Well, what do you expect Margaret Hamburg to say? 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 (see here), 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 purusing 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."
2 Comments
Happy-Happy! Joy-Joy! I'm glad she's having a wunnerful time in Shanghai.
Until US customs starts shutting down imports from any supplier of API's or intermediates that has not been inspected and improved, the Chinese really are only going to pay lip service to whatever GMP issues are brought up.
Any Chinese company that is truly compliant in every way knows the costs associated with running effective quality systems; the products coming from those sorts of companies are not likely to be very cheap.
About one out of twenty Chinese companies I work with are willing and eager to meet ex-China cGMP; the rest will do as little as possible, satisfying only their local (city or provincial) SFDA inspectors.
Any foreign company working with a Chinese pharma company for production of an API or bulk finished must be willing to spend 18 months to 3 years teaching and supervising, and be willing to do this on its own dime. Unfortunately, this is the only way I know this can be done. No Chinese company I have seen in the past 10 years has undertaken any effort to be ex-China cGMP compliant on its own initiative.
This is where associations like the Parenteral Drug Association can be very useful.