GAO: COVID-19 Complicates Already Challenged FDA Foreign Inspection Program; It Could Be 2 to 3 Years Before New Staff Are Experienced Enough To Conduct Foreign Inspection
The 10 Countries with the Most Foreign Drug Establishments Shipping to the United States as of March 2019, by Country
What GAO* Found
In December 2019, GAO found that a growing number of foreign drug manufacturing inspections conducted by the Food and Drug Administration (FDA) were in China and India (43 percent in 2018), where most establishments that manufacture drugs for the United States were located. In fiscal year 2015, FDA, for the first time, conducted more foreign inspections than domestic inspections. However, from fiscal year 2016 through 2018, both foreign and domestic inspections decreased — by about 10 percent and 13 percent, respectively. FDA officials attributed the decline, in part, to vacancies among investigators available to conduct inspections. In March 2020, FDA announced that, due to Coronavirus Disease 2019 (COVID-19), it was postponing almost all inspections of foreign manufacturing establishments. While FDA has indicated it has other tools to ensure the safety of the US drug supply, the lack of foreign inspections removes a critical source of information about the quality of drugs manufactured for the US market.
GAO also found that FDA had vacancies among each of the groups of investigators who conduct foreign inspections. FDA had 190 investigators in the United States who conduct the majority of foreign inspections, but an additional 58 positions were vacant. At the time of GAO's December 2019 testimony, FDA was in the process filling 26 of these vacancies, with 32 remaining. However, according to FDA officials, it could be 2 to 3 years before new staff are experienced enough to conduct foreign inspections. FDA also faced persistent vacancies among investigators in its foreign offices.
GAO further found in December 2019 that FDA investigators identified persistent challenges conducting foreign inspections, raising questions about the equivalence of foreign to domestic inspections. Specifically, GAO found:
- While FDA inspections performed in the United States were almost always unannounced, FDA's practice of preannouncing foreign inspections up to 12 weeks in advance may have given manufacturers the opportunity to fix problems ahead of the inspection. Investigators from FDA's China and India offices had conducted some unannounced inspections, but these staff do not perform most of the inspections in these countries (27 percent and 10 percent, respectively).
FDA Estimates of the Amount of Notice Provided to Foreign Drug Establishments Prior to Inspection, Fiscal Year 2018
Type of investigator |
Amount of notice provided |
Percentage of inspections involving this investigator type |
China office investigator |
0-5 days |
Involved in 27 percent of total number of inspections in China |
India office investigator |
0-5 days. |
Involved in 10 percent of total number of inspections in India |
U.S.-based investigator |
Generally 12 weeks |
Involved in:
|
*Overview
The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for Congress. Often called the "congressional watchdog," GAO examines how taxpayer dollars are spent and provides Congress and federal agencies with objective, reliable information to help the government save money and work more efficiently.
GAO provides Congress, the heads of executive agencies, and the public with timely, fact-based, non-partisan information that can be used to improve government and save taxpayers billions of dollars.
Our work is done at the request of congressional committees or subcommittees or is statutorily required by public laws or committee reports, per our Congressional Protocols.
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