Hickey was one of several witnesses who testified
before a hearing of the U.S.-China Economic and Security Review
Commission, which monitors and investigates the national security
implications of bilateral trade and economic relations between the
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 U.S.
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 percent of the active ingredients and bulk chemicals used
to make drugs sold in the United States come from overseas. Of
those, nearly half are made in China and India.
Between 2003 and 2013, pharmaceutical imports from China increased
192 percent, raising the potential for substandard products to reach
U.S. 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
[to top of second column]
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 in 2013 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 U.S. 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
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.
(Reporting by Toni Clarke in Washington;
editing by Steve Orlofsky)
[© 2014 Thomson Reuters. All rights
Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.