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/.

B Braun Recalls Possibly Tainted Heparin

Recall linked back to the 2007/2008 Heparin crisis that poisoned hundreds.

Andrew Zajac from the Los Angeles Times is reporting about the recent announcement by B. Braun Medical Inc., of a recall of seven lots of the anticoagulant heparin because of concerns they may be contaminated with trace amounts of oversulfated chondroitin sulfate, or OSCS, the same substance implicated in the 2008 heparin crisis that killed or seriously sickened dozens of people.

According to the Mr. Zajac’s report:

• The company said in a statement that based on current information, the recalled lots did not pose a significant health risk, but they're being pulled from the market "with the support of the U.S. Food and Drug Administration."

• "There is not a significant public health threat," FDA spokeswoman Karen Riley said.

• The active ingredient in the suspect heparin was manufactured by Scientific Protein Laboratories Inc. of Waunakee, Wis., the same company that supplied the active ingredient for the heparin distributed by Baxter International that poisoned hundreds of patients in late 2007 and early 2008.

• Riley said B. Braun's announcement reflected a decision by Scientific Protein to recall three lots of the heparin ingredient that were distributed to manufacturers in the United States, Canada and Japan. It was not immediately clear how many, if any, other manufacturers are affected by the recall.

• Both the heparin in the poisonings and in the B. Braun recall were manufactured with raw material – pig intestines – from China. An FDA-led inquiry at the time of the heparin crisis identified OSCS as the contaminant. The substance apparently was added in an effort to stretch heparin, which is subject to significant fluctuations in supply because of changes in the Chinese pig population.

• The FDA has not identified who was responsible for the adulteration, or where in the lengthy Chinese supply chain it occurred. The heparin in the B. Braun recall also is from the same batch discussed in a recent FDA inspection that found that Scientific Protein waited a year to investigate a complaint about possible OSCS contamination.

• Riley said the heparin ingredient was manufactured by Scientific Protein in 2006 and was determined to contain traces of OSCS by one of the company's medical industry customers, which called it to the company's attention in October 2008.

• Scientific Protein's "quality department did not initiate a formal investigation into this complaint until 9/9/09," according to the FDA inspection report. It's not clear whether the complaining customer was B. Braun.

Many of the facts of this incident remain to be seen and or made public. It is anticipated that there will be more voluntary recalls and information over the next several days.

Secure Pharma Chain is puzzled with this recent turn of events given the amount of scrutiny that the 2007/2008 Heparin crisis elicited within the government, industry and consumers world wide. It would appear that not all the bases were covered within the supply chain following the deaths of some many back in 2007/2008.

Secure Pharma Chain encourages all within the supply chain to avoid the issues of fraudulent, adulterated, sub-standard and counterfeit drugs by deploying authentication technologies to verify that their inventories are safe and efficacious.

To read the entire story, visit: http://www.chicagotribune.com/health/la-heb-heparin-recall-braun-20101027,0,2834227.story

To learn more about pharmaceutical authentication 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.

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.

China Denies Branding as Fake Drug Center

China says it has been unfairly dubbed as the center of fake drugs. This branding has arisen out of the numerous problems with raw materials sourced from China. However, Chinese officials think it is the overseas companies that are to blame, stating that some companies are sourcing their raw material through illegal suppliers.

"The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems," Bian Zhenjia, director of the drug safety supervision department under the State Food and Drug Administration, told a press conference.

In 2008, heparin was recalled after reports of deaths and hundreds of adverse reactions. The cause was linked to an adulterated substance found in the raw material traced to a dozen Chinese suppliers, some of whom were not even registered as pharmaceutical suppliers.

While China might deny the name, they have suffered the effects of counterfeiting domestically as well as abroad. Last year, they recalled several Chinese herbal medicines and recalled a diabetes drug in January that was linked to two deaths in Xinjiang. Samples showed the medicine contained six times the normal amount of a chemical ingredient used to lower blood sugar.

China's own regulatory authority, State Food and Drug Administration (SFDA) counted 329,613 cases of distribution of unlicensed drugs and medical products in 2007, according to the China Daily newspaper.

Chinese Heparin Producers Get Warning Over Falsified Information

FDA issues letters to two more Chinese manufacturers regarding tainted Heparin

It reads like a bad sequel as more companies have been named in the tainted heparin scandal…

Two Chinese companies have been issued warnings from the FDA for falsifying information on Heparin. Shanghai No. 1 Biochemical & Pharmaceutical said they were manufacturing heparin, when in fact they were purchasing it from two outside companies. One supplier is no longer producing the medicinal product.

The other supplier, Qingdao Jiulong Biopharmaceuticals was also given a warning letter. Jiulong was found to have produced 19 lots of heparin contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), a substance implicated in the U.S. deaths last year. The FDA further faulted them for not investigating how the substance got into the blood thinner and for exporting medicinal products without regulatory approval.

This warning letter was in response to the FDA’s inspection of Jiulong in August 2008. Jiulong told investigators that they did not ship directly to the United States. However, during inspections at U.S. facilities purchase orders were discovered indicating that the plant had been shipping heparin sodium to the U.S. since 2005. FDA also stated that in the past, the firm supplied heparin to Amphastar Pharmaceuticals Inc., a California company that supplies pre-filled syringes.

This story illustrates why analytical screening should be conducted throughout the supply chain – to ensure the quality of: those products supplied to your company, those products you supply to others, and ultimately the finished product consumed by the patient.

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

XStream Systems Stories and News for the Week of November 21, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. As counterfeits become more prevalent globally and domestically, science will play a strong role in protecting our nation’s supply chain and molecular pharmaceutical authentication will be an important part of solving this global problem:

Israel joins world effort to halt counterfeit drug sales
Inspectors went to the Tel Aviv package warehouse of the Israel Postal Company and other facilities last week, seizing drugs prohibited in Israel and others suspected of being counterfeit that had been shipped from India and China.

FDA: FDA Hosts Its First Science Writers Symposium
Recently FDA experts met with more than 50 journalists and science writers at the FDA’s first Science Writers Symposium. At this day-long event, FDA’s scientists and physicians presented on such research as the science behind the Salmonella outbreaks, melamine adulteration of food substances, and nutrigenomics – an emerging field that has the potential to prevent disease and maximize health by using genetic profiles to tailor what we eat. FDA experts also presented their novel discoveries to prevent pandemic flu, identify contaminated heparin, and analyze the safety of drug-eluting stents down to the molecular level.

FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.

Daschle Accepts HHS Cabinet Post
Former Senate Majority Leader Tom Daschle has accepted President-elect Barack Obama's offer to be Secretary of Health and Human Services.