"This report in large part is meant to frame the issue so that all of our colleagues inside the F.D.A. and external to the F.D.A. really understand how much how much the world has changed, and the necessity of how much we do business in the F.D.A. has to dramatically transformed," Dr. Margaret A. Hamburg, the F.D.A. commissioner, said in an interview with the New York Times. "This is something I've stressed as a priority from Day 1."
10 years ago, the F.D.A. dealt with six million shipments annually arriving in the United States through 300 ports. This year, the number is expected to grow to 24 million, according to the report. Nearly two-third of a ll fruits and vegetables and three-quarters of all seafood consumed in the U.S. comes from outside the country.
On the medical front, the situation is even more daunting: over 80 percent of the active ingredients for drugs sold in the U.S. are made abroad, largely in manufacturing plants in China and India that rarely see U.S. inspectors.
In 2008, government investigators estimated that the F.D.A. would need 13 years to check every foreign drugmaker's plant, 27 years to check every foreign medical device plant and 1,900 years to check every foreign food plant at its current rate of inspections.
