FDA Commissioner Margaret Hamburg Joins with Public and Private Sector Leaders in Call to Address Global Counterfeit Drug Crisis

"It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today's increasing globalized marketplace, “ stated Dr. Margaret Hamburg, Commissioner of the FDA.

Dr. Hamburg made this statement at the inaugural Counterfeit Drug Interchange Conference hosted by the Partnership for Safe Medicines (PSM).

This conference brought together more than a hundred cross-industry stakeholders to discuss ways to stem the rising tide of counterfeit and unsafe medicines.

Highlights from the press release by PSM included:

• "The FDA is firmly committed to doing all that we can to further strengthen our nation's drug supply and ensure the quality and safety of all drugs and medical products on the U.S. market," said Hamburg. "It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today's increasing globalized marketplace. And we look forward to working with Congress on legislation that will give FDA the ability to protect Americans from harmful drugs and medical products-and fulfill our fundamental public health mission."

• Today's forum underscores the severity of the problem and the interest among all segments of the pharmaceutical sector - law enforcement, patient groups, government regulators, academics and manufacturers - to come together to discuss practical solutions.

• "The U.S. has the safest drug system in the world, but that does not mean American consumers are immune. The instances of counterfeit drugs are increasing and the counterfeiters are becoming more sophisticated, which means that our drug safety is at risk," said Scott LaGanga, executive director of PSM. "PSM's goal with the Interchange is to raise awareness of the scope of this epidemic, as well as the need for global collaboration, information sharing and tools and resources that will help protect consumers across the globe."

• In addition to Dr. Hamburg, speakers included an American victim of counterfeit drugs, representatives from the Drug Enforcement Agency and the Centers for Disease Control and Prevention, law enforcement officers, and patient advocacy groups.

• At the event, PSM also announced that the Generic Pharmaceuticals Association (GPhA) has joined the organization, adding their expertise and network to PSM's efforts to keep all medicines - generic and branded - safe for consumers.

• "Given the role that generic drugs play in the global marketplace, PSM today is even more positioned to continue its battle to keep prescription medicines safe for consumers," said LaGanga. "We welcome GPhA to our membership and look forward to working together on this critical health issue."

Secure Pharma Chain endorses the need form more FDA regulatory authority especially as it pertains to dealing with adulterated, fraudulent and counterfeit medications and raw materials in the proliferating global pharmaceutical supply chain.

Secure Pharma Chain also believes that it is incumbent on all members of the pharmaceutical supply chain to proactively protect their industry, inventories and most importantly the consumer by deploying best practices, solutions and technologies to combat this deadly criminal act.

To view the entire PSM press release, visit: http://www.safemedicines.org/2010/10/fda-commissioner-margaret-hamburg-joins-with-public-and-private-sector-leaders-in-call-to-address-global-counterfeit-drug-cri.html

To learn more about anti-counterfeiting technologies for pharmaceuticals, visit: www.xstreamsystems.net.

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/.

Dallas Morning News: Investigation Reveals That Chinese Government "Hampered" FDA Probe of Tainted Heparin

In a follow up to a previous posting on a July 23rd posting of a Pharmalot.com blog, The Dallas Morning News in its Trail Blazers Blog continues the reporting on Congress questioning the FDA on their ability to work with the FDA on the Tainted Heparin probe.

According to the Dallas Morning News Trailblazer Blog:

"An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had 'severely hampered' a Food and Drug Administration probe into contaminated heparin." They wrote to FDA commissioner Dr. Margaret Hamburg, saying that "FDA officials informed them in June that the agency was 'denied full access to manufacturing and laboratory facilities,' nor were they allowed to review records." Notably, the "FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008."

The continued exposure of the lack of Chinese cooperation reveals to everyone within the pharmaceutical supply chain that there are many significant gaps in the ability of regulatory authorities to control and enforce the quality of medications that are now such a prevalent part of the pharmaceutical supply chain.

Secure Pharma Chain encourages industry supply chain leaders to take appropriate measures and deploy technologies that protect their brand, secure their inventories, differentiate themselves in the marketplace and most importantly save from harm consumers who take these medications.

To view the Dallas Morning News blog, visit: http://www.trailblazersblog.dallasnews.com/.

Drug Safety Responsibility-For Whom Does the Finger Point?

This blog posting first appeared in Secure Pharma Chain in May 2008.

This posting still remains relevant today as the issue of poor quality, fraudulent, adulterated and counterfeit medications continues to proliferate in pharmaceutical supply chains around the globe-and the regulatory ability to meet this threat remains woefully inadequate.

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw. In reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply.

Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.Now it is the consumer who is doing the pointing and he or she is pointing at us all!

To learn more about supply chain authenticity testing, 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.