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USCC: making sure Chinese APIs are safe is “hopeless task” for US FDA

By Gareth MacDonald+

14-Apr-2014
Last updated on 19-Apr-2014 at 13:25 GMT

Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.

Dennis C Shea, chairman of the US-China Economic and Security Review Commission (USCC), made this suggestion at a hearing this month after Food and Drug Administration (FDA) China chief Christopher Hickey revealed that, of the Agency’s 13 local staff, only two inspect drug plants.

Shea said inspecting the nearly 4,000 Chinese plants that ship APIs to the US is a “hopeless task” for two and a half FDA FTEs [full time equivalents] adding that “even with the bump up in numbers…if you get four or five it seems like a hopeless task.”

It seems to me…you are [the FDA in China] woefully inadepuately staffed for this particular job and you have to, by necessity, rely on Chinese FDA for their own inspection regime and the supply chain security operations of the Western manufacturers.”

Hickey agreed, telling the committee that: “We are looking forward to increasing the numbers” adding that “any US Government agency that works in China is always challenged in terms of the size of China.

In this particular area [API inspections] we do place primary responsibility on manufacturers…they have to make sure that the systems are in place and to make sure that they are manufacturing products in a safe manner.”

Hickey also said the FDA is looking to use more information from the Chinese monitoring system, citing an agreement signed by the two countries in 2007 that focused on sharing information about potential higher and lower suppliers.

However, while Hickey said the FDA has these and other measures – like border inspections and post-market surveillance strategies in place – he described overseeing production of APIs in China as a “challenge.”

Safe ingredients?

Hickey reiterated this when asked if he could assure US citizens that drugs and ingredients sourced in China are safe, telling Shea that: “Clearly there have been a number of high profile cases that have highlighted some of the challenges with safety in China not only with exported products but domestically as well.”

There’s a wide spectrum of level of proficiency among drug manufacturers in China, so there clearly are challenges…we place primary responsibility on industry, we are seeking to get more information from Chinese authorities and more tools in place to safeguard products coming into the US.”

The US agency has been trying to increase the number of staff it has in China for several years, with efforts being hampered by delays resulting from the shutdown last year and problems obtaining visa from the Chinese Government .

While, according to Hickey , progress has been made on the visa issue following the visit of US Vice President Biden to Beijing in December 2013, no new FDA inspectors have been announced.

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