Familiarity Breeds Understanding

June 23, 2009

Applied Clinical Trials

How FDA is responding to the demands of a global world, where agency-regulated products are in the trillions.

"We're not in Kansas anymore, it's a global supermarket," FDA's Murray Lumpkin, MD, MSc, told the early risers in attendance at Tuesday's 8:00 am session, FDA Goes Global: Domestic Mission, Global Presence. Lumpkin, deputy commissioner, International Speciality Programs, Office of the Commissioner at FDA, was referring to how so much of the food and medicines we use in the United States nowadays comes from outside our borders. In 2007 alone, more than 2 trillion worth of FDA-regulated products were imported. And this massive influx of goods from abroad, said Lumpkin, poses a daunting challenge to FDA.

The answer? Go local. Both Lumpkin and his copresenter on the panel, Linda Zhao, PhD, president and chief executive officer of Draco Healthcare Consulting, made it clear that: "Going global means going local." It might sound backwards at first, but it makes perfect sense. In the case of FDA, it means opening offices in countries around the world where experienced agency professionals can gain access to and work closely with local regulatory officials as well as industry. As Lumpkin explained: "We learned that in order to do our job more effectively at home, we have to do our job more efficiently abroad."

To that end, FDA opened an office in Beijing, China, in November 2008 and one in San Jose, Costa Rica, this past January. They also have new offices in India in New Delhi and Mumbai. And while employees have been hired for FDA's Middle East offices, because of security issues, a location has yet to be determined. Of course, the Agency will continue to work with EMEA, expanding an already long relationship that's being taken to the next level this summer with the employee liaison program: FDA is sending one employee to EMEA and vice versa.

But no matter where the location, the goal is the same: Obtain better and more robust data to help FDA officials back at home make better decisions. "Our borders cannot be the first line of defense," said Lumpkin. And that's where the new offices come in. Global post responsibilities will include finding out more about manufactured products, working with industry in the countries to provide better inspections, and knowing the ins and outs of a particular country's regulatory system so if a problem does arise, officials will know where to turn.

In the field      
The session's final speaker, Bruce Ross, MA, MPH, Country Director (India), FDA, echoed Lumpkin's sentiments. "Gathering better knowledge about production of products and working with counter-part agencies to understand them is incredibly important," Ross told the audience. It was a lesson he had learned first-hand when investigating China's 2008 pet food scandal that left 104 U.S. pets dead. Solving the mystery entailed a lot of foot work and detective work on the part of Ross and his team, but in the end they found the culprit, greed, and the experience prepared them for the next emergency in China: tainted Heparin. "Instead of not knowing where to go, we knew who to talk to," Ross said. "[And] the Chinese government helped us get visas in a week."

In this case, it was a previous tragedy that bred a familiarity with the Chinese agency that helped Ross and his team quickly locate the source of the Heparin. Such, thankfully, is not the case with the new FDA global offices as they aim to build the same types of knowledgeable relationships with local government and regulatory agencies. In the end, it's this closeness, and not just our borders, that FDA hopes will help protect U.S. citizens and the world. By the way, in July Ross will head to India where he will head the country's new FDA office.

Related Content:

FDA