From USA Today:
The FDA can't adequately inspect foreign drug manufacturers because its database is so outmoded it doesn't even know how many foreign firms are shipping drugs to the United States, according to testimony to Congress.
The FDA can't adequately inspect foreign drug manufacturers because its database is so outmoded it doesn't even know how many foreign firms are shipping drugs to the United States, according to testimony to Congress.
Marcia Crosse, director of health care at the Government Accountability Office, told a House hearing that without such basic data the FDA "cannot provide the assurance that the imported drugs are safe."
The FDA this year listed 3,249 foreign pharmaceutical manufacturers subject to its inspection — yet the agency cannot determine whether it has ever inspected 2,133 of them
A report by Congress a decade ago showed similar shortcomings, and that nothing had been done.In my view, the FDA cannot possibly hope to keep up - it is a lost cause, and a new solution needs to be found.
