This article is reprinted from "The Gray Sheet" – January 14, 2008
FDA is considering posting staff overseas to perform inspections and foster relationships with foreign government counterparts and industry.
"There is a very real interest in pursuing this and obviously the spotlight has been on China ... but this is not just a China issue," FDA Deputy Commissioner for International and Special Programs Murray Lumpkin said during a Dec. 13 panel discussion on FDA's international issues hosted by the Food and Drug Law Institute.
"The products that we are responsible for within the United States are no longer domestic commodities," Lumpkin said.
"For the most part, whether it's on the food side of the house or the medical products side of the house, they are global commodities. They are discovered, developed, marketed, and most importantly they are used by consumers, practitioners and patients around the world."
By establishing FDA posts in foreign countries, the agency will actually be in a better position to do its job domestically, Lumpkin said. And it will position itself to get more help from abroad.
"This is a broader issue of how do we best position our resources to help us do our job in the 21 century that we need to do around the world," he said.
"Having a presence outside the United States is simply necessary to help make our interactions with [our] counterparts more useful, more productive and more fruitful, and to meet the goals we have with this country and with the areas being served."
The overseas staff positions would be "full-time day jobs" focused on creating relationships with foreign governments and businesses, Lumpkin said. Performing foreign inspections with greater ease would be another important benefit of the posts, he added.
Though Lumpkin stressed that FDA is interested in establishing such posts in several countries, China is likely to be the first place it happens.
"It's estimated perhaps 40% of all consumer products are coming from China, and so there are significant issues there," said William Hubbard, head of the Coalition for a Stronger FDA, whose members include health care manufacturers and nonprofit public health organizations.
The old paradigm of placing most of the burden on FDA to catch a problem at the border is no longer working, he said.
"The fact that the level of import shipments is now approaching 20 million FDA regulated products, and FDA only has 450 import inspectors to cover more than 300 ports clearly indicates a mismatch," Hubbard noted.
Public comments from Health and Human Services Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach indicate strong U.S. support for establishing FDA posts in China, Lumpkin said.
The idea has been broached with the Chinese government, but negotiations are still at the beginning stage, he added.
"We're in the process right now [of] working with the Department of State on the official kinds of approaches that one takes to establish this kind of a presence within a country like China," Lumpkin said.
Cracking Down On Counterfeiting
Talks about increasing FDA's international presence come in concert with the Interagency Working Group on Import Safety's recent submission of its Action Plan for Import Safety to President Bush.
That plan includes the Memorandum of Agreement signed Dec. 11 with China to enhance regulatory cooperation in the areas of food, drugs, medical devices and animal feed (1"The Gray Sheet" Dec. 17, 2007, In Brief).
The pact requires all Chinese producers of glucose test strips and condoms to register with the Chinese government and develop a program to certify that the products meet FDA safety standards.
The United States and China also agreed to notify each other within 24 hours if the devices cause any serious adverse health consequences and to exchange lists of registered firms that manufacture the products.
Though the agreement has been criticized by some in Congress - including Sen. Richard Durbin, D-Ill., who said it "doesn't cover nearly enough products to restore our confidence in Chinese goods" -Lumpkin said that starting out with two products known to have had problems in the past will allow FDA to gauge whether the pact is working.
In the medical device area, counterfeit condoms and diabetic test strips have had the biggest impact in the United States so far (2"The Gray Sheet" Oct. 16, 2006, In Brief).
"Once we have the evidence that indeed the implemented system is giving us the assurances we want, we will then see how to expand it into the next area where we see a higher risk," he said.
Counterfeiting is one of the top three areas of concern for medical products in the international realm, Lumpkin said. The other two concern the regulation of combination products, and the shift - based on advances in genetics - from developing products for patient populations to developing them for individuals.
The World Health Organization's International Medical Products Anti-Counterfeiting Taskforce met in Lisbon in December to discuss principles and elements for national laws to combat the counterfeiting of medical products.
Among topics discussed in Lisbon were government and manufacturer responsibilities in ensuring that counterfeits do not make it onto the market, and imposing severe criminal sanctions against counterfeiters regardless of evidence of actual harm caused to others.
The sanctions "should be equivalent to those provided by national legislation for other serious crimes, and adequate to the gravity of the offenses ... including mandatory jail sentences where mitigating circumstances are not present," the taskforce said.
- Ingrid Mezo
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