Page 173 - CW E-Magazine (31-12-2024)

Special Report

the general pool. Officials told GAO
Investigator positions that new investigators typically need
250
two to three years of experience before
they can conduct foreign inspections in-
200
dependently, and they must have expe-
rience conducting foreign inspections
150
before they are qualifi ed for a position
100 in the foreign cadre or for an assign-
ment as a foreign offi ce investigator. As
50 of June 2024, 36% of investigators in
the general pool did not have the neces-
0 sary experience to conduct independent PRODUCT RANGE
Nov. 2021 2022 2023 2024 (partial) Nov. 2021 2022 2023 2024 (partial) Nov. 2021 2022 2023 2024 (partial)
Domestic-based General Pool Dedicated Foreign Drug Cadre Foreign Offi ce Investigators* foreign inspections. Offi cials told GAO
Fiscal year that the limited pool of qualifi ed investi-
Vacant gators was one of the top challenges in
Filled
recruiting investigators to fi ll foreign
offi ce investigator positions.
Fig 3: FDA Drug Investigator Vacancies, November 2021 – June 2024
Source: GAO analysis of Food and Drug Administration (FDA) workforce data. / GAO-25-106775
Investigator attrition has reduced
total number of positions in the cadre attrition, according to the GAO analysis. the total number of inspections FDA
because of funding received to conduct According to FDA data, from the start can conduct, according to the GAO
inspections under the unannounced in- of fi scal year 2022 to June 2024, FDA’s analysis. Having a less-experienced
spections pilot, which were expected to Offi ce of Regulatory Affairs (ORA) hired investigator workforce has also reduced
largely be conducted by cadre investi- 105 new investigators into the general inspection capacity. In its analysis,
gators, according to the GAO analysis. pool of approximately 230 authorized GAO said that FDA offi cials noted that
investigators and lost 105. Of these 105 newly hired investigators do not have
Foreign offi ce investigators drug investigator losses, 61% left for the same capacity to complete inspec-
Vacancies increased among foreign other FDA positions, including other tions as experienced investigators. In
offi ce investigators, particularly in China, positions in ORA; 29% left FDA; and addition, experienced investigators are
according to GAO’s analysis. FDA data 10% retired. The turnover rate for ORA less effi cient in completing inspections
show that, in November 2021, there investigators in the general pool was because they are training newer staff.
was one vacancy among six positions in more than twice as high as the ORA- According to GAO’s review of FDA
India and four vacancies among nine wide turnover rate in fi scal years 2022 data and information, about 63% of
positions in China. As of June 2024, four and 2023. As of June 2024, hiring for current investigators were hired with-
of seven positions in India were vacant fi scal year 2024 has been greater than in the last fi ve years, as of May 2024.
and seven of nine positions in China. attrition, according to the GAO analysis. GAO noted that in its analysis, offi cials
stated that, even if the total number of
Investigator attrition and impact on High rates of attrition in the general drug investigators currently on board
inspections pool of investigators limit FDA’s ability was similar to past years, it is a large
FDA has continued to recruit and to fi ll positions in the foreign cadre and challenge to maintain a similar number
hire investigators, but vacancies per- the foreign offi ces, which are fi lled by of inspections to previous years with
sist due to challenges with investigator more experienced investigators from so many new investigators.
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