US to bolster inspections of China drug production facilities amid safety concerns
Increased export volume spurs enhanced US Food and Drug Administration safety inspections of pharmaceutical production plants in China
The US Food and Drug Administration is increasing its oversight of Chinese manufacturers of pharmaceutical ingredients to improve the safety of the US drug supply chain, the director of the agency’s China office, Christopher Hickey, said on Thursday.
Hickey was one of several witnesses who testified before a hearing of the US-China Economic and Security Review Commission, which monitors and investigates the national security implications of bilateral trade and economic relations between the two countries.
Armed with new legal authority and additional funding, the FDA has begun adding staff and inspectors in China, but the process is not without challenges, Hickey said.
In 2012 the agency began to notice delays in the issuance of Chinese visas, forcing the agency to fly investigators to the country for brief and expensive visits. That situation began easing after US Vice-President Joe Biden visited Beijing in December.
“We faced delays for many months but I think when the senior levels of the Chinese government were engaged we saw some movement on the issue,” Hickey said.
About 80 per cent of the active ingredients and bulk chemicals used to make pharmaceutical drugs sold in the United States come from overseas. Of those, nearly half are made in China and India.
Between 2003 and last year, imports from China increased 192 per cent, raising the potential for substandard products to reach US consumers. The FDA has placed products from 33 Chinese facilities on import alert, meaning certain products may be refused admission into the United States.
“As the number of medical products coming from China has increased, so have the challenges,” Hickey said.
The quality of China’s supply chain made headlines in 2008 after dozens of people were killed or injured after taking Chinese suppliers of the blood-thinner heparin substituted a lower cost, adulterated raw ingredient.
Since then other quality control problems have emerged, including the use of industrial-grade gelatin to make pharmaceutical-grade gelatin capsules for drugs and food, though not on the scale of the heparin crisis.
In 2010 the FDA conducted 46 drug inspections in China. Last year it conducted 84, Hickey said. The agency currently has 13 staff in China. Using funding provided by Congress last year the agency is working to increase the number to 27.
Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, told the panel that the FDA has inspected foreign plants about every nine years on average, compared with every two to three years for US facilities.
“China is home to the highest number of sites subject to FDA inspection outside of the United States but in the past has received the lowest levels of oversight compared with other countries,” he said.
During its inspections, Hickey said, the agency focuses on a company’s systems. Investigators look at the “big picture” to assess how well firms have identified risks, what they have done to address them, how well those risks have been documented, and whether what is recorded can be verified.