FDA to beef up monitoring of imports

By Dr. Ananya Mandal, MDJun 21 2011

As Food and Drug Administration (FDA) commissioner, Dr. Margaret A. Hamburg has been trying to correct inadequately controlled imported food and drugs overwhelming her organization’s ability to monitor them.

On Monday, the F.D.A. released a rare special report titled “Pathway to Global Product Safety and Quality” that is likely to win praise not so much for the four “building blocks” it outlines for dealing with imports but for the frank way it acknowledges the problem.

“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 the world has changed, and the necessity of how much we do business in the F.D.A. has to be dramatically transformed,” Dr. Hamburg said. “This is something that I’ve been stressing as a priority from Day 1.”

A decade ago, the FDA was responsible for policing six million shipments annually coming through 300 ports. This year, the number of shipments is expected to grow to 24 million, the report noted. Nearly two-thirds of all fruits and vegetables and three-quarters of all seafood consumed in the United States now come from outside the country. The situation with drugs and medical devices is even more daunting. More than 80 percent of the active ingredients for drugs sold in the United States are made abroad — mostly in plants in China and India that are rarely inspected by the FDA.

Government investigators estimated in 2008 that the FDA would need 13 years to check every foreign drug manufacturing plant, 27 years to check every foreign medical device plant and 1,900 years to check every foreign food plant at its rate of inspections at the time.

“While the goal may be attainable in the first year, it would be impossible for FDA to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the report notes. Many in the food industry, angered by contamination scares that have cost hundreds of millions of dollars, have volunteered to pay fees directly to the FDA to underwrite more inspections.

Consumer groups have cheered this suggestion. But some Republicans in the Senate have so far refused to consider such fees, calling them an unacceptable tax. Polls have shown overwhelming and bipartisan support among voters for strengthened federal oversight of the food system.

Carl R. Nielsen, who retired as the director of the agency’s import operations in 2005, said the plan sounded reasonable as far as it went. But before the FDA can consider communicating regularly with Brussels or Beijing, he said, it needs to start talking with its offices in Texas and California.

The FDA said it's also expanding its food-safety efforts under the FDA Food Safety Modernization Act (FSMA). There will be new inspection mandates, including one to inspect more than 19,000 foreign-food facilities by the year 2016. “FDA-regulated imports have quadrupled since 2000,” Hamburg said. “The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face.”