WASHINGTON Nov 1 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
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 BRL.N, 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
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.