WSJ: Watchdog Says FDA Risked Integrity

GAO criticizes FDA saying that it risked giving the appearance of compromised integrity.

Alicia Mundy in a Wall Street Journal article reports on a Government Accountability Office (GAO) report criticizing the Food and Drug Administration (FDA) for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.

According to the Wall Street Journal article:

• A congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.

• Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG's Sandoz unit.

• Also critical of the FDA's actions are Momenta's rivals—including Teva Pharmaceutical Industries Ltd., the world's largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA's generic-drug division. The drug companies' applications are still awaiting FDA action.

• The controversy centers around Momenta's performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company's application to sell the generic version of a blockbuster blood thinner.

• As a result, "agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," including heparin-related drug approvals, the report says,

• In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta's expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.

• The FDA has said its reliance on Momenta's free work had nothing to do with its approval of the company's drug ahead of competitors'.

• Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.

• Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug's sales have topped $300 million.

• Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation . "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said.

• The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.

• The FDA said that Momenta's researchers did an excellent job identifying the contaminant. "This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists," it wrote in a response to the GAO.

• Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency's "fundamental weakness" in dealing with the surge of Chinese medical imports.

Although this article spends most of its time dealing with potential conflict of interest and integrity issues within the FDA, Rep. Barton’s final quote is the most important as it relates to the safety of the domestic pharmaceutical supply chain.

Making certain that the health care consumer here in the United States is protected from unsafe and ineffective medications is paramount.

Instead of reports and interagency finger pointing, the United States government needs to figure out who attempted to poison the American consumer and bring them to justice. Without this resolution, it seems clear that these criminal acts will continue.

Members of the pharmaceutical supply chain must take it upon themselves to make certain that their inventories are safe from adulterated, sub-standard, fraudulent and counterfeit medications.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html?KEYWORDS=heparin

To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

WSJ: Delhi's Fake Drug Whitewash

“The (Indian) government's flawed research study endangers lives and crucial pharmaceutical investment.”

Roger Bate, a Legatum Fellow at the American Enterprise Institute and one of Secure Pharma Chain’s favorite international pharmaceutical counterfeiting experts, once again writes an excellent opinion piece in the September 2nd issue of the Wall Street Journal.

Mr. Bate focuses a very critical eye on the Indian Governments Central Drugs Standard Control Organization’s study on spurious drugs within the Indian Supply Chain.

Mr. Bate challenges CDSCO’s sampling methods, the contradictions with past accepted issues and reports of pharmacies likely knowing of inspections in advance.

This is especially worrisome given the fact as Mr. Bate points out that 45% of a Indian’s pharmaceutical market is exported to more than 200 countries and that every second child in the world is vaccinated with a vaccine made in India.

Mr. Bate questions examines CDSCO’s testing and sampling protocols which ultimately he determines to be "a whitewash of a crucial problem".

Highlighted in the WSJ opinion piece:

· The proliferation of fake drugs is one of the greatest dangers facing India today. It threatens lives, discourages patients from using life-saving innovations and deters much-needed pharmaceutical investment. So it's more than a bit worrying to see the Indian government touting a new study that is little more than a whitewash of this crucial problem.

· After literally months of leaks about the results, the "Report on Countrywide Survey For Spurious Drugs" was released by the Central Drugs Standard Control Organization in July. The report, conducted over a period of seven months last year, found that of 24,136 samples, 11 or 0.045%, were fake.

· The CDSCO took pains to point out that their results flatly contradict reports over the past decade from scholars and industry groups claiming fake drug rates ranging from 3% to 35%. Indeed, the author expresses a clear aim to overcome the "apprehensions about the availability of safe and genuine medicines in India."

· But the report's results fail to pass even the most cursory of inspections. Not only are there discrepancies with international studies, but there are unexplained internal inconsistencies which undermine the findings. The report says, for instance, that its authors had no useful information about areas known for counterfeit drugs. This is inconceivable: New Delhi's Bhagirath Palace and certain markets in Agra and Aligarh are known to me, a foreigner, as major locations of the fake drugs trade.

· It's reasonable to assume the report generated untrustworthy findings because the samples were biased. Vijay Karan, a former Delhi police chief, told me that many pharmacists are routinely aware of when and by whom government surveys would be done. The report itself notes retail pharmacists in cities "refused to sale. . . the schedule drug without prescription." But of the 70 or more pharmacies in cities we visited in our studies at the American Enterprise Institute, none demanded prescriptions. Either pharmacists voluntarily and drastically changed policy in the past year—or they were alerted to who the covert buyers really were and reacted by following the letter of the law, not their usual practice.

· Conducting covert surveys requires following a careful protocol. In our peer-reviewed studies for the Public Library of Science One Journal, we were grilled by reviewers about how interviews were conducted, since poor sampling might have biased the results. Yet the CDSCO report includes only a single sentence on the importance of sampling protocols. Nowhere in the report is the drug-collection protocol actually discussed.

In the final analysis, the CDSCO report is a well-conducted analysis of probably dubious data, which makes the results useless. If this were a minor report, that might be a passable error. But given the life-threatening nature of fake drugs, it's not something the government should tolerate. A Pew poll last month found that 54% of Americans distrust drugs made in India. No wonder.

Mr. Bate’s critical analysis of the CDSCO survey is important in that it calls out those who are entrusted with a population's public safety who have fallen short of their responsibility of accurately summarizing this important issue.

Adulterated, fraudulent and counterfeit drugs are an international crime and a health care epidemic; a government that turns a blind eye and chooses to ignore the issue and proclaim a supply chain safe when common sense and history dictates otherwise invites deadly consequences.

Secure Pharma Chain encourages the pharmaceutical supply chain to protect itself by deploying technologies to protect their inventories and defend consumers from bogus, deadly medicines.

To read the entire Wall Street Journal Opinion, visit: http://online.wsj.com/article/SB10001424052748703882304575465170785077144.html

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

Baxter's Heparin Saga Continues

The Wall Street Journal writes about the preliminary legal wrangling by Baxter regarding their class action lawsuit over the 2008 contamination of heparin products which led to 81 deaths in the United States.

In the class action lawsuit, Baxter and its heparin supplier Scientific Protein Laboratories are cited as being negligent because they did not do enough to check the quality of the contaminated active pharmaceutical ingredient that ended up in heparin products distributed to patients.

According to the story in the Wall Street Journal, “Baxter and SPL are trying to block an attempt by Amphastar Pharmaceuticals to force disclosure of documents relating to the case which they claim contain proprietary and commercially-sensitive information.”

Amphastar claims that the documents could reveal important information about the origins of the tainted API.

Among the documents under dispute is the deposition of another company, Momenta Pharmaceuticals, which assisted the US Food and Drug Administration in its investigation of the scandal.

This story, like several other high profile issues regarding the quality and efficacy of pharmaceuticals, is a cautionary tale to all within the pharmaceutical supply chain to protect their products.

With an entire criminal industry that focuses on counterfeiting and what many call economically-motivated adulteration, in which ingredients are deliberately adulterated to fool lab testing and increase their value, the pharmaceutical industry, the value of their individual brand and the health and well being of the average consumer is in the cross hairs. Manufacturers, distributors and dispensers need to deploy and integrate technologies to verify and authenticate their raw materials, products, inventories and dispensed medications.

As it relates to Baxter, the FDA believes that the heparin was purposely laced with cheaper, toxic contaminants - oversulphated chondroitin sulphate – which ultimately lead to the deaths of 81 people.

To read The Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748704868604575433960537183170.html?mod=googlenews_wsj.

FDA a Paper Tiger: China and the Heparin Probe

Ed Silverman on July 22nd blogs in Pharmalot about the questions being raised in Congress and within the media of the FDA’s lack of holding Chinese officials accountabile in tracking down the issue of the deadly Heparin issue that killed dozens in the US several years ago.

In this excellent blog post, Mr. Silverman highlights:

· ...how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation.

· You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there. Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger.

· “It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Joe Barton, the top Republican on the House Energy and Commerce Committee, tells the Wall Street Journal. He and Mike Burgess, another Texas Republican who is the ranking member on the Subcommittee on Oversight & Investigations, blast the FDA for not pressing the Chinese or acting on info obtained over the past two years . The probe, by the way, comes as FDA commish Margaret Hamburg prepares for her first trip to China.

· An FDA spokeswoman tells the Journal that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.” In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

· Chinese security authorities told a US official in Beijing in June 2008, that China wasn’t investigating the heparin episode as a criminal or administrative matter, he tells the paper.

This excellent blog brings to light the ability of the US government to properly investigate serious issues with quality, adulteration, fraud and counterfeiting with an important trading partner where a significant number consumer and health care products and their raw materials originate.

The lack of regulatory cooperation between nations is a serious concern to all within health care and its consumers.

Given the inability of the regulatory authorities to work together and properly vette and secure the global supply channels. Secure Pharma Chain believes that it is critical for all members of the global pharmaceutical supply chain to take measures to protect its inventories and brand by deploying technologies that validate the authenticity and efficacies of its products.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/china-stymies-fda-probe-into-contaminated-heparin/#more-25075

To learn about supply chain validation solutions, visit: http://www.xstreamsystems.net/.

J&J Unit Recalls More OTC Drugs

Late Tuesday, Johnson & Johnson's McNeil Consumer Products division announced the inclusion of several other of its hugely popular brands to its massive OTC recall. It is now recall four lots of Benadryl allergy tablets and one specific lot of its Extra Strength Tylenol gel pills.

Including this recent recall announcement Johnson & Johnson’s McNeil Consumer Products division has issued four recalls over the past twelve months.

Various media outlets are reporting on this development:

The New York Times: "The Johnson & Johnson unit whose recall of liquid children's Tylenol and other pediatric medicines is under Congressional investigation said on Tuesday evening that it was recalling additional over-the-counter drugs." Specifically, McNeil Consumer Healthcare "said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills." According to a company statement, "'the products were inadvertently omitted' from an earlier recall -- one preceding the children's drug recall -- involving medicines made at a company plant in Puerto Rico." Although the drugmaker maintains that the chances of experiencing serious side effects are nil, it began recalling products from the Las Piedras plant in November after consumers were reportedly overcome by a mildew-like odor.

The Wall Street Journal: The smell purportedly prompted stomach pain, diarrhea, and nausea. The unit has since identified the manufacturing issue.

Bloomberg News: "the odor has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets."

Reuters: US House of Representatives Oversight and Government Reform Committee Chairman Edolphus Towns (D-NY) said, "This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson." He added, "I am troubled by what we have learned so far in our investigation, and this latest development adds to my concern."

The recent proliferation of recalls generated from pharma manufacturers due to poor quality production, inadequate quality control, cargo theft and various other adulterations to the consumer product strengthens the concept of material authentication by all members of the pharmaceutical supply chain. Material authentication, inside the products unit-of-sale container protects the members of the suppy chains inventories and the end use consumer.

To read the various reports on this recent announcement and the J&J recall from The New York Times, Wall Street Journal, Bloomberg News and Reuters, visit these sites:

http://www.nytimes.com/2010/06/16/health/16drug.html.

http://online.wsj.com/article/SB10001424052748704009804575309132577939048.html?mod=googlenews_wsj.

http://www.bloomberg.com/apps/news?pid=20601202&sid=awltXaS.MHl4.

http://www.reuters.com/article/idUSN159754220100615.

To learn more about pharmaceutical supply chain security solutions that protect the supply chain and consumers from poor quality, fraudulent, adulterated and counterfeit drugs, visit: http://www.xstreamsystems.net/.

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/.

WSJ: House Committee Investigation Faults FDA for Not Pursuing Heparin Contamination Leads

An April 30th Wall Street Journal article reports that the House Energy and Commerce Committee investigated and faulted the Food and Drug Administration for not pursuing “particular and plausible leads which could have fingered those responsible in China for playing a role in the contaminated heparin crisis two years ago.”

House members, Joe Barton (R-TX) and Mike Burgess (R-TX) sent a letter to the FDA in which they spelled out findings from the investigation, and said that the FDA has not pressed the government of China regarding Chinese companies involved.

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 concerns by foreign pharmaceutical companies have been discovered within the supply chain that could 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/SB10001424052748703572504575214420823549694.html

To learn more about material authentication solutions, visit: www.xstreamsystems.net.

WSJ: Ranbaxy Recalls Antibiotic in U.S.

The Wall Street Journal Thursday reported that Ranbaxy Laboratories, Ltd voluntarily recalled two lots of it oral antibiotic for ear, nose and throat infections.

The recall follows complaints by U.S. consumers that the antibiotic turned brown when reconstituted instead of its proper color, white. According to the FDA, this is a class II recall which indicates that the recalled antibiotic is not expected to cause health problems.

As stated in the previous blog, regarding an FDA warning letter to Apotex, 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 concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

To view the Wall Street Journal story, visit: http://online.wsj.com/article/SB10001424052702303950104575185290784049982.html.html.

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

WSJ: US Authorities Investigating Alleged Sales Of Counterfeit Insulin Test Strips

Peter Loftus in the Wall Street Journal reports that the US government is currently investigating a Florida businessman who Johnson & Johnson says sold counterfeit versions of its OneTouch diabetes test strips.

J & J has aggressively conducted this investigation, which it says involves participants in China, Pakistan and the US, for the last four years.

According to the WSJ, if charges are filed against the US distributor, Jacques Duplessis, it would be the first instance resulting from J&J's four-year effort. Notably, a 2006 FDA alert about the counterfeit strips warned that they could give inaccurate readings, causing diabetes patients to take either too much, or too little, insulin.

This incident is very relevant in that it shows that the prevalence of counterfeit medications and devices that have been a major issue in the rest of the world outside of the United States has been impacting our consumers and will likely proliferate further.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain to use a variety of technology solutions to secure their inventories specifically material authentication which allows the user to verify the molecular fingerprint of the tested material inside its unit-of-sale container.

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

To read the WSJ article, visit: http://online.wsj.com/article/SB10001424052702303591204575169990446786552.html.

FDA Asks Physicians To Suspend Use Of Rotarix Due To Contamination

The FDA has asked the nation’s physicians to stop giving their patients Rotarix, a vaccine used to protect against rotavirus.

The recommendation came after the FDA became aware of an independent U.S. research team finding an unauthorized substance, porcine cirovirus 1, or PCB-1 DNA, in multiple samples of Rotarix.

According to CNN: "Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said 'a substantial amount' of the DNA was found in the vaccine. But, he stressed, 'there is no evidence that it causes any disease. ... There is no evidence that it ever does anything.”

According to the New York Times: “For now, the decision is unlikely to disrupt routine immunizations in children since a second vaccine, this one made by Merck and called RotaTeq, remains available. RotaTeq was approved for use in the United States in 2006 and is still the more popular vaccine. Rotarix was approved in 2008 and has been used to vaccinate about one million children.”

The discovery of this virus, hastens the need for more robust Quality Control testing at all lengths of the supply chain, raw materials, manufacturer, distribution and the point of dispense to properly protect the healthcare of the global consumer.

A variety of news sources are reporting on the story including the New York Times, CNN, Wall Street Journal, Washington Post and USA Today.

To view the New York Times story, link to: http://www.nytimes.com/2010/03/23/health/policy/23fda.html.

To learn more about supply chain protections against contamination, adulteration, fraud or counterfeiting, visit: http://www.xstreamsystems.net/.

WSJ: No Cure for Fake Drugs

The Wall Street Journal reported on Tuesday on an effort within Syria to reduce the use of counterfeit drugs as the problem continues to grow and remain widespread in the Middle East.

The action within Syria resulted in the seizure in millions of dollars worth of breast cancer, leukemia and other medicines, along with tens of thousands of anticoagulant pills used in treating heart attacks and other diseases.

Included in the seizure was a large amount of equipment used to make and package fake drugs. This particular action is expected to stop at least one organization’s lucrative trade of counterfeits to Iraq, Turkey, Lebanon, Iran and Egypt.

The following are some of the highlights of the story:

• Smuggling of drugs remains a widespread and dangerous problem. Figures from the World Health Organization show it can reach 35% of all drugs in the Middle East, compared to less than 1% in the U.S. and Western Europe. One confiscated shipment by the Syrian ring to Egypt contained counterfeit copies of one brand of a leukemia drugs with a street value of over $4 million -- equivalent to 50% of the annual sales of the brand.


• Distributors not only sold the fake life-saving drugs to private pharmacies but also moved deep into the public health-care system, particularly in Iraq. A huge plastic bag seen amid the Damascus counterfeit haul contained hundreds of boxes of a treatment for mouth ulcers, all bearing the logo of the Iraqi health ministry, witnesses say.


• Authorities claim that the ring busted in Syria was the main one operating in that country. A pharmaceutical-company manager said it was the main network for Egypt as well, but others are still operating in other Middle-Eastern countries.


• One reason why drug counterfeiting has thrived in the Middle East is that authorities were unprepared for the sheer scale and sophistication of counterfeits and had neither the appropriate law enforcement framework nor the legislation to tackle them.


• "When we started the investigation, we had no idea of the scale of these counterfeit networks," the Syrian official said.


• A great proportion of the fake drugs smuggled by the network to Egypt and Syria came from China, according to Syrian Health Minister Reda Saed, sometime around 2007, the ring started making its own fake drugs, using technology mostly imported from China, the Syrian officials and the pharmaceutical-company managers said.

Secure Pharma Chain Blog, endorses a layered approach to pharmaceutical supply chain security to efficiently, economically and effectively secure the inventories of manufacturers, distributors and dispensers from fraudulent and counterfeit medications.

To read the Wall Street Journal story, visit: http://online.wsj.com/article/SB10001424052748704533204575047282075703998.html.html.

To learn more about an effective tool in combating counterfeit medications, visit: http://www.xstreamsystems.net/.

WSJ: U.S. Regulators Pressure Ranbaxy Over Factories

The Wall Street Journal in an article written by Rumman Ahmed and published in the February 8th edition, reports on the continued issues between the U.S. Food and Drug Administration and Ranbaxy Laboratories.

According to the story, the U.S. regulatory authority is accusing the drug maker of “an insufficient effort to meet manufacturing standards”.

U.S. sales, Ranbaxy’s biggest overseas markets have been depressed for more than a year because of manufacturing deficiencies at some of their plants.

This particular set of issues, based on substandard overseas manufacturing, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers from fraud, adulteration, contamination and counterfeit products.

To read the entire Wall Street Journal article, visit:
http://online.wsj.com/article/SB10001424052748704533204575046671948801274.html.html.

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

WSJ: Cargo Theft Endangering Consumers

Heists Targeting Truckers On Rise-Robberies Are "Wreaking Havoc" on U.S. Highways, Endangering Consumers

The Wall Street Journal in an article written by Jennifer Levitz, explores in general the proliferation of cargo theft in general and its impact on supply chains and consumers.

You can access the article by visiting: http://online.wsj.com/article/SB10001424052748704722304575037241392821742.html

To view solutions that protect the supply chain from adulteration, contamination, fraud and counterfeiting, visit: www.xstreamsystems.net.

FDA: Counterfeit Version of Alli May Harm Consumers

Three separate media outlets are reporting the Food and Drug Administration’s announcement about a counterfeit version of the GlaxoSmithKline OTC drug Alli.

The following are web links to stories from CNNMoney.com, the Wall Street Journal and MedPage Today.

CNNMoney.com reported, "A counterfeit version of the over-the-counter weight-loss product Alli being marketed online could be harmful to dieters, the US Food and Drug Administration warned." The agency "said the counterfeit Alli was sold in 60 mg capsules as part of a 120 count refill kit." Alli manufacturer GlaxoSmithKline "said tests showed the falsely packaged and labeled products contained a controlled substance called sibutramine."

The Wall Street Journal reports that sibutramine is the active ingredient in Abbott Laboratories' prescription weight-loss treatment Meridia. The FDA said that "sibutramine...should not be used in certain patient populations or without physician oversight." Glaxo noted that while patients should take Alli three times a day, Meridia should only be taken once daily.

The agency said the fake products are missing a "'Lot' code on its cardboard packaging," MedPage Today reported. In addition, the counterfeit has "an expiration date that includes month, day, and year...instead of month and year," and contains "plain foil inner seals as opposed to the genuine articles printed, 'SEALED for YOUR PROTECTION.'"

To learn more about technologies used to detect counterfeit medications, visit: http://www.xstreamsystems.net/.

Indian Drugmakers Seen as Benefiting from Increased FDA Regulation

The Wednesday, July 29th edition of the Wall Street Journal reports that Indian generic drug makers are most likely to benefit in the long run because of increased FDA Regulation and scrutiny. The Journal sites sources that predict that with this scrutiny by the FDA these manufacturers will be in a better position than their rivals in the United States or China when over $100 billion drugs go off patent in the next five years. Indian manufacturers have over 107 FDA approved manufacturing plants which is the highest number outside of the United States.

To read the entire story online: http://online.wsj.com/article/SB124876915285586265.html.

XStream Systems speculates that drug makers and importers/exporters globally can mitigate this advantage presumably enjoyed by Indian manufacturers by increasing their internal scrutiny and quality control measures by increasing their use of technology as they export pharmaceuticals into developed nations. Technology solutions such as XStream System’s XT250 allow the manufacturer or importer to screen and verify the quality and efficacy of medications post-manufacturer, within the pharmaceutical supply chain and its sealed unit-of-sale container.

China's Bad Medicine and Its Impact on the US

The Wall Street Journal features an informative editorial by Roger Bate in today's issue on the counterfeiting drug trade in China. Roger Bate is an expert on counterfeit drugs and is the author of the book “Making a Killing: The Deadly Implications of the Counterfeit Drug Trade.”

Mr. Bates discusses the scope of the problem in China and what the Chinese government can do to combat the issue. The black market is a huge enterprise in China employing as many as 5 million Chinese citizens in the counterfeit market. This is an alarming fact seeing as China is the fourth largest pharmaceutical exporter and supplies 40% of the global supply of active pharmaceutical ingredients (API).

The scope of Chinese counterfeiting has been felt globally as shown in these most recent incidents cited by Mr. Bates: In the United Kingdom in March of this year, Chinese counterfeit pharmaceuticals amounting to $745,000 were seized. In January of this year, two people died and nine were hospitalized due to counterfeit diabetes drugs in Xinjiang province. Last year hundreds suffered adverse reactions and at least 95 died due to a chemical ingredient that is believe to have been deliberately adulterated by Chinese suppliers.

In his paper “The Problems and Potential of China’s Pharmaceutical Industry” Bates further discusses the problem and why the world should be concerned. He states:

“With more Americans opting to procure drugs directly from overseas, often by purchasing over the Internet, understanding the causes of the counterfeit and substandard problem in China—and what can be done to combat it—has never been more important.”

To combat counterfeit drugs, he stresses the importance of collecting reliable information and coordinating consistent unbiased regulatory enforcement.

To view the editorial visit the Wall Street journal at www.wsj.com.

To view the paper "The Problems and Potential of China’s Pharmaceutical Industry” by Roger Bates and Karen Porter, visit the American Enterprise Institute for Public Research at: www.aei.org