Counterfeit Drug Blog

U.S. Identifies Tainted Heparin in 11 Countries

counterfeitdrug — Tue, 22 Apr 2008 15:30:10 +0000

In a recent article the Chinese government insisted they have the reciprocal right to inspect packaging operators in the USA as the USA insists we have the right to inspect the Chinese suppliers.

We can’t agree more with the Chinese.

Tainted Heparin is going to go down in US commerce history right next to Tylenol for J&J. The reason we have so much tainted Heparin is because drug producers are deflecting attention from ‘importers’ to ‘exporters.’

All the blame and attention is focused on the ‘exporter’ as though the US drug producers have no resources to properly inspect imports from China.

We strongly disagree.

The responsibility for ensuring the safety of drugs in the USA begins when the ocean container or the cargo flight lands on US soil… not when it exits at a foreign country.

US drug producers are 100% accountable for the ‘importation’ of contaminated Heparin.

Maybe if the drug producers spent less time and money trying to kill legislation to ensure the safety of the drug supply chain, there will be less people killed by inadequate inspections of imports by the drug producers ?

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April 22, 2008

U.S. Identifies Tainted Heparin in 11 Countries

WASHINGTON — A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States.

But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be reciprocal.

“We don’t have a strong evidence to show that it is heparin or its contaminant that caused the problem,” said the official, Ning Chen, second secretary at the Chinese Embassy.

Mr. Chen said that illnesses associated with contaminated heparin had occurred only in the United States, which he said suggested that the problem arose in this country.

Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had conceded that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

“Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events,” Dr. Woodcock said. “We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

The dispute is a sign of growing tensions between China and the United States over the safety of Chinese imports. China has in recent years exported poisonous toothpaste, lead-painted toys, toxic pet food, tainted fish and now, contaminated medicine.

Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for Tuesday in the House and Thursday in the Senate.

China has lurched between defensiveness and cooperation on issues of product safety. Last year, it initially blocked the F.D.A. from investigating tainted pet food and accused foreign forces of exaggerating the issue. Then in July, China said that it had executed its former top food and drug regulator for taking bribes and promised reforms.

The F.D.A. sent a warning letter on Monday to Changzhou SPL, the Chinese plant identified as the source of contaminated heparin made by Baxter International in the United States. It warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities.

Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.

The F.D.A. has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Deborah Autor, director of compliance at the F.D.A.’s drug center, said the agency did not know the original source of all the contamination or the points in the supply chain at which it was added.

Officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February, officials said.

Separately, the Government Accountability Office will release a report on Tuesday showing that the F.D.A. would need to spend at least $56 million more next year to begin full inspections of foreign plants. It would need to spend at least $15 million annually to inspect China’s drug plants every two years, which is the domestic standard.

Bush administration officials have acknowledged problems associated with poor inspection of overseas plants and have plans to improve the situation. But President Bush’s budget does not provide the F.D.A. with funds to hire more inspectors.

At its present inspection pace, the F.D.A. would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.

Proposals circulating on Capitol Hill would increase the agency’s financing and charge domestic and foreign manufacturers fees to pay for inspections.

“Even the Bush administration seems to understand the potential peril that these foreign firms pose, but they offer only vague plans to address the problems and they refuse to spend more than a fraction of the money needed to protect the public,” said Representative John D. Dingell, a Michigan Democrat who leads the House Committee on Energy and Commerce.

The F.D.A. has announced plans to open inspection offices in three Chinese cities, but the agency has yet to get permission from the Chinese government. Mr. Chen said any inspection agreement should be reciprocal. “Will the U.S. government accept the Chinese F.D.A. to set up in the United States?” he said.

Dr. Woodcock said the Chinese had agreed to test heparin lots before allowing them to be exported. But Dr. Moheb Nasr, director of the drug agency’s office of new drug quality assessment, said that the Chinese test might not be sensitive enough to identify the contaminant.

Dr. Woodcock assured patients, however, that all heparin supplies in the United States had been tested with the most sensitive assays and had been found to be uncontaminated.

Scientific Protein Laboratories and Changzhou SPL said the company regretted the agency’s decision to send a warning letter that, it said, did not reflect the company’s current safety practices. The company said it had no way of detecting a contaminant present in heparin supplies throughout China.

Baxter International, which bought heparin ingredients from SPL and sold the finished drug in the United States, said that its tests confirmed that the contaminant could cause illness. It disputed the F.D.A.’s analysis that its product was linked with 81 deaths, saying it had identified only 5 in which its product “may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused the death.”

Deaths linked to the drug may have been concentrated in the United States because American doctors may be more likely to use large, quickly infused amounts of the drug, said drug officials. Also, the F.D.A. may track serious side effects better than its counterparts abroad.

http://www.nytimes.com/2008/04/22/health/policy/22fda.html?hp

Heparin Is Now Suspected in 62 Fatalities Across U.S.

counterfeitdrug — Tue, 22 Apr 2008 15:22:13 +0000

April 10, 2008

Heparin Is Now Suspected in 62 Fatalities Across U.S.

The number of suspicious deaths in the United States linked to the blood thinner heparin has risen to 62 from 19, with most of them reported this past December, January and February, according to the first detailed analyses of heparin fatalities by the Food and Drug Administration.

The F.D.A. is still investigating whether those deaths and hundreds of allergic reactions were caused by a heparinlike contaminant made in China that was added to the drug somewhere during the manufacturing process.

The drug agency defined suspicious deaths as those involving one or more allergic reactions or a drop in blood pressure. There have been no reports of deaths since the end of February, after Baxter International recalled heparin made with ingredients from a Chinese supplier.

The agency’s Web site reported Tuesday that the 62 deaths covered a 14-month period that began in January 2007. In comparison, the agency said, there were three suspicious deaths involving heparin in all of 2006.

The F.D.A. had earlier identified the contaminant as a chemically altered substance that slipped through standard testing screens because it mimicked heparin. The agency was able to spot the additive only by using a more sophisticated test.

Investigators have not yet established how or why the additive, called oversulfated chondroitin sulfate, ended up in heparin, though the fact that it is cheaper to make than the actual drug points to the possible involvement of counterfeiters.

In addition to Baxter, companies that have recalled heparin products made with Chinese ingredients include Covidien, formerly Tyco Healthcare, and B. Braun. Both Covidien and Braun said that they had received no reports of adverse reactions from the heparin and that the recalls had been undertaken merely as a precaution.

Similar recalls of the drug have occurred in Germany, Denmark, France, Italy and Japan.

Heparin is made from the mucous membranes in pig intestines. It is commonly used in dialysis and in many types of surgery.

Drug regulators in China, the world’s biggest supplier of heparin ingredients, have said they are tightening supervision over production of the drug, which involves thousands of small family workshops that gather and treat the raw material from pig intestines.

http://www.nytimes.com/2008/04/10/health/policy/10heparin.html

No…no… California … Yes…Yes… drug counterfeits

counterfeitdrug — Tue, 25 Mar 2008 22:45:36 +0000

The California Board of Pharmacy today announced its decision to extend the deadline for implementation of e-pedigree laws to 2011.The probability that California will actually implement item level pedigree January 2011 is very low.

Pharmacy Board to Weigh Delays on Drug Tracking

counterfeitdrug — Tue, 25 Mar 2008 14:28:12 +0000

Pharmacy Board to Weigh Delays on Drug Tracking
HEATHER CHAMBERS

The California State Board of Pharmacy will meet in San Diego for a second time this year to weigh arguments for delaying implementation of a statewide drug tracking system scheduled to take effect Jan. 1.

Drug companies big and small have lobbied for additional time on the requirement, which would put in place an electronic system, known as an “e-pedigree,” to track prescription drugs along the supply chain.

The pharmacy board has the authority to delay requirements for two years, as it did once before, though board members have made clear their desires to keep the deadline intact.

Virginia Herold, executive officer of the board, said members are weighing possible impacts on the industry.

“We’ve received a lot of inquiries, a lot of statements from the industry that the industry may not be ready by 2009 but may be ready by 2011,” she said.

Fake drugs, including those that have been diluted or altered, have become a growing concern in the industry. According to the state pharmacy board, 3.4 billion prescriptions were dispensed in the United States in 2006. If only 1 percent of those drugs were counterfeit, 34 million prescriptions would be affected.

From 2000 to 2004, the FDA reported a tenfold increase in the number of cases investigated involving counterfeit drugs.

Congress passed a law in 2007 that required the FDA to develop standards for a national tracking system by 2010. But federal standards have been put on hold, which means California could lead the way for electronic drug tracking as early as Jan. 1.

Supporters Admit

Even supporters admit that wholesalers and pharmacies might not be able to put electronic tracking in place by 2009. Two bills introduced in late February aim to modify current legislation. SB 1270, introduced by Sen. Gilbert Cedillo, D-Los Angeles, pushed to impose tracking requirements by an unspecified date. A proposal by Sen. Mark Ridley-Thomas, D-Los Angeles, SB 1307, would require a “unique identification number” on bottles of drugs.

Bill Hubbard, a former FDA associate commissioner said he thinks the pharmacy board should require pedigrees beginning Jan. 1 but allow more time for electronic track-and-trace systems.

“We think that, over time, this is going to be a widespread technology because it’s really the next generation of the grocery store scanner that we’re used to,” he said. “But that may be another 10 or 15 years away.”

Doug Farry, managing director in the San Diego office of McKenna Long & Aldridge LLP, pointed to challenges involved in the regulation of an e-pedigree system. If federal regulations were to take effect before California’s system went into effect, he said the FDA could face difficulties in enforcing the rules.

“The FDA was really built to regulate the safety and efficacy of drugs — that they’re not killing you and they’re working as advertised,” Farry said. “Enforcement mechanisms for retailers and others who manufacture these drugs are more unique challenges to their scope of authority.”

http://www.sdbj.com

Protection against counterfeit drugs too important to rush

counterfeitdrug — Tue, 25 Mar 2008 13:31:22 +0000

Protection against counterfeit drugs too important to rush

The pharmacy board will meet on March 25 in San Diego to consider whether or not it is necessary to move the deadline to implement an electronic pedigree system back to 2011. Although the law’s intent to protect the consumer against counterfeits is sound, practical realities may force a reconsideration of the deadline.

While a tracking system is a good idea, the devil is in the details. Those participating in the supply chain — from pharmaceutical companies to community clinics to mom-and-pop drugstores — are greatly concerned about implementing a law that won’t work because of the unanswered questions of what an e-pedigree would entail — including what standard is right for the entire chain, what technology to use, what frequencies are mandated, how pill containers versus injectables would be treated, how to weather the costs of pedigree readers and writers, and, critically, who would be the owner, guardian and steward of the information. The law says the e-pedigree needs to be interoperable, but no federal or state standards exist. Additionally, there is no technology in place that is interoperable and compatible throughout all stages of distribution.

This raises another concern: California is the only state to require e-pedigree down to the unit level. Yet as more and more states start passing their own, different statutes, the potential for chaos in trying to fulfill all these different rules may become increasingly costly. These costs, as well as the direct costs associated with pharmacy implementation of just the California law, estimated by Rite-Aid to be $80,000 per pharmacy, will fall upon consumers.

Because of these issues, the Board of Pharmacy should extend the deadline for two years.

But in addition, during this time, the legislature should see the e-pedigree law as the beginning of drug safety efforts in the state, not the end. The key problem unaddressed by this law is the Internet. To protect against harmful drugs from this growing source, we need to ban Internet sales of drugs unless these facilities are licensed to practice in California and are subject to rigorous oversight standards. This can be done through the Verified Internet Pharmacy Practice Sites accreditation program of the National Association of Boards of Pharmacy. This safety effort can also be effectively promoted by prohibiting credit card companies from executing any transactions associated with online sales of drugs unless the site is approved by the VIPPS program.

The bottom line is that we all want our drugs to be safe. We need an e-pedigree law implemented that works, and we need legislation to address problems with the Internet. By extending the deadline for the e-pedigree law so the practical concerns can be addressed while simultaneously dealing with the problem of online drug sales, we in California can lead in the effort to ensure safety in the drug supply chain — a leadership role we should aspire to.

http://www.capitolweekly.net

After 19 deaths, California pharmacy board urged to delay e-pedigree

counterfeitdrug — Tue, 25 Mar 2008 13:27:10 +0000

Pharmacists debate the efficacy and impact of California’s forthcoming e-pedigree rule.

The California Board of Pharmacy continues to press forward with the January 2009 deadline for implementing its e-pedigree requirements even as it listens to a growing chorus of calls to the board for a delay. The National Community Pharmacists Association, Pharmaceutical Research and Manufacturers of America, Generic Pharmaceutical Association, McKesson, Pfizer, Teva, and many other drug companies submitted letters formally requesting a two-year delay in implementation. The California law is designed to combat counterfeiting by creating an easily traceable electronic record of the entire life cycle of a product from manufacture to dispensing or destruction. Under the law, after January 1, 2009, no wholesaler or pharmacy may sell, trade, or transfer a prescription drug at wholesale without providing an electronic pedigree. Furthermore, no wholesaler or pharmacy may acquire a prescription drug without a pedigree. The law also allows the board discretion to delay implementation an additional two years until 2011.

Other states, like Utah and Florida, have instituted more limited pedigree requirements, but the California law is the most far reaching. The Food & Drug Administration has advocated for a national approach, but the federal pedigree regulation in the Prescription Drug Marketing Act (PDMA) has been challenged in an ongoing court battle between the secondary wholesaler RxUSA and the FDA. The judge in the case has granted a preliminary injunction while the case proceeds.

National pharmacy chains are hoping that the California rules will serve as the template for other state pharmacy boards. “There has to be a uniform standard established,” stressed Philip Burgess, R.Ph., national director of pharmacy affairs at Walgreen Co. “If California is able to come up with a standard that can be adopted by the manufacturers, the wholesalers, and the retailers, then it does have a unique opportunity to set the standard for the rest of the country.”

Despite the long lead time for the rule, many companies are telling the board that they will not be ready in time. Technological hurdles with RFID (radio frequency identification) technology have slowed implementation, although new generations of RFID tags and supply-chain software have made great strides. Just as significantly, e-pedigree requires both changes in workflow and significant investment throughout the supply chain. “I don’t believe that a thorough financial analysis has been done on the implementation of electronic pedigree,” maintains David Fong, Pharm.D., senior VP of pharmacy & family care at California-based Safeway. “Who’s picking up that cost?”

“It shouldn’t be a question of whether Safeway is ready as much as whether the supply chain is ready, because we can do our part,” added Fong. “We don’t believe that on January 1, 2009, the supply chain will be ready to comply with the rule.”

In testimony before the board last month Steve Perlowski, National Association of Chain Drug Stores’ VP of industry relations, requested that the board allow pharmacies to continue two practices that would otherwise be banned by the new regulations. Perlowski urged the board to extend the deadline for inferencing until 2013 and to allow existing inventory up to two years beyond the compliance date to sell through the supply chain. With the practice of inferencing, when a shipment is received from a reputable manufacturer with no history of problems, pharmacies check the number of packages against the receiving documents and infer that if there is no sign of tampering that the shipment is safe and accurate. According to Lynn Rolston, CEO of the California Pharmacists Association, the board doesn’t have statutory authority to give pharmacies extra leeway, but the organization is hoping to sponsor legislation to handle the problem.

Others pharmacists worry about the broader impact e-pedigrees will have on the industry. “The deeper issue is the cost on pricing policy in general,” explained Stephen Schondelmeyer, Pharm.D., Ph.D. director, PRIME Institute, College of Pharmacy, University of Minnesota. “E-pedigree puts the manufacturers in control of their product from the time it leaves their plant till it gets to the patient. So they can enforce price maintenance all the way through the system, but that’s never talked about when we talk about e-pedigree. We need to honestly evaluate economic policy for pharmaceuticals. We have many policies on the books that were there for other reasons that dramatically affect our cost structure, and that’s why we pay 50% to 60% more than most other countries for the same drug.”

www.modernmedicine.com

19 dead – We need more time to stop it ?

counterfeitdrug — Tue, 25 Mar 2008 13:20:08 +0000

LA Times -

Delays thwart drug tracking system

The pharmaceutical industry says its needs more time to gear up for a novel state plan to fight counterfeiting.

March 25, 2008

News of as many as 19 deaths in the United States linked to contaminated blood thinner heparin from China has generated new concerns about how to keep bad drugs from finding their way into the marketplace.

But if California’s 5-year-old effort to fight counterfeit drugs is a guide, the task may be tougher than it looks.

The pharmaceutical industry has repeatedly balked at implementation of the state’s first-in-the-nation law approved in 2004 that would require manufacturers and retail pharmacies to create an electronic system to record a drug’s journey from factory to patient.

The system was to be in place by Jan. 1, 2007, but the California Legislature in 2006 extended the deadline until next January. Today, the state Board of Pharmacy will consider another extension — this time until 2011.

Big pharmaceutical companies, drug wholesalers and retail pharmacy chains say they can’t meet California’s Jan. 1 deadline and are asking for more time. Various industry associations have begun a quiet, coordinated campaign to promote the extension, hiring lobbyists and both Republican and Democratic-oriented firms that specialize in political strategy and media.

But state regulators say they’re worried that further delays could endanger public health. “In 2011, they’ll want 2013. In 2013, they’ll want 2015,” said state board member Stan Goldenberg, a Los Angeles pharmacist. “They’ll keep the ball in the air until something bad happens.” He said, “They’re playing Russian roulette with the consumers of California.”

The board, Goldenberg said, wants to be proactive.

“We are desperately seeking cooperation from the pharmaceutical industry,” he said. “But we are not getting their cooperation” except for certain smaller manufacturers.

Stronger regulation is overdue, said Virginia Herold, executive officer of the pharmacy board. “We’ve learned that we cannot trust the supply train, and there are bad players.”

The U.S. Food and Drug Administration has also had no luck implementing a national system to fight counterfeit drugs.

FDA spokesman Christopher Kelly acknowledged that the agency has run into a number of legal and administrative delays in instituting its own rules over the last 20 years. The FDA, he said, “supports California’s efforts to further secure the drug supply chain.”

The World Health Organization estimates that counterfeit drugs account for less than 1% of the nation’s drug supply, but even that small number could mean that Californians are picking up 3 million prescriptions a year filled with phony pills and liquids, state regulators warn.

At the heart of the 2004 California law is the “electronic pedigree” system that would trace drugs back to production. When the Legislature postponed the start of the program in 2006, it also toughened it by mandating that the industry install electronic readers to track serial numbers on each salable unit of a drug at key points along the distribution system.

The Legislature first acted after an estimated 200,000 bottles of fake Lipitor, one of the nation’s most widely used medications for controlling cholesterol, were recalled in 2003, causing a national outcry.

Drug companies say that they’ve been working diligently to meet California’s tracking deadline but contend that they need more time to overcome technical and financial challenges.

“If the law were implemented next year, McKesson would not be able to deliver vital medications throughout the state,” said a letter to the board from McKesson Corp., the San Francisco drug company that is one of three main national drug wholesalers and distributors.

“The health and safety of Californians would be best served if the e-pedigree implementation date is delayed until 2011,” the company said in a letter to the board.

The industry wants the pharmacy board to approve the two-year delay today. As a backup, pharmaceutical companies are sponsoring a bill that, if passed, would indefinitely put off the date for starting to electronically track medicines.

Some drug makers say they aren’t sure they can meet a deadline, even if it’s extended to 2011.

“It’s going to be hard to know right now. We need time to do research and development,” said Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Assn. “The industry may need additional time.”

Even if they approve the two-year delay, state regulators say they hope to persuade all participants in the drug supply system, including manufacturers, distributors and retailers, to begin voluntarily complying with as much of the electronic tracking law as feasible: by putting bar codes or radio frequency identity chips on products and installing scanners throughout the manufacturing, distribution and sales system.

Under current law, the pharmacy board would be empowered to make such actions mandatory after Jan. 1, 2011.

Acting quickly is essential, said Rick Roberts, who discovered in 2000 that he’d been taking a counterfeit human growth hormone to counteract AIDS-related atrophy.

“It was a nightmare. Not knowing whether I did damage to myself really consumed me,” said the University of San Francisco professor, who has since recovered. Drug counterfeiting, he said, is a “heinous crime.”

marc.lifsher@latimes.com

RFID Fails the counterfeit test

counterfeitdrug — Sat, 08 Mar 2008 17:57:16 +0000

When the California Board of Pharmacy decided to endorse RFID as a mechanism for ePedigree of drugs, they were willingly led down the path of false sense of performance. While serialization is an excellent approach for anti-counterfeit measure, below is an example of how RFID does not perform as a security mechanism.

Hackers Find a Way to Crack Popular Smartcard in Minutes

Security on RFID-enabled smartcards is easily broken by young hackers.

People are starting to wake up to the fact that RFID-enabled smartcards now can be far more easily, and cheaply, cracked than ever before, as a trio of young computer experts recently showed.

These are a particular type of processor-embedded cards, and are different from credit cards. The actual decryption work by the researchers was done on the widely deployed Mifare Classic wireless smartcard, now manufactured by a Philips spinoff, NXP Semiconductors. Decrypted, the cards can be counterfeited, and users’ personal and bank data is exposed.That card is the basis of such new systems as the Dutch OV-Chipkaart, being rolled out in The Netherlands as part of a multi-billion dollar nationwide transportation ticketing system, and the so-called CharlieCard, used in the Boston subway system. The decryption breach triggered a firestorm of controversy, and Dutch authorities apparently have halted the rollout and are investigating the vulnerabilities.The card can be used in debit/credit transactions with the user’s bank account. This personal and important data is encrypted on the Mifare Classic with a proprietary encryption scheme.The newest attack was demonstrated at the 24th Congress of the Chaos Computer Club in Berlin last December. Interest in the study has been spreading steadily from the arcane world of security hackers. One of the researchers is Karsten Nohl, a graduate student in the University of Virginia’s Computer Science Department, in Charlottesville, the other two are Henryk Plotz and “Starbug.” The trio apparently demonstrated a practical and effective way to break the Mifare encryption key, confirming what many cryptographers had suspected.

The team used an inexpensive RFID reader to collect encrypted data, and then reverse-engineered the chip to figure out the encryption key to decipher that data. They examined the chip under an optical microscope and used micro-polishing sandpaper to remove a few microns of the surface at time, photographing each of the five layers of circuitry. Nohl wrote his own optical recognition software to refine and clarify the images, and then patiently worked through the arrangement of the logic gates to deduce the encryption algorithm, a task made possible by the fact that the Mifare Classic relies on a secret key of no more than 48 bits.

“Regardless of the cryptographic strength of the cipher, the small key space therefore permits counterfeiting of any card that is read wirelessly,” the team wrote in a follow-up statement issued on Jan. 8. “Knowing the details of the cipher would permit anyone to try all possible keys in a matter of days,” the researchers noted. “Given basic knowledge of cryptographic trade-offs and sufficient storage, the secret keys of cards can be found in a matter of minutes.”

The Dutch transit system actually uses two other types of tickets or cards, and both have been successfully attacked by other researchers.

Nohl and his colleagues noted that other types of Phillips RFID tags, such as the Hitag2+ and Mifare DESfire, are not affected by their findings.

RFID security concerns have become pronounced over the past year or so, as hackers and researchers make more concerted efforts to understand the vulnerabilities. In mid-2007, one team used readily available RFID gear to read the Electronic Product Code data on tagged boxes loaded on a tractor-trailer. A year earlier, another group raised the specter that RFID tags could be infected with computer viruses.

Law & Order – NBC Episode on counterfeit asthma inhaler

counterfeitdrug — Thu, 21 Feb 2008 02:57:22 +0000

Even producers of Law & Order appreciate the impact of counterfeit drugs.

A Park Avenue dentist is murdered and evidence points to his young patient. Wednesday, February 20, 2008 at 9PM.

An episode of a series of murders related to counterfeit drugs. The fictitious Shore Labs drug producer that manufactures an asthma inhaler as well as a mouthwash, Snow-Mint, that are tainted with DEG.

The FDA inspector discovers the tainted mouthwash at a dollar store and reports to his FDA supervisor, Leslie Lezard.

The FDA Deputy Director, Atlantic Division, covers up the tainted mouthwash by conspiring with the drug producer to avoid recalls.

The FDA Deputy Director was a former drug lobbyist and college ‘buddy’ of the drug producer, Bing Shore.

3 children dead. 2 adults dead.

The only thing missing in the episode was a letter from Shore Labs to the California Board of Pharmacy requesting a delay to January 2011 for e-Pedigree compliance.

Holst Center reports breakthrough in organic RFID

counterfeitdrug — Wed, 20 Feb 2008 02:46:50 +0000

Holst Center reports breakthrough in organic RFID

We’ve achieved a significant leap forward in RFID integration into packaging rather than labels, which presents the prospects of aligning RFID with datamatrix costs.

While Siemens and Kurz owned PolyIC is proud of achieving an 8 bit printed polymer RFID tag, competing with BASF and Weyerhaeuser, Holst achieved a 64 bit 13.56 MHz plastic organic tag.

This achievement brings serialization capabilities closer to printed electronics and will bring item level serialization at a cost of a penny or two. At least a plastic rectifier and plastic circuit is a significant leap away from silicon.

Holst Center (http://www.holstcentre.com), which was founded by the Belgian nanoelectronics research center IMEC and the Dutch research center TNO, have announced a plastic 64-bit inductively-coupled passive RFID tag operating at 13.56MHz. With a record 780bit/s data readout of 64 bits over 10cm, the device approaches item-level tagging requirements.

The tag generates a 5-fold higher bit rate compared to state-of-the-art plastic RFID systems. The achievement paves the way for low-cost high-volume RFID tags to replace barcodes. The RFID system consists of a low-cost inductive antenna, capacitor, plastic rectifier and plastic circuit, all on foil. The LC antenna resonates at 13.56MHz and powers up the organic rectifier with an AC voltage at this frequency. From this voltage, the rectifier generates the DC supply voltage for the 64-bit organic transponder chip which drives the modulation transistor between the on and off state with a 64bit code sequence. The foil with the transponder chip was processed with the state-of-the-art organic electronics technology provided by Holst Center partner Polymer Vision.

Organic vertical diodes have been used in the rectifier since they outperform organic transistors for rectification at frequencies at and above 13.56MHz. At an RF magnetic field strength of 1.26A/m the rectifier generates an internal transponder supply voltage of 14V. At this voltage, the 64-bit designed code is read out at a data rate of 787bits/s. The reading distance is up to 10cm. The organic 64bit transponder chip, fabricated by Polymer Vision (http://www.polymervision.com), is using organic bottom-gate p-type Pentacene thinfilm transistors from soluble precursor route. It comprises only some 400 transistors and is thereby significantly smaller than previous designs.

Unrelated to the Holst plastic RFID product, printed RFID is the fabrication of dual-gate organic thin-film transistors usingplasma-enhanced atomic layer deposited 150 nm thick Al₂O₃ and 300 nm thickparylene as gate dielectrics and pentacene as a semiconductor. Thethreshold voltage (V_th) is changed from 14.5 to –1.5 V whenthe voltage bias of the top-gate electrode is changed from–10 to 20 V. The voltage transfer characteristics of an inverterwith a dual-gate driver transistor and a single-gate load transistor,specifically, swing range and inversion voltage, have been artificially controlledby changing the voltage bias of the top-gate electrode.

About Holst Centre
Holst Centre is rapidly evolving into an internationally recognized center for open innovation in technologies for wireless autonomous sensor-based microsystems and systems-in-foil. Holst Centre was established in 2005 by the Flemish research centre for nanoelectronics and nanotechnology IMEC and the Dutch research institute TNO. From the start, it is financially supported by the Dutch Ministry of Economic Affairs and can count on the approval of the Flemish Government. Located on the High Tech Campus in Eindhoven, Holst Centre can benefit from the state-of-the art on-site facilities. Holst Centre has over 100 employees (growing to over 200 by 2010) and a network of over 15 industrial partners. More information: www.holstcentre.com

About Polymer Vision
Polymer Vision is the pioneer and mobile industry leader of a revolutionary new generation of mobile devices enabled by rollable displays. The company’s first product, the Readius®, is a pocket sized device combining a large 5″ rollable display with 3G high speed connectivity. It is designed around ‘always available’ and ‘real time updated’ personalised news and information of the user. The Readius® is the first member of a family of Polymer Vision products that will offer consumers large rollable displays (5″-to-9″) in small pocket size devices. These devices fulfill a growing demand for larger mobile displays to compliment the accelerating trend towards mobile content, applications and mobile advertising. In 2007 Polymer Vision was the winner of the 3GSM Global Innovation Award. In October of 2007 Polymer Vision acquired the whole of the business activities of Innos Limited UK, the manufacturing subcontractor of the company’s rollable displays and integrated this into Polymer Vision Ltd. More information: www.polymervision.com

About IMEC
IMEC is a world-leading independent research center in nanoelectronics and nanotechnology. Its research focuses on the next generations of chips and systems, and on the enabling technologies for ambient intelligence. IMEC’s research bridges the gap between fundamental research at universities and technology development in industry. Its unique balance of processing and system know-how, intellectual property portfolio, state-of-the-art infrastructure and its strong network of companies, universities and research institutes worldwide position IMEC as a key partner for shaping technologies for future systems. IMEC vzw is headquartered in Leuven, Belgium, has a sister company in the Netherlands, IMEC-NL, concentrating on wireless autonomous transducer solutions, and has representatives in the US, China and Japan. Its staff of more than 1600 people includes more than 500 industrial residents and guest researchers. In 2007, its revenue (P&L) is estimated at about EUR 235 million. Further information on IMEC can be found on www.imec.be.