July 14, 2024

F.D.A. Confronts Challenge of Monitoring Imports

WASHINGTON — The Food and Drug Administration commissioner, Dr. Margaret Hamburg, has repeatedly expressed alarm about the waves of imported food and drugs overwhelming her organization’s ability to monitor them, but through the first two years of her leadership she had not provided a strategy to deal comprehensively with this problem — until now.

On Monday, the F.D.A. released a rare special report titled “Pathway to Global Product Safety and Quality” that is likely to win plaudits 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 in an interview. “This is something that I’ve been stressing as a priority from Day 1.”

A decade ago, the F.D.A. was responsible for policing 6 million separate shipments coming through 300 different ports. This year, that number is expected to grow to 24 million shipments, 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 alarming. More than 80 percent of the active ingredients for drugs sold in the United States are manufactured abroad — mostly in manufacturing plants in China and India that are rarely inspected by the F.D.A. Half of all medical devices sold in the United States are made abroad. Many kinds of antibiotics, steroids, cancer medicines and even aspirin are no longer produced in the United States, or in many cases anywhere in the Western world.

Government investigators estimated in 2008 that the Food and Drug Administration 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. And with imports growing faster than the agency’s inspection force, those numbers have only grown.

Many popular over-the-counter medicines and vitamins are made almost entirely in Chinese plants that have never been inspected by the F.D.A. Domestic suppliers often boast that they test their imported ingredients rigorously, but such sampling is akin to testing a bucket of soil from a mountain and then declaring the entire mountain free of pollutants.

And once these products reach American shores, almost nothing is done. The F.D.A. has a few hundred inspectors — not even enough for every port. The most they know about the vast majority of imports is a brief description on a computer screen. They crack open a tiny fraction of all shipments and send to the agency’s laboratories an even tinier fraction. Less than one pound in a million of imported seafood even gets a visual inspection.

Monday’s report acknowledges that “the safety of America’s food and medical products remains under serious threat,” and it lists a few recent and deadly scares: contaminated heparin from China, counterfeit glucose monitoring strips and tainted pet food from China.

The F.D.A. won new powers to police foreign foods in legislation signed by President Obama in January, but with those new powers came new responsibilities: The law directed the agency to inspect at least 600 foreign food facilities within the next year and then increase that number every year afterward. But instead of raising the agency’s budget to perform those inspections, House Republicans voted last week to cut it.

“While the goal may be attainable in the first year, it would be impossible for F.D.A. 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, have volunteered to pay fees directly to the F.D.A. to underwrite more inspections. Consumer groups have cheered this suggestion. But 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.

So in the absence of the people and money needed to perform its functions adequately today, Dr. Hamburg has proposed creating integrated “global coalitions of regulators dedicated to building and strengthening the product safety net around the world,” the report states. To support this integrated network, “F.D.A. intends to develop a global data information system” so regulators can talk to each other.

Carl R. Nielsen, who retired as the director of the Food and Drug Administration’s import operations in 2005, said the plan is acceptable. But before the F.D.A. can consider communicating regularly with Brussels or Beijing, it needs to start talking with its offices in Texas and California, he said.

“Until you repair the in-house computer system, how are you going to create an international one?” Mr. Nielsen asked.

Indeed, a computerized alert system for imports that was started at the F.D.A. in 2001 is still not complete. But Dr. Hamburg said in the interview that despite possible budget cuts and challenges domestically, the agency has no choice but to become more globally engaged. And just stepping up inspections at the border will not be enough, she said.

“It’s all very nice for people to feel that we have one of the safest food supplies in the world,” she said, repeating a phrase House Republicans used to justify cutting the agency’s budget. “But we really need to recognize that our food is increasingly coming from this complex supply chain and coming from parts of the world where there are not as robust standards and practice. And we cannot be complacent.”

Article source: http://www.nytimes.com/2011/06/21/health/policy/21food.html?partner=rss&emc=rss

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