FDA struggles to inspect overseas pharmaceutical suppliers
The Food and Drug Administration's efforts to inspect the manufacturing integrity of overseas pharmaceutical suppliers before their products reach U.S. consumers still fall short, a congressional watchdog agency representative warned.
The FDA has been under fire from Capitol Hill and numerous consumer advocacies for allowing tainted and mishandled pharmaceuticals into the U.S. market. A dozen deaths have been recently linked to improperly made Heparin, an anticoagulent, from China.
The FDA has the authority to physically inspect products offered for import, and if there's sufficient evidence of a violation, prevent entry at the border.
Marcia Crosse, director of health care for the Government Accountability Office, in written testimony on April 22 told House lawmakers that the FDA should conduct more inspections overseas instead of waiting for dangerous pharmaceutical products to arrive in the United States.
'Regular inspections of manufacturing establishments are an essential component of ensuring drug safety,' she said. 'Conducting testing of finished dosage form drug products cannot reliably determine drug quality.'
The GAO's research showed that FDA annually inspects only 8 percent of the registered overseas manufacturing sites. 'At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection,' Crosse said.
From fiscal years 2002 to 2007, FDA conducted 1,429 inspections of overseas manufacturing sites and three quarters of these were concentrated in 10 countries. According to the GAO, the lowest rate of inspections in these 10 countries was in China, for which FDA inspected 80 of the estimated 714 establishments, or fewer than 14 locations per year on average.
Technical problems also persist in how FDA conducts its overseas inspections, the GAO said.
'Unlike domestic inspections, FDA does not arrive unannounced at a foreign establishment. It also lacks the flexibility to easily extend foreign inspections if problems are encountered,' Crosse said in her testimony. 'Finally, language barriers can make foreign inspections more difficult than domestic ones.'
In fiscal 2007, the FDA spent about $10 million on inspections overseas, with an average cost per inspection ranging from $41,000 to $44,000.
The GAO acknowledged several positive steps recently taken by FDA, including improving the consistency of information about overseas drug producers in its automated systems and the development of international offices dedicated to inspection work. But the GAO warned these initiatives just scratch the surface of the problem.
'Our analysis suggests that it could cost the agency $67 million to $71 million each year to biennially inspect each of the 3,249 foreign drug establishments on the list that FDA used to plan its fiscal year 2007 GMP (good manufacturing practice regulations) surveillance inspections,' Crosse said. 'Based on these same estimates, it would take the agency $15 million to $16 million each year to inspect the estimated 714 drug manufacturing establishments in China every two years.'
The current FDA budget projections for overseas inspection work are $11 million for fiscal 2008 and $13 million in fiscal 2009.
In fiscal 2009, FDA proposed establishing a reinspection user fee. Reinspections are conducted to verify that corrective actions the FDA has required establishments to take in response to previously identified violations have been implemented. The fee would help the FDA to recover this cost when reinspections are required.
As part of its 'Beyond our Borders' initiative, FDA wants to establish permanent offices overseas. The agency believes these offices will improve cooperation and information exchanges with foreign regulatory bodies, allow for rapid response to emergencies, and improve quality of drug production.
Initially, FDA plans to set up offices in the Chinese cities of Beijing, Shanghai and Guangzhou, comprising eight FDA employees and five Chinese nationals. The FDA hopes to open the first office in Beijing by late 2008, followed by the other two in 2009.
FDA is considering opening similar offices in India, the Middle East and Latin America.
'While the establishment of both a foreign inspection cadre and offices overseas have the potential for improving FDA's oversight of foreign establishments and providing the agency with better data on foreign establishments, it is too early to tell whether these steps will be effective or will increase the number of foreign drug inspections,' Crosse said. ' Chris Gillis