W140 N9504 Fountain Blvd.
Menomonee Falls, WI  53051

Local: 262.255.6150
Toll Free: 800.444.5144
ATL Home

Donfucius Says: March 25th, 2015. 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


ATL's Quality Corner

Posts Tagged ‘track and trace’

Drug Packaging Serialization.

July 14th, 2010

New FDA final guidance jump-starts track and trace.

This article courtesy of Stephen Barlas and Contract Pharma Magazine

serialization binary codes

The FDA’s publication of the final guidance on a standard numerical identifier (SNI) for pharmaceutical packages at the end of March awoke the drug industry from its track and trace slumber. Manufacturers, distributors, pharmacies and their vendors had been snoozing since September 2008, when California pushed back its e-Pedigree implementation date, an action with significant national implications. Instead of having to put unique serial numbers on packages starting January 1, 2011, California, responding to pleas from an ill-prepared drug industry, pushed back that e-Pedigree deadline to January 1, 2015. One-half of all drug packages arriving in the state on that date will have to have unique serial numbers printed on them. The other half will have to follow suit one year later.

“Everybody took a deep breath when the California Board of Pharmacy delayed its e-Pedigree requirement,” agreed Ruby Raley, director, healthcare solutions, Axway, a company that provides the software to run the data repositories that hold information about drug package pedigrees as an individual package moves from the manufacturer to (perhaps) a repackager to a wholesaler and on to the retail or hospital pharmacy. Axway is involved in numerous track and trace pilots with a number of major pharma companies. “Nothing happened last year,” she remarked.

Now, publication of an FDA-approved package serialization scheme has given the pharmaceutical industry a reason to restart its version of California Here I Come. Whereas the California Board of Pharmacy provided no specifics on package serialization, the FDA has; manufacturers no longer have to wait and guess what might be acceptable in the Golden State come January 1, 2015, a date that, given the complexities of e-Pedigree compliance, isn’t so far away.

James McCrory, vice president, products and technology at rfXcel Corp., said, “The SNI guidance is a big deal in three ways. It reflects new interest in federal government safety of prescription drugs, provides endorsement of GS1, which is pretty big since people have been hanging back waiting to see what happens, and matches what leaders and distributors and manufacturers are doing in their own pilots.” The SNI essentially endorses the serialization standard adopted by the international standards group GS1. GS1 has one serialization standard for numbers printed in 2D barcodes (GT10) and a second one for numbers printed on radio frequency identification (RFID) tags (G10).

An agreed-upon format for an item-level SNI is only the first step in a closed-loop e-Pedigree (often used synonymously with track and trace) system such as the one adopted by California, and likely to be endorsed by Congress. Other follow-on elements include:

Security framework for data exchange,

Record retention policies,

SNIs at the pallet and case level,

Standardized chain-of-custody data to be tracked by logistical units,

Standardized electronic data exchange format,

Data carriers with specific encoding formats identified,

Guidelines for reporting exceptions noted by supply chain participants, and

Hierarchy of the SNIs expected in a shipment.

The FDA SNI provides a first-step level of certainty to manufacturers, in terms of compliance with federal expectations, and assures them that the U.S. is moving in the same basic direction as other countries, many of whom are far more advanced in their national track and trace requirements. That is all true despite the limitations of the FDA guidance: it is a suggested package identification formula. There is no federal requirement that drug manufacturers follow it, much less put a serial number on each item-level package.

The limits of the FDA guidance, some of its nuances and its failure to address the important issue of which technology should be used to print the SNI have all combined, apparently, to seal the lips of pharmaceutical manufacturers who just three years ago were touting their track and trace efforts. Prominent proselytizers such as Pfizer, Abbott and Purdue Pharma have declined to comment on the FDA final guidance on an SNI. “I ran this request up the flag pole and have learned that we are unable to grant interviews on this topic,” explained Libby Holman, spokeswoman for Purdue Pharma, which has been an aggressive track and trace experimenter because of its manufacture of OxyContin, a popular target of drug diverters.

Tom McPhillips, vice president, U.S. Trade Group, Pfizer Inc., did not return an e-mail requesting comment. Mr. McPhillips, in his comments to the FDA after the draft guidance was published, asked the agency not to require manufacturers to print the national drug code (NDC) as part of both the machine readable and human readable SNI. The FDA rejected that request.

Nonetheless, manufacturers support the specificity of the SNI, and its agreement with GS1 standards, which gives them more certainty than California’s prescription for a unique serial number. The only guidance in the Golden State law, according to Virginia Herold, executive officer of the California Board of Pharmacy, is that the number be part of an “interoperable” track and trace system. The FDA-recommended SNI is a unique combination of two numbers printed on a package label that identifies the drug inside the package. The FDA final guidance specifies that half of the SNI is the national drug code (NDC), which is essentially unique for each drug made by each manufacturer, coupled with a unique serial number for the second half, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric or alphanumeric and should have no more than 20 characters. The SNI should be both machine and human readable.

The use of a GS1-compatible SNI means that manufacturers following the FDA guidance are very likely to comply with European, Brazilian, Norwegian and other national requirements for drug package serialization. Meanwhile, other countries are putting track and trace requirements into place, in some instances with more speed than the U.S. Ms. Raley explained that governments footing the bill for public healthcare (e.g. the EU, Brazil, Turkey) are especially concerned about counterfeit product sneaking into the country, since the government does not collect taxes on those transactions. “People are sneaking product in at the border, that is driving government concerns,” she explained.

In the U.S., the FDA has been more concerned about the prospective impact of counterfeit drugs on public health and safety. The 2007 Heparin recall underlined the value of track and trace (had it been deployed by the pharmaceutical chain) with regard to drug recalls. Preventing thefts is an important affiliate benefit, too. In March, thieves broke into an Eli Lilly warehouse in Enfield, CT and stole $75 million worth of prescription drugs. The crooks took pallets of the anti-cancer drugs Gemzar and Alimta, the schizophrenia drug Zyprexa, the antidepressant Cymbalta and other prescription medicines. Theoretically, those stolen drugs could not come back into the legal distribution chain if they had SNIs printed on 2D barcodes or RFID tags on each package’s label.

It is clear that manufacturers are the big winners, relatively speaking, from the final guidance. Scott Melville, senior vice president for government affairs for the Healthcare Distribution Management Association (HDMA), said, “The FDA guidance provides manufacturers and the entire pharmaceutical supply chain with needed clarity.” But while the HDMA has welcomed the guidance, it clearly did not get everything it wanted. For example, the HDMA had not wanted the FDA to endorse an “alphanumeric” as a serial number option.

However, Anita Ducca, senior director, regulatory affairs at HDMA, acknowledged the FDA was responsive to her group’s concerns. “We had a number of things we wanted the FDA to change from its draft guidance and for the most part the agency did that,” she states. “Our members are ready and willing to work within the parameters of the guidance.”

Neither did hospitals and pharmacies get exactly what they wanted. Some pharmacy groups had also pushed for a different SNI. The American Society of Health System Pharmacists (ASHP) had urged the FDA to modify the NDC number so that its components included the RxNorm CUI as the drug/form/ dose component of the code. Justine Coffey, JD, LLM, director, federal regulatory affairs, said, “Currently, ASHP members are struggling with inconsistencies relating to the National Drug Code (NDC) and its application to barcode point-of-care, clinical information systems, and hospital financial systems.”

Axway’s Ms. Raley noted that hospitals are particularly concerned about avoiding medication errors, especially given the passage of the health care reform bill, which mandates a number of new payment methodologies based on the hospital reducing errors of all kinds. She explained that many drugs come in many formulations and doses, information which will not be gleaned from the SNI endorsed by the FDA. Ms. Raley pointed out that hospitals are particularly sensitive to this issue given the publicity generated by the misadministration of Heparin to twins born in November 2007 to the actor Dennis Quaid and his wife.

Minor reservations aside, the HDMA’s Mr. Melville emphasized that the final guidance allows his members and everyone else to move forward. “The first step in an e-Pedigree system is putting a number on the package,” he said. “The second step is what you do with that number.”

For distributors a big issue is how the SNI is printed on the item-level package label. The two options that have emerged over the past half-decade are a 2D barcode or a radio frequency identification (RFID) tag. Distributors have generally favored RFID tagging, since they could check in packages to their warehouses without a reader having to be “in the line of sight” with the individual package. This saves them time, which is important because any e-Pedigree requirement costs the distributor money and earns the company no profit. But RFID tags are expensive, and manufacturers have generally pushed for printing serial numbers within 2D barcodes, not just because the labels are cheaper, but because the packaging lines can run faster than they could if RFID tags are printed on the package. Moreover, RFID tags cannot be used on some products.

The final guidance on the SNI appears, however, to endorse 2D barcode serialization without actually saying so. “The FDA landed on 2D,” stated Ms. Raley. “It is very clear they talked about the total acceptability of 2D although they did not rule out RFID.” RFID does have some significant shortcomings when it comes to package use, such as its deleterious effect on biologics.

Robert Celeste, director, healthcare, GS1 US, said that in fact all the manufacturers who have done pilots, and are doing them now, are putting serial numbers on packages via 2D barcodes. Some are also putting RFID tags on the product label, and on cartons and pallets. He believes it is possible that RFID tags on item-level packages may have utility – if their per unit price comes down – in certain applications, for example, where products must be kept at certain temperatures.

The final guidance, however, is silent on serialization of cartons and pallets, which the California Board of Pharmacy, just to cite one interested party, had pushed for, and on which the FDA had asked for comments.

While the pharmaceutical supply chain now knows that the SNI is the baseline for complying with California’s e-Pedigree requirement, everyone up and down the chain is pushing for federal legislation that would make the California requirement, or some close version of it, national law and might resolve outstanding technology questions as well. The 2007 congressional law that required the FDA to publish some sort of SNI within 30 months – it did not specify guidance versus more legal regulation – also told the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The FDA received comments but has done nothing to impose a technology solution, which various players in the drug distribution chain would probably oppose, but which is clearly necessary.

In the 2007-2008 session of Congress, Reps. Steve Buyer (R-IN) and Jim Matheson (D-UT) introduced the Safeguarding America’s Pharmaceuticals Act, which would have established a federal e-Pedigree mandate. That law has not been reintroduced in the current Congress, perhaps, suggested Ms. Herold of California’s Board of Pharmacy, because members of the House and Senate have been overwhelmed with healthcare reform, financial reform and economic recovery. Also, the same sense of urgency that disappeared in California in September 2008 disappeared from Congress at about the same time.

As the HDMA’s Mr. Melville put it, “We want a uniform federal pedigree standard. We can’t have barriers to movement of products.” He added that Reps. Buyer and Matheson, at a hearing on March 10, stated they are working on a redrafted version of their bill. “We are very hopeful it will be reintroduced soon,” said Mr. Melville. “We expect it to look like the California implementation schedule.”

The End

Stephen Barlas is a freelance writer who has written several articles on pharmaceutical packaging for Contract Pharma. He can be reached at [email protected].

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


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.


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.


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.


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.


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.

FDA Requests $4.03 Billion To Protect Public Health.

February 1st, 2010


For Immediate Release: February 1, 2010

The FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science. FY 2011 request represents a 23 percent increase over FY 2010 budget

The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.

“The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” said FDA Commissioner Margaret A. Hamburg, M.D. “This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects the FDA’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. Funding in the FY 2011 request also supports new regulatory authority to regulate cigarettes and other tobacco products received in June 2009. The proposed budget includes support for the FDA’s investment in addressing the challenges of the 21st century. The FDA envisions a transformed U.S. food safety system that focuses on prevention, increased efforts to address medical product safety challenges and a focus on modernizing regulatory science at the FDA.

These four initiatives are the major highlights for the FY2011 budget increases.

* Transforming Food Safety (+ $318.3 million)

The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

* Protecting Patients (+ $100.8 million)

The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

* Advancing Regulatory Science (+ $25.0 million)

Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

* Tobacco (+ $215.0 million)

An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

Loss Prevention Via Security Packaging.

December 31st, 2008

Increase in Drug Tampering Reports & Loss Prevention Spark New Security Considerations

Photo Above: Your profits and consumer loyalty can explode and literally “go up in smoke”, just as these defective (fake OEM) batteries did. Take simple steps in loss prevention through security packaging.

Efforts to identify and intercept phony medications are taking on a greater urgency amid increased concerns that tampering and counterfeiting may become an attractive vehicle for organized crime rings and even terrorists. Very few companies treat these events as viable loss prevention opportunities.

The profitability of expensive new drugs used to combat cancer and other diseases along with the growth of Internet and cross-border purchasing has raised the potential for exploitation motivated by greed.
Over the last decade there’s been a huge increase of tampering with or copying high value drugs that were largely injectables; now the trend seems to be more in changing labels-buying low potency materials then affixing high potency labels.

For example, vials of the anti-anemia drug Epogen were discovered with phony lot numbers. After analyzing the contents, the drug’s manufacturer sent letters alerting pharmacists and distributors that the vials each contained 2,000 units of the drug-far less than the 40,000 claimed on the labels.

A month later, manufacturer Ortho Biotech Products issued a warning to health care professionals that counterfeit lot numbers of their anti-anemia drug Procrit had been uncovered in Texas. In the process of the Epogen investigation, the Procrit vials were also found to contain concentrations of the active ingredient 20 times lower than the amount listed on the labels. How does this affect you, the consumer? How does this affect you, the brand owner? Simple: as a consumer, any fake drug can kill you. As a brand owner, lawsuits can cripple your company, and loss of public faith in your product could be devastating.

Photo Above: Security Label. Where is the covert feature? In the ink? In the adhesive? In the varnish? Just on page three? As a brand owner, only you will know, and this can be changed from production run to production run.

Consider the following loss prevention steps.

Secure your packaging against counterfeiting, tampering, fraud and diversion. This requires collaboration with someone who has the expertise and resources to provide a solution that is tailored specifically for your brand. ATL is one of the most respected security solutions providers. We offer a wide variety of technology, and we have the engineering capability to design, manufacture, and implement a security packaging solution that makes sense for you.

Photo Above: Security Labels can be “tracked and traced” all over the world, in a matter of seconds. This is a very valuable attribute for inventory controls and loss prevention.

Our printing, holographic, and overt/ covert layering production experience allows ATL to customize a security solution that can incorporate a combination of security layers such as holography, forensic digital codes, micro text, serialization, bar-coding (including 2D), track and trace, and tamper evident materials. We can combine these techniques to develop an effective security packaging solution that can work in combination with each other, or as a rotated defense (different features with varried production runs).

Photo Above: Jim Stiglich and Jeff Lord (ATL Security Label Specialists) travel the globe educating consumers and brand owners alike in anti-counterfeiting loss prevention.

Many of these solutions add a decorative dimension to your package – adding brand authentication and brand protection to your design. These same solutions reaffirm to your customers that you care about their safety and well being. And here is the kicker….

Loss Prevention. As a brand owner you can solicit your insurance company to reduce your rates. You can prove to them that you have the necessary security features that will aid law enforcement agents in the field. You will also have the evidence in place that will stand up in court. At pennies per unit, isn’t preventing a loss worth your time and effort?

Photo Above: Donald Dobert, President, ATL, speaks at the Pennsylvania Convention Center (Cold Chain Conference). The subject was anti-counterfeiting and loss prevention. Other speakers included Phil Viggani (ID Global Corp.), Nathaniel Lipkus (Gilbert’s LLP, Lawyers, Patent & Trademark Agents), and Craig Thurber (United States Department of Homeland Security).

Earl Nightingale said it best: “As Ye Sow, Ye Shall Reap…..”
“We will receive not what we idly wish for but what we justly earn. Our rewards will always be in exact proportion to our service.”