WASHINGTON (Reuters) - U.S. regulators inspect few foreign makers of pharmaceutical ingredients and have no accurate count of how many companies supply the American market, a watchdog arm of Congress said on Thursday.
Data from the Food and Drug Administration suggest the agency inspects only 7 percent of foreign drugmakers each year, the Government Accountability Office (GAO) told lawmakers.
The FDA lacks an accurate list of foreign sites subject to inspection because officials rely on conflicting databases, the GAO said. The agency cannot say how many of the overseas sites have never been visited, the GAO added.
Investigators uncovered similar problems when they reviewed the FDA’s oversight of foreign drug manufacturers in 1998, said Marcia Crosse, the GAO’s director of health-care issues.
“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,” Crosse told the House of Representatives Energy and Commerce subcommittee on oversight and investigations.
Foreign-made medicines are common in Americans’ medicine cabinets. More than 80 percent of active pharmaceutical ingredients now come from other countries, with more than half from India and China, lawmakers said.
The FDA is required to inspect U.S. drug plants every two years, but there is no set timeline for foreign facilities that supply drugs or their ingredients to the United States.
One agency database lists more than 3,000 foreign sites registered to market drugs in the United States in fiscal 2007, while another put the number as high as 6,800.
At the current pace, it would take the FDA 13 years to inspect each of the 3,000-plus firms once, the GAO said.
The hearing came amid concerns about unsafe goods imported from China - from seafood to pet food to toothpaste and toys.
Witnesses said the U.S. drug supply remained the safest in the world but they worried that dangerous medicines might reach consumers amid a flood of imports and lax FDA oversight.
William Hubbard, a former FDA associate commissioner, said the nation was vulnerable.
“My concern is it’s only a matter of time if we don’t fix this,” Hubbard said.
FDA Commissioner Andrew von Eschenbach said the agency was “taking an aggressive approach” to adapt to the rapid globalization of drug manufacturing. Initial steps 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,” von Eschenbach told the committee.
Bruce Downey, chief executive of generic drugmaker Barr Pharmaceuticals Inc, said 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,” said Downey, chairman of the Generic Pharmaceutical Association.
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.