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FDA Still Lags in Inspecting Foreign Drug Manufacturers
(CNSNews.com) – The Food and Drug Administration has made some progress, but not enough, in assuring the safety of drugs manufactured overseas and marketed in the United States, says the research arm of Congress.
In a recent report, the General Accountability Office said it is “urgent” that the Food and Drug Administration implement GAO’s prior recommendations to better protect the public health.
The GAO first identified weaknesses in the FDA’s foreign drug-inspection program in 1998. Again in 2008, the GAO found that the FDA had inspected relatively few foreign drug manufacturers in the fiscal years 2002 through 2007.
GAO also found that because of inaccurate information in its databases, the FDA did not even know how many foreign drug-makers were subject to inspection in that time period.
The question of foreign drug inspections gained urgency in the spring of 2008, when Chinese-made heparin -- a blood thinner -- was linked to dozens of deaths and adverse reactions in Americans who took the drug. The FDA had not inspected the Chinese plant which made the drug for the U.S. market.
In its 2008 report, the GAO recommended that the FDA increase inspections of foreign drug establishments and improve the information it receives to manage the foreign drug inspection program.
Last month, the GAO issued a follow-up report examining the FDA’s progress in those areas since 2008. It found that although the FDA conducted more foreign drug inspections between fiscal 2007 and 2009, it “still conducts relatively fewer foreign drug inspections each year than it conducts domestically.”
According to the GAO, drugs manufactured in more than 100 countries were offered for entry into the United States in fiscal year 2009.
The numbers
In fiscal year 2009, FDA conducted 424 inspections of foreign drug manufacturing facilities, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively, the GAO reported.
Using a “priority” inspection list developed by the FDA, the GAO estimated that the FDA inspected only 11 percent of foreign drug makers on that priority list in fiscal year 2009.
“At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once,” the report said. “In contrast, in that same year, FDA conducted 1,015 domestic inspections, inspecting approximately 40 percent of domestic establishments.” The GAO estimated that at this rate, the FDA could inspect domestic drug makers approximately once every 2.5 years.
The GAO also said the FDA is not following the GAO’s recommendation, made in 2008, that it inspect the “riskiest” facilities—those that experience manufacturing defects, for example – regardless of where they are located.
“Instead, its foreign inspections continue to be driven by the establishments listed on an application for a new drug, instead of those already producing drugs for the U.S. market,” the GAO reported.
On the positive side, the October 2010 GAO report said that the FDA is taking steps to collect more accurate information on foreign companies that are registered to market their drugs in the United States. However, the report noted that the effort to improve the FDA database is in its early stages.
GAO noted that the FDA also is exploring ways to collaborate with foreign regulatory authorities to exchange information about drug plant inspections.
GAO concluded that the FDA “has begun to respond” to the GAO's earlier recommendations. However, “it has not yet fully addressed these weaknesses at a time when the volume of imported drugs and the number of foreign establishments producing these drugs have been increasing.”
The Health and Human Services Department, which oversees the FDA, reviewed the GAO report “and agreed that more progress is needed in order to meet the challenge of safeguarding the nation's drug supply in today's global marketplace,” the GAO said.
