SAFETY FIRST

By Patricia A. Earl,
Executive Strategist
VP Business Development
XStream Systems, Inc.

As succinctly stated in the earlier blog post, it is a near certainty that the United States pharmaceutical industry will face growing counterfeiting issues in the coming years.

These increasing occurrences will impact the industry in a number of important ways. The primary, and most obvious, concern is the liability problem. Trial lawyers have eagerly pursued businesses throughout the chain of custody when filing claims in other product liability areas.

A second issue regarding counterfeiting is integrity. From a professional and personal standpoint, members of the pharmaceutical industry do, and should, want to assure the end users of the products that they are safe and effective. Add to this the desire for safety and efficacy in a regulatory environment that when functioning properly will demand accountability. When companies within this industry sell or distribute products, they should be exactly what the customer expects.

The third issue is trust…and reliability. In order for our industry to grow effectively and for each of our companies or institutions to thrive, our customers must be able to trust us and the products that we deliver. Counterfeits, regardless of where they exist in the distribution chain, undermine the customers’ faith in the industry as a whole.

A final issue that I wish to discuss is the possibility of government intervention in the pharmaceutical distribution process. If counterfeiting becomes more prevalent and risks to patients are growing, then Congress, the Executive branch and its regulatory agencies will face increasing public pressure to “do something.” In this scenario is likely that they will respond with knee jerk mandates. Given government history in other industries, those mandates can be too severe, and at the same time, generally ineffective.

Finally, the pharmaceutical distribution chain should address a proactive posture to assure the integrity of the product. If done thoughtfully, this would limit liability, maintain integrity, enhance trust and reliability and, perhaps, preempt overreaching government meddling. Leaders in the pharmaceutical industry should implement counterfeit detection technology now to protect our reputations and our bottom lines.

When, Not If, a Major Pharmaceutical Counterfeit Incident Will Impact the US Supply Chain In 2009

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

As I have traveled around the country speaking with many pharmaceutical industry and supply chain thought leaders in 2008, it seems apparent to me that all those in the know realize that the United States will shortly be facing a major health care crisis caused by the introduction of large amounts of counterfeit pharmaceuticals into the supply chain.

The question among these leaders is not if, but when.

I am predicting something in 2009. And it won’t be something as subtle as the counterfeit heparin which officially wasn’t a counterfeit, but poor manufacturing process caused by counterfeit raw materials. The number of casualties will go well beyond the 250 or so officially considered killed by the bad heparin. I am guessing we in the United States will be dealing with something that will affect thousands of lives this time. Unfortunately this incident or number of incidents, will force many within the industry and regulatory agencies to finally act aggressively and begin doing things that will actually solve the problem.

Just for the record, I consider counterfeit raw materials a counterfeit and officially labeling it otherwise does not make the consequences any less deadly. I don’t believe officials will be able to pass the next incident off as bad manufacturing practices, because likely it will not be quite as subtle.

I don’t like to predict doom and gloom, but my outlook for this healthcare issue is based on some pretty significant evidence that points me to this ultimate conclusion.

• The continued rise in the estimated counterfeit percentage of the supply chain globally. Most experts believe that globally, in third world and developing countries that up to 50% of the medication within their supply chain is counterfeit or adulterated.

• The rise in percentage of counterfeit and adulterated medications in the supply chain in non-third world countries. Some European countries estimate averages above and beyond 10% of the medications within their supply chain are counterfeit or adulterated.

• The fact that over 90% of the raw materials and 60% of the production of medication globally (including Europe and the United States) is now done in countries with some of the highest rates of counterfeit medications within their supply chain.

• High death rates in Africa and Asia based on either the consumption of counterfeit or adulterated medications or diseases like malaria which were not properly treated because of counterfeit or adulterated drugs.

• The FDA hastily opening three major field offices in China and the deployment of thousands of inspectors overseas in an overt but questionable effort to somehow police hundreds of thousands manufacturers and suppliers importing billions of tons products into the United States into hundreds of ports of entry.

• The fact that nearly every major pharmaceutical manufacturer and pharmaceutical distributor in the United States has had to deal with significant liability because of a counterfeit or adulterated medication within their brand or distributed through their companies. The reality is though even after spending millions in attorneys, court cases and settlements there is still not a significant deterrent or protection of their inventories, in fact now given the increased globalization these same entities are in fact more vulnerable now than they were ten years ago.

• The global economy as it continues its slide will continue to fuel individuals and well financed organizations to continue their harmful but profitable enterprises of counterfeiting medications.

• Finally and of most significance to me is the fact that when XStream deployed an XT250 system within a small secondary distributor in the Southeast United States, our system discovered four individual counterfeit medications within the first sixty days of authenticating their inventory.

There are many more “signs” or evidence that I could point to but I think that I have made my point. This is one of those "perfect storm" issues where all of the elements of a significant disaster seem headed for a major collision and the United States consumer is the tiny boat hoping to stay afloat and above water.

I hope I am wrong, but unfortunately, I know I am right. Maybe not about the exact date but now it is a matter of when, not if.

About the author: Alan Clock is a veteran of over 20 years within the pharmaceutical industry. He has served in senior positions with pharmaceutical distribution companies and disease management organizations. He is currently the Senior Vice President of XStream Systems, a high tech start up focused on a revolutionary solution to the authentication of pharmaceutical products within their sealed unit of sale. He can be reached at aclock@xstreamsystems.net. For more information on XStream visit their website at www.xstreamsystem.net.

XStream Systems Stories and News for the Week of December 12, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to counterfeited, adulterated and contaminated medicinal products:


Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient
The recall is effective immediately and is being undertaken because these lots of STARCAPS contain an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.

The company’s investigation to date has indicated that an additional lot of raw material intended for use in the production of STARCAPS which has been stored in sealed drums since the time of its importation into the U.S. is also contaminated with Bumetanide. This information seems to indicate that the contamination occurred at the point of production of the raw material in Lima, Peru.


China blacklists 74 websites selling fake herbal drugs
China's traditional medicine watchdog has issued a blacklist of 74 Beijing-based websites suspected of selling fake herbal medicines online and warned consumers not to buy their products.

Herbal medicine is a huge industry in China with sales in the first 11 months of 2007 totaling 118 billion yuan (17.1 billion dollars) and up to one billion dollars of these sales were overseas sales, according to the Hong Kong-based consulting firm China Commodity Marketplace.

Sierra Leone: Le 1 Billion Fake Drugs Destroyed
Freetown — Ministry of health and sanitation has teamed up with the pharmacy board to dispose of more than Le1 billion worth of counterfeit, substandard, expired and fake drugs.

Communication is the key – How is the FDA extending communication on Threats to Public Safety?

To better reach the public on safety issues throughout the pharmaceutical supply chain, the Food and Drug Administration (FDA) is collaborating with WebMD. This will allow the FDA to expand its Consumer Health Information and give the consumers important information on product recalls and emerging public health safety issues in a timely manner.

FDA’s website currently gets 6 million viewers a month from the regulatory pharmaceutical industry while the WebMD site is geared to consumers and gets 49 million viewers a month.

This extends the FDA’s current efforts in consumer communications such as “Andy’s Take” which is a weekly online audio broadcast on the FDA initiatives in ensuring public safety.

Consumers can access the latest FDA information on WebMD’s “Protect Your Health” page. Information is provided for food safety, medication safety, cosmetic safety, product recalls and a guide to reporting problems to the FDA.

We, at XStream Systems applaud the FDA on their expansion of communication with the general public. This combined with patient’s ability to communicate problems back to the FDA completes the two-way communication needed between patients and the authority that regulates their medications.

Are Counterfeit Drugs in the U.S. Supply Chain?

The general consensus has always been that only a small amount of counterfeit drugs are in the domestic supply chain. True relatively speaking, the percentage of counterfeits found in the United States is lower (estimated at around 1%) than some underdeveloped countries (estimated as high as 50%).

However, this does not paint the whole picture… The U.S. has almost 43% of the market share, which means there are still thousands of counterfeit pills in our distribution cycle. To the consumer that is a victim, it matters not whether he is in the company of many fellow victims or only a few.

Furthermore, the frequency of counterfeits is increasing in more developed countries such as the U.K and the U.S. Now, incidents are showing up in the regular supply chain as you can see from the following news items:

First Foreign National Extradicted For Importing And Distributing Counterfeit Pharmaceuticals Drugs In U. S. Sentenced To Prison
Randy Gonzales, 40, a citizen of the Republic of the Philippines, was sentenced to prison for his role in a scheme to manufacture, import and distribute counterfeit pharmaceutical drugs in the United States.

Gonzales was extradited to the United States from Bangkok, Thailand on March 26, 2008 and indicted four days later. Special agents of the Immigration and Customs Enforcement (ICE) and the Food and Drug Administration Office of Criminal Investigations (FDA)seized more than 60,000 counterfeit Viagra pills and 15,000 counterfeit Cialis pills. The counterfeit drugs were valued at more than $776,000.


Miami Man Sentenced To 20 Years For Massive Drug Diversion Operation
A Miami man has been sentenced to 20 years in prison for running a massive drug diversion operation that made millions of dollars in illegal profit. Jose Luis Perez, 52, had illegally bought expired, counterfeit or adulterated medicines, relabeled them and shipped them through a series of his own pharmaceutical firms in order to sell them to mainstream suppliers.

Investigators were tipped off by a Cincinnati pharmaceutical wholesaler who, while filling a prescription, noticed that the wrong pills were inside and the accompanying paperwork was for a different drug.

At Perez’ Hialeah warehouse, law enforcement officers found $500,000 of prescription pills used for the treatment of HIV-related illnesses, Schizophrenia and erectile dysfunction. Law enforcement also found counterfeit labels and prescription paperwork for more that $8 million-worth of pharmaceuticals.


Local pharmacist, businesses disciplined by state
(Nov. 30, 2008; The Telegraph) In 2006, Hudson resident Richard Minasian, owner of Nashua-based Armin Medical LLC, pleaded no contest in a Florida court that he and a Miami man had sold drugs with fake pedigrees.

That same year, the New Hampshire Board of Pharmacy revoked Minasian's license to sell drugs for at least 10 years, and he was assessed a $29,000 fine, but $20,000 of it was stayed for two years pending good behavior.


As these stories indicate, government intervention is gearing up and we at XStream Systems applaud the increased authority given to FDA and law officials to seize products and prosecute criminals. But the reality is that these undercover operations often take a year or more to complete. During this time consumers, wholesalers, and repackagers are exposed.

Now is time for businesses to protect themselves and their customers by effectively securing their on-site inventories. It is too late to hide our heads in the sand and deny that counterfeits exist – they do and what are the implications for you if they unknowingly pass through your hands!

Diethylene glycol, killer on the prowl

Nigerian death toll rises in tainted infant teething drug

The latest victims to greed are the smallest among us…….

Over 45 babies have died in Nigeria from the tainted teething syrup, "My Pikin Baby Teething Mixture". The medicine is contaminated with diethylene glycol, causing kidney failure in the children who died.

The National Agency for Food, Drug Administration and Control (NAFDAC) has shut down the manufacturer of "My Pikin", Lagos-based Barewa Pharmaceuticals, as well as a company called Tranxell Ltd, which is believed to have supplied chemicals to Barewa and possibly to other local drugs manufacturers.

Diethylene-glycol-contaminated products have had a long history in dealing death. This chemical, which is used in antifreeze, is sometimes added illegally as a cheaper sweetener or thickening agent with deadly results.
So deadly in fact, that the catastrophic deaths following its first use in medicines led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act.

In 1937 more than 100 U.S. citizens, many of them children, died when diethylene-glycol was added to an antibiotic to make the liquid form, Elixir Sulfanilamide.

And their deaths were painful as noted in a grieving mother’s letter to President Franklin D. Roosevelt:

"The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."

According to the World-wide Organization of the Health during the 1980's and 1990's more than 600 people were killed by this type of contamination.

Furthermore it continues still today and is becoming more prevalent. In 2007, Diethylene glycol was found in contaminated toothpaste manufactured in China. Over a hundred people died in Panama. That same year The New York Times reported that about 900,000 tubes turned up in the United States, including correctional facilities, juvenile detention centers, and some hospitals, as well as discount stores.

In today’s global economy ingredients can be manufactured anywhere and consumers rely on companies to look out for their safety. Authentication of raw materials is essential to ensure the safety of consumers and mitigate the risks of contamination to the finished product.

XStream Systems Stories and News for the Week of November 28, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the safety of our supply chain. Recent incidents such as the adulteration of heparin and the discovery of melamine in baby formula have heightened consumer’s awareness of safety risks to our food and drug supply.

U.S. pays millions for unapproved drugs
The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s.

Republican Lawmaker Asks GAO to Review FDA Handling of Heparin
The FDA may not have used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities, according to a Republican congressman. “Based on the available information … there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths,” Rep. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, says in a letter to the Government Accountability Office (GAO).

FDA Finds Melamine Traces In U.S. Infant Formula
Bloomberg News reported that the industrial chemical melamine was found in U.S. infant formula in trace amounts that pose no health concern, according to FDA. Since September, some 50,000 children in China were sickened by melamine-tainted milk and several died.

We at XStream Systems believe that molecular pharmaceutical authentication will play a major role in the coming years to protect us from contaminated, adulterated and counterfeit products. To learn more about how this can be done, please visit www.xstreamsytems.net.

Prescription Drugs Kill 300 Percent More Americans than Illegal Drugs

Death by prescription is on the rise. An analysis of 168,900 autopsies conducted in Florida in 2007 found that three times as many people were killed by legal drugs as by cocaine, heroin and all methamphetamines put together.

This trend is mirrored nationally as the DEA confirms that the number of people abusing prescription drugs in the United States has jumped 80 percent in six years to seven million.

While illegal drug use is down with teens, prescription abuse is on the increase. Prescriptions are often obtained without a prescription at an online pharmacy. This year, The National Center on Addiction and Substance Abuse at Columbia University reported that of the 365 websites that advertise controlled substances, 85% of them do not require a doctor’s prescription.

In answer to this growing problem the senate passed the Ryan Haight Online Pharmacy Consumer Protection Act to curb online prescription drug trafficking, abuse, and availability. The recently passed bill amends the Controlled Substance Act by requiring face-to-face prescribing, DEA-endorsement before a pharmacy can dispense, and stiffer penalties for violators.

The bill was named after Ryan Haight, a California honors student who died from an overdose of the painkiller Vicodin he obtain over the internet by posing as a 25 year old man with chronic back pain.

We at XStream System applaud this legislature to protect our citizens and encourage consumers to purchase prescriptions only through licensed brick and mortar pharmacies or online pharmacies certified through Verified Internet Pharmacy Practice Sites (VIPPS).

How Do You Classify Counterfeit Pharmaceuticals?

No Two Counterfeits Seem the Same...
By: Alan Clock, Senior Vice President, XStream Systems, Inc.

As our solution continues to discover counterfeit medications within the US Supply Chain, we have found that there is little official direction in the way of classifying pharmaceutical counterfeit incidents. What we are discovering is that within our universe of deployed and pilot units within the pharmaceutical supply chain (full line wholesalers, secondary distributors and reverse logistics) there is a wide variety of pharmaceutical counterfeit activities that do not fit into one easy classification.

What our end users have found within their inventories demonstrate a wide array of counterfeit medications with a variety of sophistication, quality and ways that they are introduced into the supply chain.

It seems apparent to us that these incidents should not be classified in one broad bucket and would require an industry or regulatory body to more granularly classify counterfeits so as to better understand and ultimately eliminate them as a health risk to all consumers.

We at XStream Systems attempted to tackle this classification issue recently and found that our discussion denigrated into a very long discussion with little output. Usually we got stuck on the finer points of when, where and how and how this impacts the nature and ultimate “class” of the counterfeit.

Undeterred, I posed the question to several industry leaders at an Anti-Counterfeiting Conference that I attended in Washington DC with unfortunately the same results.

Ultimately, I went on-line and found the industry’s most trusted organization, the Pharmaceutical Security Institute’s definition and although they seemingly have the best take on the issue as a whole, they too defer to another organization, the World Health Organization for guidance:

PSI's definition of counterfeit medicines is built upon the definition utilized by the World Health Organization (WHO). Counterfeit medicines are products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product. This definition applies to both branded and generic products.

It still seems to me based on our recent experience that this definition and classification is not enough given the massive evolution and proliferation of the counterfeit pharmaceuticals. We need something better to drill down and interdict the problem at its various cores in order to eradicate it.

I now pose the question to the public...

How Do You Think Counterfeit Pharmaceuticals Should Be Classified?

I anxiously await your responses.

Scales “Weigh In” and are Found Inadequate

By Brian Mayo, President and CEO, XStream Systems, Inc.

While analytical instruments work well in a forensic laboratory environment, the pharmaceutical industry is struggling to detect counterfeit medications throughout the distribution chain. Sophisticated analytical instruments typically require access to the exposed medications and a highly trained operator to interpret the results. But what about the warehouse worker handling sealed prescription medicine? How does he/she know if any counterfeit products have been received in the large shipments that have been received? The bottles cannot be opened, and the warehouse workers are clearly not trained well enough to operate the analyzers even if they could get access to the medicines inside the bottles.

Often times wholesalers, dispensers, and re-packagers settle for an inexpensive and fast solution: a scale that weighs the bottles. Bottles are simply checked by weighing them and verifying if the weight is proper. Unfortunately counterfeiters can and have been matching the weights contained within each prescription bottle. The industry is being lured into a false sense of security. Checks are being done along the way and everything appears ok. Only after passing through many hands and finally being opened does one discover the truth, that the contents inside are not what was expected. By that time, the counterfeiter is long gone and untraceable.

The war against counterfeits is always a cat and mouse game. As new methods of checking for counterfeits are created, new methods of avoiding it usually follow. Multiple protection measures may be required over time. Hopefully enough checkpoints are put into place to discourage counterfeiters, who then go off looking for easier prey elsewhere. Just take a close look at a $20 bill to see its layered checking methods such as the serial numbers, special inks, special paper, imbedded thread, holographic images, and fine print resolution. These have evolved over time, as the counterfeiting schemes became more sophisticated.

Unfortunately the pharmaceutical industry is now the easy prey. Here we are, in the 21st century, with many companies still relying on weighing bottles of drugs to protect the public against counterfeit drugs. Why? Well, for one thing when this was implemented, counterfeit drugs did not seem prevalent. Counterfeit drugs did not seem to be such a big problem. Now they are a $40B industry and growing rapidly. A second reason is that the right authentication technology has, until now, not been available.

The next phase of combating counterfeit drugs centers around three very important requirements.

1. There needs to be the ability to penetrate inside sealed bottles and packages to reveal what’s truly inside.

2. There needs to be an analytical tool that somehow determines exactly what the drug is, and not just simply how much it weighs.

3. The new method needs to be easily done by anyone, anywhere in the supply chain.
All three of these very important requirements are met by the XT250™ Material Identification System offered by XStream Systems. Any warehouse worker can rapidly and easily authenticate drugs inside sealed bottles, by automatically verifying the drug’s molecular structure.

The majority of counterfeit drugs detected so far by the XT250 system had previously passed the weighing test. This indicates that counterfeiters are well aware of the weighing process in the supply chain and successfully circumvented those checks. Now that the XT250 system is verifying the molecular structure of the drug, counterfeiters can only reproduce the actual drug to avoid detection by the XT250 system. The counterfeiter’s job just got a whole lot harder… Counterfeiters, it’s now your move.

XStream Systems Stories and News for the Week of November 21, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. As counterfeits become more prevalent globally and domestically, science will play a strong role in protecting our nation’s supply chain and molecular pharmaceutical authentication will be an important part of solving this global problem:

Israel joins world effort to halt counterfeit drug sales
Inspectors went to the Tel Aviv package warehouse of the Israel Postal Company and other facilities last week, seizing drugs prohibited in Israel and others suspected of being counterfeit that had been shipped from India and China.

FDA: FDA Hosts Its First Science Writers Symposium
Recently FDA experts met with more than 50 journalists and science writers at the FDA’s first Science Writers Symposium. At this day-long event, FDA’s scientists and physicians presented on such research as the science behind the Salmonella outbreaks, melamine adulteration of food substances, and nutrigenomics – an emerging field that has the potential to prevent disease and maximize health by using genetic profiles to tailor what we eat. FDA experts also presented their novel discoveries to prevent pandemic flu, identify contaminated heparin, and analyze the safety of drug-eluting stents down to the molecular level.

FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.

Daschle Accepts HHS Cabinet Post
Former Senate Majority Leader Tom Daschle has accepted President-elect Barack Obama's offer to be Secretary of Health and Human Services.

Will the FDA’s China Office Protect US Consumers?

The Washington Post, New York Times, Bloomberg News and a variety of other media outlets all have stories today announcing the Food and Drug Administration (FDA) deploying staff and opening its first office in Beijing, China.

This is the FDA’s reaction to China’s increasing role as a major exporter to the United States in food, drug and consumer products. Unfortunately China is also the world leader in exporting counterfeit, adulterated and contaminated products and the FDA is attempting to slow down the dangerous impact to US consumers. Recent high profile examples of counterfeit, adulterated and contaminated products include the recent heparin contamination which resulted in over 250 deaths in the US, the pet food contamination with melamine and the huge issue over lead paint on children’s toys. Most experts agree that these examples of toxic products within our consumer supply chain represent only a fraction of the dangerous products that are reaching our shores on a daily basis.

Apparently the FDA has plans this year to open up other offices throughout China and certify third-party inspectors who can approve and qualify the safety of exports to the United States.

The question is when will the FDA deploy a materials analysis technology that can look inside product packaging to inspect and protect the US consumer instead of throwing bodies at a high expense to attempt to catch the problem before it gets into our supply chain?

Stay tuned, we at XStream Systems are trying our best to introduce our revolutionary technology as a solution to catching the problem before it impacts our nations health.

Weekend News Highlights International Epidemic of Counterfeit Medications

XStream Systems found an op-ed article in the New York Times regarding the health epidemic in the third world regarding poor quality and counterfeit medications and a story reported by Bloomberg News about the seizure of millions in counterfeit malaria, HIV and tuberculosis drugs in SE Asia.

The phenomenon of counterfeit, adulterated and contaminated pharmaceuticals continues to grow and flourish as our global economy declines.

Until technology solutions such as XStream’s XT250 become ubiquitous, this malady will continue to proliferate and impact those beyond the third world.

Op-ed: More needs to be done to ensure safety, quality of drugs in the developing world.

In an op-ed in the New York Times (11/15, A21), Roger Bate, author, director of the health advocacy group Africa Fighting Malaria, and resident fellow at the American Enterprise Institute, wrote that, "if aid organizations are serious about combating the spread of deadly diseases in the developing world, they must do more to ensure the safety and quality of drugs."

According to Bate, the importations of counterfeit medicines "are only part of the problem." Bate explained that in order "deal with the scarcity of drugs, many poor governments have turned to local production." Still, "local producers often make low-quality" medicines. "Many poor countries," he wrote, "lack the regulatory structure needed to monitor safety and effectiveness. Some do not even have laws against selling substandard drugs, and none have sophisticated agencies like the" Food and Drug Administration (FDA).

Bate concluded that aid organizations must first "give technical and financial support to governments' sincere efforts to maintain strict drug inspection standards." Second, they should "always refuse to subsidize any low-quality drugs." And finally, organizations need to "insist that only brand-name and generic products approved by stringent drug agencies like the FDA be distributed."


Interpol seizes more than $6.65 million of counterfeit medicines in Southeast Asia.

Bloomberg News (11/17, Bennett) reports, "Interpol seized more than $6.65 million of counterfeit medicines against malaria, HIV, and tuberculosis in Southeast Asia and made 27 arrests, disrupting the region's fake drug trade for the second time in three years."

According to Aline Plancon, an officer involved in the "five-month investigation called Operation Storm," officials "seized more than 16 million pills, including fake antibiotics for pneumonia and child-related illnesses." Operation Storm "involved almost 200 raids" conducted across "Cambodia, China, Laos, Myanmar, Singapore, Thailand, and Vietnam."

Health officials were particularly concerned by "copies of a class of malaria drugs called artemisinins." Fake "artemisinin-based treatments containing small amounts of the medicine are helping the parasite responsible for malaria to evade authentic drugs in patients near Cambodia's border with Thailand, a recent study showed."

Government Seizes Contaminated Heparin STILL in the US Supply Chain?

In a news report, the Federal Agents seized contaminated Heparin a full seven months following the recall. Read the full story.

It seems shocking that after confirmed deaths of over 250 people that this type of product would still be in the domestic supply chain. “I think that this is an illustration of how many gaps that remain in the process and the system that leaves the US consumer at risk,” stated Alan Clock, SVP of XStream Systems. “Those within the supply chain that believe that they are not vulnerable or that the burden of product safety lay elsewhere are in for a rude awakening when not if the next counterfeit or adulterated products hit their warehouse or store shelves.”

To learn more about XStream Systems revolutionary materials analysis solution to counterfeit, contaminated or adulterated products please visit us at www.xstreamsystems.net.

How do Recalls Affect Consumer Loyalty?

A new study release by Deloitte shows that safety issues costs companies millions of revenue dollars. The study shows that when consumers hear of product safety and/or quality issues, more than half of them switch products for nine months or more, increasing the likelihood that they would discontinue the brand use entirely.

Modern consumers are less tolerant of recalls and over 49 percent are extremely concerned with product safety. Those population segments with the greatest concern are women (53%) and seniors (56% of those over the age of 55).

In addition, recent recalls from China have left the public with a distrust of items manufactured there. Over 73 percent stated they were extremely apprehensive about items manufactured in China.

To see how loyalty is affected, just look at last year’s recall issue where thousands of pets died from tainted products resulting in the largest recall of pet food in US history. Today, pet owners, even in this economic downturn, are reluctant to change to a cheaper pet food. ….

A recent article by the associated press stated “That's because many pet owners, who upgraded their kibble after contaminated pet food killed or sickened thousands of animals last year are leery of switching back…..”

So what can companies do to assure their customers that their products are safe? Consumers want safety information on the package, on the company website, and from the government. Furthermore, testing materials for consumer safety is a necessity.

Build and they shall come – But, test and assure and they will stay.

Pharmaceutical Regulatory News Headlines - Week of October 31, 2008

In the United States, Halloween is the day for Tricks and Treats. But - Globally regulatory authorities have Penalties not Treats for would be counterfeiters.

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. Global regulatory authorities are now recognizing the increasing threat these fraudulent products place on their citizens and are taking legal actions to discourage it:

Saudi Arabia: Local Markets Flooded with Counterfeit Drugs
Agreements were made on Tuesday to step up legal action against counterfeiters in Saudi Arabia to ensure consumer safety. According to Abdullah Al-Abdelgader, a pharmaceutical manufacturing director, counterfeit drugs account for around 30-40 percent of medicines sold at local pharmacies and hospitals in Saudi Arabia and expose consumers to great risk. In the Gulf area, the counterfeiting economy accounts for $13 billion, with a share of $4 billion in the Saudi market. ("Some 30-40% of Medicines Sold Locally 'Are Counterfeit', Says Manufacturer," Saudi Gazette, October 22, 2008)

FDA Oversight of Foreign Drugs Lacking
The Food and Drug Administration is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections, according to a report by the Government Accountability Office. The House Energy and Commerce Committee introduced a bill that would mandate foreign inspections at a rate close to that of FDA inspections of U.S. plants. U.S. companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years. ("FDA Is Faulted for Oversight of Foreign Drugs," Wall Street Journal, October 21, 2008)

Nigeria: Government Takes Steps to Block Counterfeit Drugs
The National Agency for Food and Drugs Administration and Control (NAFDAC) has blocked 22 Indian pharmaceutical companies from importing and distributing drugs in Nigeria. The agency has outlawed the use of about 40 imported drugs in the country, describing them as potentially dangerous for human consumption. As part of its efforts to curb drug counterfeits, NAFDAC is advocating for greater public education and awareness. ("Fake Drugs: NAFDAC Bans 22 Indian Firms," AllAfrica.com, October 22, 2008)

XStream Systems thinks that its penetrating authentication technology can be an integral part of the comprehensive solution to this global problem.

Economic Downturn Means Counterfeit Medications Likely to Increase

As the economies around the globe continue to teeter and decline, it seems apparent that those same dynamics will trigger an increase in the criminal enterprises that deal in counterfeit medications.

This next year, we anticipate a sharp increase in reported instances of counterfeit pharmaceuticals discovered within the pharmaceutical supply chain.

“All of the economics drivers that are driving the economy down, give counterfeiters the perfect environment to flourish, “stated Alan Clock, Senior Vice President at XStream Systems. “Consumers and healthcare providers that are looking for cheaper medications often look outside of the secure sources and can easily fall prey to unscrupulous suppliers who may be selling counterfeit or adulterated medications.”

As consumers look for value in purchasing medications, it is important to buy products from established, licensed drug stores. Only buy products on-line that are affiliated with a national chain drug store or licensed pharmacy benefit organization.

Most importantly, remember, if it sounds too good to be true…it probably is. Let the buyer beware, especially when you are buying your medications in a troubled economy.

XStream Systems Stories and News for the Week of October 24, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Demand for Foreign Products Changing FDA, Official Says
The FDA needs to shift its approach on imports to one that minimizes risk at each point in the product life cycle — from foreign manufacture to domestic use, according to Timothy Ulatowski, director of compliance in the agency’s Center for Devices and Radiological Health. The FDA will release a draft guidance soon that outlines standards for third-party certification programs for FDA-regulated products, he said. It also is preparing a draft guidance on good importer practices.

A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient.

FDA To Open Multiple Inspection Offices Abroad By Year-End
The U.S. Department of Health and Human Services will send the first FDA inspection teams to new offices in China, India, Europe, and Latin America before the end of 2008, according to HHS. "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partner, including China," stated HHS Secretary Mike Leavitt.

FTC Breaks Up Spam Network Which Illegally Sold Drugs Online
The Federal Trade Commission said Tuesday that it has broken up a global spam network responsible for sending billions of illegal messages encouraging consumers to buy unsafe male-enhancement and weight loss pills. The spam network, which processed credit card information in Cyprus and Georgia, used servers in China to host its websites. The FTC said the network used by this operation compromised tens of thousands of computers around the world and was capable of sending up to 10 billion spam messages per day. The bogus drugs were shipped from China and India.

XStream Systems Stories and News for the Week of October 17, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Study Finds Prescription Drug Packaging Varies In Quality
The quality of prescription drug packaging from leading manufacturers varies considerably, according to a study by Pharmacy Healthcare Solutions Inc. (PHSI), a finding that could affect the integrity of the medications contained in them.

Bush signs anti-counterfeiting bill
President Bush signed a bill creating an intellectual property czar to beef up U.S. enforcement of laws against pirated and counterfeited products, including pharmaceuticals.

New Zealand: Death Highlights Dangers of Ordering Drugs Online
Earlier this year, Graham David Goodwin of Blenheim died after taking drugs that included an anti-depressant he had ordered online and had mailed to him. As a result, Parliament is being urged to crack down on the illegal importation of prescription medicines.

Sex Doctor Sold Dodgy Tablets
Dr George Patino, 48, dubbed the “King of Viagra” was jailed for his part in a multi-million pound fake medicine ring. He sold thousands of counterfeit impotence tablets to customers across the world.

Pharma Execs Ask - How Can I Halt Counterfeit Drugs?

That’s the question of many in the pharmaceutical industry. How can I secure my brand? How can I be sure that counterfeits don’t infiltrate my supply chain? How can I minimize my risk? And……What are the breaking technologies available in pharmaceutical authentication and supply chain security?

To discuss these questions, leading executives are planning to attend The Center for Business’ Premier Forum on Anti-Counterfeiting and Anti-Diversion Strategies October 20-21, 2008 in Vienna, VA. Regulatory officials, pharmaceutical organizations, and solution providers will be presenting various perspectives on the problem.

Alan Clock and John Lundquist from XStream Systems will be speaking on authentication technologies and how they can be implemented and integrated with existing safeguards to provide a comprehensive solution against counterfeit, adulterated and tampered drugs.

If you would like to register or would like more information on the event, please visit www.cbinet.com.

Largest European Seizure: Two Million Counterfeit Pills Seized in Brussels Airport

Two million counterfeit pills have been seized in Brussels Airport. The seizure of the drugs which originated in Mumbai, Indian and were bound for West Africa is the largest confiscation of counterfeit medicine in Europe.

The three Indian shipments contained counterfeit pharmaceuticals labeled as Tramal, a painkiller, and Fansidar, an anti-malaria drug.

Africa already has the daunting task of trying to control its malaria outbreaks without further obstacles of fake treatments. Many countries, organizations, and businesses have been aiding Africa to fight malaria and therefore, counterfeit medicine is a real threat to their work. In some countries up to 60% of anti-malaria drugs are fake and are aiding in the drugs resistance to current therapies.

Furthermore, the biggest victims are the children, because according to the Worlds Health Organization (WHO) a majority of malaria deaths are children under the age of five and Fasidar is one of the drugs given to pregnant women for the prevention of malaria.

The scope and intent of this particular case leads us to ask – Is any medication safe? How can we protect our most vulnerable medications? We believe the answer can be found in pharmaceutical authentication which verifies the drug itself. With nothing added and nothing destroyed; the method can be programmed to test various oral medications.

To learn more of this fascinating technology, see XStream Systems website at http://www.xstreamsystems.net/products.html.

Schwarzenegger Terminates the Momentum of E-Pedigree in California

In a story reported in Drug Store News, Tuesday, California Governor Arnold Swarzenegger signed a bill which essentially pushes back the deadline for compliance of e-pedigree requirements within the supply chain until 2017.

Given the seriousness of the threat of counterfeit, adulterated and contaminated medications within the US pharmaceutical supply chain it is apparent that manufacturers, distributors and dispensers still need to take precautions to protect their drug inventories.

XStream’s EDXRD technology allows each member to independently protect itself from counterfeit and adulterated medications without an elaborate and expensive process that only tracks the transaction.

California governor signs e-pedigree bill,

SACRAMENTO, Calif. - Gov. Arnold Schwarzenegger handed California pharmacies a major victory Tuesday, signing into law a bill that gives the state's drug retailers some breathing room in their effort to comply with electronic pedigree and track-and-trace technology requirements for prescription drugs.

Schwarzenegger signed into law SB 1307, which revised the technology requirements for establishing the origin and movement of prescription drugs through the supply chain. Included in the law is a provision that pushes back the deadline for compliance for California pharmacies from Jan. 1, 2011, to Jan. 1, 2017.

The decision reflects the recommendations of pharmacy leaders for a gradual and more workable implementation process for new e-pedigree requirements. A number of pharmacy representatives testified before the Enforcement Committee of the California State Board of Pharmacy, asking for an extension that would allow them enough time to adopt the track-and-trace technology needed to establish every drug's pedigree.

California warns Residents not to flush pharmaceuticals

What happens to your unused pharmaceuticals? Many consumers are concerned with the increased numbers of pharmaceuticals showing up in our drinking water. Some states are answering this issue with collection and or recycling programs.

The California state and local officials are teaming with the U.S. Environmental Protection Agency for a "No Drugs Down the Drain Week," starting with events Oct. 2. The program recommends that drugs be dropped at special collection sites or tossed in the trash.

Some states collect unused drugs and then destroy them and according to according to the National Conference of State Legislatures, 36 states have recycling programs for prescriptions to be redistributed to needy individuals. The regulations for these states vary, but the general provisions for recycling are as follows:

• All donated drugs must not be expired and must have a verified future expiration date.
• Controlled substances as defined by the federal Drug Enforcement Administration are usually excluded and prohibited.
• A state-licensed pharmacist or pharmacy must be part of the verification and distribution process.
• Each patient who receives a drug must have a valid prescription form in his or her own name.

On the surface this is at the least a protection for our environment, and at the most a fine humanitarian effort…but the only safe way that drugs can be properly recycled and properly dispensed for those in need is to make certain that they are authentic by using a non-destructive verification process.

XStream Systems, XT250 is designed to authenticate and verify materials inside its container without degrading or destroying the material.
Save the environment and help those in need, recycle drugs by authenticating them.

Obama and McCain Both Support Drug Re-Importation

As the 2008 Presidential Campaign heads into its inevitable heated conclusion and the individual campaigns separate themselves on the issues, it may be time to reflect briefly on an issue that both Barrack Obama and John McCain seem to be in agreement.

Both Barrack Obama and John McCain have publically stated their support of drug re-importation as a way to curb the high price of pharmaceuticals.

Given this seemingly rare consensus it is important to realize that there is a significant possibility that drug re-importation may become a reality once the new administration comes into power.

There are certainly many pros and cons to the issue and many reasons why there is significant support for this stance by both candidates. It is important however to understand the considerable danger that re-importation magnifies if it becomes law.

As we all know by now, the issue of counterfeit, adulterated and contaminated drugs has been proliferating both domestically and globally dramatically in recent years. To date the United States has little in the way of regulations or solutions in place to adequately protect the domestic pharmaceutical supply chain from this threat, outside of weak state pedigree laws which attempt to track the transaction of drugs from the manufacturer to the drug store.

If the re-importation of drugs becomes a reality, the potential threat of even more counterfeit, adulterated and contaminated medications reaching the American consumer will automatically triple given the supply chain’s inability to adequately track and authenticate the actual contents of the medication.

This is where XStream Systems technology can save the day. XStream’s XT250 system has the ability to authenticate and verify the contents of a sealed container in a non-destructive manner. Authenticating the contents of the imported pharmaceuticals will be critical in making certain that pharmaceuticals imported from other countries are clinically safe and efficacious.

Please visit XStream Systems website at www.xstreamsystems.net for more information on this technology.

Do counterfeiters have no shame?

Who would target innocent children in the pursuit of money? Fourteen babies have been hospitalized with kidney stones after drinking what is thought to be counterfeit baby formula. This recent scheme seems targeted toward the poorer rural areas of China where young families have turned to discounted milk powder to lower their household costs.

Why did they choose infant formula? – Well, just as in the case of the adulterated heparin, as demand exceeds supply so does the increased risk of susceptibility to counterfeiting. Over the past few years, increases in the cost of raw milk coupled with the decrease of dairy farming have further complicated this matter.

Sanlu, one of the four largest powdered milk companies in China, has stated that the product labeled as theirs is a fake and has sent their own personnel to investigate. This, however, is little consolation to the poor rural families whose babies are now suffering.

This is not the first case of deadly Chinese baby formula. In 2004, thirteen infants died and 170 were left malnutrition and underdeveloped by counterfeit formulas with little or no nutritional value which were sold under 45 different brands and manufactured in over 141 different factories.

The mere expanse of the operation is disheartening and its implications frightening in light of the fact that China is one of the largest exporters in pharmaceutical ingredients to the U.S.

We must fortify our inspection and authentication methods to ensure our brands integrity. Fool me once shame on you …. Fool me twice shame on me.

Track and Trace versus Inspection and Authentication Technologies?

In a comparison of Track and Trace versus Inspection and Authentication technologies it is apparent that Track and Trace solutions such as RFID, bar coding, holograms, tracing and pedigree products are not a one-size-fits-all solution to protecting the domestic and global pharmaceutical supply chain.

Track and Trace products might be sufficient, when employed throughout the Supply Chain to protect it from Drug Diversion which is one source of counterfeit activity, but these Track and Trace technologies cannot provide full protection for the product within the package. For example, how can anyone expect a Track and Trace product to determine if, either in the manufacturing or distribution process, the wrong ingredient was purposely or accidentally added into the product? Pedigree or Serialization may help, after a threat has propagated to the general public and was detected by other means, to help backtrack to the source of the problem. But by then it may be too late and the consumer will have already suffered.…

Only through the use of Inspection and Authentication technology such as XStream Systems’ XT250 Pharmaceutical Authentication System can those within the drug supply chain immediately inspect and authenticate the product within the container. Don’t let problems reach the general public. Stop the issues in their tracks.

For more information on XStream Systems and the XT250™ Pharmaceutical Authentication System, visit their website at www.xstreamsystems.net.

FDA says drug stores sold expired medications

The Medicine Shoppe, a subsidiary of Cardinal Health (one of the “Big Three Distributors”), sold expired or presumed fake prescriptions to their customers. Granted this was just two of their stores located in Baltimore, but it does make one wonder – How did this happen?

Especially troubling is that this may just be the beginning. In Europe, officials are seeing an upward trend of expired product simply being relabeled to appear good. It is estimated that 10% of medicines sold there are counterfeited or adulterated.

The Medicine Shoppe's suspect medications and the conditions they treat include:

• Lisinopril (20 milligrams) _ hypertension
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg) _ cough
• Gabapentin (100 mg, 300 mg and 400 mg) _ epilepsy
• Metoprolol (50 mg) _ hypertension
• Nifedipine (30 mg) _ hypertension
• Diclofenac Sodium (30 mg) _ anti-inflammatory
• Glucophage (500 mg Extended Release) _ diabetes
• Glucovance (125 mg and 500 mg) _ diabetes
• Glipizide/Metformin (2.50 mg/250 mg) _ diabetes
• Furosemide (20 mg) _ diuretic
• Tamoxifen Citrate (10 mg) _ breast cancer
• Metformin HCl ER (500 mg) _ diabetes
• Calcitrol (0.25 micrograms) _ osteoporosis

It has long been assumed that if product was purchased straight from the manufacturer and/or one of the major distributors, that naturally, the medicine was pristine. However, these days that assumption, sadly, is no longer valid. This year alone, we have witnessed recalls from Baxter for adulterated heparin, Ranbaxy for counterfeit HIV medications, and NOW a major drug store chain for fake or expired prescriptions.

To view the full article from Associated Press, click here.


Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Ranbaxy Probed Over Counterfeit Medicine

In an article that appeared in the Washington Times, the Justice Department is investigating whether Ranbaxy Laboratories Ltd., which supplies generic drugs to the U.S. market and to President Bush's global AIDS initiative, has falsified data, followed sub-par manufacturing practices and distributed counterfeit medicine.

The filing stated that "allegations from reliable sources indicate a pattern of systematic fraudulent conduct" by the company. The allegations include that in its application process, the company submitted fabricated data to the Food and Drug Administration for generic drugs to be distributed in the U.S. and anti-retroviral drugs to be distributed in other countries as part of the President's Emergency Plan for AIDS Relief.

This is yet another example of potentially counterfeit product distributed widely in the global pharmaceutical supply chain that would have passed all Track and Trace methods of interdiction. These products have been distributed and consumed because pedigree or tracing processes do not authenticate the medication inside the container.

XStream Systems XT250 would have been able to discover the fraudulent and counterfeit material before they were distributed and dispensed because the technology verifies the molecular structure of the medication inside the sealed container.

To learn more about the XT250, visit our website at www.xstreamsystems.net.

To read more of the Washington Times article click here.

Making a Killing: The Deadly Implications of the Counterfeit Drug Trade

This book written by Roger Bate and published by American Enterprise Institute for Public Policy Research is an excellent encapsulation of the growing danger that is facing consumers globally. In his book Bate masterfully researches the history, scope, globalization, causes and current solutions on the issue of counterfeit pharmaceuticals.

Unfortunately this is an issue that far too few industry and government thought leaders are aware of, adequately educated on or are taking the proper steps to protect their company or constituents against.

Bate recommendations seem to be fixed primarily on dated technologies such as e-pedigrees and RFID as the answer to protecting the drug supply chain. Regrettably he seems unaware of other technologies like XStream Systems' XT250 that can authenticate medications inside a sealed container and which teamed with or in a standalone fashion can properly protect inventories throughout the global and domestic pharmaceutical supply chain. Here’s hoping that as Bate follows up on this well written book, he goes beyond his excellent foundation of the issue and deeper and further in researching potential solutions.

All-in-all, Making a Killing is an excellent book that is a must read for everyone involved in the healthcare industry and the pharmaceutical supply chain.

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.

Cargo Theft: A Major Rx Supply Chain Issue

The June 23, 2008 issue of Drug Topics contains an article about the ever increasing issue of cargo theft and its impact on the drug supply chain.

Given the high dollar value of pharmaceutical shipments, shipments of all types of medications lead the list of targets for transit thieves.

Much of the article is based on a presentation at a National Boards of Pharmacy meeting by FBI Special Agent Ryan Toole. The article states, “….in 2005 there were reported thefts of $14 million worth of Lipitor (atorvastatin, Pfizer) and Viagra (sildenafil citrate, Pfizer), and $29 million worth of Novartis products. However, Toole said, there's a long list of types of drugs stolen, including those for acid reflux, cancer, depression, hypertension, stroke, and many other conditions.”

Obviously once these products are stolen, these medications often make their way back into legitimate channels via non-legitimate enterprises in a variety of formats. The major concern is what happens to the product once it is in the hands of the thieves. Once in the hands of a thief, the products and their containers can be altered, contaminated, diluted or diverted. It is, however, certain that at some point these products will ultimately find their way to the hands of a consumer in a format that may not be safe for consumption.

These types of thefts make the case for an authentication technology that can verify the molecular structure of the material inside the sealed container such as the XStream Systems’ XT250™ Material Identification System. Operating in conjunction with Track and Trace processes or as a standalone technology, the XT250 protects the inventories within each step in the supply chain from receiving products that have been highjacked and altered.

View the article in full at this link to Drug Topics.

The Challenges of Product Safety in a Global Market Place

Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs Administration recently spoke at the Import Safety Summit and posted his view of import safety in his newsletter Andy’s Take:

“You are aware that an increasing number of products – especially those affecting your health, like food and medical products – are being imported from beyond our borders. This has raised great concern recently about FDA’s ability to ensure the safety of those products. This week, I attended a summit with hundreds of industry leaders to collectively address the challenges of product safety in a global market place.

My take is that the challenge of imported product safety will increase because as American consumers, we have come to expect - and even demand – year round variety in the food we eat. And because the production of many of the drugs and medical devices we use is now a global enterprise. So if we are going to want safety in all these products, it will require a collective effort, through collaboration with industry and international regulatory counterparts. This is to build safety in to the production of food and medical products as well as to create systems that assure their safety through distribution and consumption.

That’s why the FDA is accelerating initiatives like our participation in a groundbreaking program with partners in the European Union and Australia. Through a new pilot program we will jointly plan, allocate, and conduct certain inspections of facilities in developing countries that manufacture the starting materials for many of the drugs you take. If this program is successful, it could be expanded to include other types of drug manufacturing facilities. By leveraging the resources of each agency and sharing vital information, the number of foreign facilities in our inspection data base expands while allowing FDA to target its resources on products that we believe present the highest risk to US consumers.”

We at XStream System agree with Commissioner vonEschenbach on the importance of safety throughout the distribution chain and believe that the molecular pharmaceutical authentication possible with the XT250™ Material Identification System will further the industry’s ability to ensure safety to the consumer.

Inter-Industry Summit Discusses Import Safety in Washington DC

A representative from XStream Systems attended a unique event in Washington DC this week. The event, titled the Inter-Industry Import Safety Summit, was an unusual partnership of twelve industry associations and their membership. The impetus behind the summit was an effort to promote a “robust exchange of ideas and information that will further help our industries assure the safety of consumer products regardless of where they are made.”

The gathering of nearly 350 people included speeches by government officials including Michael Leavitt, Secretary of Health and Human Services and Andrew von Eshenbach, Commissioner of the Food and Drug Administration.

Secretary Leavitt, at the Summit, made a significant announcement regarding the U.S. collaborating with the European Union and Australia on inspections of overseas manufacturers of drug ingredients as a way to check more plants. Regulators from the countries will inspect different plants and then share their findings under a pilot program to alleviate duplication and inefficiencies in this process.

In a Medical Products Panel discussion during the Summit, executives from J&J, HDMA, Barr Labs, MedImmune, Schering-Plough and Bayer discussed pharmaceutical safety and the effects of counterfeit and adulterated medications within the Global Supply Chain. The Panel was chaired by Commissioner von Eshenbach from the FDA.

Significant in the Panel discussion was that most were of the opinion that technology needed to be part of the solution of counterfeit and adulterated products within the supply chain and those current initiatives to date with Track and Trace technology is effective to a point but only tracks the transaction of the product.

The industry associations which sponsored the Summit were:

• American National Standards Institute
• Biotechnology Industry Organization
• Consumer Healthcare Products Association
• Food Marketing Institute
• Generic Pharmaceutical Association
• Grocery Manufacturers Association
• Healthcare Distribution Management Association
• National Fisheries Institute
• National Restaurant Association
• Pharmaceutical Research and Manufacturers of America
• Retail Industry Leaders Association
• Toy Industry Association, Inc

XStream Systems to Present at Anti-Counterfeiting Conference

XStream Systems, Inc. announced today that it is scheduled to present at an Anti-Counterfeiting and Anti-Diversion conference which will be held on October 20 -21, 2008 in Vienna, Virginia.

The Center for Business Intelligence (CBI) has organized an annual conference to examine this extremely topical and important issue near the nation’s capitol.

The program of the conference is focused on preparing industry thought leaders for pending Federal Legislation and in the discussion of combating the illicit trade of pharmaceuticals by implementing security measures and tracking system.

XStream will be presenting a break out titled; Materials Authentication and Verification within the Pharmaceutical Supply Chain: Working with and Moving Beyond Track and Trace.

“We are excited about discussing the alternative solutions that work with and go beyond the capabilities of Track and Trace technologies to a group of influential industry stakeholders, “stated Alan Clock, SVP of XStream Systems. “No one product or solution will totally protect the global and domestic drug supply, the attendees of this conference will have a major influence in shaping the protection of the medications on which we all rely.”

To find out more about the CBI Conference or XStream Systems, visit the sites below:
http://www.cbinet.com/show_conference.cfm?confCode=PC08089&field=speakers
http://www.xstreamsystems.net/news.html