WSJ: J&J Details Recall Troubles

In the May 18 edition of the Wall Street Journal, Jonathon Rockoff writes about new details emerging from the problems with Johnson and Johnson’s production and recall of certain children's medicines. These details are coming forward as the company faces growing scrutiny in Washington, D.C.

Many of the details were obtained via a letter, dated May 1st from Johnson and Johnson to doctors and poison control officials.

Here are some of the highlights from the article:

· Some samples of recalled infants' Tylenol were tested to contain as much as 24% more active ingredient than shown on the label, according to a letter that J&J's McNeil Consumer Healthcare unit sent to doctors and poison-control officials that was reviewed by The Wall Street Journal.

· The company said the suspect medicines hadn't reached the marketplace, and its testing of other batches that had been released to the market didn't find any problems. "But we cannot confirm that all the individual bottles were within specification or that 24% would have been the maximum," according to the letter, which didn't indicate when or how the testing was done.

· The letter was dated May 1, the day after J&J recalled certain children's and infant's Benadryl, Motrin, Tylenol and Zyrtec cold and pain medicines after discovering unspecified manufacturing problems. The company said at the time that the medicines could contain higher concentrations of medicine than they should, among other potential issues, but didn't specify an amount.

· The J&J unit inadvertently neglected to include one version of Children's Zyrtec in the recall for five days, according to an email sent to the company's over-the-counter sales force. It told its sales force on May 5 that the 1 milligram grape version of children's Zyrtec "was inadvertently not included" in the recall.

· A spokeswoman for J&J's McNeil unit said the company sent the letter about infant Tylenol to health-care professionals in connection with the recall, and its "health assessment" indicates the chance that the recalled medicines will cause harm is remote.

· In conjunction with the April 30 recall, J&J's McNeil unit shut down the Fort Washington, Penn., plant that made the recalled products until it could fix the manufacturing issues and assure quality production. The company said that in addition to overly high concentrations of ingredients, the recalled liquid products may contain inappropriate levels of inactive ingredients or tiny metallic particles left as a residue from the manufacturing process.

· A Food and Drug Administration inspection of the plant had also found bacteria in raw materials set aside for use to make several lots of Tylenol.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748704912004575252923733201114.html

To learn more about supply chain security and verification solutions, visit: http://www.xstreamsystems.net/.

CNNMoney.com: Serious Side Effects of Tylenol Recall Investigated

CNNMoney.com Senior Writer Parija Kavilanz reported on May 25th on the Food and Drug Administration investigation into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson.

McNeil is also under a Congressional investigation regarding the recall, the House Committee on Oversight and Government Reform has scheduled a hearing on May 27th to examine the recall.

Highlights from the report include:

• Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

• The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

• Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.

• The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a "remote" potential for serious health problems.

• McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

McNeil's latest recall is its fourth in the past seven months:

• In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
• In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
• In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

To view the CNNMoney.com story, visit: http://money.cnn.com/2010/05/25/news/companies/tylenol_recall_adverse_consumer_complaints/index.htm.

India's Fake Drugs Are a Real Problem

India’s Food and Drug Administration recently conducted a series of raids to combat counterfeit drugs. Large amounts of counterfeits were seized in these raids and several individuals were arrested.

Roger Bate, a leading authority on counterfeit drugs recently wrote an article for the Wall Street Journal on these raids and the prevalence of counterfeit drugs in this region.

Below are some of the highlighted statistics cited in the article:

• In 2009, Bate examined five essential medicines in 52 different pharmacies in Delhi and Chennai. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient.


• In a more recent investigation of Delhi’s wholesalers, they discovered that 7% of all tested samples were substandard and 3.6% were likely counterfeit.


• Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities.


• In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.


• Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.


• The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be.


• Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady.

In the article, Bate discusses the huge profits to be made and the necessity for stricter enforcement and how new technology can be used to combat this deadly menace.

XStream Systems has an anti-counterfeiting solution that allows wholesalers to molecularly verify the quality and authenticity of their inventory. In a world where what you see is not always what you get, our penetrating technology authenticates the medication and not just its packaging.

To learn more about XSteam Systems Solution visit: www.xstreamsystems.net.

For the full article visit: www.wsj.com.

Canadian Man Pleads Guilty to Selling Counterfeit Cancer Drugs

Tuesday, Hazim Gaber, 22 of Edmonton, Canada, pleaded guilty to selling counterfeit cancer drugs over the internet. Gaber admitted selling what he falsely claimed was the experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the United States, Canada, the United Kingdom, Belgium and the Netherlands between October and November 2007. According to the plea agreement, Gaber charged $23.68 for 10 grams of the purported DCA, $45.52 for 20 grams or $110.27 for 100 grams, plus shipping.

DCA is an experimental cancer drug not yet approved for use in the United States or Canada. DCA is an odorless, colorless, inexpensive, relatively non-toxic experimental cancer drug that is highly sought after by cancer patients. A doctor at the University of Alberta in Canada published a report in early 2007 summarizing the results of a study, which showed that DCA caused regression in several cancers, including lung cancer, breast cancer, and cancerous brain tumors.

Gaber sold the counterfeits through a website named DCAdvice.com, which falsely claimed that it was the only authorized representative to sell DCA and was affiliated with the University of Alberta. Further lab analysis determined that the substances sold contained starch, dextrin, dextrose or lactose, and contained no DCA.

Gaber faces a maximum prison sentence of 20 years on each of the five counts of wire fraud to which he pleaded guilty. Gaber also faces maximum fines of $250,000 per count. As part of the plea agreement, Gaber agreed to forfeit or cancel any website, domain name or Internet services account related to this fraud scheme.


XStream System applauds all the regulatory and enforcement agencies involved in the capture of this counterfeiter: Criminal Division’s Computer Crime, Intellectual Property Section, Assistant U.S. Attorney Peter Sexton of the U.S. Attorney’s Office for the District of Arizona. the Edmonton Police Service, the Alberta Justice Office of Special Prosecutions-Edmonton, the Competition Bureau of Canada, the U.S. Postal Inspection Service, the Federal Trade Commission and the Alberta Partnership Against Cross Border Fraud, The Criminal Division’s Office of International Affairs and the Phoenix FBI Cyber Squad.

To view the Dept of Justice Press Release visit: www.justice.gov.

To view information regarding counterfeit detection solutions visit: www.xstreamsystems.net.

USTR Lists the Global Hotspots for Counterfeit Drugs

The United States Trade Representative (USTR) recently released their annual Special 301 report on global advances and watch lists for Intellectual Property (IP) enforcement.

The Czech Republic, Hungary, and Poland were removed from the watch list. Czech Republic was removed due to their improved board control and enactment of stricter criminal penalties. Hungary was removed due to their increase of IP enforcement. Poland was eliminated due to significant reduction of pirated goods at border markets.

Saudi Arabia was removed from watch list in Feb. 2010 for its advances in controlling the distribution of counterfeit medicines. Israel is listed as status pending as it works with USTR to resolve their problems with counterfeit medicines.

Currently countries on priority watch list include: Algeria, Argentina, Canada, Chile, China, India, Indonesia, Pakistan, Russia, Thailand, and Venezuela.

• China – although China has made great strides in IP regulation, counterfeiting still remains widespread and China’s IPR enforcement regime remains largely ineffective and non-deterrent. In China, many bulk Active Pharmaceutical Ingredients (API) used in manufacturing medicines avoid regulatory oversight by declaring falsely that they will not be used in manufacturing pharmaceutical products.


• Russia – brand manufacturers continue to report counterfeit problems of their trademarks especially for consumer goods, distilled spirits, agriculture chemicals, biotechnology, and pharmaceuticals.


• Algeria laws ban imported pharmaceuticals in favor of local production. In addition the USTR has concerns of weak protection of patents.


• Argentina has a backlog of pharmaceutical patent applications and USTR cites the need for stronger protection against IPR infringement.


• Canada - displays weak enforcement of IP rights and border protection.


• Chile - has displayed a willingness to work with the U.S. Pharma industry, but still falls short in some areas.


• India – although India has made advances in IP enforcement, the USTR still shares concerns regarding widespread counterfeit medicine and an enforcement regime that remains ineffective at addressing this problem.


• Indonesia shows an overall deterioration of IP protection and enforcement including its inability to address the counterfeiting of pharmaceutical products.


• Pakistan – has made significant advances in patent applications, but needs an effective system to address patent issues.


• Thailand – piracy and counterfeit remain widespread. In the pharmaceutical industry they need to strengthen their IP protection and enforcement.


• Venezuela - does not recognize pharmaceutical patents.

To read the entire report visit: www.ustr.gov.

McNeil Announces Sweeping Recall of Infants’ and Children's OTC Products

In an April 30th announcement, McNeil Consumer Healthcare in consultation with the U.S. Food and Drug Administration (FDA), stated that they are voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

McNeil Consumer Healthcare stated that they were initiating this voluntary recall because some of these products may not meet required quality standards.

According to McNeil the recall is not being undertaken on the basis of adverse medical events but as a precautionary measure and advises parents and caregivers should not administer these products to their children.

Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

For a complete list of the products, visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

FDA Sends Warning Letter to Pharmaceutical Supply Chain

In an open letter to pharmaceutical stakeholders within the supply chain, the FDA took the unusual step of warning and urging them to take further steps to protect themselves and the supply chain given the increase in cargo and warehouse thefts of FDA regulated products.

The letter signed by Michael Chappell, Acting Assistant Administrator of Regulatory Affairs appears in its entirety below:

April 28, 2010

Food and Drug Administration
Rockville, MD 20857

Dear Stakeholder:

FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including prescription and over-the-counter medicines, vaccines, medical devices, and infant formula. These crimes threaten the public health because product that has left the legitimate supply chain poses potential safety risks to consumers. There have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling. We do not want to see this increase in thefts continue. We would like to share our thoughts on steps that your members should take to minimize the risk of such thefts, as well as how FDA can work together with your members when a theft has occurred to address the public health risks associated with the stolen products.

Of course, the best intervention is to prevent these thefts from occurring in the first place. Firms engaged in providing medical products and infant formula to the public have a fundamental responsibility to continuously review their warehouse physicalsecurity and security practices and procedures for transporting products to ensure that measures are in place to minimize the risk of warehouse and cargo theft. These measures are important throughout the supply chain-starting from the point of manufacturing, continuing through the distribution of the product and to the retail outlet or other point where the product will be sold.

Your members should ensure that their business partners and carriers review and have strengthened their storage and in-transit security practices as welL. Your members need to be one-step ahead of thieves in securing their warehouses and product transport.

When a theft occurs, FDA is committed to work with the affected firm to minimize the public health risks and ensure an appropriate public health response. The agency has developed streamlined procedures to rapidly respond to reports of theft and ensure consistency as we work with firms that have experienced a cargo or warehouse theft.

We would like your members to promptly notify FDA's Office of Criminal Investigations (OCI) as soon as possible when a theft has occurred by contacting OCI's Headquarters office at 800-551-3989 or by accessing the OCI web site (ww.fda.gov/oci). OCI wil ask for information about the theft to assist FDA in evaluating an appropriate regulatory response. In the attached Appendix A to this letter, we have listed the types of, questions that an FDA District Office may ask about the incident. FDA also encourages prompt reporting to law enforcement agencies.

Typically, FDA's District Office closest to a firm's corporate headquarters will follow up with their regulatory contact. The District Office will request that the firm provide information pertaining to the stolen products, including a risk assessment and an actionplan, as expeditiously as possible. (See Appendix A.)

In some cases, the appropriate public health response may be a market withdrawal for product already in the supply chain with the same lot numbers as the stolen product.

We recognize the impact that such a withdrawal may have on consumers, the supply chain, and a firm's business operations, and the agency is ready to work closely with firms to determine the appropriate steps to consider in order to protect the public.Depending on the circumstances, a prompt and effective response to a theft wil reduce the need for such a market withdrawal.

Prompt public notification of the theft is a critical step in protecting the public health because it alerts others in the supply chain and the public to look out for the stolen products and to be skeptical of offers for these products at unusually low prices or from aperson outside the legitimate distribution chain. In addition, if persons in the supply chain are looking out for these products, it becomes more difficult for the thieves to sell the products back into the legitimate supply chain. If a firm experiences a cargo orwarehouse theft, we strongly encourage it to prepare a public notice for posting on its website or as a press release as soon as possible after the theft. FDA is ready to provide comment on the public notice in an expeditious manner if the firm would like toshare it with the agency before release. FDA's District Office will coordinate this review with the firm. FDA will typically provide a link to the firm's public notification on FDA's new Cargo Theft website. http://www.fda.gov/ICECI/CriminalInvestigations/ucm182888.htm

As you may know, FDA has been working with manufacturers, wholesalers, and retailers on ways to further secure our nation's supply chain from counterfeit, diverted, unapproved, and otherwise misbranded or adulterated products. We have now addedstolen products to this effort. FDA is working with the medical products and infant formula supply chain to identify best practices and provide other guidance on how to prevent and respond to cargo/warehouse thefts.

FDA hopes and expects that your members and others in the supply chain will immediately review their in-transit and warehouse security practices and take proactive measures to prevent opportunities for theft. It is also prudent for your members to planin advance, for how they would respond to such an incident, since swift action is essential.

We look forward to continued dialogue with participants in the supply chain to identify best practices and other steps that can be taken to further ensure that American consumers can be confident about the safety and quality of medical products and infantformula sold in the U.S.

If you have any questions related to this letter or cargo theft generally, please contact Dr. Ilisa Bernstein, Director of Pharmacy Affairs, FDA, Office of the Commissioner, Office of Policy at 301-796-4723 or ilisa.bernstein@fda.hhs.gov.

Michael Chappell
Acting Assistant Adminstrator Regulatory Affairs


The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.

To learn more about material screening/anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

To read the entire FDA letter online, visit: http://www.fda.gov/ICECI/CriminalInvestigations/ucm209979.htm
To learn more about material authentication solutions, visit: http://www.xstreamsystems.net/.