Pharmalot: FDA Commish 'Feels Very Encouraged' About China

Ed Silverman in his excellent blog, Pharmalot offers his opinions and commentary on comments made by FDA Commisioner Margaret Hamburg during her recent tour of China.

Some of Mr. Silverman’s commentary includes:

· There she is in Shanghai, touring some facility with Chinese government officials who, of course, will do their best to make sure she doesn’t catch a whiff of a contaminated active ingredient or come within 100 miles of a gray market supplier. And there is international diplomacy to consider, after all - who buys all that US government debt?
· Despite being labeled a paper tiger by a pair of Congressman who are angry over the lack of progress into the Heparin probe the FDA commish was all smiles as she explained her view of the relationship between her agency and its Chinese equivalent.
· “I leave feeling very encouraged by the partnership we’ve developed here,” Hamburg tells the Associated Press. “This is a priority for China as it is for the United States.” She adds the two agencies are pursuing a “common agenda” to improve manufacturing practices and regulate supply chains.
· The FDA has set up offices in three Chinese cities and is cooperating in training and joint inspections, among other areas. But as the AP notes, more than 20 million imports of FDA-regulated products are expected this year, and less than 1 percent are inspected. Earlier this year, the FDA began using an automated system to sort through millions of foreign shipments and identify food and drugs that are most likely to be contaminated.
· But “we will never have the resources physically and financially to inspect all those facilities,” Hamburg readily concedes. “It is not a simple problem to eliminate in terms of the practice of bad actors who are willing to put human health at risk to make more money. It is an area we are continuing to monitor very carefully.”

Clearly it does not appear that the US and the FDA is coming into this process with a strong hand.

It seems doubtful that in the near term unless there is some epic tragic event that disables or kills a large population within a developed nation that the Chinese will cooperate or make the necessary changes within their system to demand a higher level of regulatory and industry compliance to basic good standards and practices.

As China continues to produce more and more raw materials and finished pharmaceutical products that are consumed around the globe, it is vital that the members of the global pharmaceutical chain (manufacturers, distributors and dispensers) verify the quality of the products within their inventories to protect both their businesses and more importantly the consumer.

To read the entire Pharmalot blog post: http://www.pharmalot.com/2010/08/fda-commish-feels-very-encouraged-about-china/#more-25617.

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

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.

Two Men Charged for Illegally Importing Counterfeit Medications

The U.S. Department of Justice (DOJ) announced the arrest of two people for illegally importing counterfeit weight loss products including GlaxoSmithKline’s alli.

According to the DOJ, the two Chinese born men, imported weight loss products they claimed were cheaper versions of FDA approved medications.

Sengyang Zhou, a Chinese national was arrested in Hawaii last week. Zhou, during the course of the investigation implicated himself as the maker of the counterfeit Alli.

Qin Ming Hu, a U.S. citizen, born in China was arrested in Plano; Texas last week. According to the DOJ the charges could result in nearly 20 years of prison time and hundreds of thousands in fines for Zhou and several years in prison and fines of nearly $250,000 for Hu.

"The Food and Drug Administration will work together with other government entities to aggressively target those individuals who put the public's health at risk by selling counterfeit drugs," FDA Commissioner Margaret Hamburg said recently in a published statement.

The two men were apparently successful in marketing their bogus products over the Internet to consumers seeking less expensive medications online. The counterfeit medications, identical to the packaging of the branded medications, reportedly contained dangerous levels of the active ingredient used in the authentic drugs.

XStream Systems encourages all members of the pharmaceutical supply chain to use an authentication process to verify their inventories and protect healthcare consumers from dangerous adulterated, fraudulent, sub potent and counterfeit medications.

To learn more about an anti-counterfeiting technology which is being used to discover fraudulent, adulterated and counterfeit drugs in the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

FDA Sets Up Shop in Mexico

The US Food and Drug Administration (FDA) has continued its expansion outside of the United States with the opening of an office in Mexico. This is now the third FDA office in Latin America after Costa Rica and Chile.

The move is the latest in an effort by the FDA to influence foreign markets, and in particular in areas which serve as important importation partners into the US supply chains including pharmaceuticals, medical devices and food.

The new office which is based in the capital, Mexico City, "represents an important step as we re-design our product safety strategy," commented FDA Commissioner Margaret Hamburg.

Mexico is the largest pharmaceutical market in Central America, with 2009 sales estimated to reach around $9bn and expected to grow to nearly $15bn over the next five years, according to Business Monitor International. It is the second-largest pharmaceutical market in Latin America as a whole.

XStream Systems encourages the continued expansion of the FDA into countries that are important trading partners but also suggest that regulatory bodies and supply chains, internationally and domestically, utilize technologies like EDXRD to protect itself from fraudulent, adulterated and counterfeit materials.

To learn more about supply chain protection technologies, visit: www.xstreamsystems.net.