Each year, the US Food and Drug Administration (FDA) inspects “relatively few” foreign facilities producing drugs for sale in the USA, and the agency’s assessment of them is based on inaccurate data, says a damning new report from Congressional watchdog the Government Accountability Office (GAO).
Of the two databases used by the FDA to compile a list of facilities which are eligible for inspection, one estimates that about 3,000 such plants need to be inspected and the other puts the figure at 6,800, while the FDA’s own registration database contains information about facilities which are not subject to inspection, says the GAO. Moreover, although companies are required to re-register annually, the agency does not remove from its database those which fail to do so, nor does it routinely verify that a registered facility makes a drug for the US market, it adds.
During fiscal years 2002-7, the FDA inspected 1,479 foreign drug manufacturing establishments. While the GAO officials say the FDA does not know how many are subject to inspection, they estimate that it inspects around 8% of foreign facilities in a given year. “At this rate, it would take the agency more than 13 years to inspect these establishments once,” they comment, and points out that, in contrast, the FDA estimates that it inspects domestic facilities about once every 2.7 years.
Moreover, it generally inspected the overseas establishments only if they were named in an application for a new drug, says the report, which stresses: “it is important [that the FDA ensures] that foreign and domestic establishments with similar characteristics are inspected at a similar frequency.”
The GAO is also highly critical of how the agency ensures that corrective action has been taken after it has found serious deficiencies at foreign facilities, noting that inspections are “not always timely.” The report points out that while FDA identified deficiencies during most foreign inspections during 2002-7, inconsistencies in its databases make it difficult to assess how it classified the results of specific inspections.
Finally, it says, while the FDA issued 15 warning letters to foreign facilities where it found serious deficiencies in the five years, its subsequent inspection of four of the establishments cited occurred between two and five years later, and this was generally because they had been named in a new drug application. Moreover, at three out of these four, the FDA found that corrective actions had been taken but also discovered additional deficiencies.
Democratic Representative John Dingell, who chairs the House Committee on Energy and Commerce and was one of a group of legislators who asked the GAO compile its report, said its findings “confirm that that we have reason to be concerned about the safety of imported drugs. Foreign inspections are alarmingly low and I’m especially disturbed that decisions about which foreign facilities are inspected is driven by drug approval process instead of surveillance needs,” he said.
Democratic panel member Bart Stupak pointed out that Americans are increasingly relying on drugs which are made outside the USA “and often in countries that lack any semblance of suitable regulatory system.” The GAO report confirms that “the system deployed by FDA to police those facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate,” he said.
Republican panel member Joe Barton added that steps being taken by the FDA to address some of these problems, by investing in new information systems and creating field offices to increase its international presence, are helpful, but much more needs to be done. Congressional leaders are working closely together to develop legislation on the safety of imported drugs, he noted, adding: “there isn’t any daylight between Republicans and Democrats on the core issue.”
