Opening China Offices Brings FDA Early Test On Bridging Globalization Gaps

FDA's opening of offices in China will be an early test of how the agency handles the challenges of globalization, not only in working with foreign governments but also in restructuring itself to operate with worldwide footing.

One immediate organizational test for FDA's first overseas offices - which opened in Beijing, Guangzhou and Shanghai during November - will be to bridge the differences between American and Chinese oversight practices, and cultural differences between regions of FDA itself.

While most of the headquarters staff of the China Office hails from the Office of International Programs - where new unit is now housed - most of the in-country staff previously worked for the Office of Regulatory Affairs (see chart: " ¹ Who's Who In FDA's China Office? ").

FDA is emphasizing the close collaboration that OIP and ORA will have as part of the endeavor. "The selection of inspectors was performed in conjunction with ORA," FDA said. "The assignment of inspection and the quality oversight of the inspections by our foreign-posted inspectors will be done through ORA."

Still, even dotted-line reporting structures could lead to inconsistent oversight standards that industry often complains about when discussing how to improve manufacturing compliance standards.

How Best To Regulate International Affairs?

The intertwining of OIP and ORA is underscored by the former Associate Commissioner for International Programs Melinda Plaisier's move in October to become director of the Central region office in ORA.

FDA's effort to create an overseas inspectorate comes as ORA itself is undergoing significant personnel and structural changes, beginning with the retirement of director Margaret O'Keefe Glavin (² (Also see "FDA’s Office Of Regulatory Affairs Loses Chief, Policy Manager" - Pink Sheet, 7 Jul, 2008.), p. 10).

Benjamin L. England, a former regulatory counsel to FDA's associate commissioner for regulatory affairs, suggested that the structure of FDA's China operations would make the effort less efficient than it could be.

"I think FDA ought to have people in China," said England, who is now in private food and drug law practice. "But the people they're putting in China report to [Deputy Commissioner for International Affairs and Special Programs Murray] Lumpkin ... but they're not inspectors. They're primarily facilitators and policy wonks."

FDA says the China office's mission is not simply to facilitate inspections. "These are not 'inspection' posts, but, 'FDA' posts staffed with senior technical experts, and, in some cases, inspectors," the agency noted.

"The posts have a multi-factorial mission, of which, in some areas, inspections are a component, but clearly not the only focus." The focus of the post - and the six other international offices FDA plans to open - "is getting robust information to allow FDA to make better product admission decisions. One way such information can be obtained is by inspections, but by no means is that the only way."

The office also will gather data from counterpart agencies, in-country industries and third-party certifiers, FDA said.

Third-Party Inspections Needed In China

Arvin Shroff, former deputy director of FDA's Office of Enforcement, said working with third parties holds the key to success for FDA in China.

"There's no way these eight people can do any justice. I think it's going to be a lot of paper review," he said.

Shroff said document translation likely will remain a concern even with bilingual FDA staff and with English translations provided by Chinese companies. FDA translators will spend much of their time verifying companies' translations.

"The amount of documents they will get will be tremendous," he said.

According to Shroff, FDA most likely will ask companies for records of internal audits conducted by third parties. While the companies do not have to comply, FDA can refuse any product's entry into the U.S. on suspicion of the product's quality.

The agency has been more aggressive in seeking third-party information lately, taking the Indian generics firm Ranbaxy to court to get such records as part of an investigation of manufacturing problems (³ (Also see "Tighter Inspection Provisions In Dingell Safety Bill Could Follow Ranbaxy Alert" - Pink Sheet, 29 Sep, 2008.), 2008, p. 12).

With more than 500 Chinese drug component manufacturers exporting to the U.S., it will be difficult for FDA's staff there to rapidly inspect all those firms. FDA officials in the past have conducted about 15 inspections per year in China, but that figure is set to increase as the safety of products from overseas has become a hot-button political issue.

The extent to which FDA's international efforts are seen as a success almost certainly will depend on how many more U.S. headlines appear about tainted food and drugs from overseas.

But the aftermath of the U.S. elections may give FDA a bit of breathing room. Ousted House Energy & Commerce Committee Chairman John Dingell, D-Mich., publicly berated the agency as he developed legislation which would force it to conduct more inspections. And while his successor, Henry Waxman, D-Calif., is certainly an advocate of tough manufacturing oversight, he does not appear to make it as high a priority as Dingell did, which could mean fewer hearings for industry and FDA (⁴ (Also see "Waxman Takes Legislative Driver’s Seat With Energy & Commerce Move" - Pink Sheet, 24 Nov, 2008.), p. 8).

In the meantime, FDA continues to build out its other ⁵ overseas offices. India appears to be the next furthest along, with the director and about half the staff hired.

The goal for an office in India is to have a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector, spread over at least two cities.

- M. Nielsen Hobbs ([email protected])