There are potentially tens of thousands of dangerous pharmacy websites, sometimes referred to as “rogue online pharmacies,” polluting the Internet and endangering the health of consumers worldwide. There are a much smaller group of safe domestic online pharmacies. Then there are an even smaller group of safe international online pharmacies, ones that we have verified, that sell many medications at much lower cost. However, when Americans purchase from these international online pharmacies (often because they can’t afford medication domestically) and import safe and effective medications, they are under most circumstances violating U.S. laws, which poses a quandary for regulators, public health officials, and even some people working over at Big Pharma. What’s right and wrong? How do we get rid of the rogues without overreaching and endangering public health by stopping Americans from obtaining safe medication internationally over the Internet?

In our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health…

How to Shut Down Dangerous Rogue Online Pharmacies without Curtailing Online Access to Safe and Affordable Medication

Targeted and effective government enforcement, and private voluntary actions against rogue online pharmacies, need not interfere with the safe provision of low-cost medications from international online pharmacies. National and international actions conducted via annual campaigns entitled ‘Operation Pangea’ have successfully shut down and blocked thousands of rogue online pharmacies without shutting down safe international online pharmacies.[1] In Pangea, FDA cooperates with Interpol and other criminal enforcement agencies by alerting Internet service providers, domain registrars, and other online gatekeepers (see discussion below on gatekeepers) about suspect websites. The agencies also conduct enhanced surveillance at international mail facilities, where prescription orders are seized, as well as initiate the seizure and take downs of rogue online pharmacies through court orders.

The most thorough and legalistic takedown actions against rogue online pharmacies are by order of a court of competent jurisdiction. Such court orders are obtained and used by FDA’s Office of Criminal Investigations. In Pangea VI, the FDA, in its public relations, focused on the takedowns of three rogue online pharmacies that were clearly fraudulent in pretending to be websites operated by popular U.S. chain pharmacies.

U.S. consumers attempting to go to the following three websites will view a screen that notifies them about the court order and seizure: http://www.canadianhealthandcaremall.com/, http://www.walgreens-store.com, http://www.c-v-s-pharmacy.com.

Creating a rational but expedited system for obtaining court orders to shut down rogue online pharmacies will provide a pathway that respects due process of law, Internet freedom principles, and access to affordable medicine.

As a federal contractor, LegitScript can (and may currently) serve a valuable investigative role for the FDA in its efforts to identify and monitor rogue online pharmacies and their activities, particularly because its classification system does not conflate safe international online pharmacies with rogue online pharmacies.

Prioritize Online Pharmacy Enforcement Targets: Properly Defining “Rogue Online Pharmacy”

As explained above, the GAO report’s use of the phrase “rogue Internet pharmacy” is at times inaccurate and wrongly identifies safe international online pharmacies as “rogue.” Additionally, the GAO report inaccurately communicates that “The Food and Drug Administration Safety and Innovation Act enacted in 2012 required that we report on problems posed by ‘rogue’ Internet pharmacies.” There is no mention of the word “rogue” or the term “rogue Internet pharmacy” in FDASIA. The GAO report included the positions of, and research conducted by, the NABP and LegitScript, but misrepresents or misunderstands critical distinctions in how they classify online pharmacies. GAO’s stakeholders, NABP and LegitScript, have conflicting classification systems when it comes to defining “rogue online pharmacies.” For lawmakers and regulators to prioritize and identify the right targets for enforcement actions to protect the public health it is critical to properly define this phrase, as it’s so commonly misapplied.

NABP’s classification system does not accurately describe the scope of online drug sales because it groups safe international online pharmacies together with dangerous ones in a category called “rogue.” As discussed above, the NABP designates any online pharmacy that is based outside the U.S. and sells to Americans as “rogue,” regardless of its safety credentials. This misleading classification blurs the clearly distinguishable lines between dangerous rogue pharmacy practices and safe international online pharmacy services.

In contrast, LegitScript does distinguish between safe international online pharmacies and rogue online pharmacies. Like the NABP, LegitScript’s program does not “approve” international online pharmacies that sell to consumers in the U.S., regardless of their credentials. However, safe international online pharmacies are not classified as “rogue” by LegitScript.com. Instead, safe international online pharmacies, such as those approved by PharmacyChecker.com, are generally categorized as “unapproved.” While the “unapproved” designation may scare consumers who are seeking safe and affordable medication away from a safe online pharmacy, it does distinguish safe international online pharmacies from “rogue online pharmacies.”

The GAO’s report inaccurately describes LegitScript’s classification terms, which may cause its readers to miss these critical distinctions. GAO writes that LegitScript classifies Internet pharmacies into one of four categories: “(1) legitimate, (2) not recommended, (3) rogue, (4) pending.” LegitScript does not have a category called “not recommended,” which is a category used by the NABP to mean “rogue.” In fact LegitScript is explicit that “unapproved” online pharmacies are not rogue:

“Unapproved” Internet pharmacies are those for which LegitScript has verified some lack of compliance with LegitScript’s international Internet pharmacy verification standards or applicable laws or regulations but that do not meet the definition of being ‘rogue.’ [2]

Further, a “lack of compliance” may have nothing to do with safety but could refer to technical violations of drug importation laws (i.e. personal drug importation from licensed pharmacies that require valid prescriptions). Under this classification system, a Canadian online pharmacy could meet the highest safety standards, and be safer than a U.S. pharmacy, and still be “unapproved” if it dispenses to consumers in the U.S.

The examples of rogue online pharmacies found in the GAO report explicitly demonstrate its failure to distinguish between safe and dangerous online pharmacies. In Figure 3, page 28, the GAO report shows a picture of the home page of an online pharmacy called CanadaDrugs.com. The GAO report reads: “Figure 3: Screenshot of a Rogue Internet Pharmacy Website That Received a Warning Letter from FDA in 2012 as Part of Operation Pangea”. Unlike a rogue online pharmacy, CanadaDrugs.com meets very high standards of pharmacy practice and is approved in the PharmacyChecker.com Verification Program, a member of the Canadian International Pharmacy Association, two of the credentialing agencies cited by experts for using quality standards.[3] LegitScipt classifies CanadaDrugs.com as “unapproved” not “rogue”.[4]

CanadaDrugs.com has operated a pharmacy in Canada selling medications internationally for almost 15 years. It is licensed by the Manitoba Pharmaceutical Association as an International Prescription Service.[5] CanadaDrugs.com has sold safe and effective medications to millions of consumers without any reported problems. It did not receive a warning letter from the FDA because it is a “rogue” site, but because the FDA decided to use its enforcement authority to cite CanadaDrugs.com for selling certain foreign, but legal and genuine, versions of medications to individuals in the U.S. that are considered unapproved and/or misbranded when personally imported.[6] FDA could have sent a similar warning letter to any safe online pharmacy based outside the U.S. that sells prescription medication into the U.S. The letter also warned CanadaDrugs.com that it was selling Domperidone, which is no longer approved in the U.S., but is approved in many other countries. CanadaDrugs.com removed that medication from its website.

It is likely that CanadaDrugs.com was wrongly labeled a “rogue” in the GAO report because its owner is a target of an FDA investigation over his alleged involvement — through other companies he operated – in the wholesale importation of counterfeit Avastin that was given to patients in U.S. medical clinics.[7] Avastin was not sold by the website CanadaDrugs.com. Imported and domestically sold counterfeit medications are a serious threat to the public health, especially counterfeits of life-saving products. FDA resources are rightly and efficiently expended on criminal investigations to protect the U.S. drug supply from counterfeit drugs. However, the existence of wholesale businesses responsible for distributing the counterfeit Avastin does not mean that CanadaDrugs.com is not a safe international online pharmacy. Christopher Weaver of the Wall Street Journal wrote, “There is no indication that fake medicines were sold through the company’s consumer-focused website, CanadaDrugs.com.”

The GAO report provides examples of two other sites, which appear to be actual “rogue” online pharmacies. AllMedsPharmacy.net advertised the sale of prescription drugs without a prescription. According to the FDA, the site was found selling counterfeit and misbranded drugs, as well as controlled substances to Americans. Interestingly, the site is still operating and appears to have revised its policies to require a prescription.

The other “rogue” online pharmacy identified in the GAO report is called NewPharm.net. Its operators plead guilty to smuggling counterfeit and misbranded drugs into the U.S., including selling controlled substances, specifically Meridia, without a valid prescription. Unlike AllMedsPharmacy.net, NewPharm.net ostensibly required a prescription but it was one based on a “free doctor consultation” offered by the online pharmacy itself. In the investigation, federal agents purchased prescription medications without a valid prescription; the products often came from China or India, and the sellers intentionally hid the ingredients of the packaging. The GAO report noted, “Laboratory results of drug samples purchased by federal agents revealed that the drugs were not genuine versions of the approved drugs that they purported to be.”It’s difficult to discern exactly what this means in terms of drug quality and safety but it indicates that the website’s operators were committing fraud by fooling consumers into thinking they were buying a certain brand product when they were not. (The actual product may have been a genuine generic version from another country).

A cursory evaluation of CanadaDrugs.com by GAO should have led its authors to conclude that it was fundamentally different from the other two sites mentioned, due to its verifiable licensure, long history of pharmacy safety, and transparency. Indeed, CanadaDrugs.com could be used as a good example of why millions of Americans have benefited for many years from lower cost medications from other countries.

A proper and practical definition of “rogue online pharmacy” is a drug-selling website that intentionally sells fake, adulterated, or unlicensed medication; genuine and regulated medication that is not dispensed by a licensed pharmacist and/or pursuant to a valid prescription; or engages in fraud. That definition focuses on the combined factors of public health protection, domestic legal compliance (where the products is dispensed from), and access to affordable medication. Under that definition, an online pharmacy is not a rogue if it meets all the criteria below:

• Requires a valid prescription
• Publishes verifiable and truthful contact information
• Fills orders through licensed pharmacies
• Sells regulated medications, produced under GMP
• Dispenses prescription orders via licensed pharmacists
• Takes reasonable measures to protect personal and financial information

In contrast, a “rogue online pharmacy” does one or more of the following:

• Doesn’t require a prescription
• Doesn’t publish verifiable or truthful contact information
• Doesn’t fill orders through licensed pharmacies
• Doesn’t sell regulated medications (this would encompass counterfeit drugs)
• Dispenses prescription orders via unqualified personnel
• Doesn’t protect personal and financial information

Using the definition and guidance above, lawmakers and regulators have a clear roadmap to identify those online pharmacies operating domestically and abroad that endanger the public health and those that do not.

The Online Gatekeepers

Search engines, domain registrars, credit card companies and payment processors have the ability to shut down or more significantly curtail access to dangerous rogue online pharmacies (or any company operating online) by prohibiting service to them. They are sometimes referred to as “Gatekeepers.” Cooperation among such companies through CSIP, and in collaboration with government agencies, already curtails access to rogue online pharmacies by preventing them from advertising on search engines, suspending domain registrations by registrars, and preventing their use of merchant accounts so they can’t offer customers credit card processing.[8] Unfortunately, such actions have already overreached to affect safe international online pharmacies. Safe international online pharmacies are banned from advertising on major search engines, as noted in the Google case, are having difficulty finding credit card processing due to new online pharmacy restrictions by VISA, and some have had their domains actually locked by registrars.[9]

Search Engines

In February of 2010, Google banned non-U.S. pharmacies, including safe international online pharmacies, from advertising on its U.S. search marketing programs; began requiring NABP-approval to be a pharmacy advertiser; and, just prior to its policy changes, implemented new technical solutions for blocking rogue online pharmacies.[10] Until that time, Google’s policies allowed safe international online pharmacies approved by PharmacyChecker.com to advertise, but did too little to effectively block advertising by rogue online pharmacies, domestic or foreign, that were not approved by PharmacyChecker.com. Google’s ban on international online pharmacy advertisers “includes foreign sites selling safe drugs to patients with valid prescriptions.” The best policy for public health is to maintain the strict block on rogue online pharmacies but remove the ban against safe international online pharmacies.

Some pharmaceutical companies are now calling for the removal of all non-U.S. online pharmacies from organic search results, arguing that banning online ads is not enough.[11] Eli Lilly is pushing for a policy of “delisting,” a process whereby search engines such as Google and Bing would remove any non-U.S. online pharmacy from their search results viewed in the U.S. Google attests that it will not censor its listings in this extreme manner except under court order. On its blog Google states: “It’s not Google’s place to determine what content should be censored – that responsibility belongs with the courts and the lawmakers.”[12] Despite its claims, Google does build into its search algorithm a demotion signal targeting websites for which it has received a large number of Digital Millennium Communications Act (DMCA) take down requests[13] and it may do so for other such requests as well.

Domain Registrars

For a website to operate it needs to work with a domain name registration service, such as those offered by GoDaddy, Register.com or EasyDNS. Putting pressure on registrars to disallow service to rogue online pharmacies is another method of pushing them out of business. LegitScript has used this mechanism to help shut down many rogue pharmacy sites.[14] Often, however, a rogue online pharmacy will just move to another registrar. To prevent that from happening registrars have the ability to “lock” domain names (“DNS locking”) to actually prevent a website from moving to a different registrar, thereby putting that particular websites out of business.

In cases where pharmacy-related websites are clearly dangerous, DNS locking should be pursued. However, measured policies should prevent such aggressive enforcement without a court order in the case of safe international online pharmacies or those deemed “unapproved” by LegitScript but not “rogue.” This enforcement discretion is justified for public health reasons, but also because private sector, voluntary actions — in this case, those long sought by the pharmaceutical industry — should not be the catalyst for ending access to safe international online pharmacies, which is their commercial goal. Governments should have to explicitly request such actions of registrars and ICANN when they believe the public health imperatives justify it.

Furthermore, in the absence of the measured protocols recommended above, unencumbered DNS locking would advantage rogue online pharmacies vs. safe international online pharmacies. The former are often fly-by-night websites, while the latter have often existed for a decade or more and aren’t likely to return to the marketplace with another website. It would be indefensible to shut down the safest international online pharmacies and leave tens of thousands of foreign rogue pharmacy websites to rush in to fill the void.

In a letter from January of this year, the NABP alerted registrars that they should take down online pharmacies upon the request of NABP or LegitScript without a court order. NABP is careful to note “exceptions” that appear (but the letter is not explicit) to relate to LegitScript’s online pharmacy classification of “unapproved” – safe international online pharmacies that fall outside of U.S. regulations. The letter reads:

We confirm that LegitScript is well aware of where exceptions exist to these common global standards (e.g. where pharmacy licensure reciprocity exists as a matter of regulation) and Internet pharmacies falling under an exception are not designated as rogue and not included in rogue Internet pharmacy abuse notifications to Registrars. [15]

The NABP and LegitScript are within their rights to notify domain registrars about online pharmacy registrants, their practices, and legal considerations. However, domain registrars are only required to abide by requests of a court order to take down a registrant’s website.

To date, NABP’s and LegitScript’s requests to domain registrars appear to target “rogue online pharmacies” as per LegitScript’s – not NABP’s – definition creating a de facto standard that forms the basis for appropriate guidance to domain registrars. A standard of legal compliance, as per LegitScript’s terms, combined with exceptions for legally and safely operating online pharmacies, is the one that best serves the public health. To meet this requirement, approval by either LegitScript or PharmacyChecker.com, should be sufficient for a domain registrar to permit and maintain service to an online pharmacy. One domain registration company called EasyDNS already has adopted this policy.[16]

The Role of the Internet Corporation for Assigned Names and Numbers (ICANN)

ICANN, an international non-profit organization, is responsible for managing core technical components of the Internet relating to domain names, Internet protocol numbers, and protocol port and parameter numbers. Under ICANNs Registrar Accreditation Agreement (RAA), registrars accept responsibility to disallow illegal activity among registrants (websites). NABP and LegitScript argue that one way of shutting down rogue online pharmacies is for ICANN is to more fully enforce its RAAs, whereby registrars must respond dutifully to notifications about illegal activity by shutting down domain names and locking them even without a court order. The FDA is frustrated with ICANN for not doing more along these lines.[17] Again, there is a measured policy response for ICANN, which involves pressuring registrars to disallow service to sites that are truly “rogue online pharmacies” but not safe international online pharmacies.

Credit Card Companies/Payment Processors

Most online merchants, whether they sell books, computers, or drugs, take payments by credit card. Preventing them from offering credit card payment options is another method of curtailing the use of online pharmacies. It has become harder for online pharmacies to obtain merchant accounts to offer credit card payments unless they are credentialed by the NABP or LegitScript. Many safe international online pharmacies are being refused service, which means that Americans who buy from these online pharmacies have difficulty making payments to them. Some Americans who use international online pharmacies now pay for their medications by personal check instead of using a credit card.

Online pharmacy merchants are categorized as high risk operations by payment processing companies. Rogue online pharmacies have greater chargebacks, refund requests, and fraud complaints from consumers. In contrast, credit card processing for safe international online pharmacies has not been high risk, meaning their transactions are generally trouble free, as would be expected with a credentialed U.S. online pharmacy.

Some non-U.S. payment processors are willing to work with safe international online pharmacies, but now charge very high transaction fees to justify the “risk.” Rogue online pharmacies use fraud in order to obtain merchant accounts by pretending not to be an online pharmacy business, securing the account, and then offering medication for sale – a “bait and switch” operation. Therefore, private sector “voluntary actions” – ironically – lead to a situation where rogue online pharmacies may be able to acquire reasonable credit card processing terms while safer online pharmacies have far more difficulty.

Transparency

The Center for Safe Internet Pharmacies (CSIP), working with LegitScript, and in concert with the Alliance for Safe Online Pharmacies, is the organizational vehicle for private sector actions against rogue and illegal online pharmacies. Due to the public health ramifications, CSIP should be transparent in its enforcement actions. It should correctly define for consumers, regulators, and the public health community, what pharmacy sites are “rogue” and are subject to private sector takedown efforts. CSIP should also take the following actions:

• Clearly state what recourse companies and people have if their businesses are shut down by actions taken by CSIP’s members.
• Provide information on those sites that were shut down, and the reasons they were shut down based on applicable laws.
• Identify the precise public health risk of a website refused service or shut down.

The Obama administration, as discussed below, was the catalyst for CSIPs creation. If the federal government is going to deputize private actors in carrying out law enforcement-type actions that affect the health of Americans, then it should compel transparency from those actors. Not only should CSIP communicate what they are doing to protect consumers from the dangers of rogue online pharmacies but, perhaps more importantly, if safe international online pharmacies are more directly targeted for takedown by CSIP in the future, then consumers who rely on those online pharmacies for obtaining medicine they cannot afford locally should know why CSIP ended their online access to safe and affordable medication.

[1] U.S. Food and Drug Administration, press release, “FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies, June 27^th 2013; see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358794.htm [Last accessed 10/21/2014].

[2]LegitScript Internet Pharmacy Certification Standards. See https://www.legitscript.com/pharmacies/standards [Last accessed 10/7/2014].

[3] Safe international online pharmacies, such as ones approved in the PharmacyChecker.com Verification Program, fill orders with licensed pharmacies, require valid prescriptions, publish accurate mailing address and phone number, encrypt web pages on which personal and financial information is transmitted online, and do not share a customer’s information with third parties. See http://www.pharmacychecker.com/sealprogram/choose.asp [Last accessed 10/7/2014].

[4] See http://www.legitscript.com/pharmacy/canadadrugs.com [last accessed 6/25/2014].

[5] Manitoba Pharmaceutical Association, License# 32195 International Prescription Service: see http://mpha.in1touch.org/company/roster/companyRosterView.html?companyRosterId=5 [Last accessed 10/7/2014].

[6] U.S. Food and Drug Administration Warning Letter to CanadaDrugs.com, 9/21/2012; see http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm321068.htm [Last accessed 11/13/2014]. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm321068.htm.

[7] Weaver, Christopher, “FDA Warns of New Batch of Fake Cancer Drug,” Wall Street Journal, February 6, 2013, see http://online.wsj.com/news/articles/SB10001424127887324900204578286483013578190?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424127887324900204578286483013578190.html [Last accessed 10/7/2014].

[8] CSIP identifies its voluntary principles for refusing service to pharmacy websites: http://www.safemedsonline.org/wp-content/uploads/2014/03/CSIP-Principles-of-Participation.pdf. Under this policy, safe international online pharmacies are potentially subject to refusal of service.

[9] In Fall 2014, I was informed that a safe international online pharmacy, which was not a member of the PharmacyChecker.com Verification Program, but apparently met similar standards, was shut down and locked by the U.S. registrar GoDaddy.

[10] Non-prosecution agreement between Google, Inc. and the United States Attorney’s Office for the District of Rhode Island, Department of Justice, August 19^th, 2011: http://googlemonitor.com/wp-content/uploads/2011/05/Google%20Agreement.pdf.

[11] Supra note 54. View a video of the testimony by Eli Lilly about delisting here.

[12] Barea, Adam, Legal Director, Google, Inc., “Combatting Rogue Online Pharmacies,” June 18, 2013, Google Public Policy Blog, see http://googlepublicpolicy.blogspot.com/2013/06/combating-rogue-online-pharmacies.html [Last accessed 10/29/2014].

[13] Gold, Matea and Tom Hamburger, “Google Faces New Pressure From States to Crack Down on Illegal Drug Sales,” April 15^th, 2014, Washington Post, see http://www.washingtonpost.com/politics/google-faces-new-pressure-from-states-to-crack-down-on-illegal-online-drug-sales/2014/04/15/6dfc61fa-be6d-11e3-b195-dd0c1174052c_story.html [Last accessed 10/29/2014].

[14] LegitScript, press release, “LegitScript Shuts Down 6,700 Rogue Internet Pharmacies,” June 28, 2013; see http://www.prnewswire.com/news-releases/legitscript-shuts-down-6700-rogue-internet-pharmacies-213544321.html [Last accessed 11/13/14].

[15] Masnick, Mike, “Pharmacy Lobbyists Lie to Registrars If We Complain About a Site It Must Be Taken Down, No Questions Asked,” January 10,^, 2014, TechDirt, see https://www.techdirt.com/articles/20140110/12140025836/pharmacy-lobbyists-lie-to-registrars-if-we-complain-about-site-it-must-be-taken-down-no-questions-asked.shtml [Last accessed 10/29/2014].

[16] Masnick, Mike, “EasyDNS Tries to Balance Bogus Requests to Take down Legit Foreign Online Pharmacies Against Truly Rogue Pharmacies,” August 26^th, 2014, TechDirt, see https://www.techdirt.com/articles/20140824/07373128307/easydns-tries-to-balance-bogus-requests-to-take-down-legit-foreign-online-pharmacies-against-truly-rogue-pharmacies.shtml [Last accessed 10/29/2014].

[17] Elder, Jeff, “ICANN, Regulators Clash Over Illegal Internet Drug Sales,” October 27, 2014, Wall Street Journal, see http://online.wsj.com/articles/icann-regulators-clash-over-illegal-internet-drug-sales-1414463403.