especially with small packages, the FDA will often allow them to ignore the laws and let the package through, citing the Personal Importation Policy.
Situations like this make the case against importing drugs from foreign Internet Pharmacies difficult to argue against. If the ones appointed to regulate the practice of drug importation will look the other way, why should it not be legal? Though the health risks are high, the present situation is not unlike the days of Prohibition, when authorities looked the other way because of what they thought was a pointless and ultimately uncontrollable law.
Though there have been convictions and federal suits against some pharmacies, such as in the Norfolk Men's Clinic case in February 20028, and others, these are but a mere handful of the possible convictions that could be laid if the FDA were to focus entirely on this aspect of their work. It leaves a large gap for other pharmaceutical companies to fill with illegal prescription drugs. One of the possible suits the FDA has been considering persuing is actually against the local governments of states like Wisconsin and Illinois and Vermont, all of whom have opted to import Canadian drugs for use in their municipal health plans for city and state employees. The states see the option of importing cheaper drugs as an easy way to save tax-payer dollars, but the FDA maintains that it is illegal and unsafe. For instance, the city of Springfield, Massachusetts claims to have saved $750,000 USD (as of January 2004) since the inception of its program to import Canadian drugs in the summer of 2003.9 While the FDA has no solid plans to move forward with legal action against these states and cities, they say they are not ruling it out yet.10
Ironically, while the FDA is busy considering filing suit against local governments, large companies like Pfizer, GlaxoSmithKline and others have been investigated to see if they are guilty of breaking anti-trust laws and colluding to increase profits by not selling to foreign Internet Pharmacies that are able to buy their products at lower prices due to price controls in their respective countries.11 Of course, Canada is one of the main countries housing these sites. The problem here is that drugs manufactured in the U.S., and then sent through normal distribution lines to affiliate companies in Canada, are finding their way back into the U.S. This circumvents the buying of the more expensive version of the very same drug by U.S. citizens. Instead of paying higher prices for a drug at your local pharmacy, you are able to buy the very same thing over the internet for much less. The only difference is that the batch of the drug purchased through the internet was probably designated to be used in Canada. This obviously takes profits out of the hands of big pharma companies, who will understandably do whatever is in their power to prevent it.
So, while FDA is too busy to go after the Internet Companies selling products illegally and re-introducing products back into the U.S., the companies who are trying to stop that practice at its roots are being investigated for collusion and anti-trust. This state of affairs seems to be a grasping at straws, with no real solution to actually stop the real problem of rogue Internet Pharmacies. Inevitably, the Internet Pharmacies win by not being investigated. In many ways, it seems like they are able to carry on with their business while the authorities run around them in circles.
This does nothing to help the reputation of the reliable Internet Pharmacies that have arisen despite negative press. The National Association of Boards of Pharmacy formed the group Verified Internet Pharmacy Practice Sites (VIPPS), an easy service that any Internet Pharmacy can join to prove they are reliable to customers. VIPPS will verify their practices, inspect their business site and allow them to associate themselves with VIPPS on the Internet and in advertising. This is much like an ISO rating for a manufacturer, allowing the consumer to know that the site is deemed reliable by an outside, educated source.
Groups like VIPPS are a step in the right direction, but they are only the beginning of real on-line regulation of Internet Pharmacies. VIPPS has no authority other than to act as a reliable witness of what a company's practices are like. There must be a federal regulatory board to truly manage the volume and variety of drugs being sent to customers in the U.S. At present, there is very little that can be done other than to make symbolic arrests from time to time, until legislation is changed.
For the current situation, only a federal law that took power away from states would truly work to weed out dangerous internet pharmacies, at least in the U.S. This seems very unlikely to happen, as it is the opposite of basic American law-making philosophy. Beyond the borders of the U.S., regulators must simply rely on goodwill and attractive foreign affairs to stop pharmacies that target the U.S. as their main source of revenue for illegal prescriptions drugs.
Ultimately, Internet Pharmacies are a good thing. Though I have argued using the various reasons why they presently do not work, I think the companies represent a right that should not be taken away from consumers who need them. There are many people in the U.S. who rely on Internet Pharmacies from Canada to provide them with the only resource they can afford to assist them in getting well. Though large pharmaceutical companies have made some efforts to provide free medication to desperate cases, it is the less desperate cases that are more likely to be found in greater numbers and without health plans. They are not quite sick enough to be hospitalized, but just sick enough for their quality of life to be so poor that they will eventually die painfully. For these people, the chance to pay much less for something they need immediately should not be taken away. However, it will do them no service to provide dangerous, rather than helpful, alternatives to expensive drugs. True legislation needs to be created before authorities can offer them this kind of help.
One step in the right direction has been the passage of the Medicare Prescription Drug, Improvement, and Modernization Act in 2003, which allows the FDA to accept larger imports of foreign drugs into the U.S. as long as they meet certain stipulations.12 Unfortunately, this law seems to be somewhat weak, having little ability to control the influx of illegal drugs. The situation as of the GAO's report in October 2004 shows a basically unchanged situation. Nonetheless, it is a movement towards the kind of legislation that will ultimately bring change to the industry.
At present there seems to be no real answer to what is essentially a free-for-all industry that is making as many legitimate businesses rich as illegitimate businesses. This situation will only serve to create more problems than solutions unless the issue is dealt with soon. Yet, without a shift in FDA policy and focus, which is highly unlikely to happen, the Internet Pharmacy industry will only continue to do as it sees fit. With profits that continue to rise as the Internet become more ingrained in the collective culture of the planet, and more people begin to have access to the Internet, the increase in both buyers and sellers of prescription drugs will eventually mushroom. If there are no checks and balances in place to stop criminal activity, it will flourish. This shows that solutions need to be found sooner rather than later to protect those who need the drugs and those who seek to abuse them. Ultimately the best prescription for users of Internet Pharmacies right now is "Buyer Beware."
1. U.S. Seniors Seek Out Foreign Internet Pharmacies. http://www.internetweek.com/e-business/showArticle.jhtml?articleID=49900992.
2. Worldwide Drug Sales Estimated To Cross $270 Billion By 2003. http://www.bccresearch.com/editors/RC-181R.html.
3. Quoted from NOC Magazine, Spring 2004 issue. Export of Prescription Drugs to the US. pg. 8.
4. CRS Report for Congress. Prescription Drug Importation and Internet Sales: A Legal Overview. January 2004. RL32191. Pg. 7.
5. GAO Heinrich, Janet. Report to Congressional Requesters. Internet Pharmacies: Adding Disclosure Requirements Would Aid State and Federal Oversight. October 2000; GAO-01-69. Pg. 21.
6. GAO Heinrich, Janet. Report to Congressional Requesters. Internet Pharmacies: Adding Disclosure Requirements Would Aid State and Federal Oversight. October 2000; GAO-01-69. Page 3.
7. CRS Report for Congress. Prescription Drug Importation and Internet Sales: A Legal Overview. January 2004. RL32191. Pg. 7.
8. Statement Of William K. Hubbard Associate Commissioner For Policy, Planning, And Legislation Before The Committee On Government Reform U.S. House Of Representatives March 27, 2003. Http://Www.Fda.Gov/Ola/2003/Pharmsales0327.Html.
9. CRS Report for Congress. Prescription Drug Importation and Internet Sales: A Legal Overview. January 2004. RL32191. Pg. 10.
10. CRS Report for Congress. Prescription Drug Importation and Internet Sales: A Legal Overview. January 2004. RL32191. Pg. 11.
11. CRS Report for Congress. Prescription Drug Importation and Internet Sales: A Legal Overview. January 2004. RL32191. Pg. 14.
12. CRS Report for Congress. Prescription Drug Importation and Internet Sales: A Legal Overview. January 2004. RL32191. Pg. 5.