US FDA poised to up China inspections after favourable FY14 budget

US FDA gets budget for more China inspectors

The US FDA is positioned to increase drug plant inspections in China after US President Barack Obama signed a $1.1tr (€881bn) budget for fiscal 2014 into law on Saturday.

Analysts are still assessing the precise impact the 2014 budget – which is detailed in a 1,500 plus-page document – will have on US Government agencies and how each will spend the finances it has been assigned.

What is clear is that the US Food and Drug Administration (FDA) has been given the money it said it needed to fund operations when it submitted its budget request last year.

Steven A. Grossman, deputy director of advocacy group the Alliance for a Stronger FDA, told our sister publication BioPharma-Reporter.com last week that: "FDA received almost exactly the amount and by-center distribution that the President requested last February.So, yes, FDA received what it asked for which itself a remarkable accomplishment in our tight budget environment."  

How the FDA will spend its money remains to be seen but, assuming the agency follows the basic plan set out last year, it is likely that around $5m of the $10m budget it asked for for inspections in China will be spent on visits to drug plants.

In its request the agency said: “With the resources requested in this initiative, FDA will perform additional foreign inspections in China, focusing on facilities that produce drugs and drug ingredients that pose the greatest risks to patients in the United States.”

FDA will also conduct training with Chinese drug authorities to enhance their ability to regulate pharmaceutical products exported to the United States, and will do outreach and education activities with Chinese manufacturers on implementing measures to meet FDA requirements for safety and efficacy.”

In its request the agency also said it will hire and train new inspectors in China in 2014 and expects to be performing more than 120 site visits in the country each year by fiscal 2016.

China approval

China is a well-established source of pharmaceutical and drug ingredients for the US and the FDA already has a team of eight inspectors in the country and in 2013 asked Chinese authorities for permission to hire more staff.

In December the US agency announced that Chinese authorities have agreed to allow it to increase the number of inspectors stationed in the country.

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