Monday, August 16, 2010

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 learn more about pharmaceutical supply chain authentication solutions, visit:

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