Can You Believe It? J&J Announces Another Recall...

McNeil Consumer Healthcare Initiates Yet Another Voluntary Recall Of Certain Products.

Just when you thought it could not get much worse for J &J, on Friday Johnson & Johnson’s McNeil Consumer Healthcare Division, in consultation with the U.S. Food and Drug Administration recalled certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

The J &J company statement said that the recalled products were manufactured at the McNeil plant in Fort Washington, Pennsylvania prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.

In addition, McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

According to the press release, McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products.

On all levels this is a saga of an industry giant that has poorly managed the entire process of production, product quality control, regulatory affairs and public relations. J&J’s entire corporate image, trusted brands, executive management and financial future is in a significant state of decline.

J&J’s announcement of a comprehensive plan to clean up its production and public image is a operational and PR process that should have been initiated many months ago.

The lost sales, enormous expense in recalls and cost to the brands has to be a huge hit to J&J's bottom line.

This story is a cautionary tale for all, not making an investment in and failure to take the necessary steps to assure quality control and to protect your brand from sub-standard production, poor quality raw materials, fraud, adulteration and counterfeit will cost the stakeholders and consumer.

What are the odds that we will see another recall from J&J soon?

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

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/.

Stolen Drugs Found Back in US Supply Chain

The US Food and Drug Administration is alerting the pharmaceutical supply chain regarding the reappearance of drugs stolen in a 2008 cargo theft.

On October 17, 2008, a shipment of Carbatrol and Adderall XR made by Shire Pharmaceuticals was stolen en route between the company's manufacturing facility in North Carolina and a distribution center in Florence, Kentucky.

In the theft nearly 35,000 capsules of Carbatrol, which expired between April 30 and May 31 of this year, were stolen.

Shire recently announced that some of these stolen pharmaceuticals have begun to appear in its expired returns and that some of the stolen medication may still be on the pharmaceutical market and a possible threat to consumers.

Shire warns that the drugs taken during pharmaceutical cargo thefts are unsafe because they may have experienced improper storage and handling or tampering outside of the secure supply chain. Additionally the drugs may have been adulterated or their packaging used for counterfeit medication.

The product lot numbers for the stolen Carbatrol are 2172127 and Adderall XR are 2385012.

Those who come in contact with these products should contact the FDA's Office of Criminal Investigations at 1-800-551-3989.

Secure Pharma Chain encourages all within the pharmaceutical supply chain to verify and authenticate the medications that they distribute and dispense to make certain that the product within their inventories are safe and efficacious.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/

2010, The Year That Counterfeit Drugs Becomes a $75B Global Business

Alan Clock, SVP, XStream Systems, Inc.

As we find ourselves with a little over four months left in 2010, Secure Pharma Chain is re-posting a blog from January regarding the proliferation of counterfeit drugs globally this year.

In 2005, the Center for Medicines in the Public Interest (CMPI), released a report projecting global counterfeit drug sales to reach $75 billion in 2010. At the publication of the report, this projection was a 92% increase from the 2005 estimate of $39 billion of worldwide counterfeit drug sales. Most global experts then and now do not dispute this estimate. In fact, many would not argue the point that today, this estimate may be entirely too conservative and the real financial impact and overall number is much higher.

In 2010, we as a society face a global health catastrophe that will impact people of all countries, race, religion and economic strata.

What will be the key factor that will turn this issue around in the new decade?

"The business of selling fake prescription drugs to unsuspecting consumers is burgeoning, and is a global industry," stated Peter Pitts in 2005, senior fellow for health care studies at the Pacific Research Institute and director of the CMPI. "Nearly $39 billion, or 11 per cent of global pharmaceutical commerce will be counterfeit this year (2005)," added Mr. Pitts. "By 2010, that number will nearly double. We must enact controls to strengthen the security of our health care system from outside threats."

At the time that this report was published, Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration stated. "The increasing flow of counterfeit drugs represents a significant public health threat. We must step up our efforts to safeguard the drug supply -- we certainly should not weaken those controls."

Even with these dire predictions and public support for action in 2005, there has been little appreciable progress in the domestic and international efforts to stem the flow of this worldwide health care crisis. Regulatory, law enforcement and industry efforts to date have been inconsistent overall and seemingly lack an overall perspective of the severity and impact of this issue.

One of the most startling examples of the deadly impact of the global counterfeit medication epidemic is the World Health Organization’s (WHO) estimate that nearly 2,000 children die each day in Africa as a result of bogus drugs. Counterfeit medications in underdeveloped countries not only do not treat illness and disease but are now a major factor in creating drug resistant strains of deadly diseases such as malaria, tuberculosis and HIV/AIDS.

With the proliferation of counterfeit medications and the impact to people all over the world, the issue, in its extreme, is only now beginning to garner important public awareness.

The public awakening to this deadly scourge is the first critically important step in motivating public and industry leadership to move forward and take action.

With a motivated and aware public, elected and industry leaders will be encouraged to step up their efforts to protect their constituents, businesses and customers.

When properly inspired, these leaders will look to strengthening regulatory authority and in expanding their technology/ processes to thwart these nefarious sources of a deadly criminal act.

To learn more about technologies that are used to combat counterfeit medications, 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.

Reuters: Counterfeit Drugs on Rise, Pose Global Threat

“Unwary consumers buying counterfeit drugs on Internet.”

On May 19th, Reuters posted a story written by Stephanie Nebehay regarding the recent World Health Organization meeting in Geneva, Switzerland.

The article encapsulates the proliferation of this deadly crime and the difficulty in countries around the globe in developing a comprehensive strategy in dealing with it. Although many nations realize the deadly consequences, there are many commercial interests including generics and intellectual properly rights which are complicating efforts to fight this illicit activity on a global scale.

The following are some of the highlights from Ms. Nebehay’s report:

· Production and sale of counterfeit drugs is on the rise in rich and poor countries, with more unwary consumers buying them over the Internet, experts warned on Wednesday.

· Fake or substandard versions of medicines are often hidden in cargos taking circuitous routes to mask their country of origin as part of criminal activity worth billions, they add.

· "They put people at risk of harm from medical products that may contain too much, too little, or the wrong active ingredient and/or contain toxic ingredients," said Margaret Hamburg, head of the U.S. Food and Drug Administration (FDA). "Counterfeiting is growing in complexity, scale and geographic scope," she said in a speech to the annual ministerial meeting of the World Health Organization (WHO).

· In wealthy countries, counterfeiting often involves "expensive hormones, steroids and anti-cancer medicines and pharmaceuticals related to lifestyle," a WHO report said.

· But in developing countries, especially Africa, counterfeit medicines are commonly available to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS, it said.

· Margaret Chan, WHO director-general, said that illicit products had also increased the problem of drug resistance, including to vital anti-malarials and HIV/AIDS drugs. "For a patient, any medicine with compromised safety, efficacy or quality is dangerous," she said.

· Major generic drug makers in India and Brazil, backed by health activists, charge that concerns about counterfeit drugs are being hijacked by pharmaceutical companies keen to protect their patents against legitimate generic competitors.

· (Margaret) Chan said that her United Nations agency would not be drawn into policing intellectual property (IP). "The role of the WHO should be concentrating on public health, not on law enforcement nor intellectual property enforcement."

· There were 1,693 known incidents of counterfeit medicines last year, a rise of 7 percent

Drug counterfeiting is a widely growing, deadly illicit act that is impact millions each year while most of the world’s population remains ignorant of the dangers that they face daily as they consume medications.

Secure Pharma Chain Blog, encourages the pharmaceutical supply chain in advance of regulatory mandates to deploy technology and solutions to protect their inventories and the consumer from this deadly criminal deed.

It is incumbent upon industry to lead the way to supply chain safety and protect their businesses and consumers.

To learn more about pharmaceutical supply chain safety technologies, visit: http://www.xstreamsystems.net/.

To read the entire Reuters article, visit: http://www.reuters.com/article/idUSLDE64I26E20100519.

Miami Herald: U.S. Agents Search for Dangerous Foreign Drugs in Mail

“The Food and Drug Administration stepped up inspections of counterfeit prescription drugs smuggled into Miami and other cities through the U.S. mail.”

Jay Weaver in the Miami Herald writes an interesting story which appeared in the May 14th edition about the interdiction of dangerous foreign drugs at the U.S. Food and Drug Administration Foreign-Mail Inspection Facility in West Miami-Dade.

Earlier this month, “dozens of federal agents completed a three-day blitz at the facility, poring through piles of packages filled with illegal pharmaceutical drugs, dietary supplements and home remedies mailed from foreign countries.”

The FDA led operation, was designed to interdict thousands of unapproved medicines, most of which were sent from Latin America and the Caribbean.

Here are some of the highlights from the Mr. Weaver’s article:

· The FDA has zeroed in on hot spots such as Miami, Los Angeles and New York for random inspections of counterfeit and misbranded prescription products that are not allowed to enter the country.

· Many are purchased from foreign suppliers over the Internet, an increasingly risky shopping place for pharmaceutical drugs with unsafe ingredients, inaccurate dosages and false expiration dates.

· ``When counterfeit and unapproved drugs come into this country, it is compromising the overall drug system that we have,'' said David K. Elder, a senior FDA official. ``We're trying to prevent their release into the U.S. market.''

· The vast majority of intercepted pharmaceuticals, diet pills and home remedies are returned to sender. ``We have no authority to destroy them,'' Charles-Julien said. ``We have to send them back.''

· Some inspections have led to criminal investigations by the FDA and ICE, including South Florida probes into Brazilian diet pills laced with speed that are sold over the Internet.

· Last year, the Miami Customs facility processed about 36 million pieces of foreign mail. Of that total, inspectors referred between 8,000 and 10,000 foreign parcels containing unapproved medications to the FDA for further evaluation.

· Last year, FDA and ICE agents completed a major criminal investigation in Houston that targeted Chinese national Kevin Xu. He was convicted of distributing counterfeit and misbranded drugs for blood clots, prostate cancer, Alzheimer's and schizophrenia.

· In 2008, federal prosecutors in Denver indicted a Greek national, Georgios Xydeas, on charges of selling counterfeit and misbranded prescription drugs. He was accused of selling the Chinese-supplied drugs, such as Viagra, Cialis and Xanax, to Internet pharmacies.

· FDA special agent Michael Kurisky said… that buying prescription drugs from Canadian suppliers might seem safe. But he stressed that many Canadian website distributors are supplied by sources in Asia or Eastern Europe. Said Kurisky: ``The ingredients are bad.''

This article demonstrates just one of the ways that fraudulent, adulterated and counterfeit medications enter this country illegally and find their way into the domestic pharmaceutical supply chain.

Secure Pharma Chain Blog recommends that all members of the supply chain utilize a variety of technologies to protect themselves from allowing these bogus medications into their inventories.

To learn more about authentication solutions that verify the contents of a product inside its unit-of-sale container, visit: http://www.xstreamsystems.net/.

To read the entire Miami Herald article, visit:
http://www.miamiherald.com/2010/05/14/1628577/mail-clampdown-dangerous-drugs.html#ixzz0pFqOm5Pq.

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/.

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.

FDA Issues Second Warning Letter to Apotex

The Food and Drug Administration has posted on their website a March 29th warning letter to Apotex, Canada’s biggest drug company citing lapses that included charred particles in a diabetes drug, contamination of an antihistamine and a drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment.

The FDA letter also claims that Apotex had failed to notify regulators in a timely fashion about such problems.

This is the second warning letter by the FDA to Apotex is less than a year which is highly unusual for the agency.

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.

The New York Times has an excellent article about this FDA letter, written by Natasha Singer and published on April 15th.

To view this article, visit: http://www.nytimes.com/2010/04/16/business/16generic.html.

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

HealthDay: Fake Drugs Bought on the Web Pose Big Health Risks

2.5 million men in Europe alone may have taken counterfeit Viagra, study says.

Amanda Gardner from HealthDay makes another spin on the story about the International Journal of Clinical Practice report regarding the dangers of internet pharmacy purchases of prescription drugs which has been blogged on Secure Pharma Chain Blog earlier. This excellent story appears below:

FRIDAY, Jan. 29 (HealthDay News) -- People who buy prescription medications over the Internet, especially drugs purporting to treat erectile dysfunction, are playing Russian roulette with their lives, a new study contends.

At best the drugs won't help you and at worst they could kill you, the review article said.
"You may be wasting your money or you may actually be hurting yourself," said Dr. Margaret E. Wierman, professor of medicine at the University of Colorado at Denver and chief of endocrinology at the Denver VA Medical Center, who was not involved with the study.
Counterfeit Internet drugs are a mushrooming problem. Seizures of fake drugs in Europe quadrupled between 2005 and 2007. And the number of investigations undertaken by the U.S. Food and Drug Administration increased by a factor of eight between 2000 and 2006, according to the study, published in the International Journal of Clinical Practice.

The sale of counterfeit drugs has almost doubled in the last five years, and will hit $75 billion in 2010, according to one estimate, making it one of the more lucrative illicit drug markets.
As many as 2.5 million men in Europe may have taken counterfeit sildenafil (Viagra), the study authors stated.

"It's a very significant problem and I think there are people who are being injured," said Dr. Ira D. Sharlip, a spokesman for the American Urological Association and clinical professor of urology at the University of California, San Francisco. "The only way to avoid the problem is not to buy on the Internet."

Viagra-like tablets bought on the Internet aren't necessarily any cheaper than the real thing, but they do allow buyers to avoid the shame factor often associated with asking for this type of drug.
"The motivation is the anonymity of buying drugs on the Internet. It's embarrassing to some men to go to a pharmacy and pick up his Viagra prescription, and it's also embarrassing for some men to go to a doctor and say, 'I have erectile dysfunction. I need some Viagra,'" Sharlip said.
The problem of fake drugs isn't limited to impotence treatments.

According to the study, two pregnant women died after they were given injections of a counterfeit iron preparation for anemia, and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup that was contaminated with diethylene glycol, which is often used as antifreeze in cars.

So many things can go wrong with Internet purchases.

"The purity of the medication or the quality of the medication is under no sort of scrutiny or any type of oversight to determine if, first of all, it is the correct medication. And second, if it is correct is it in the correct dosage?" said Dr. Michael Chehval, chief of urology at St. Louis University.

Study author Dr. Graham Jackson, a cardiologist at London Bridge Hospital in the United Kingdom, said: "The first danger is people don't know what's in it. Some are just talcum powder or brick dust, while some have a bit of Viagra or Cialis and some chemicals that have nothing to do with it. One batch actually contained amphetamine, which is an addictive drug. Tablets are made shiny with road paint or shoe polish. The content of the medication could be anything."
In 2008, four men in Singapore died after ingesting counterfeit impotence drugs that had been contaminated with a blood-sugar-lowering agent, the study reported.

And bypassing the involvement of a competent doctor means red flags could be missed.
"Erection problems can be an early warning sign of heart disease or diabetes," Jackson said. "If you do have a problem and don't see a doctor, diagnosis of those important conditions can be missed. Men with no symptoms at all who get an erection problem usually are an average of three to five years away from a heart attack. Instead of going to the Internet, they should be going to their doctors to find out if they are at risk and to do something about it."

Problems also can occur when the impotence drugs actually do contain phosphodiesterase type 5 inhibitors (PDE5), the main ingredient in Viagra, as well as vardenafil (Levitra) and tadalafil (Cialis).

"People with underlying heart problems are at risk for cardiac events if they take this class of medication," Chehval said.

According to the review article, about one-third of men reported sidestepping a health-care professional when buying erectile dysfunction drugs.

"This is a really serious issue. We can fix the erectile dysfunction and we can also fix the chances of getting a heart attack," Jackson said.

Jackson is editor of the journal and reported multiple ties to pharmaceutical companies, including Pfizer, which makes Viagra. The review article covered more than fifty studies published between 1995 and 2009 and was conducted by British, Swedish and American researchers.

To read the story online, visit: http://healthday.com/Article.asp?AID=635386.

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