FDA Needs More Inspectors, Updated Databases, According To FDA Official

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health
Article Date: 29 Feb 2008 - 5:00 PDT

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FDA needs to hire more inspectors and update its database that tracks approved prescription drugs, Janet Woodcock, the agency's deputy commissioner for scientific affairs and chief medical officer, said on Wednesday, CongressDaily reports. Woodcock testified at House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies hearing (Edney, CongressDaily, 2/27).

Woodcock said FDA focuses its inspections on U.S. drug manufacturers, conducting 1,200 domestic inspections annually, compared with 300 international inspections, which accounts for about 10% of all firms shipping prescription drugs or ingredients to the U.S. (USA Today, 2/28). Woodcock did not say how many more inspectors would be necessary to increase safety, but she said FDA needs "enough to have a reasonable coverage of both domestic facilities and out-of-country facilities" (CongressDaily, 2/27). President Bush's fiscal year 2009 budget request would provide enough funds to hire an additional 31 inspectors, but much of that funding would come from prescription drug user fees, which have not been approved, FDA officials said. The agency currently employs 232 inspectors (AP/Wall Street Journal, 2/28).

In addition, Woodcock said that the agency needs to integrate several databases to improve prescription drug tracking, especially for drugs manufactured abroad. The current system allows drugmakers to create their own drug codes, which can lead to unapproved drugs entering the system, according to Woodcock. She added that the import system "corrupts the database" by duplicating entries with similar information. Deficiencies within the databases impede FDA's ability to determine where drugs are manufactured and when they were imported to the U.S., Woodcock said (CongressDaily, 2/27). Woodcock "appeared to make a commitment" during the hearing to provide lawmakers with estimates of the number of additional inspectors needed and the cost of combining the databases, according to CQ HealthBeat.

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Subcommittee Chair Rosa DeLauro (D-Conn.) "lashed out" at Woodcock during the hearing, "rebuking her for blaming regulatory weaknesses at the agency on inadequate funding," CQ HealthBeat reports. DeLauro said much of FDA's poor drug oversight is a result of inadequate management, not a lack of funds, adding that FDA's Center for Drug Evaluation and Research has received $2.3 billion in funding since 2001 and "should have a lot to show for the money." However, the agency still lacks basic regulatory tools, including a complete inventory of approved drugs and their location of manufacture, a complete list of clinical trials and a mechanism for monitoring drug companies to ensure that they are following up on promises to complete postmarket safety studies, DeLauro said (Reichard, CQ HealthBeat, 2/27).

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