A couple of weeks ago, LegitScript’s President appeared on CNN to discuss what the news station described as the “Feds’ Crackdown on Online Pharmacies.” As noted in the story, the search warrants:

… centered around two pharmacies, one in the Chicago suburb of Des Plaines, Illinois, and the other here in this small town south of Salt Lake City.

The CNN story identified pharmacist Kyle Rootsaert as the pharmacist and owner of both pharmacies, interchangeably known as “Roots Pharmacy” and “Rand Pharmacy” over the last couple of years. According to the search warrant, JRBHealth Internet pharmacy network websites such as your-rx.com (now defunct) were utilized to facilitate orders on these pharmacies’ behalf.

The FBI’s search warrant is a watershed event in online pharmacy regulation in the United States. Here’s why.

Historically, a number of rogue Internet pharmacy networks have sought to present their operations as legitimate, and evade scrutiny by the Drug Enforcement Agency, by only selling non-controlled prescription drugs prescribed by physicians who have never examined the patients in person. The federal Controlled Substances Act, which the DEA enforces, explicitly prohibits the sale of controlled substance prescription drugs prescribed in this way. However, the Food, Drug and Cosmetic Act (FDCA), which the FDA enforces, doesn’t contain explicit language about online prescriptions or consultations (or, explicitly define what constitutes a “valid” prescription.) Thus, rogue Internet pharmacy owners have tried to be strategic, only listing non-controlled substances like Soma, Viagra or tramadol, and claiming that they are acting within the bounds of the law.

What’s significant is, the execution of the search warrant against Roots and Rand pharmacies indicated that the federal government doesn’t buy that line of reasoning. Indeed, the search warrants were predicated on the legal theory that mass online consultations in lieu of physical examinations are not the basis for a legitimate prescription, and if drugs are knowingly dispensed on this basis, it is akin to simply selling drugs without a prescription at all, and thus constitutes the crime of “Misbranding” under federal law (that is, the drugs are officially considered “misbranded”).

Also relevant was the fact that the physician, Dr. William E. Morrow, was not licensed in the states where the patients ordering the drugs were located. In other words, the federal government looked to state regulations dictating where a physician, pharmacy and pharmacist must be licensed; in this case, the notion that the physician was practicing without a valid license in the state where the patient was located contributed to the legal theory of Misbranding, a federal crime.

In several respects, this is similar to the pre-Ryan Haight Act era, in which pharmacies and prescribing physicians argued that the Controlled Substances Act did not explicitly require that a prescription be based on a prior in-person examination, but the DEA was able to investigate, indict and prosecute those DEA registrants anyway. Internet drug dealers have responded to the Ryan Haight Act by peddling the few prescription drugs that are addictive but are not controlled substances (Soma, tramadol and fioricet, to name three). The Roots/Rand pharmacy search warrants suggest that this approach will ultimately not be considered legitimate and will not survive legal scrutiny.

In the Huffington Post, LegitScript’s President discusses the problem of unapproved drugs – medications that may have been “grandfathered in” to the US drug safety system, but have not been subjected to the same safety and efficacy evaluation as FDA-approved medicines.

In describing the problem, the article says:

Why are unapproved drugs so readily available in the US? To understand the problem, consider the history. The current drug approval process was launched in 1962, following a previous overhaul in 1938. Since 1962, the FDA has prohibited the dispensing of any prescription drug unless it has been proven safe and effective by a science-based system designed to put the patient’s safety first.

But in 1938 and again in 1962, Congress created a loophole for drugs already on the market – allowing drugs already in use prior to 1938, and then prior to 1962, to be “grandfathered in,” exempting them from the requirement to be proven safe or effective. Each time, the loopholes made sense: immediately removing nearly every existing drug from the market en masse would have left the United States bereft of the best medicines available at the time.

While it’s not to say that all unapproved drugs are safe or ineffective, the simple fact is that there is less certainty as to safety and efficacy, due to the absence of participation in the FDA drug-approval process. The article additionally states:

While it is true that there are a limited number of drugs not subjected to the FDA approval process for which no substitute exists and so they should continue to be available unless there is information that they are unsafe, we have to ask whether most of these once-reasonable exemptions have lived past their natural age, becoming great- and great-great-grandfather clauses. After all, science has evolved; new drugs have been approved; and our collective understanding of drug safety has improved beyond measure.

Read the full article here.

Periodically, we get asked about the safety of Canadian Internet pharmacies. We recently ran across a website, oaktreecanadianpharmacy.com, that illustrates our concerns pretty well.

At first glance, oaktreecanadianpharmacy.com looks like it must be a legitimate, safe Internet pharmacy. It says “All prescriptions dispensed by Granville Pharmacy,” and provides an address in British Columbia. It has the name and picture of the licensed pharmacist, Dawn Polley. Indeed, the pharmacy in question, Granville Pharmacy, has a pharmacy license.

But then, dig a bit deeper. First, the FAQs ask, “Do you ship to Canada?” The answer: “At this time we do not ship any of our products to Canada.” Huh? We thought that all of the prescriptions were dispensed by “Granville Pharmacy” in British Columbia. Why would a legitimate Canadian pharmacy not ship to addresses in Canada?

The answer is that Granville Pharmacy isn’t providing US residents drugs from the same source that Canadian customers receive drugs from. To be clear, if you are in Canada, Granville Pharmacy most likely provides drugs that are “Health Canada-approved.” But if you are in the US, at least some of the drugs do not come from the same source or supply chain. In other words, they can’t ship drugs ordered from this website to Canada because the drugs aren’t really approved in Canada, so they’d potentially be violating Canadian law if they did so.

What typically happens with licensed Canadian “International” Internet pharmacies is, the orders will be routed to a supply center outside of either the US or Canada, such as in Turkey, Barbados, India or elsewhere, and then shipped to US residents. The drug costs are lower than they would be for genuine Health Canada-approved drugs from the actual Canadian pharmacy, which improves the profit margin for the pharmacy. This would not be legal for orders shipped to Canada, which is why the website won’t accept orders shipped to Canada. It also isn’t legal in the US, because the drugs are considered unregulated, falling outside of the FDA-approved supply chain. In short, the drugs may be perfectly safe and genuine, or they may not be – and pharmaceuticals that are substandard, adulterated, knock-offs or even counterfeit have been found in the supply of drugs sourced this way.

So why don’t the authorities crack down on this? Well, because the “pharmacy” is outside US jurisdiction, US-based pharmacy regulators have no authority to stop it; because the customer/patient is outside Canada, the Canadian authorities have no jurisdiction to stop it.

In addition to the fact that the drugs are considered unregulated, it’s important to note the lack of transparency. Combining the domain name, the address in Canada, the pharmacy licensed in Canada, and the picture of a Canadian pharmacist, everything about the website is designed to reassure Internet users that the drugs are coming from Canada, and that US residents are getting the same assurances of safety and authenticity that a Canadian resident would receive. But if that were the case, why wouldn’t the website accept orders from Canada?

Furthermore, consider the domain name registration for oaktreecanadianpharmacy.com. Instead of being openly registered to Granville Pharmacy, it utilizes an anonymous domain name registration service with an address in Madiera, Portugal. It’s not unreasonable to ask why – and what the domain name registrant wants to keep hidden from the public.

Although it wouldn’t make it legal or safe, oaktreecanadianpharmacy.com should be open and transparent about the source of drugs. If the drugs come from India, Turkey, or elsewhere, Granville Pharmacy should state that up front – not disseminate information leading Internet users in other countries to believe that they are being afforded the same drug safety protections that Canadian residents receive.

As rogue Internet pharmacy networks become more sophisticated, even US government websites are at risk. Today, we’re taking a look at how a rogue Internet pharmacy linked to a criminal network operating out of Russia and Eastern Europe has hacked into a US government website.

The Millennium Challenge Corporation, a US foreign aid agency, utilizes a “.gov” top-level domain, which is assigned to the control of the US government. Domain names ending in .gov are typically administered by the General Services Administration.

A quick visit to mcc.gov indicates that all seems well from the home page. However, a search for drugs like Viagra or Cialis, pharmaceuticals that are frequent targets of counterfeit drug Internet pharmacies, shows results for a no-prescription-required “Canadian” Internet pharmacy (actually run out of Russia) within mcc.gov itself.

Two of the illicit results are located within a folder called “/blog/” that either already existed, or was illicitly uploaded to the mcc.gov server. (The genuine MMC blog is within a folder called /pages/ on the server, not /blog/.) Within this folder are links such as these:

• www.mcc.gov/blog/?order=7 (Video Clip)
• www.mcc.gov/blog/?order=3430 (Video clip)

The code illicitly uploaded to mcc.gov automatically redirects Internet users to therxdrugs.net, a rogue Internet pharmacy that is an affiliate of Russian affiliate network GlavMed, a notorious spam and fraud organization headquartered in Russia. GlavMed is well-known to top Internet security researchers that LegitScript is allied with, such as KnujOn, Cyveillance, and HostExploit. Here, it is important to differentiate between a blog comment with a hyperlink to an illicit pharmaceutical website (which would not typically constitute hacking), and the automatic redirection of the mcc.gov website itself, which indicates that code has been surreptitiously uploaded to the government server.

As for the rogue Internet pharmacy therxdrugs.net, it is registered to one Alexey M. Arkhipov, with an address in Shilovo, a few hundred miles southeast of Moscow. The domain name registration is via a Chinese Registrar (TodayNIC), and the content is hosted in Germany.

Why would a rogue Internet pharmacy do this? The reasons are found partly in the search algorithms utilized by Google and other search engines, which are thought to give particularly high rankings to .gov websites, or websites linked to by .gov websites. (This is believe to be because .gov domains, like .edu domains, denote credibility.)

The reason for concern here should be clear.

• First, the security of .gov websites is important. If rogue Internet pharmacies can infiltrate one .gov website, it’s reasonable to ask whether others can be infiltrated as well.
• Second, GlavMed is not a run-of-the-mill website operated by a small-time prescription drug dealer. GlavMed is arguably the leading rogue Internet pharmacy network in the world, behind copious amounts of unregulated pharmaceuticals, spam, and no-prescription-required sales via the Internet.
• Third, if a Russian organized crime network (an accurate description for GlavMed) can upload content from a .gov website, then they can download it as well, potentially acquiring sensitive information.

Yet more cause for concern: therxdrugs.net is co-located with a Chinese website, googbot.cn. Googbot was a worm noted by Symantec as “opening a back door on the compromised computer.” To put this in perspective, there are only seven domains utilizing that particular IP address; therxdrugs.net and googbot.cn are two. (Four other are rogue Internet pharmacies; the fifth is yahbot.cn, another Chinese website.) It’s reasonable to view therxdrugs.net and googbot.cn as having a meaningful connection.

Drilling down further, even though there is no obvious content on the home page for googbot.cn, the malicious code remains at googbot.cn/php/example/pharm.txt, which may be the code inserted into the .gov website, as well as others. Indeed, that precise code is uploaded to the website of Baptist Bible College (bbc.edu), within the faculty page of KCCheng, specifically at the URL faculty.bbc.edu/kccheng/?pp=340 as well as faculty.bbc.edu/kccheng/?pp=2201.

With respect to the infiltration of .gov sites by rogue Internet pharmacies run out of China and Russia, the problem is this: if .gov websites are not secure from rogue Internet pharmacies, it’s legitimate to be concerned as to their security from other organized criminal elements that do not have the United States’ best interests at heart.

As our readers know, LegitScript has recently been taking a look at another aspect of drug safety: the dispensing of unapproved drugs, both online and offline. In this regard, a recent lawsuit filed by two drug manufacturers against the FDA will be interesting to watch.

On their FDA Law Blog, the firm of Hyman, Phelps and McNamara note the recent filing of a lawsuit by two makers of morphine sulfate, Cody Laboratories and Lannett Co. As the Hyman firm explains:

The lawsuit is (to our knowledge) the first challenge arising from FDA’s Unapproved Drugs Initiative, which was kicked off in June 2006 with the publication of the Agency’s Compliance Policy Guide (“CPG”)…The Cody/Lannett lawsuit stems from FDA’s March 2009 decision to issue Warning Letters to nine companies, including Cody and Lannett, to stop manufacturing fourteen unapproved narcotic drugs, such as high concentrate morphine sulfate oral solutions, morphine sulfate immediate release tablets, hydromorphone, and oxycodone. At that time, FDA concluded that marketed unapproved morphine sulfate products are “new drugs [under the FDCA] and not grandfathered and that manufacturing and marketing of these products without an approved application constituted a violation of the Act.”

Understanding the history. Understanding the relevance of this lawsuit requires understanding the history of the FDA’s unapproved drug initiative. Much of the current drug approval process was formed in 1962. At that time, drugs that were already on the market were allowed to be “grandfathered in” – meaning, they could lawfully be dispensed by pharmacies without going through the FDA approval process, until and unless there was some change in formulation, labeling, et cetera, to the drug. That made a lot of sense, at first. But today, being that nearly 50 years have since passed, the FDA’s position has increasingly been that very few drugs will likely meet the criteria for “grandfathering.”

What this means for patients. To put this in layman’s terms, let’s say that you have a prescription for morphine sulfate. There are a variety of formulations and strengths of the drug: not all morphine products are the same. The FDA has reviewed and approved a few of these, but other formulations are not approved and thus, may not be safe and effective. But in some cases, the manufacturers have argued that if they’ve been making the same product since before 1962, they should be considered “grandfathered in,” and the drug shouldn’t have to go through the FDA drug approval process, which can be lengthy and costly. In this particular case, the FDA had sent a warning letter to the manufacturers, stating that their version of the drug is “unapproved.”

What to watch for. While it would be premature for us to venture an opinion on a pending lawsuit, it does raise a variety of interesting issues. Regardless of which way the lawsuit goes, a few important principles come into play.

1. First, as a matter of general principle, it’s important not to weaken the FDA’s ability to enforce existing laws and regulations, particularly regarding unapproved drugs. Whatever the merits of this particular case, a decision that would chill the FDA’s ability to require that only safe, effective medications be dispensed could be disadvantageous to patients in the long run.
2. Second, as a general matter, this highlights the fact that drugs considered by the FDA to be “unapproved” (and thus not necessarily safe or effective) are, apparently, still being manufactured and are presumably being dispensed to patients. Indeed, a recent article suggested that nearly 75 million prescriptions dispensed each year in the US may be for drugs considered by the FDA to be unapproved.
3. Third, again without reference to this specific case, it would seem axiomatic that as our collective knowledge of chemistry, drug safety and medicine improves, we should expect that in most or all cases, the exact formulation of a drug available in 1960 is probably not going to be the best that’s potentially available in 2010, fifty years later. Indeed, it is possible to conceive of a situation in which an anti-FDA decision would actually incentivize manufacturers not to make needed updates to drug formulations.

LegitScript will continue to watch and report on developments in this area over the next several months.

Just a few days after our recent blog about a lawsuit filed against the FDA by two drug manufacturers, the complaint was dismissed in federal court.

At its heart, the lawsuit challenged the FDA’s authority in two respects. First, the lawsuit targeted the FDA’s unapproved drug initiative, which seeks to remove unapproved versions of pharmaceutical products from the market, especially in cases where an approved version of that particular drug exists. Second, although not explicitly described as such, the lawsuit, if successful, would have arguably weakened the FDA’s authority to issue warning letters – not only as part of the agency’s Unapproved Drug Initiative, but overall.

In dismissing the complaint, the court focused in part on the fact that a warning letter from the FDA is just that – a warning – and is not (yet) an enforcement action. As such, the court found, the case was not “ripe” for adjudication, since no enforcement action had actually been taken.

Because (the drug manufacturers) are attempting to enjoin an anticipated enforcement action…(granting the manufacturers’ request) would be without foundation and a wholly inappropriate interference with FDA’s charge to protect the public health. (…) Plantiffs seek to enjoin a possible future FDA enforcement action to remove their unapproved (drug) from the market.

Stepping back from this particular decision, it is worth remembering that the warning letter process utilized by the FDA is not the normal course of action for enforcement and regulatory agencies: for example, the DEA or FBI, if they investigative and detect the illegal sale of pharmaceutical products, will generally not “warn” a potential defendant, but will simply act, via arrest or indictment. FDA may certainly do the same, but the warning letter process arguably saves significant resources by effectuating compliance without launching a formal legal process.

While the decision might be appealed, for now, the court’s decision indicates that the FDA’s Unapproved Drug Initiative specifically, and warning letter process generally, remain on solid legal ground.

A recent Washington Post article indicates that the FDA is taking fresh and welcomed steps to tackle the ongoing problem of unapproved drugs on the consumer market.

The article indicates that the Food and Drug Administration (specifically, FDA drug compliance Director Deborah Autor) is leading an initiative to rid the market of potentially dangerous unapproved medications. Ms. Autor will be confronting the challenges posed by unapproved drugs with a comprehensive plan that evaluates the public health risks, examines legal issues and identifies incentives to get drugs approved. The plan also helps seeks to educate the public and aggressively promote the role of enforcement.

In the Post article, the FDA’s Director of the Center for Drug Evaluation and Research (CDER) had praise for Ms. Autor, crediting her with “persistence and laser like focus to this goal, and conceived and executed strategy. In doing so she improved drug safety for the American people.” Similarly, Steven Galson, a former U.S. Surgeon General and FDA official, said that she "developed the program under budget constraints, withstood scrutiny and criticism from some in the drug industry and Congress, successfully navigated the internal FDA process and took aggressive action to clamp down on the illegal drug market.”

It’s important to understand the central and important role that the FDA plays in protecting the public health from unapproved drugs – medicines that have not been subject to the FDA’s rigorous drug approval process, and accordingly, have not been confirmed to meet the FDA’s drug safety and efficacy requirements. LegitScript recently urged leading pharmacies to be aware of this issue, and has encouraged the FDA to refocus on the unapproved drug issue.

Unapproved drugs can take a variety of forms. LegitScript’s primary focus has been unapproved drugs via “rogue” or “unapproved” Internet pharmacies. (Prescription drugs imported directly from outside of the US directly to the patient are, in almost all cases, considered unapproved by the FDA.) However, there are also numerous prescription drugs that may be sourced domestically but have not been verified as meeting the FDA’s safety and efficacy requirements. Indeed, one of Autor’s findings was that many of the drugs predating the approval process or “grandfathered” drugs have been altered in their dosage, formulation and administration and therefore would no longer appropriately be “grandfathered” under federal drug safety laws, and cannot be verified as safe and effective.

We’ve typically described such unapproved drugs as a “gamble”: in some cases, the patient will get something safe and effective, but in others, they do not. LegitScript welcomes the FDA’s updated focus on unapproved drugs, and notes that both pharmacies and patients will benefit from continuing education as to which drugs are considered unapproved.

As our readers may know, LegitScript has identified Internet pharmacies that sell prescription drugs not in accordance with US federal or state laws, and the entities that facilitate, advocate for or profit from those websites. Among these is an Internet pharmacy verification company no longer used by major search engines called PharmacyChecker, a company that advocates for Internet pharmacies that do not operate in accordance with US federal and state pharmacy and drug safety laws.

As the search engines have taken positive steps to require Internet pharmacy advertisers to adhere to stricter legal standards, PharmacyChecker has publicly blamed LegitScript for the discontinuation of its relationship with the search engines. While untrue, LegitScript does assist Google with Internet pharmacy monitoring. In retaliation, PharmacyChecker has recently launched a defamation campaign based on false information against LegitScript, including personal attacks against our company’s President.

LegitScript’s approach has been to try to rise above the mudslinging. We regret having to respond at all, but welcome the opportunity to set the record straight.

PharmacyChecker and its relationships with illegal Internet pharmacies

In the months before PharmacyChecker lost its recognition from the major search engines, it was revealed via multiple sources that PharmacyChecker had approved, as part of its paid program, Internet pharmacies that were selling prescription drugs not in accordance with legal requirements, including without a prescription. Some of this information was exposed by LegitScript. Some examples:

• CNN exposed pharmnet.com, a PharmacyChecker-approved Internet pharmacy, the ads for which redirected to pages within pharmnet.com selling controlled substances without requiring a valid prescription. (Incredibly, in a subsequent email to LegitScript, PharmacyChecker’s Vice-President, Gabriel Levitt, argued that because after the controlled substance was selected for purchase on pharmnet.com customers would then be directed to a payment website called “rx-checkout.net,” pharmnet.com itself could not have been known to be acting illicitly.)

• LegitScript was interviewed on CNN about LiveWellRx.com, which sold us an addictive prescription drug (Soma) without a prescription despite the fact that we posed as a 13-year old. The website was PharmacyChecker approved at the time we conducted the test buy.

• On its own website, PharmacyChecker listed shopeastwest.com as PharmacyChecker-approved, despite the fact that the website was selling drugs without requiring a prescription from overseas. This was exposed by LegitScript.

Previously undisclosed rogue Internet pharmacy websites approved by PharmacyChecker

LegitScript has documented other PharmacyChecker-approved Internet pharmacy websites selling or facilitating the sale of unregulated drugs without a prescription over the last couple of years. We have not made these public, but today, will start with one additional, not-previously-disclosed example.

The graphic to the left is a PharmacyChecker Seal of Approval for tenpharmastores.com. While the website was PharmacyChecker-approved, it referred Internet users to websites offering controlled substances such as Vicodin without a prescription. (Note that the website’s content has changed since then.) Our analysis indicated that the website remained PharmacyChecker approved for about nine months, enabling the website to advertise with the major search engines.

LegitScript has documented other similar activity by other PharmacyChecker-approved websites. LegitScript reserves the right to make that information public if future baseless allegations and defamatory blogposts are made against LegitScript, and if existing false publications are not corrected.

Simply put, websites like tenpharmastores.com were a source of revenue for PharmacyChecker, which in turn enabled those illicit websites to advertise with the search engines and sell unregulated pharmaceuticals, including controlled substances without a prescription. This profitable arrangement is no longer available, due in part to LegitScript’s role in documenting the illegal activity of websites like livewellrx.com and tenpharmastores.com that had been approved by PharmacyChecker as part of its paid program.

False Statements by PharmacyChecker

PharmacyChecker has made other false allegations, including a recent one that LegitScript has approved Internet pharmacies with “rogue affiliations” in violation of our own standards. The allegation is false and unsupportable, and the pharmacy websites mentioned do not violate LegitScript or NABP standards, nor is LegitScript’s approach inconsistent.

The basis of PharmacyChecker’s allegation is that numerous Internet pharmacies in our database purchase prescription drugs from Cardinal Health, a licensed national wholesaler that sells drugs to thousands of pharmacies nationwide. Cardinal Health supplied pharmaceuticals to two Tulsa-area hospital pharmacies (neither approved by LegitScript) where pharmacy employees stole or diverted pharmaceuticals between 2005 and 2008 (an incident that PharmacyChecker incorrectly states was “discovered” in 2010, when it was clearly earlier). Cardinal Health paid a fine because of inadequate supply control on two occasions.

PharmacyChecker points to LegitScript’s 11th standard, which states:

Affiliated websites. The pharmacy, website, pharmacy staff, domain name registrants, and any person or entity that exercises control over, or participates in, the pharmacy business must not be affiliated with or control any other website that violates these standards.

This is not a serious argument. PharmacyChecker appears not to understand the nature of the rogue Internet pharmacy world, in which illicit pharmaceutical suppliers rely heavily on affiliate networks (which is what “affiliation” refers to) to propagate hundreds of similar websites offering unregulated drugs. That isn’t what’s happening here. In fact, PharmacyChecker declined to identify the websites in question. We challenge PharmacyChecker to do so. We predict that they will not (or cannot) do so, because it knows that it can’t survive a defamation lawsuit from those pharmacies by implying that they have “rogue connections.”

In short, after approving numerous rogue Internet pharmacies itself, PharmacyChecker looked through our database (which is public) to try and find a mistake we’d made; couldn’t turn up anything; and this was the best they could do.

More False Statements or Accusations by PhamacyChecker

PharmacyChecker has made other false accusations. Several seem to emanate from an unfounded theory that PharmacyChecker is the victim of a secret, wide-ranging conspiracy by the federal government and pharmaceutical companies, all orchestrated by LegitScript. Consider:

PharmacyChecker false statement. LegitScript is a front for or is funded by pharmaceutical companies, and as such, lacks independence.

The truth. As we have stated on numerous occasions, LegitScript is an Internet start-up funded 100% (yes, one hundred percent) by our staff. We accepted no outside investment at all. As with many start-ups, for the first couple of years, we had no revenue except that which came from our own pockets. LegitScript staff owns 100% of the company, and no investment or funding has ever come from any third party, including any pharmacy, pharmaceutical wholesaler, manufacturer, or any similar entity. On no occasion has LegitScript or anyone associated with it ever accepted any grant, gift, funding, endowment, donation, contribution, or any sort of investment whatsoever from any third party.

PharmacyChecker apparently finds it difficult to believe that an Internet pharmacy verification service can truly be independent, not bought off by part of the industry. Indeed, LegitScript does not accept any money from pharmacies that we approve; PharmacyChecker does, including those that are not in compliance with federal and state regulations.

Other false statements. PharmacyChecker has made a number of other false statements regarding LegitScript implying that:

• LegitScript’s President set up a lobbying firm to lobby for corporate (impliedly pharmaceutical company) clients last year. This is simply false. There isn’t anything remotely true about it.
• That while in government, LegitScript’s President “switched the focus of a government report” to target PharmacyChecker at the best of “big pharmaceutical interests.” This is false. It’s true that a government letter from a White House senior official to a member of Congress identified PharmacyChecker as not being a “reliable” verification service. The letter clearly indicates that it came from the nation’s Drug Czar and was developed in coordination with the DEA and FDA, which concurred with the assessment of PharmacyChecker’s unreliability.
• That LegitScript’s President, while in government, “misused his government position” to advocate for LegitScript. Again, false. LegitScript’s President left his government position effective April 27, 2007; LegitScript was not officially formed until weeks after that, and legitscript.com’s website did not even go “live” until more than a year later.

Wrap-up

LegitScript regrets the necessity to respond to this disinformation, but believes it is important to set the record straight.

LegitScript is the only Internet pharmacy verification service recognized by the National Association of Boards of Pharmacy and is a founding member of the Alliance for Safe Online Pharmacies. We have no financial relationship with the pharmacies we review. PharmacyChecker is not NABP-recognized, and because it operates a for-payment Internet pharmacy verification program, it has a financial relationship with the Internet pharmacies it approves, whether the website is licit or illicit.

PharmacyChecker is understandably upset that LegitScript played a role in exposing their approval of websites like pharmnet.com, livewellrx.com, tenpharmastores.com, and others that sold unregulated pharmaceuticals and/or prescription drugs without a prescription. Earlier this year, the three major search engines announced that PharmacyChecker approval would no longer be recognized by their respective ad programs. This has resulted in PharmacyChecker’s program having less value and presumably less revenue. Additionally, the foreign Internet pharmacies that PharmacyChecker is aligned with (and concedes are not considered legal by the FDA) have lost the ability to advertise online in the US.

This explains, but does not justify, the launching of a disinformation campaign. PharmacyChecker is promoting the view that it is the victim of a massive conspiracy by the federal government and “big pharmaceutical companies”, all orchestrated by LegitScript in order to “deny Americans safe, inexpensive medications.” This is paranoid nonsense that has no place in reasonable debate. If PharmacyChecker is a victim, it is a victim of its own inability or unwillingness to distinguish between pharmacy websites that dispense prescription drugs in the US in accordance with Federal and state laws, and those that do not.

Last week, LegitScript sent letters to the heads of several large pharmacy chains encouraging them to protect their customers by ensuring that they are only dispensing FDA-approved medications. The letters were sent as a part of a new public education initiative on unapproved drugs that is complementary to our ongoing efforts regarding Internet prescription drug safety.

To put the letters into context, any prescription drug sold in the United States must be, by law, “FDA-approved.” This ensures that it has been subjected to rigorous testing and deemed both safe and effective. If studies show that the medication does not meet the standards needed for approval, then the FDA is bound to deny its application. FDA approval is considered the “gold standard” throughout the world. Americans know that if they fill a prescription at a pharmacy within the United States, they are being provided with drugs that are “FDA-approved” and that provides them with a piece of mind. After all, if you are ill and need medication, you want to know that what you are taking is actually going to work!

Over the last 50 years, there have been a few exceptions to the requirement that prescription drugs be FDA-approved. The FDA drug-review system has evolved over time, and took a leap forward in the 1960s. Drugs that were on the market prior to 1962, and that have not been modified in any way (including their labeling or marketing) since then, can be “grandfathered in” as legal drugs, even if they are not technically “FDA-approved.” If that is, there is no FDA-approved version of the drug currently on the market.

In the 1960s and 1970s, grandfathering those non-FDA approved drugs made sense: the process was new, and the FDA could not have simply ordered all drugs that had been around since the 1950s or before off the market. But now that nearly 50 years have passed, very few unapproved drugs meet the exemption requirements: either there is an approved version of the drug, or something about the drug (chemical makeup, labeling, etc.) has changed. Accordingly, in 2006, the FDA launched the unapproved drugs initiative to identify unapproved drugs that do not or should not meet the exemption requirements and remove them from the market.

Why is this important? In short, it’s a health issue. If you have a medical condition, you want to know that the drug you are taking to treat it will actually work. We’ve learned a lot about medicine since the 1950s, and what may have been the “best available” then is not, in the vast majority of cases, the safest and most effective option now. The FDA has indicated that there are probably extremely few drugs that can legitimately be grandfathered in.

Over the next several weeks, LegitScript will be taking a closer look at some unapproved drugs, and their availability online and offline, as a resource to help inform patients who may be taking an unapproved drug know whether there are better options.

Additionally, in cases where there is now an FDA-approved version of the drug, there are a variety of patient assistance programs to assist individuals without insurance or who otherwise find it difficult to afford their prescription medications. We’ll be looking at ways to help make that information available as well.

Earlier today, the White House Intellectual Property Enforcement Coordinator’s Office released a strategy on Intellectual Property enforcement. The document addresses the problem of rogue Internet pharmacies, and suggests that the Obama Administration will bolster IP enforcement as another tool to address the problem.

Traditionally, much of the approach regarding rogue Internet pharmacies has been on the public health risks. However, intellectual property enforcement provides another avenue to strike at the problem, and is inextricably tied to health and public safety risks. After all, most rogue Internet pharmacies, besides selling prescription drugs without a prescription, are engaged in violation of intellectual property rights at some level or another (especially patent and trademark infringement).

Among its other content, the IPEC strategy:

Praises Google, Yahoo and Bing for requiring VIPPS accreditation. The strategy states: “Google, Yahoo and Bing recently updated voluntary protocols designed to prevent the sale of sponsored results for unlawful businesses selling counterfeit medications online…the US Government applauds these efforts by the private sector and will continue to work with these companies and other search engine operators, advertising brokers and payment processors to explore methods to prohibit paid advertising for online illegal pharmaceutical vendors.”

Calls for the establishment of a Counterfeit Pharmaceutical Interagency Committee. The strategy states that the Commitee…”shall examine the myriad of problems associated with unlicensed Internet pharmacies, health and safety risks in the U.S. associated with the distribution of counterfeits…"

Recommends private sector cooperation to address the problem. The strategy urges “…content owners, Internet service providers, advertising brokers, payment processors and search engines, to work collaboratively, consistent with the antitrust laws, to address activity that has a negative economic impact and undermines U.S. businesses, and to seek practical and efficient solutions to address infringement."

Cites LegitScript data. The report cites LegitScript in a couple of places, noting that “LegitScript, an online pharmacy verification service, identified over 36,000 online pharmacies as of March 2010 that do not meet the standards for certification by this company.”

The third point, urging private sector cooperation to address the problem, is a good one. Rogue Internet pharmacies rely on “safe haven” Domain Name Registrars, ISPs, boutique payment processors and other third parties to stay in business. The counterfeit drug problem is not insurmountable: Registrars such as GoDaddy, eNom, Directi, Name.com, Sibername and others, as well as ISPs and payment service providers, have the ability to help make the Internet a safer place through the sort of voluntary adoption of standards that the strategy refers to. Some of these companies (and all three search engines’ sponsored ad programs) have adopted such policies.

LegitScript applauds the Administration’s intellectual property enforcement strategy, and looks forward to supporting enforcement efforts designed to make the Internet a safer place.