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Regulatory Focus™ > News Articles > As White House Announces Breakthrough for FDA in China, Could Warning Letters Increase?

As White House Announces Breakthrough for FDA in China, Could Warning Letters Increase?

Posted 06 December 2013 | By Alexander Gaffney, RAC,

If you follow the US Food and Drug Administration's (FDA) Warning Letters with any regularity, you know that the agency has been keeping a tight eye on Indian pharmaceutical manufacturers. But under the terms of a recent agreement, Chinese companies might soon find themselves in similar circumstances.

Background

FDA has long been hamstrung in its ability to inspect foreign manufacturers of pharmaceutical products, and in particular generic pharmaceuticals and active pharmaceutical ingredients (APIs) used in both. That's because foreign inspections are considerably more difficult and expensive to conduct. It costs more to travel there, inspectors need to obtain temporary or permanent visas, translators need to be made available, and sometimes just accessing a facility can be a burden.

But that situation underwent several major changes in 2012 under the terms of the Food and Drug Administration Safety and Innovation Act (FDASIA).

FDASIA contained two major provisions that are proving instrumental in increasing foreign-based inspections. First, it contains the Generic Drug User Fee Act (GDUFA), which for the first time ever allows FDA to collect user fees from all manufacturers and sponsors of generic drugs and APIs to help fund the inspection of those facilities.

Second, the law allows FDA to find a facility's products to be presumptively adulterated if FDA's inspectors are delayed, denied or refused entry into a facility. The agency has already cited this authority in Warning Letters to Indian manufacturers, such as 2013 letters to Wockhart and Fresenius Kabi.

Boots on the Ground in India, Eyes on China

Those authorities have had a lot to do with a surge in inspections this year in India, where FDA has sent several major Warning Letters to large manufacturers alleging serious problems. As Focus noted last week, recipients include Wockhardt (2), Fresenius, Hospira, Promed and Posh Chemicals.

But why the focus on India? After all, prior to the passage of FDASIA, FDA investigators had found plenty of objectionable conditions in Chinese facilities. If Warning Letters have a conspicuous absence of anything this year, it's objectionable conditions found in Chinese facilities.

In 2013, FDA has issued just five Warning Letters to companies based in China. By contrast, Chinese companies received 15 the year before.

As Ed Silverman of Pharmalot has reported, the perceived focus on India might not be an accident. In August 2013, Silverman reported that FDA had been unable to obtain visas for its staffers to work on a long-term basis in the country, something made possible by $10 million in FDA funding through FDASIA.

Permanent FDA outposts are intended to make routine inspections easier, but without being able to send new staff to its China facility, FDA's inspection capabilities have been stagnant.

"[So] far, the agency has been unable to send more investigators, except those who are permitted to make short-term trips to conduct inspections," Silverman wrote.

The Situation in China: Due to Change?

But now that situation is poised to change, an FDA representative tells Focus. Under the terms of an agreement reached on 5 December 2013 between the White House and Chinese officials, China will allow a "substantial increase in the number of US food and drug inspectors stationed in China," according to a White House statement.

"China also committed to take steps towards introducing a framework for registering manufacturers of bulk chemicals that can be used as active pharmaceutical ingredients, which would be a critical step in combatting dangerous counterfeit pharmaceuticals around the world," the White House statement continues. "In addition, China took an important step to strengthen the protection of pharmaceutical innovations by announcing that patent holders will be able to submit additional data to support their patents after filing their initial applications."

While the move is undoubtedly positive for the US pharmaceutical industry at large owing to its increased patent protections, it also raises the prospect of something else: More Warning Letters for Chinese manufacturers.

India, which saw just six Warning Letters in 2012, has already seen 13 Warning Letters since FDAISA became law.

If similar trends hold true for Chinese companies, 2014 could be as excruciating for them as 2013 was for Indian manufacturers.

White House Statement

Pharmalot