NEWARK, N.J.– The Food and Drug Administration s system of inspecting foreign pharmaceutical companies is broken, making it impossible to ensure the growing number of drugs and drug ingredients coming from abroad are safe, witnesses told a congressional panel yesterday.
Marcia Crosse, director of public health for the Government Accountability Office, said the FDA has too few inspectors and insufficient resources and can only visit a small fraction of foreign manufacturers every year. She said the FDA does not even have reliable data on the number of foreign plants exporting drugs to the United States that should be subject to inspection.
The FDA cannot provide needed assurances that the drug supply reaching our country is appropriately safe, Crosse told the House Energy and Commerce oversight and investigations subcommittee.
Crosse said the FDA has one database indicating there were 3,000 foreign establishments registered to market drugs in the United States, while another database indicates about 6,800 foreign manufacturers actually import medicines.
She said data suggest the FDA may inspect only about 7 percent of foreign drug plants in a given year, meaning it would take the FDA 13 years to inspect each foreign establishment just once. By law, domestic plants must be inspected every two years.
FDA Commissioner Andrew von Eschenbach acknowledged the problems, asserting we must revamp our entire strategy, our entire game plan with a global approach that will include greater resources, new science, technology and cooperation with foreign governments.
But he also assured the panel there are safeguards in place to protect the public, pointing out that FDA approvals of new drugs are manufacturer-specific and include requirements regarding how and where a medicine is made.
We shouldn t leave people with the impression the drug supply is unsafe, von Eschenbach said.
Bruce Downey, chairman of Barr Pharmaceuticals, told the subcommittee there is no justification for the paucity of foreign inspections. But, he said, U.S. drug companies like his own have tight controls on their drug supplies, routinely inspecting raw material suppliers, testing the ingredients and the final products to ensure quality.
Carl Nielsen, former head of import operations for the FDA, testified the increased volume of all types of imports, including drugs, has overwhelmed the agency. And while there are too few inspections of prescription drugmakers abroad, Nielsen said, inspections of companies that make over-the-counter drugs are nonexistent.
The FDA knows very little about the conditions of most manufacturers of foreign drugs, Nielsen said.
He said the entire import program has been a stepchild at the FDA at a time of rapid globalization. Without a big investment in technology and manpower, Nielsen said, the situation will continue to deteriorate.
William Hubbard, a former FDA deputy commissioner, testified drugs coming to the U.S. are less safe at a time of decreasing protection.
He said that in China, a nation with an increasing share of drug production, it is estimated 200,000 to 300,000 deaths a year are attributed to substandard medicines.
If they can t protect their own people, we can t depend on them to protect us, Hubbard said.An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the United States are imported.