GAO REPORT ON FDA RESOURCES, INFRASTRUCTURE NEEDS REQUESTED

Executive Summary

GAO REPORT ON FDA RESOURCES, INFRASTRUCTURE NEEDS REQUESTED by Senators Burdick (D-ND), Kennedy (D-Mass.), Cochran (R-Miss.) and Hatch (R-Utah) in an Oct. 20 letter to the General Accounting Office. "We request that the GAO submit to us a report analyzing the infrastructure and resource needs of the FDA to meet the demands of our research efforts and carry out its mission into the next century," the letter said. The senators asked that the report be submitted by Feb. 15, 1989. GAO was asked to address several questions, such as "Are the present FTE ]full time equivalent[ levels ]at FDA[ adequate, and if not, what level is necessary?" The senators are also seeking information on "the relative infrastructure and resource needs for consideration of current and future approvals for new human drugs, animal drugs and medical devices, including biologics produced using recombinant DNA technology." Other questions include: "Do indications presently exist to establish a Senior Biomedical Scientific Service within the FDA to attract and maintain a cadre of highly trained experts? If so, what are they and how could such a program be implemented? "Are there recruitment and retention problems at the FDA, particularly with nonmanagerial scientists and entry level reviewers? "What is the present role of visiting scientists, extramural consultants and advisory committees at FDA? Are they optimally utilized? "What is the present capacity of the FDA research facilities, including equipment and instrumentation in the research laboratories? Are they adequate? "Are the computer capabilities of the FDA adequate to meet the demand? Are there improvements in the communication systems which would facilitate the drug review and approval process? Are the present computer systems sufficient to begin electronic processing of new drug applications?" The four senators noted that testimony presented at recent Senate committee hearings on FDA have highlighted a lack of adequate resources at the agency. They told the GAO that "the Congress plans to work during the 101st session to ensure that the Food and Drug Administration can adequately meet the growing demand of this nation's research program." The letter was addressed to Charles Bowsher, U.S. comptroller general, at the GAO. All four senators supported a bill (S 2468), the "FDA Revitalization Act of 1988," which sought to provide for the agency's resource needs. The majority of the provisions in the original revitalization bill, introduced by Hatch, did not progress further than the Senate committee level. However, the bill's provision to establish a biotechnology demonstration project at FDA's National Center for Toxicological Research passed Congress as part of separate legislation on FDA appropriations ("The Pink Sheet" Oct. 3, p. 3). The request to GAO was applauded by a recently formed coalition of drug firms and medical professional groups called the "FDA Council," in a Nov. 2 press release. The new association includes such firms as Alza, Cambridge BioScience, Genentech, Merck, Pfizer, Sandoz, Squibb and Upjohn.