FDA Cannot Properly Inspect Foreign Companies That Manufacture Medications, Medication Ingredients, Report Finds

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Public Health
Article Date: 24 Apr 2008 - 12:00 PDT

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FDA does not have adequate resources to inspect foreign companies that manufacture medications or medication ingredients, and current funding levels for the agency will not address the issue, according to a Government Accountability Office report presented on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Newark Star-Ledger reports. The subcommittee convened the hearing in response to reports that contaminated batches of the blood thinner heparin contained an active ingredient supplied by a Chinese manufacturing facility that FDA had not inspected (Cohen, Newark Star-Ledger, 4/23).

According to the report, FDA inspects only 8% of the more than 3,000 foreign companies that manufacture medications or medication ingredients shipped to the U.S. (Rockoff, Baltimore Sun, 4/23). FDA also lacks accurate data on which foreign companies manufacture medications or medication ingredients shipped to the U.S., the report found (Newark Star-Ledger, 4/23). In addition, the report estimated that FDA would require $67 million annually to inspect such companies every two years. FDA has budgeted only $11 million for such inspections in 2008 and $13 million in 2009, according to the report (Greising, Chicago Tribune, 4/22).

Marcia Crosse of GAO said, "Given the growth in foreign drug manufacturing for the U.S. market and the current large gaps in FDA's foreign drug inspections, FDA will need to devote considerable resources to this area if it is to increase the rate of inspections." She added, "FDA plans currently call for incremental increases that will have little impact in the near future" (Newark Star-Ledger, 4/23).

Von Eschenbach Testimony
At the hearing, FDA Commissioner Andrew von Eschenbach acknowledged the problems cited in the report but "emphasized that increased funding and staffing wasn't the entire solution," the Baltimore Sun reports (Baltimore Sun, 4/23).

In response to questions from lawmakers about the amount of funds FDA would require to increase inspections of foreign companies that manufacture medications or medication ingredients, he said, "I would like to have the resources that would enable us to do a systemic overhaul of the entire system, not one that is related to the number of inspections" (Edney, CongressDaily, 4/22). Von Eschenbach added that the "solution needs to be much more comprehensive than simply inspecting a facility" (Freking, AP/Chicago Tribune, 4/22). He cited the need to place FDA inspectors in China, increase cooperation with foreign regulators, update agency information technology systems and expand use of third-party certification (Carey, CQ Today, 4/22).

In addition, von Eschenbach said, "I believe we are making progress, but the problems are substantial, and they require substantial effort" (Chicago Tribune, 4/22).

Lawmaker Comments
House Energy and Commerce Committee Chair John Dingell (D-Mich.) said, "I believe that FDA is clearly not up to the task, as it cannot or will not undertake the reforms needed to protect Americans from this threat from abroad or get the resources that they need" (Newark Star-Ledger, 4/23). Dingell told von Eschenbach, "You are carrying water for an administration that is not giving you the resources you need" (Baltimore Sun, 4/23).

Subcommittee Chair Bart Stupak (D-Mich.) said, "If we don't make some rapid progress in fixing the foreign drug inspection program, the next ... heparin tragedy will soon be upon us" (AP/Chicago Tribune, 4/22).

Dingell has proposed draft legislation that would make broad regulatory changes to FDA and increase funds for the agency. Under the bill, FDA would inspect all facilities that manufacture medications and medication ingredients every two years (CQ Today, 4/22).

C-SPAN video of the hearing is available online (C-SPAN, 4/23).

NPR's "All Things Considered" on Tuesday included a discussion with Crosse (Block, "All Things Considered," NPR, 4/22). Audio of the segment is available online.

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