When President Obama included in his budget submission in April a $10 million funding boost for FDA inspections in China, it looked like the regulator would begin strengthening its presence in the country. Since then, the project has stalled, with the FDA frustrated by an inability to obtain long-term visas for staff.
The FDA began talking to Chinese regulators about expanding its presence in the country in February 2012--and the U.S. State Department got involved 8 months later--but has made little progress, Pharmalot reports. The delays stem from difficulties in acquiring the visas FDA staff need to work in China on a long-term basis. The FDA planned to use its funding boost to swell its ranks of China-based inspectors from three to 20--11 of whom would visit pharma plants--but it currently only has 8 direct hires in the country.
The lower-than-hoped-for headcount makes the FDA reliant on short-term visits by U.S.-based inspectors. While the FDA is identifying some manufacturing indiscretions using this model, it believes it is more effective to have people on the ground in China. These in-country staff can learn the nuances of the Chinese system, build contacts and help local regulators develop their own inspection capabilities.
The FDA is publicly optimistic that the impasse can be resolved. "[China's Ministry of Foreign Affairs has] undertaken an extensive, government-wide process to review FDA's plans. While this process has taken longer than the FDA had hoped, we trust that our two governments will soon be able to come to final agreement on this issue," an agency spokesperson told Pharmalot.
- read the Pharmalot article