Fact sheets were issued by both sides, plus a joint fact sheet was put out there as well. Interesting PR and diplomatic tactic reminiscent of our favorite all-time US-China document. The food, feed, pharma and medical device information can be found here on the US Department of Health and Human Services site.
I took a look at the drug and device agreement because it is related to my legal practice. I haven't done too much animal feed-related work recently, so I gave that one a pass. Essentially the agreement is all about products that are being exported from China into the U.S., although the agreement technically applies to products going both ways. Obviously there has been a lot of talk recently about quality problems with Chinese products, but in the drug area, this has actually been an issue for quite some time. This is also a very serious public health issue, so I'll keep the usual sarcasm to a minimum here.
The agreement sets up a registration system for exporters, applicable first to firms designated by the U.S. or China. Exporters that fail to meet requirements would be investigated. Adoption of WHO standards and information sharing between law enforcement agencies of the parties would also be developed. Special cooperation on the regulatory, standards and enforcement fronts would be established to deal with counterfeit drugs and devices.
There has been talk of the US FDA establishing a local office in China, presumably in Beijing, that would assist in information sharing and possibly to give the US government a local platform from which it could conduct limited on-site inspections in cooperation with SFDA. Having the manpower to do this will be a key issue.
As usual, this is a framework agreement whose success or failure all depends on what is done in the future. If good, qualified personnel are involved on both sides and sufficient resources brought to bear by both parties, this could be a useful mechanism. If it is all a political show, then it's bullshit.
Some early reaction from the opposition party in the U.S.:
Some Democrats welcomed the agreements but said they didn't go far enough. While the deals improve the FDA's access to Chinese facilities, they don't guarantee access or specify how much latitude U.S. inspectors can have, said Sen. Richard Durbin of Illinois. "It is important that once a tainted product is traced back to a production facility our inspectors be granted full unrestricted access and that we have a sufficient number of safety officials in place to deal with the problem."
I'm a fan of Dick Durbin, particularly his efforts on the Iraq War. However, in this case he is trying to out-tough the Bush Administration by demanding even more. Not really a useful exercise, in my opinion. This is merely a first step, and probably a decent one at that. Is it realistic to ask for guaranteed access to Chinese facilities by US inspectors? This isn't the IAEA, it's a product safety issue. Would the U.S. allow Chinese government officials to have wide-ranging inspection rights over American facilities? That would surprise me.
So we'll keep an eye on this and see what happens.