The venerable agency inspects few foreign makers of pharmaceutical ingredients and has no accurate count of how many companies supply the American market, the GAO says. FDA data suggests the agency inspects only 7 percent of foreign drugmakers each year and lacks an accurate list of foreign sites subject to inspection because officials rely on conflicting databases. And the FDA can’t say how many overseas sites have never been visited, Reuters reports.

Investigators uncovered similar problems when they reviewed the FDA’s oversight of foreign drug manufacturers in 1998, Marcia Crosse, the GAO’s director of health-care issues, told the House Energy and Commerce subcommitte on oversight and investigations. “Until FDA responds to systemic weaknesses in the management of this important program, it cannot provide the needed assurance that the drug supply reaching our citizens is appropriately scrutinized and safe.”

More than 80 percent of active pharmaceutical ingredients now come from other countries, with more than half from India and China, lawmakers notes today. And while the FDA is required to inspect US drug plants every two years, there’s no set timeline for foreign facilities that supply drugs or their ingredients to the US. One agency database lists more than 3,000 foreign sites registered to market drugs in the US in fiscal 2007, while another put the number as high as 6,800, Reuters writes.

At the current pace, it would take the FDA 13 years to inspect each of the 3,000-plus firms once, the GAO says. The hearing came amid concerns about unsafe goods imported from China - from seafood to pet food to toothpaste and toys. Witnesses told the committee that the US drug supply remained the safest in the world, but they worried that dangerous meds might reach consumers amid a flood of imports and lax FDA oversight. “My concern is it’s only a matter of time if we don’t fix this,” says William Hubbard, a former FDA associate commissioner.

For his part, FDA commish Andy von Eschenbach insists the agency is “taking an aggressive approach” to adapt to the rapid globalization of drug manufacturing. Initial steps that he cites include improving computer systems and deploying FDA personnel to foreign locations for long-term assignments. “We agree we must revamp our entire strategy…we are doing this,” Andy told the committee.

Bruce Downey, Barr’s ceo and head of the Generic Pharmaceutical Association, says companies rigorously inspected ingredient suppliers on their own and performed extensive product testing. “I think we have a very safe system because of all the safeguards built in.”

Lawmakers will pursue legislation to give the FDA more funding for inspections and computer upgrades, said Michigan Democratic Rep. Bart Stupak, the subcommittee chairman. “I believe we have an opportunity to fix FDA’s foreign drug program before Americans are sickened or killed,” he said.