#legitscript

株式会社TETRA（代表取締役：手塚 諒）は、同社が運営する女性向けオンライン診療サービス「Your Pill（ユアピル）」が、国際的な医療コンプライアンス認証である「LegitScript Healthcare Merchant Certification」を正式に取得したことをお知らせいたします。

Where there's medicine, there's money.

That statement should come as no surprise to anyone who has ever looked at a medical bill or filled a prescription: Pharmaceuticals alone are a more than $800-billion market ($300 billion of that is in the United States alone).

But the statement has an important corollary: where there's money, there will always be people seeking to influence the rules for how that money can be made, and by whom.

In May 2007, LegitScript was founded by John Horton, a former aide in the White House Office of National Drug Control Policy (ONDCP). After five years working for the “Drug Czar,” John Horton founded the company with the intent of helping people be sure that they are buying safe and genuine prescription medication on the Internet.

LegitScript is the only Internet pharmacy verification and monitoring service endorsed by the National Association of Boards of Pharmacy (NABP), which represents the state pharmacy boards that license and regulate pharmacies.

Among the first Internet pharmacies to be verified by LegitScript was drugstore.com, which was initially approved by the NABP itself as a legitimate Internet pharmacy back in 1999, a mere seven months after it was first launched. (In March, pharmacy chain Walgreen Co. announced its intention to buy drugstore.com for about $429 million.)

Since that first approval, LegitScript has approved over 300 Internet pharmacies, including veterinary Internet pharmacies, as safe and legitimate. This makes the company the largest online pharmacy verification service in the world. Additionally, the company’s database monitors over 60,000 rogue Internet pharmacies that sell prescription drugs without a prescription or unregulated health care products to Internet users.

LegitScript’s services are good news for those of us concerned about the legitimacy of online pharmacies, as the authorities continue to battle against the rapidly growing crisis of illegal, disreputable and, in some cases, extremely dangerous pharmaceuticals online.  The problem of substandard drugs being sold online to the unsuspecting, was recently featured on a CBS 60 Minutes segment which aired in mid-March 2011.  Just getting a glimpse of some of the deplorable conditions under which so many of these drugs are being manufactured, was a valuable wake-up call to everyone filling prescriptions online.

Here’s an example of the scope of this problem:  in San Diego a grand jury handed down an indictment listing 313 counts against 18 people for operating an illegal online pharmacy that netted over $126 million within a two-year period.  Amazingly, this network (which included doctors, druggists, credit card processors and websites that advertised the illegal goods) purportedly received over one million internet orders from customers in all 50 states.

The Internet is sometimes compared to the “Wild West” -  a place without any rules. The sentiment is understandable, but incorrect:  the Internet does have rules. These rules are supposed to ensure the growth of the Internet in a way that fosters legitimate personal and commercial activity, but prevents an out-of-control explosion of fraud and crime.  The Internet Corporation for Assigned Names and Numbers (ICANN),  is the organization that accredits (and can de-accredit) domain name registrars, like GoDaddy, Network Solutions, eNom and others, and require companies who register domain names, to prohibit website owners from using their domains for unlawful purposes. Without exception, this rule is also reflected in each Registrar’s Terms and Conditions, thus formalizing and protecting the company’s contractual right to suspend domain names for unlawful activity. Once a Registrar becomes aware that a website is engaged in criminal activity, the company has the legal authority and technical ability to suspend the domain name, rendering the illegal and fraudulent content inaccessible. This self-policing is meant to balance freedom of speech with safety and legitimacy as the Internet continues to evolve.

Supported with evidence from National Association of Boards of Pharmacy (NABP) members, including two state boards of pharmacy and three Canadian pharmacy regulatory agencies, John Horton’s LegitScript notified 16 domain name registrars that rogue Internet pharmacies were using their services. The Minnesota Board of Pharmacy, the Texas State Board of Pharmacy and a number of Canadian regulatory agencies provided proof of forged pharmacy licenses displayed by certain rogue sites.  In response to LegitScript’s letters and documentation, which also included proof that sites were selling prescription drugs without a valid prescription, 11 of the registrars suspended service to the websites in question. Five other registrars were either noncompliant and did not shut down services to rogue Internet drug sites, or were partially non-compliant.  Click here for John Horton’s full report on LegitScript vs. rogue sites.

The good news is, most of the Registrars we contacted acted to prevent the further use of their services by websites engaged in illegal or fraudulent activity. Part of the reason for this report is to recognize and applaud the actions taken by those Registrars, including GoDaddy, Directi, SpiritDomain, and several others.  However, a handful of Registrars – three in the United States (eNom, UK2Group and Moniker), one in Russia (CentroHost) and one in the Netherlands (Realtime Register) – after being notified about the criminal behavior in question, declined or even refused to take steps to prevent the continued use of their registration services by these websites. In some cases, it appears that they even permitted re-registration of the websites’ domain names.  In their responses to us, the most common refrain we heard from the Registrars that elected to allow these websites to continue using their registration services was that the company is “only the Registrar” and, even if they receive information that their registration services are being used in the furtherance of criminal or fraudulent activity, will not do anything without a court order.  Beyond mere common sense, there are four primary reasons that the Registrars could (and should) have terminated their relationship with these illicit websites:

1.     By law, individuals or companies who become aware that they, or something in their control, are being used to facilitate criminal or fraudulent activity, but do nothing about it, may themselves be held responsible, especially if a financial relationship exists between the parties (e.g., Registrar and registrant).

2.     It is precisely because these companies are Registrars, not in spite of it, that they are bound to act once put on notice, not turn a blind eye to criminal activity.

3.     Due to the “jurisdiction-less” nature of the Internet itself, Registrars should know that in many cases, a court order is an impossibility – a fact that cyber-criminals count on.

4.     As we show, several Registrars did move to stop their domain name registration services from being used in furtherance of unlawful activity.

Consumer protection is top priority for the FDA (Food and Drug Administration) as well as for LegitScipt, founded by John Horton in 2007.  Part of the job of the FDA is to protect the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use.  LegitScript complements this by monitoring and policing Internet drug distributors selling low cost  drugs of questionable quality through illegitimate websites.

As the only corporate entity whose standards for online pharmacy verification and investigation are recognized by the National Association of Boards of Pharmacy (NABP), LegitScript has unique abilities.  They have established their credibility in the areas of Internet compliance research and investigations, and online pharmaceuticals market research.   LegitScript’s president and founder, John Horton, is a former prosecutor who worked for the White House on prescription drug control policy issues, and now helps monitor police Internet sites which sell prescription drugs to the public.  Keeping Internet pharmaceutical firms in compliance with established rules and regulations has become a personal and professional priority for John Horton.  Between the FDA and LegitScript.com, our level of protection is increased substantially.

There is also a more consumer-friendly recall search engine on the FDA’s website where consumers can search for food, drugs and other product recalls easier and quicker than ever before.  The search engine brings together information going back to 2009 from recall announcements, news releases and other sources.  All of the data is aggregated into a table format giving the date of the recall, product name, description and the reason for the recall.

Under the new law in effect, the FDA is required to indicate whether the recall is ongoing or has been completed.  In addition, unlike under the previous law, the FDA now has mandatory recall authority for products other than infant formula.  In other words, the new system is much more comprehensive and includes foods and feed products – providing increased general protection to us all.

Before actually launching the new search engine, the FDA consulted with stakeholder groups, including the Center for Science in the Public Interest, Consumers Union, Food Marketing Institute, Grocery Manufacturers Association, the Pew Health Group, and Safe Tables Our Priority in an effort to gain their insights on how to most effectively and easily communicate recall information to consumers.  The FDA also encourages and welcomes suggestions from anyone with firsthand experience in communicating vital information to the public concerning recalls.

Each year tens of thousands of counterfeit prescription drugs enter the U.S. ranging from sugar pills that fail to deliver any medical benefits, to those containing actual toxins that can cause serious harm, including death.  In either case, the consumer becomes the victim and suffers harm to varying degrees.  Over the past several decades, through the combined efforts of regulators and private industry watchdogs, such as LegitScript, an Internet company founded by John Horton, we have a better sense of what works and what doesn’t in the fight against drug counterfeiters.

A relatively new class of drugs called “biologics” is creating formidable challenges for industry regulators.  Because biologics include a wide range of living entities such as vaccines, blood, gene therapy, tissue, even recombinant proteins (to name just a few), and are created by biological processes (as distinguished from chemistry), they have added major therapeutic benefits for the treatment of many diseases.  They have been shown effective in treating some ailments for which no therapies were available, and others where previously existing therapies were clearly inadequate.  As a result, they will inevitably be a target for counterfeiters intent on making outrageous profits at the expense of patient safety.  So what can be done to prevent prescription drug counterfeiters from injecting the U.S. market with fake biologics, especially with the advent of “biosimilars” – a sort of “generic” version of biologics?

First, as John Horton has written for the Huffington Post, the FDA is currently considering what is called an “abbreviated pathway” for approving legal knock-offs of biologics (called “biosimilars”) that will enable copycat and thus cheaper versions of these life-saving medications to become FDA-approved. It’s important to ensure that this process doesn’t cut corners: the FDA should hold biosimilars to the same standards of safety as the original biologics. Unlike non-biologic medicines, where a “generic” version is more or less an exact chemical replica, biosimilars can never truly be identical to the original biologic. Hence, the only way to ensure the same level of safety is to require similarly rigorous clinical testing for biosimilars as is required for the original biologics.

Second, be watchful about how counterfeiters operate. Some have been known to insert convincingly real-looking counterfeits into the normal prescription drug supply chain. “Track and trace” technology affords regulators and drug companies the ability to follow a drug’s supply chain back to the origin.

Individuals process information in varying ways.  Some of us are more responsive to visual input; some of us are inspired more by auditory input.  Regardless of which camp you belong to, we all tend to respond similarly to numbers.  Therefore, here are some numbers behind the potential threat posed by non-compliant internet pharmacies dispensing drugs of questionable quality.

Currently, there are 66,736 internet pharmacy websites in LegitScript’s database.  Of that amount, a mere 339 are identified as legitimate by Legit Script, representing slightly more than one half of 1% of the database.  Legit Script is the only Internet pharmacy verification and monitoring service endorsed by the National Association of Boards of Pharmacy (NABP), which represents the state pharmacy boards that license and regulate pharmacies.  Headed by John Horton, they are also the leading Internet pharmacy verification and Internet enforcement service in the United States.

Records show that 1,232 websites are candidates for approval, leaving more than 97% that do not meet standards.  E though these internet pharmacies are identified as not meeting present standards, they continue to fill prescriptions and orders from customers who are hoping to reduce the cost of their medications.  LegitScript expects that most of these are legitimate, although a few will fail to meet the criteria.

Studies show that 64% of retail chain drug stores have an internet presence, but without an NABP certification.  Chain drug stores are generally legitimate and pose no problem to consumers, but acquiring NAPB approval would provide added certainty to consumers who use those websites.

The magnitude of this threat is so great that the U.S. Food and Drug Administration website lists 35 tips and warnings in just one (1) article entitled The Possible Dangers of Buying Medicines over the Internet.  This article should be mandatory reading for anyone about to purchase drugs, or fill a prescription online.