FDA Posts Investigator In Singapore, But Trims Foreign Office List

FDA's Office of International Programs consolidates its China offices to "strategically focus its resources." FDA shifts away from primarily a domestic focus to global as drug criminal organizations spread globally

FDA continues stretching its criminal enforcement capacity beyond US borders, moving into Southeast Asia, but the agency's Office of International Programs is shrinking its world footprint at the same time.

The Office of Criminal Investigations recently posted an agent in Singapore, the office's second outside the US. Another is located at Europol headquarters in The Hague, Netherlands.

Extending OCI into other countries is part of the agency's effort to be more proactive fighting drug counterfeiting, diversion and other crimes, Director George Karavetsos said.

"I also know the chilling effect that it has on criminal organizations operating overseas, when you hit them in their own backyards," Karavetsos said at the Food and Drug Law Institute's Enforcement, Litigation and Compliance conference.

"We're working and coordinating daily … with our foreign law enforcement counterparts to identify and dismantle these criminal organizations."

The Singapore agent, apparently focusing on internet-related criminal issues, is located at the Interpol Global Complex for Innovation, a research and development facility for crime and criminal identification, innovative training, operational support and policing partnerships for the global cyber environment, FDA said.

FDA would not comment on whether it will post agents in other parts of the world.

Karavetsos said he wants OCI to "continue to innovate and evolve to meet the trends and schemes that are being perpetrated here domestically, but also internationally."

OCI, like the rest of FDA, is shifting away from a primarily domestic focus to a global reach as drug criminal organizations have grown globally. The office has an agent tracking overseas police agency activity and also created a cybercrimes unit looking at websites selling drugs to US consumers illegally.

Its Europol agent also helps FDA remain abreast of activities throughout Europe (Also see "FDA’s New Criminal Investigations Chief Wants Global Reach" - Pink Sheet, 23 Mar, 2015.).

Five Foreign Offices Closed Since 2012

FDA has opened multiple international offices to work with foreign governments and better respond to issues that arise in those countries. But after operating 13 offices in 2012, the agency has reduced the total to eight. FDA closed the five officers "to strategically focus its resources in the regions," the agency said.

Offices in Parma, Italy, closed in 2012; locations in Shanghai and Guangzhou, China, closed in 2014; and FDA's Pretoria, South Africa, post closed in early 2015, the agency said (see map below).

China operations were consolidated into FDA's Beijing location. The agency's Europe Office, which includes posts in London and Brussels, now covers Italy. And staff at its Silver Spring, Md., headquarters will handle "priority issues in the region previously covered by the Pretoria office," the agency said.

The closures could limit FDA's impact long-term, especially in China, where inspection challenges became the genesis of FDA's foreign office concept. But the agency said it "remains committed to all of these regions and will continue to engage in priority activities."

FDA also closed its office in Amman, Jordan, in 2013 and moved its base for work in that region to its US headquarters (Also see "FDA Closing Office In Jordan To Better Leverage Shrinking Resources" - Pink Sheet, 7 Oct, 2013.).

The House Energy and Commerce Committee recently asked FDA to answer a number of questions about why offices closed as well as its plans for filling vacancies in the remaining foreign locations (see story this issue, (Also see "Energy And Commerce Members Want FDA Overseas Operations Update" - Pink Sheet, 25 Jan, 2016.)).

Some of the closures could have been expected, given FDA's recent fiscal plans. Its fiscal 2016 budget request included proposed cuts in field operations to focus on its highest priority compliance and other activities (Also see "FDA Field Operations Would Endure Reductions Under Budget" - Pink Sheet, 9 Feb, 2015.).

FDA opened the foreign offices to enhance its reach as supply chains for medical product and other industries extended around the world. Foreign offices also were intended to allow FDA to inspect facilities outside the US more easily and expeditiously (Also see "FDA Plans To Rely On Non-U.S. Regulators In Global Drug Quality Initiative" - Pink Sheet, 2 Jun, 2014.).

FDA also wants to rely on trusted regulators to share information about facilities and other issues. FDA could use information gathered by the European Medicines Agency and others to better target its resources, but the agencies are having difficulty reaching sharing agreements (Also see "FDA Mutual Reliance With EU On Inspections Is Slow Going" - Pink Sheet, 19 Oct, 2015.).

China Staff Grows In Fewer Locations

Even though it closed two of its offices in China, FDA continues to boost its staff based there. As of Dec. 18, the agency had 17 employees assigned to the China office, with six scheduled to begin a detail to conduct inspections during the January-March quarter, FDA said.

Five of the China office staffers have been hired but not yet deployed and will work on drug-related issues, the agency said.

Additions to the China office were slowed by the amount of time the country used to issue visas for FDA workers it had promised (Also see "FDA Talks Drug Safety With China, But Visas Still Elusive For Staff" - Pink Sheet, 22 Sep, 2014.).

[Editor's note: "The Pink Sheet" also published this article. "The Tan Sheet" brings selected complementary coverage from our sister publications to our subscribers.]

Source: FDA