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US FDA inspection system outdated, slow: GAO report

Medicexchange News - Medicexchange News

The US Food and Drug Administration's system that monitors inspections of drug manufacturing plants worldwide is outdated and inaccurate, according to a government report released on Wednesday.

The FDA, which oversees products that account for roughly one-third of imports, inspects just eight per cent of facilities outside the United States each year, the Government Accountability Office (GAO) also said in a September report released by a bipartisan group of US lawmakers.

Additionally, the FDA does not know how many foreign establishments are actually subject to inspection, it added.

The report confirmed what the agency itself has acknowledged as gaps in its ability to check every company at every location.

FDA spokeswoman Heidi Rebello had no immediate comment on the report.

Concern about the FDA's oversight of foreign drug manufacturers rose earlier this year after the finding of a contaminant in some batches of the blood-thinner heparin made with raw ingredients from China. Dozens of deaths were reported.

US House of Representatives Energy and Commerce Chairman John Dingell, a Michigan Democrat who was among those requesting the report, said the findings confirm "that we have reason to be concerned about the safety of imported drugs."

Dingell has floated legislation that would dramatically reshape the FDA's inspection programs for foods and drugs. The far-reaching bill is not expected to pass this year but may gain traction next year.

Sen. Charles Grassley, an Iowa Republican who is backing similar legislation in the Senate, said he hoped the GAO's findings would spur lawmakers to act.

According to the report, it would take the FDA 13 years to inspect all foreign facilities that make products imported to the United States. US plants are checked every 2.7 years.

The agency made progress in 2007 but since 2002 has still inspected just 1,479 sites overseas, the report said.

Even when the FDA found problems, "the agency generally did not restrict importation of drugs manufactured by these establishments," GAO said. For the five years between 2002 and 2007, the agency issued just 15 warning letters to foreign manufacturing sites.

FDA's databases used to track inspections are also incomplete. The GAO said the system includes information on facilities that are not subject to inspection, among other problems.

Agency officials have said they lack enough money and staff to fully inspect all makers of FDA-regulated products more regularly. It would take about $225 million annually to check drug manufacturing sites around the world every other year, they said in May.

Inspecting food processors would cost even more.

(Reporting by Susan Heavey, editing by Gerald E. McCormick)