Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety.

Back in 2008, FDA opened its first foreign offices as part of its response to the globalization of the pharmaceutical and device supply chains. In 2010, GAO recommended that FDA track the contributions these offices in China, India, Europe and Latin America make in protecting medical products entering the US.

But now, GAO says in a report issued Tuesday: “While FDA officials shared examples of the foreign offices’ accomplishments, they do not systematically track such information, nor have they fully assessed the extent to which the offices are helping to ensure drug safety.”

Drug Inspections

FDA conducted drug inspections in 68 countries from fiscal year 2010 to 30 June 2016, with 76% of these inspections coming from 10 countries, GAO says. Establishments in India were the most frequently inspected, followed by those in China and Germany.

In addition, the FDA staff at these foreign offices, which currently numbers 29 and have a budget of about $35 million, have been involved in only a small fraction of foreign drug inspections.

“Specifically, of the total number of drug inspections conducted between fiscal year 2010 and June 30, 2016 (4,384), investigators assigned fulltime to the foreign offices participated in 241 (5 percent) of these inspections. The total number of drug inspections conducted each year by these full-time investigators ranged from 29 to 52, with the India office investigators conducting about two-thirds of the total number of inspections,” GAO says.

The Generic Drug User Fee Amendments Act (GDUFA) of 2012, which authorized FDA to collect user fees from industry, provided new resources to hire 80 additional investigators focused on inspecting generic drug manufacturers. FDA officials said that these investigators have primarily been assigned to foreign inspections, though during the period GAO reviewed, they participated in a relatively small percentage of the total number of foreign drug inspections (about 8%).

“While foreign office investigators have participated in for-cause inspections, for example, FDA officials said there is no tracking of the foreign offices’ actions that led to such inspections in the first place. Therefore, if foreign office staff collect and share intelligence about an establishment in a host country with domestically based FDA staff that results in an action, which spurs a for-cause inspection or detaining a product at the border, this contribution is not assessed by any performance measure,” GAO explains.

China and India

And for India and China (see the Focus review of Form 483s or deficiency reports for India and China manufacturing sites in 2015), which produce about 80% of the active pharmaceutical ingredients for the US, and where FDA has seen some of the worst cleanliness and inability to follow US regulations, the numbers are only slightly better than in the recent past.

For drug inspections, GAO notes that the goal of increasing the overall number of inspections in India and China has not yet been fully realized, as the number of inspections conducted by the India office has decreased since fiscal year 2013 and the number of inspections conducted by the China office has only just reached a new high in fiscal year 2016.

Since 2014, FDA says it has overcome challenges in obtaining visas for FDA employees in China, though GAO notes that as of July 2016, there were only 11 of 18 authorized investigators in China and three of 13 authorized investigators in India.

The China office also currently has one post in Beijing, though it previously had posts in Guangzhou and Shanghai, which closed in 2014. Similarly, the India office currently has one post in New Delhi, but it previously had a post in Mumbai that closed in July 2016.

As of July 2016, GAO says the foreign offices were authorized to have 54 full-time positions overseas, but 25 of these positions (46%) were vacant. The India office has the highest vacancy rate at 68% (13 vacancies), followed by the Latin America office at 43% (three vacancies), the Europe office at 33% (one vacancy) and the China office at 32% (eight vacancies).

FDA Has Improved Its Foreign Drug Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its Foreign Offices