FDA Lays Out Global Strategy to Monitor for Dangerous Foods, Drugs

BY Betty Ann Bowser  June 22, 2011 at 10:18 AM EST

Pills; Flickr user hitthatswitch
(Photo by Flickr user hitthatswitch)

In an unusual special report Monday, the Food and Drug Administration laid out a strategy it hopes will help it do a better job of policing America’s food and drug supply. Called the Pathway to Global Product Safety and Quality, the 36-page document outlines a plan to work globally to track the international movement of food and drugs.

FDA Commissioner Dr. Margaret Hamburg said the agency will form coalitions with other nations to develop a global data system and place more emphasis on risk analysis by modernizing the FDA’s computer capabilities.

“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. The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission.”

The agency report acknowledged that “the safety of America’s food and medical products remains under serious threat” and listed several recent deadly incidents including tainted pet food and the drug heparin, both made in China.

Allan Coukell, director of medical programs at the Pew Heath Group, said the report was significant “because FDA was very open about how challenging this problem is.” Coukell said that historically the agency has had the attitude “that they could handle it all by themselves.” But now “they’re saying the world has changed — it’s a global world and the status quo won’t do”.

The report said nearly two-thirds of all the fruits and vegetables and 80 percent of all the seafood consumed by Americans come from outside the United States. Half of all medical devices are imported and 80 percent of the ingredients in drugs sold here are manufactured in another country.

Most of those ingredients come from manufacturing plants in China and India, which are rarely, if ever, inspected by the FDA.

In 2008 the Government Accountability Office estimated it would take FDA 13 years to inspect every foreign drug manufacturing plant with the agency’s current resources. And although Congress passed a sweeping food safety bill last year that went into effect in January, the FDA currently faces a $265 million budget cut from Congress.

In an interview with the NewsHour, Hamburg said that “funding is a huge bullet in terms of meeting this critical issue,” but she said the key to success will be spreading the costs “by better coordinating with counterpart agencies in other parts of the world, industry partners and other common stakeholders to target our resources.”

“We have asked for additional money, but beyond that we need to focus on our partnerships to better utilize the resources we already have,” she said.

The report acknowledged the funding problems more bluntly, saying “it would be impossible for FDA” to move to a higher level of food inspections “without a substantial increase in resources or a complete overhaul in the way it operates.”

Questions have also been raised about the FDA’s ability to update its information technology systems at current funding levels. “It is one of the weaknesses of the agency,” Pew’s Coukell said, adding that the “FDA’s ability to execute its global strategy” will depend to some degree on being able to update that capability.

Dr. Hamburg has repeatedly talked about the need for improving the U.S. food and safety system since becoming commissioner two years ago, expressing alarm over the sheer quantity of food and drugs coming into the country and the FDA’s inability to monitor them.