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Donfucius Says: July 23rd, 2014. Random Bits Of Wisdom.

  1. “As a child my family’s menu consisted of two choices: take it or leave it!” — Buddy Hackett
  2. “Nature gave men two ends – one to sit on and one to think with. Ever since then man’s success or failure has been dependent on the one he used most.”Donfucius
  3. Preach the Gospel at all times, and when necessary use words.” — Aaron Rogers Quoting Francis of Assisi
  4. “Diplomacy is the art of saying “Nice doggie” until you find a rock.” — Will Rogers
  5. “Before they invented drawing boards, what did they go back to?” –Patti Molloy
  6. “The way we’re going… if I called up another pitcher, he’d just hang up the phone on me.” — Any Brewers Manager
  7. “When someone is impatient and says I haven’t got all day,” I always wonder, “How can that be? How can you not have all day?” — George Carlin
  8. “We’re fools whether we dance or not, so we might as well dance.” — Old & Wise Japanese Proverb
  9. “Blessed are the cracked – for they are the ones who let in the light.” — Donfucius
  10. “Good judgment comes from experience, and a lot of that comes from bad judgment.” — Will Rogers
  11. “I don’t mind how much my Ministers talk, so long as they do what I say.” — Margaret Thatcher

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Posts Tagged ‘supply chains’



Drug Safety: An Update From The FDA.

April 6th, 2010

Statement of Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug Administration, Department of Health and Human Services

Before the Committee on Energy and Commerce Subcommittee on Health, U.S. House of Representatives, March 10, 2010

Joshua Sharfstein

INTRODUCTION

Mr. Chairman and Members of the Subcommittee, I am Dr. Joshua M. Sharfstein, Principal Deputy Commissioner at the Food and Drug Administration (FDA or the Agency) in the Department of Health and Human Services (HHS). Thank you for the opportunity to discuss the safety of the American drug supply.

Protecting Americans from unsafe or contaminated drugs is not just an important responsibility of FDA-it is our core charge. Drug safety was the primary reason for the passage of our guiding statute. In 1937, more than 100 people, including many children, died from ingesting Elixir Sulfanilamide, which contained the deadly poison diethylene glycol. Congress then passed, and President Franklin D. Roosevelt signed, the Federal Food, Drug, and Cosmetic Act (FD&C Act) to prevent future catastrophes.

And yet, as you know, the threat remains.

I would like to thank the Subcommittee for its leadership on this issue. Numerous hearings in this chamber have helped the public understand the challenge of regulating a global marketplace. Members of this Subcommittee, along with the Chairman of the full Committee and the Chairman Emeritus, were key architects of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gave the Agency significant new authorities and resources to address postmarket safety. In this testimony, I will address two important issues: import safety and the implementation of the drug safety authorities in FDAAA.

IMPORTS

As the Subcommittee’s work has documented, globalization has created new risks and challenges for the safety of the drug supply. Where Americans once used drugs that were mostly manufactured domestically, now up to 40 percent of the drugs we take are imported, and up to 80 percent of the active pharmaceutical ingredients in the drugs we use are from foreign sources. In addition to the growth in the sheer volume of imports and foreign facilities, there has been an increase in the variety and complexity of imported products, and a large expansion in the number of countries involved in producing these products-including many with less sophisticated regulatory systems than our own. Simultaneously, the supply chain from raw material to consumer has become more and more complex, involving a web of repackagers and redistributors in a variety of locations. This makes oversight significantly more difficult and leaves weaknesses through which counterfeit, adulterated, and misbranded products might infiltrate the legitimate supply chain.

A few examples:

* In 2007 and 2008, contaminated heparin (a blood-thinning drug) came from China and was linked to deaths and a number of serious allergic-type reactions here at home.

* Counterfeit Tamiflu (oseltamivir phosphate) was discovered during the novel H1N1 outbreak.

* In 2007, Xenical (orlistat) capsules ordered over the Internet were found to be composed only of talc and starch.

* In January 2010, counterfeit Alli (orlistat) was discovered, which did not contain the active ingredient but instead contained varying amounts of the stimulant sibutramine, which can lead to serious toxicity if used by people with certain cardiac diseases.

These are global problems. Contamination and counterfeit drugs represent a much greater threat in the developing world, where the systems of laws and regulatory oversight do not afford much protection. And these problems can pose a risk to us at home, when, for example, patients do not get fully treated for infection abroad because of ineffective drugs and as a result, drug resistance intensifies.

Bucket shop 1

Photo above: Fake drugs are made on equipment like this in filthy conditions.

Photo below: Fake drugs are re-labeled and re-packaged so they look “genuine”. This puts you at risk. This could kill you.

Bucket shop 2

When the modern FDA was created in 1938, imports were a tiny part of the products used in our country. Our focus was on stopping harmful products at the border through inspections of imported goods. This approach is adequate to the challenge when the volume is small. But it fails when an estimated 20 million shipments of FDA-regulated imports come into the country each year. To fulfill our public health mission in a global age, FDA must adopt a new approach-one that addresses product safety by preventing problems at every point along the global supply chain, from the raw ingredient through production and distribution, all the way to U.S. consumers.

We are moving from an approach based on reacting to problems to one that proactively prevents such problems from ever occurring. In the food arena, this approach to prevention is embodied in legislation passed by this Committee and the full House of Representatives, and which is now awaiting action in the Senate. This bill would for the first time allow FDA to establish basic preventive controls throughout the food production process and give the Agency strong enforcement authorities and resources to meet these obligations.

In the arena of drugs and other medical products we are taking a number of steps to begin making this shift within our current authorities.

First, we are seeking better controls at the point of production, wherever that may be.

We now have permanent FDA offices in Beijing, Shanghai, and Guangzhou, China, in New Delhi and Mumbai, India, in San Jose, Costa Rica, Mexico City, Santiago, Chile, and soon, Amman, Jordan. These offices enable us to have a regional presence around the world, a home base from which to undertake a range of important activities, including building regulatory capacity. We now have more than 30 agreements with foreign counterparts to share inspection reports and other nonpublic information that can help us make better decisions about the safety of foreign products. So if a shipment of contaminated drugs shows up in a port in Italy, we will hear about it swiftly and be on the lookout for products from the same shipper.

Second, we are working with industry to help them strengthen the safety of their supply chains. In this day and age, companies should be able to effectively demonstrate that safety, quality, and compliance with international and U.S. standards are built into every component of every product and every step of the production process. Some companies already do a terrific job at this, tracking where and how their products and their components are made and the path taken to reach our shores. In fact, I have met with some companies that react with incredible swiftness to questions about the integrity of their supply chain. Obviously they have a vital interest in ensuring confidence in the safety and quality of their products and their brand. These best practices need to become standard practice throughout industry.

There is much more to be done. As Secretary of Health and Human Services Kathleen Sebelius noted when she appeared before this Committee on February 4, 2010, FDA needs additional tools to move our oversight capabilities into the 21st century. FDA needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement.

DRUG SAFETY AUTHORITIES IN FDAAA

I will now turn to the drug safety authorities in FDAAA, a milestone legislative achievement that has helped the Agency protect the public health in many different ways.

Because no amount of premarket study can provide the full information about what the benefits and risks of a new drug will be when it is used by the general population, FDAAA provided important new authorities to enhance our ability to monitor approved drugs after they are marketed and to take definitive action when needed. Under FDAAA, FDA can require drug sponsors to conduct postmarketing studies and clinical trials, make certain safety-related labeling changes, and develop and put into place risk evaluation and mitigation strategies (REMS)-all with the goal of better identifying and managing the risks of drugs on the U.S. market.

Here are some details.

With respect to label changes, as of February 28, 2009, FDA had used its new authorities to require safety label changes in individual or classes of drugs 32 times since March 25, 2008. For example, FDA required safety label changes to add the risk of a life-threatening neurological disorder to the prescribing information for certain antidepressants, and changes to the prescribing information of a class of antibiotics to warn about the risk of tendon rupture.

With respect to risk management, if FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh the risks of the drug, FDA can require manufacturers to have a REMS in place when a drug comes on the market, or implement one later if FDA becomes aware of new safety data . The authority to require REMS provides FDA a very useful set of tools that can be used to reduce the risks of marketed products, while allowing patients to benefit from lifesaving and other beneficial treatments that could not be safely marketed without a risk management program.

In the design of REMS with elements to ensure safe use (the most comprehensive REMS programs), FDA is mindful of the provisions in FDAAA stating that the elements to ensure safe use must be, among other things, commensurate with the specific serious risk listed in the FDA-approved labeling of the drug, not be unduly burdensome on patient access to the drug, and be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.

Most of the REMS with elements to ensure safe use include educating prescribers about the risks and appropriate use of the drug as a condition of certification or enrollment in the REMS program. Other programs require enrollment by pharmacists and sometimes patients as well. Some programs require the prescriber to monitor the patient immediately following drug administration and for a period of time afterwards. Each of these programs is designed to provide critical information to clinicians without unduly restricting access to the drugs.

We have learned that designing and implementing the most comprehensive REMS requires a careful balancing of the need to adequately manage risks and also to maintain patient access to important medications. Since using this authority is a work in progress, FDA is committed to addressing the concerns we have heard from prescribers, pharmacists, distributors, and payers about their roles in implementing REMs and from patient groups about the effects of REMS on access to needed products, and are planning to hold a public meeting to hear from these and other stakeholders. Additional implementation challenges include ensuring consistency in the handling of safety problems with all products, including over-the-counter (OTC) products and generic drugs; the lack of clarity in certain provisions of the law with respect to REMS; and burdens imposed on application holders and FDA that do not contribute significantly to drug safety. We would be very happy to discuss the lessons we have learned over the last two years with Congress and work together to fine tune the program so that it can be even more effective in improving public health.

Sentinel Initiative

FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis system to link and analyze health care data from multiple sources. On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System-a national, integrated, electronic system for monitoring medical product safety. The Sentinel System, once up and running, will enable FDA to actively gather information about the postmarket safety and performance of its regulated products-a significant step forward from our current, primarily passive safety surveillance systems. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. FDA has gathered public input on issues related to the creation and development of Sentinel, held numerous meetings and a public workshop, and established a working group consisting of representatives of numerous federal agencies to share information and discuss issues related to ongoing efforts that are complementary to Sentinel. FDA has awarded key contracts for a pilot project to gather information that will be essential to fully implementing the Sentinel System.

Track and Trace

Scanner (Small) with bottle

FDAAA also required the development of standards for the identification, validation, authentication, and tracking and tracing of prescription drugs as a step towards further securing our nation’s drug supply. Very shortly, FDA will issue a guidance establishing a standard for unique identification for prescription drug packages, which ultimately will help in identifying the whereabouts and authenticity of drug packages and distinguish them from counterfeits.

SAFE USE INITIATIVE

Before I close, I would like to briefly mention a new drug safety initiative at FDA called the Safe Use Initiative. Every approved drug has both benefits and risks. Underlying FDAAA is the principle that Congress wants to see the benefits maximized for patients and the risks minimized. We all want patients to get better on medication and avoid unnecessary injuries, even death, as a result of preventable medication errors or misuse. In November 2009, we announced the launch of FDA’s Safe Use Initiative. Through this initiative, FDA will identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm. FDA will then work with hospitals, doctors, nurses, patient groups and others to recognize and mitigate these risks. In a voluntary complement to the REMS program, we will use our understanding of drug risk as a tool to gather partners together and develop and implement strategies for progress.

CONCLUSION

Over the last seven decades, so much has changed in pharmaceutical science and drug regulation. Yet in 2007, when scores of patients died of contamination in Bangladesh, and in 2006 when children died in Panama, the culprit was familiar. It was diethylene glycol, or DEG-the very same poison that had led to the passage of the FD&C Act in 1938.

FDA’s work is far from done. The scientists, doctors, nurses, inspectors, and other public health professionals who make up FDA thank you for your support and confidence in our mission.

Thank you very much for the opportunity to testify today. I welcome your ideas and your questions.

Joshua M. Sharfstein, M.D.

“To Counterfeit Is Death: Y2K+10 Version”. The Bucket Shops. How Counterfeiters Harm The Public.

January 23rd, 2010

What is a Y2K+10 (year 2010) bucket shop? How does a bucket shop affect the manufacturer of legitimate brands? Look at the two photos below, one of a counterfeiter’s equipment (the bucket shop), and one of a counterfeiters press (also a bucket shop). These facilities can be in a basement or garage, and are usually filthy.

If you are a regular visitor of “The President’s Corner”, then you know that counterfeiting has been around since the birth of our nation. Early United States currency had “To Counterfeit Is Death” printed on the notes. This was a serious crime in the years 1759 – 1777 (and beyond). But let me try and get you to think about a new paradigm: “To Counterfeit Is Death – Y2K+10 Version”. The counterfeiters of the new millennium (Y2K) really do kill people. Diluted vaccines, tainted baby formula, prescription drugs with very little (or no) active ingredients at all – these are the lowest of all possible crimes. The counterfeiters seldom see their victims. If they get caught, their fines are minuscule, no more than just a “slap on the wrist”. How do the criminals attack your legitimate products? And more importantly – how do you fight back?

Counterfeiters rip you off by reformulating (dilution or complete fakes) and re-packaging – the replacement of labels with copies. This is huge problem at all levels of the supply chain. Fraudulent labels are used to change the dates of expired product, make false claims or misrepresentations, and inflate pricing. (Pricing can be inflated because a 5 mg dose can be reprinted to claim a 40 mg dose). Quite often these (counterfeited) prescription drugs are administered to very weak cancer or aids patients, and the doctors think the drugs are not working because of the advanced state of the disease. Little do the doctors realize they may be giving their patients diluted or fake medicines. This is why I say “To Counterfeit Is Death”.

Brand Owners Can Fight Back. Tamper Evident Labels (ATL Secur-Lock or Pharma- Void) use substrates that effectively deter re-marking and counterfeiting fraud. This helps prevent a negative economic impact on your brand. The label face stock combines a tamper evident feature with covert authentication. Labels using this substrate are very difficult to remove (they destroy themselves when removed) . . . and can be easily distinguished from a fake.
When combined with ATL’s covert printing, tamper evident substrates can be your cornerstone of a highly protective labeling solution. Tamper evident substrates features include:
- Destructible, paper-based face stock
- Non-reproducible covert security fibers
- Distribution limited to approved secure suppliers

Tamper Evident Substrates Benefits
- Label cannot be removed without visible damage
- Effectively deters re-marking
- Assures product authenticity, or provides or provides simple in-field authentication
- Secure chain of custody
- Covert Authentication
- Tamper Evidence

Twelve Elements Of A secure Supply Chain/ Cold-Chain. Quality Management of the distribution channel begins and ends with the brand owner. Below is the first slide of a presentation I recently made to “Cold Chain Distribution Professionals” at the Philadelphia Convention Center.

I recommended a 12 step approach to strengthen their cold-chains (the logistical system of safely delivering their products). My advice to them is detailed in “The President’s Corner” published October 4th, 2008.
If you would like to discuss your anti-counterfeiting needs, please contact ATL for a no obligation conversation” about your supply chain. We feel that we have solid experience in anti-counterfeiting. I’ll say this over and over – our main focus is not that you buy something from ATL, rather that you learn from knowledgeable people about the perils of counterfeiting.

I will end this segment with the following words of wisdom: “Believe it is possible to solve your problem. Tremendous things happen to the believer. So believe the answer will come. It will.” — Norman Vincent Peale

Til Death Do You Part?

March 12th, 2009

We would like to give you a glimpse of the counterfeit drug issues as they exist today. The simple fact is that your life may be at risk, or the life of someone close to you. As you read of the startling facts, please look for the words “ATL Security Note”. At this juncture we will recommend a solution that will inhibit (or eliminate) the counterfeiters ability to provide you (the public) with fake or diluted medicines.

Photo Above: Illicit drugs that were gathered during a law enforcement raid.

Counterfeit Medications – History

First documented cases of counterfeit medicines date back to 4th century BC. For more than 2,000 years, issue of fraudulent production of medicines has mostly been ignored.
Today it is multi-billion-dollar worldwide trade. Fake drugs are estimated to lead directly to the deaths of more than 500,000 people a year across the globe.

WHO (World Health Organization)

Definition of a Counterfeit Medicine

“A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with fake packaging.”

Counterfeit Medications

The illicit business is worth $18 billion. It is estimated that it will double in the next two years. It represents about 10% of all pharmaceutical sales worldwide.
30% of medicines in Russia and some countries in Africa, Asia and Latin America are counterfeit. In wealthy nations this figure is approximately three percent.
In the United States this equates to eight million packs of medicines worth approximately $975 million a year.
Approximately 25% of all emails – 15 billion messages a day – are spam advertising drugs. 50% of medicines offered by websites that conceal their physical addresses are fakes. Counterfeited, diverted, and diluted medications make more illicit money than cocaine and heroin.
In 2005, more than 500,000 single doses of fake medicines were discovered across Europe. In 2006 this number had shot up to 2.5 million. Only because fake drugs have spread from local markets to more global outlets, aided by the rise of the internet, has the world recognized the magnitude of the problem.

Photo Above: This machine is manufacturing fake drugs.

WHO & IMPACT

In February 2006, WHO created first global partnership known as International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). It is made up of all 193 WHO Member States on voluntary basis. The goal is to improve coordination and harmonization across and between countries so eventually production, trading and selling of fake medicines will cease.

IMPACT focuses on following key areas:
Looks at existing laws in countries.
Provides effective models countries can use.
Develops set of principles for establishment of appropriate legislation and penal sanctions.
Coordinates action at local levels between health authorities, police, customs, and judiciary institutions to ensure proper regulation, control, investigation and prosecution.
Helps countries with weak regulatory systems to strengthen them.
Comprised of five working groups to combat the spread of counterfeits:
- legislative and regulatory infrastructure
- regulatory implementation
- enforcement
- technology
- communication

The United States and Fake Medicines

The US is a lucrative market for counterfeiters of medicines and medical devices. This is because of high prices, a large market, widespread internet connectivity, and complex supply chain. Counterfeits are not normally manufactured in US. They are distributed through online pharmacies, most of which are outside the United States.

50% of medicines sourced from websites that conceal their physical address are counterfeit. These websites advertise and supply medicines illegally, with no prescriptions.
The fake drugs are discovered in the regulated supply chain, through licensed wholesalers, parallel traders, and pharmacies.

Thus, counterfeit medicines reach patients necessitating batch recalls. Fake medicines found in US regulated supply chain are designed to deceive pharmacists and patients into believing that they are genuine. Often only laboratory analysis reveals counterfeit product.

ATL Security Note: the need for lab analysis can be reduced by the use of a mixed and rotated “layered” security approach in labels and packaging. Invisible forensic digital markers can authenticate the product as genuine from virtually anywhere in the world.

Counterfeit medicines discovered in US typically contain reduced amount of active
pharmaceutical ingredient, or wrong ingredient, or no ingredient.

All counterfeit medicines are dangerous.

There are also reports of counterfeit medical devices discovered in US, or seized on their way to US.
Drug counterfeiting occurs less frequently in the US due to strict regulatory framework that governs production of drug products and distribution chain, and enforcement against violators.
The FDA works to ensure overall quality of drug products that consumers purchase from US pharmacies remains high.
The FDA advises pharmacists, physicians, and other healthcare professionals on drugs most likely to be counterfeited and how to identify them.

A suspect patient may have received counterfeit drug if:
He has unexplained worsening of medical condition or unexpected side effect.
He reports drug tastes or looks different, tablets chipped or cracked.
He experiences unusual burning at injection site.

Photo Above: Are you willing to keep taking drugs that are not authenticated as genuine? Will you do this until “death do you part?”

The Internet

Online pharmacies offer benefits of convenience, privacy, and (often) cheaper prices.
Many online pharmacies appear reputable and similar to legitimate retail pharmacy websites BUT sell fake pills that:
- do not contain medicine approved by regulators.
- have doses that are too strong or too weak.
- contain dangerous ingredients.
- aren’t manufactured using safe standards.
- aren’t labelled, packaged or shipped properly.
- are out of date.

Online pharmacies flourish because the public cannot get many new medicines for cancer, dementia, or influenza from publicly funded services. Many sites connected to other sites and have multiple links making investigation difficult. There are jurisdictional challenges as regulatory and enforcement issues cross international lines. The system is difficult to regulate – but governments can do more to warn public of the dangers.

India

India accounts for approximately one-third of counterfeit (fake, diverted, or diluted) drugs.
The EC claims India largest source of 2.7 million counterfeit drugs was seized by its customs in 2006.
India is the number one source of counterfeit medicines, followed by UAE and China.
India’s existing regulations pose little deterrence to unscrupulous drug vendors.

India is to introduce the death penalty for sale and manufacture of fake and counterfeit medicines that cause grievous harm. The minimum prison sentence is to be increased from five to ten years. There will be higher fines for those convicted for trading in fake drugs.

Drug regulatory officials are often in collusion with manufacturers of fake medicines.
It is against the law to sell fake drugs for domestic use, but no regulatory requirements apply to India’s export market.
Common fake drugs are antibiotics, drugs for tuberculosis, malaria, and cough syrups, as well as ingredients for lifestyle drugs.
Exportation of Active Pharmaceutical Ingredient (API) plays integral role in the manufacture of counterfeit medicines.

ATL Security Note: the use of a mixed and rotated “layered” security approach in labels and packaging works just the same when protecting the public for the purity of API (Active Pharmaceutical Ingredients). Invisible forensic digital markers, color-shifting inks, and other covert features can protect the public by ensuring the API are genuine. This is commonly known as maintaining the “pedigree”.

During first six months in 2005, more than 250kg of sildenafil citrate, Viagra’s active ingredient, were exported from India to Europe. Out of one kilogram sildenafil citrate, approximately 14,000 tablets of counterfeit Viagra-pills can be produced. If sold at normal market price of genuine Viagra a profit of up to 2,000% could result.

Photo Above: Real and fake drugs, side by side. Which would you take?

China

In China, between 200,000 and 300,000 people are estimated to die each year because of counterfeit or substandard medicines. The current baby formula incidents are a sad reminder of the human pain and suffering.

China has 80,000 chemical companies, and the FDA does not know how many sell ingredients used in drugs consumed by Americans. China exports “drug ingredients” to customers in 150 countries.

China’s State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies.
Corruption and lack of protection for whistleblowers undermines China’s attempt to establish a more rigorous drug regulatory system.

In 2007, a series of scandals involving counterfeit pharmaceutical exports led to intense international pressure on the Chinese government. This resulted in conviction and subsequent sentencing to death of the country’s two top drug regulators for accepting bribes.
Some counterfeiters have the same equipment used by pharmaceutical companies.
Cases have occurred of pharmaceutical laboratories that manufacture genuine drugs during business hours and produce counterfeits at night.
Counterfeiters have set up companies that provide service of disposing of expired medicines, thus they obtain real expired medicines that they repack and re-label.

ATL Security Note. Repackaging and relabeling (as described above) could be detected if an invisible forensic code was used in security packaging for the pharmaceuticals. If this covert technique was used, the break in the pedigree could be discovered before the consumer is harmed.

Photo Above: Fake hologram (left), and genuine hologram (right).

ATL Security Note. The following is a portion of the FDA’s conclusions from 2006: “The FDA’s vision of a safe and secure prescription drug supply chain is based on transparency and accountability by all persons who handle the prescription drug throughout the supply chain. With the implementation of the pedigree regulations in December 2006, the FDA expects that supply chain stakeholders will move quickly to adopt electronic track and trace technology, implementing RFID or an alternative track and trace technology in a phased-in approach. Although there are important issues that still need resolution, these issues should not hinder the forward progress and momentum toward widespread adoption. In the meantime, the FDA believes that public health would be better protected if all stakeholders work cooperatively to enable all distributors to pass pedigrees.”

The 2006 Report also considered several technical issues related to adoption of electronic track and trace technology that were perceived as obstacles to implementation and are in need of resolution. These include:
Mass serialization and unique identification of each drug package; and Universal pedigree with national uniform information.

As a brand owner ATL believes that you can protect the public by maintaining a record containing information regarding each transaction that results in a change of ownership of a given drug or pharmaceutical ingredient. This includes its sale by the manufacturer, through the wholesalers, distributors, and pharmacies.
As a brand owner, ATL can work with you to develop:

Lot or batch codes;
Integrated Mass Serialization;
2D DataMatrix Codes;
Forensic (invisible, non-degradable, nano-molecular markers);
Many other covert techniques.

In the 1950′s, when W. Edwards Deming tried to teach U.S. Manufactures about statistical quality control, he was not listened to. At the time, the stigmas of the past (as well as arrogance and ignorance) lived within the powerful decision makers in this country. Dr. Deming went on to huge success in Japan. He believed in quality before it was a buzzword.

“We are here to make another world.” W. Edwards Deming

Photo Above: W. Edwards Deming.

I believe that U.S. pharmaceutical manufacturers (and other brand owners) must protect the public from harm by providing safety and security for the genuine purity of their products. The citizens of the world must demand this.

“We must not inhibit our forward thinking by the comfort levels of the past. If something is not working, you must fix it, repair it, or invent a new paradigm. If you don’t, how many people are you willing to harm for the sake of a few dollars?” Donald J. Dobert, President, ATL.

Security Packaging May Become Law In Obama Administration

January 31st, 2009

2009 – New Year, New President, New Packaging?
(Article courtesy Pharmaceutical & Medical Packaging News)

President-elect Barack Obama will expect manufacturers to take immediate action to protect the drug supply chain, or else face regulation. This prediction comes from two members of the Partnership for Safe Medicine’s board of directors, Marvin D. Shepherd, Ph.D., and Bryan A. Liang, M.D., Ph.D., J.D. Shepherd is president, Partnership for Safe Medicines, as well as director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas-Austin. Liang is vice president, Partnership for Safe Medicines. He is also executive director, Institute of Health Law Studies, California Western School of Law; and co-director, San Diego Center for Patient Safety at the University of California, San Diego School of Medicine. The Partnership for Safe Medicines is a coalition of more than 50 organizations and individuals dedicated to protecting consumers from counterfeit medicines.

“As president, Obama won’t have the patience that President Bush had waiting for industry,” explains Liang. “The onus will be on industry, and the message will be, ‘If you don’t do it, we will make you do it.’ ”

Shepherd believes that Obama will see to it that FDA mandates both serialization and authentication. “A layered approach will be favored, and companies will get to choose what technologies are employed. But the number of layers to be used may be dictated.”

Photo Above: New laws may prevent consumers from buying “fake” drugs. A layered approach (multiple anti-counterfeiting levels) protects the public and is an excellent loss prevention tool.

Efforts to increase supply-chain safety could go further than Obama and vice-president-elect Joe Biden had originally foreseen. On the Obama-Biden Web site, www.change.gov, the team suggests that “allowing the importation of safe medicines from other developed countries” is one way the United States can reduce healthcare costs. However, Obama is reevaluating his long-standing support of drug importation programs in light of tainted medicines and other goods made in other countries, according to the Partnership for Safe Medicines. “People may be backing away from reimportation after safety concerns arose from China,” says Liang. “Expect to see a greater regulatory role, similar to what Obama is supporting in the Food Safety Bill.”

Shepherd expects that unit-of-use packaging will be favored for safety reasons. The ideal scenario would be “a bottle or blister package from the manufacturer with 30- or 60-day supplies and security devices for the pharmacist and for the patient each to use. The security code could be linked somehow with the product’s expiration date. If pharmacists aren’t counting pills, they will have time to verify each package.”

Such changes demand collaboration among manufacturers and their packaging partners, distributors, and pharmacists, says Shepherd. “We need a coordinated, voluntary effort. Without it, the government will step in with dictates.”

Fight Back & Be A Champion. Philadelphia Won The World Series By Mastering The Basics. You Can Win, Too. Here Are 12 Anti-Counterfeiting (Loss Prevention) Tips:

November 11th, 2008

Defeating the counterfeiters is almost as good as winning the World Series. It’s a matter of your hard work paying off.

ATL’s Twelve (Cold-Chain) Anti-Counterfeiting (Loss Prevention) Tips
- Reprinted By Popular Demand From October 4th, 2008

Recently, in Philadelphia, I spoke to pharmaceutical and bio-technology companies (the makers of life saving vaccines). I recommended a 12 step approach to strengthen their cold-chain (the logistical system of safely delivering their products). My advice to them was that they understand the following:
1. Cold chain system weaknesses;
2. Quality System Management of the cold chain;
3. Risk Management Tools (including FMEA – Failure Modes & Effects Analysis);
4. Cold chain variation (Mean & Standard Deviation);
5. The “68-95-99.7 Rule” (and the law of large numbers);
6. Out of specification “assignable causes”;
7. Packaging and equipment validation (including IQ-OQ-PQ);
8. The risks of measurement error (Repeatability & Reproducibility);
9. Layering of anti-counterfeiting techniques;
10. How counterfeiters attack, their use of bucket shops;
11. M&R (mix and rotate) overt and covert anti-counterfeiting measures;
12. Forensic Codes (invisible, digital, and non-degradable) for “fail-safe” authentication.

Why not contact ATL for a free “honest to goodness, no obligation conversation” about your supply chain? We feel that we have solid experience in anti-counterfeiting. Our main focus is not that you buy something from ATL, rather that you learn from knowledgeable people about the perils of counterfeiting. We consider it our mission to help you protect the public. We would like to consider it your mission to take a leadership role and do the right thing.

Penn State football coach, Joe Paterno, said it best:
“Success without honor is an unseasoned dish; it will satisfy your hunger, but it won’t taste good.”

Donald J. Dobert – President, ATL

The Tainted Baby Formula/ Milk Tragedy – From Wisconsin To China. Is It Zhende (Real) Or Jiade (Fake)? How To Fight Back.

October 17th, 2008
Chinese Child Lies In Hospital - Victim Of Tainted Milk

Chinese Child Lies In Hospital - Victim Of Tainted Milk

A hundred years ago, babies who couldn’t be breast-fed usually didn’t survive. Today, although breast-feeding is still the best nourishment for infants, infant formula is a close enough second that babies not only survive, but thrive. Commercially prepared formulas are regulated by the Food and Drug Administration.
The safety of commercially prepared formula is also ensured by the agency’s nutrient requirements and by strict quality control procedures that require manufacturers to analyze each batch of formula for required nutrients, to test samples for stability during the shelf life of the product, to code containers to identify the batch, and to make all records available to FDA investigators.
The composition of infant formula is similar to breast milk, but it isn’t a perfect match, because the exact chemical makeup of breast milk is still unknown. Human milk is very complex, and scientists are still trying to unravel and understand what makes it such a good source of nutrition for rapidly growing and developing infants. John C. Wallingford, Ph.D., an infant nutrition specialist with FDA’s Center for Food Safety and Applied Nutrition, says that “infant formula is increasingly close to breast milk.”
More than half the calories in breast milk come from fat, and the same is true for today’s infant formulas. This may be alarming to many American adults watching their intake of fat and cholesterol, especially when sources of saturated fats, such as coconut oil, are used in formulas. (For adults, high intakes of saturated fats tend to increase blood cholesterol levels more than other fats or oils.) But the low-fat diet recommended for adults doesn’t apply to infants.
“Infants have a very high energy requirement, and they have a restricted volume of food that they can digest,” says Wallingford. “The only way to get the energy density of a food up is to have a high amount of fat.” While greater knowledge about human milk has helped scientists improve infant formula, it has become “increasingly apparent that infant formula can never duplicate human milk. Human milk contains living cells, hormones, active enzymes, immunoglobulins and compounds with unique structures that cannot be replicated in infant formula.”

Illicit Baby Formula In Wisconsin
In 2007 a New Berlin (Wisconsin) grocery wholesaler was under investigation by the FBI on suspicion of buying and selling large quantities of stolen infant formula. Among other things, FBI agents saw approximately 200,000 cans of infant formula, some of which bore indicia (indications) of having been stolen. The FBI indicated that the company regularly received shipments of suspected stolen formula and repackaged the formula before it was sold.
The company “cleaned” the cans by removing store labels and price tags, wiped dust from the cans, repacked the cans into cartons of six, and shrink-wrapped the cartons. One search of trash at the firm’s warehouse (by agents in 2006) revealed that the company had sold more than 17,000 cans of infant formula over an unknown time period. These illicit sales would have generated more than $200,000 in revenue. More about safety risks below (at formula safety).

The China Tragedy. A Blow To Free Society.

Fear Grips Parents Over Tainted Milk & Baby Formula

Fear Grips Parents Over Tainted Milk & Baby Formula

In China, recent deaths related to tainted baby formula should trigger an alarm on more than one front. In the Chinese language, there is one pair of words that you hear constantly: zhende (meaning real, authentic), and jiade (meaning fake, imitated). This pair of words is especially important when shopping, as it depicts the difference in quality between brand name and counterfeit goods. But beyond a difference in quality, zhende and jiade also imply a difference between trust-an unwritten contract-and distrust-the absence of such contract. The deadly, ongoing scandal with tainted baby formula signals an erosion of Chinese trust in supposedly high quality, brand name products-zhende-and a setback to the development of a contract society.

The Chinese economy is growing by double digits. Their citizens hope that this will develop into a “reform and opening” to bring a higher standard of living. Part of this standard of living is symbolized in brand name products. Both small and large cities alike, with the support of officials at all levels, have stores emblazoned with names like Nike and Adidas, among others. Many of these stores and products are jiade (fake). The labels may be inscrutably similar, but the quality will almost assuredly be different. To domestic consumers willing to spend the money on the real deal, however, there is an unspoken contract: we are willing to pay if you are willing to deliver. When it comes to the well being of children, parents are universally willing to pay for zhende (authentic).

The company that is responsible for the tainted baby formula (we will call Comp-X) has essentially become a counterfeit of itself. During months of questions, tests, and reports from both parents and at least one pediatrician, the company continued to sell a product that was not zhende (authentic). Many believe that the Olympics propaganda and journalistic “security” measures stifled coverage of the fake baby formula, the “tainted product”. China is not yet a free and open society, so I believe that China’s period of strict censorship actually provided the company with a real (zhende!) opportunity. It was an opportunity they did not seize.

Hong Kong Police Check Shelves For Counterfeited Baby Formula And Tainted Milk Powder

Hong Kong Police Check Shelves For Counterfeited Baby Formula And Tainted Milk Powder

Above: Logo Of Product Being Removed From Chinese Stores

Above: Logo Of Product Being Removed From Chinese Stores

Comp-X did not quietly recall their tainted formula. They did not instruct health care centers to warn parents of babies with kidney stones that their children’s formula may be playing a role. Instead, Comp-X bribed noisy victims, ironically, with offers of more of their products. The responsibility that Chinese citizens expect from Comp-X was absent. Customers expect to fulfill their part of a public contract with Comp-X through paying more. In return, they expected a product that was not jiade (fake). Yet, for months, infants were suffering the result of Comp-X’s broken contract.

Inspection And Testing Of Counterfeited Milk Powder/ Baby Formula

Inspection And Testing Of Counterfeited Milk Powder/ Baby Formula

This is not the first deadly crisis involving baby formula. In 2004, 13 children died after being repeatedly fed formula that, unbeknownst to their parents, contained no nutrients whatsoever. The difference between the two crises, however, again illustrates the larger problem. The perpetrators of the 2004 incident were the makers of a counterfeit, off-brand product-jiade (fake). This time around, the perpetrator is Comp-X, a brand long held as zhende (authentic).

The difference between buying zhende (authentic) and jiade (fake) generally just means the difference between enjoying a treat and suffering upset stomach. For others, buying zhende or jiade can mean the difference between a year’s salary and a herd of dead livestock, as in cases of counterfeit animal feed. In 2004, although no parent wished his or her child ill, the price of buying jiade was a child’s life. Now, however, to the horror of millions, and a huge setback in the development of a contract society, the lines have blurred.

Why Target Baby Formula?
In the United States, baby formula is one of the more popular items with counterfeiters because of the ease of selling it. It has great street value. There are a lot of young mothers who are willing to pay 50 cents on the dollar for stolen formula. There is a high demand because baby formula is expensive. The consumers buying the stolen formula are young parents with not a lot of money to spend. Today, stolen formula is sold at places like flea markets or over the Internet. This poses a health risk because baby formula is temperature-sensitive.

Formula Safety
The conditions in which counterfeiters are warehousing perishable goods (including those with an expiration date) can be dangerous-even fatal-to consumers. Some baby formula has been stored in garages with rodents running across storage facilities that have no temperature controls whatsoever. When it gets hot the baby formula will break down in nutritional value if it is kept out of its correct temperature range.

The counterfeiters are good at hiding their craft. As part of their operations, the counterfeiters will clean, repackage, and re-label goods to make them appear as legitimate products. They will also switch labels, particularly if items are damaged or out of date. They think nothing of switching labels from one brand of formula to another. Counterfeiters also make counterfeit labels. (see article dated October 8th, 2008, “The Bucket Shops”).

In some cases counterfeiters may even sell the products back to the retailer, unbeknownst to them. And frequently, counterfeiters will sell the products via Internet Web sites, such as eBay. The ease with which criminals can use the Internet to sell the stolen goods now makes it more difficult to investigate these crimes.

Fighting Back

In addition to working with law enforcement, many retailers are trying to make it harder for counterfeiters to disguise the origin of the product. Many of them now stamp their product with their company name and logo, and a store number so that the retail source of the product can be identified if uncovered in a theft or for other purposes, such as a product recall.

Above: Parents In China Worry - The Chain Of Custody Has Been Lost And Children Are At Risk

Above: Parents In China Worry - The Chain Of Custody Has Been Lost And Children Are At Risk

Combating The Counterfeiters. ATL Security Solutions: Each member of the supply channel has to understand that the solution must be a collaborative, united effort to assure the safety of products that pass through their hands. This includes confirming the legitimacy of the item’s source; the doctor, wholesaler, ADR, distributor, manufacturer, and API (Active Pharmaceutical Ingredient) sources.

All it takes is one bad apple: It could be one counterfeiter; one diluted product; one re-dated product; one product with fake labels; one false repackaging run… if any of these events occur, and the secure supply channel is broken, the patients are at risk.

ATL Security Labeling Systems (TM) has a solid product line to assist you in the detection of counterfeiting and diversion. Our brands make it more difficult to steal.
From the pedigree papers to the end user, our SecurBook (TM) labels can provide a complete (100%) supply channel authentication. Identical forensic markers on (pedigree papers, bulk containers, individual units) can be scanned and read to ensure 100% accuracy. This will verify that the brand has not been counterfeited. Patented, portable-scanning units can verify and authenticate in the field.

How Does This Work? ATL Pharma utilizes the unique technology of IDGLOBAL. This consists of custom forensic markers with digital data for tracking. Specific ATL SecurBook labels contain an invisible and non-degradable forensic marker. When applied (or linked) to pedigree documentation, packaging, and containers, the supply channel becomes “secure”, because all “digital data” scans must match as identical. If they match, brand authentication and anti-counterfeiting are ensured. This is why we call ATL brands the “Secur” product line.

Invisible (Non-degradable) Forensic Marker Is Your Assurance Of Brand Authenticity

Invisible (Non-degradable) Forensic Marker Is Your Assurance Of Brand Authenticity

ATL can provide custom solutions tailored to your specific supply channel.
Other ATL Pharma brands include:
SecurLock: Tamper-Evident breakaway closure;
SecurDetek: Invisible, Hidden Page Marker;
SecurMark: Anti-Counterfeiting holograms;
SecurStretch: Tamper-Evident Unit Closure;
SecurPly: Booklets for soft squeeze tubes;
PharmaVoid: Security Closure/ Destructible Tapes;
Triple-Ply: Three-Tier overt and / or covert levels of anti-counterfeiting;
D2 WAO: Wrap-Around style (up to 19 panels) that fit most cylinders-
(U.S. Patent Applied For).

Brand protection (safeguarding the public) doesn’t cost much more than the labels and packaging in use today. If you are a brand owner, why not do the right things. Provide your customers with layered anti-counterfeiting overt and covert protection.

Remember always: “It is a terrible thing to see and have no vision.” Helen Keller