The U.S. Food and Drug Administration has struggled for more than a decade with language barriers when inspecting foreign drug manufacturing facilities and frequently relies on translators provided by the companies under examination, raising questions about impartiality and accuracy of information, a government investigator told lawmakers.
One FDA inspector had to resort to using a translation application on their phone to interpret information and interviews while conducting an inspection at a drug facility in China, Mary Denigan-Macauley, director of healthcare at the Government Accountability Office, said at a Dec. 10 hearing.
More than 60% of manufacturing facilities where drugs are made for the U.S. market are located overseas, Denigan-Macauley told members of the House Energy and Commerce Oversight and Investigations Subcommittee. The FDA has estimated that about 40% of finished drugs and 80% of active pharmaceutical ingredients are manufactured overseas, she said.
The GAO has questioned the FDA's ability to oversee the global supply chain — a situation government investigators have considered a high-risk matter for the past decade.
The FDA's inspections of foreign facilities have also been on Congress' radar in recent months after cancer-causing toxins were discovered in commonly used medicines for high blood pressure and heartburn — the topic of another Capitol Hill hearing in October.
The FDA has struggled to hire and retain enough inspectors. But employing translators has also been problematic, Denigan-Macauley said.
Translators do not generally accompany the agency's English-speaking inspectors to drug facilities in foreign countries, she said.
"This is particularly problematic in China, Japan and South Korea," Denigan-Macauley told the subcommittee.
At times, the drug company employee who is providing the translation does not have the knowledge and technical expertise to reliably communicate with the FDA inspectors, so the information collected by the U.S. regulator could be inaccurate, she said.
Rep. Diana DeGette
Other times, the drugmaker could be intentionally providing misinformation through a translator, Denigan-Macauley added.
She noted that foreign nationals who work for the FDA's drug inspections office in China have identified instances when biopharmaceutical companies have misled inspectors by incorrectly interpreting what was being said.
With the FDA relying on drug company employees or agents to do the translations, "what could go wrong," remarked Rep. Greg Walden, R-Ore., ranking member on the Energy and Commerce Committee.
Rep. Diana DeGette, D-Colo., chair of the Oversight and Investigations Subcommittee, noted that lawmakers discussed the language barrier problems with FDA foreign inspections back in 2007.
"I remember that hearing because I was there, and it was shocking," DeGette said.
Denigan-Macauley pointed to a 2008 GAO report that first raised concerns about the FDA's challenges in conducting foreign inspections and the accuracy problems the language barriers created.
During the Bush administration, regulators announced new proposals in 2008 to address the language situation and vowed to fix the problem.
While the FDA has made significant changes overall with its foreign inspection processes over the past decade, progress has not been made in providing translators, Denigan-Macauley said.
FDA inspectors interviewed by the GAO for a new report said language barriers created challenges in conducting foreign inspections, particularly in parts of Asia, including China and Japan. In addition, they told the GAO that inspection activities, including reviewing documents and interviewing employees, took longer to complete at sites where they ran into language barriers.
U.S. Food and Drug Administration Center for Drug Evaluation and Research Director Janet Woodcock
The FDA inspectors also raised concerns about having to rely on translators who were not independent from the companies being examined.
"Specifically, 11 investigators told us there can be uncertainties regarding the accuracy of the information being translated, particularly when investigators rely on the translation provided by an employee of the establishment being inspected," the GAO reported.
One FDA inspector raised concerns about conflicts of interest when manufacturers used their own employees to translate, GAO said.
Some drugmakers use paid consultants to act as translators, who then simultaneously coach the companies during the inspection process, another FDA inspector told GAO.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency was working on the translator issue.
"We do have the funding and we are working on getting contracts for independent translators per country that are not related to the firm or any other part of the country," Woodcock told the subcommittee.
"I think it would be better for us to have our own translators," she added. The FDA drug chief noted a large number of independent translating groups exist in foreign nations that the agency could contract with to provide those services.