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Better Safeguards Needed for Imported Food, Drugs: Report

U.S. needs to bolster safety systems in developing countries, prevent fraud, Institute of Medicine says

WEDNESDAY, April 4, 2012 (HealthDay News) -- A new report urges the U.S. Food and Drug Administration (FDA) and other government agencies to play a stronger part in poor countries to ensure the safety of food and medications coming into the United States.

The report, prepared by an independent panel at the Institute of Medicine (IOM) and released Wednesday, said efforts to bolster safety systems should take three to five years.

"The recommendations in this report represent the committee's consensus on how to best bridge the gaps in food and medical product regulatory systems in low- and middle-income countries," report committee chair Jim Riviere said in an IOM statement.

A consumer advocacy group spokesman commented on the recommendations.

"Many parts of the report make good sense," said Jaydee Hanson, a senior policy analyst at the Center for Food Safety. "But having a good inspection system requires money."

And, according to Hanson, who was not involved in the report, the FDA doesn't have enough funds to institute more overseas inspections, much less expand its efforts in the United States.

"You don't have money going into the food safety system nationally or internationally," he said. "Basically, the FDA is supposed to accomplish more with the same or less money."

The need for these measures appears pressing as the United States imports more of its food and medicines than ever before and was highlighted earlier this year when a counterfeit version of the cancer drug Avastin was brought into the country.

On Wednesday, the FDA confirmed that another counterfeit version of Avastin -- containing no active ingredients -- has turned up in U.S. medical practices.

Counterfeit vials of Avastin were probably not harmful, but did not contain the active ingredient in the real drug, according to Roche, the Swiss drug maker.

Regulators in Europe said traces of salt, starch and acetone, a solvent found in paint thinner, were found in an analysis of the fake drug's contents, the Associated Press reported in February.

"More than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs come from abroad, as does 85 percent of the seafood Americans eat, according to federal estimates," the IOM statement noted.

Last year, the FDA did only 600 inspections internationally, so it is likely that things fall through the cracks, Hanson said. "If you're talking doubling that each year, with the volume of foods and drugs we import, that's not much."

The FDA-sponsored report calls for a number of changes to improve inspection of food and drugs abroad, including working with other developed countries around the world that also inspect food and drugs so efforts are not duplicated.

"These are multi-sectoral recommendations that involve action from a variety of stakeholders. We believe that the changes we suggest could greatly improve the safety of food and medical products around the world," said committee chair Riviere, director of the Center for Chemical Toxicology Research and Pharmacokinetics at the College of Veterinary Medicine at North Carolina State University in Raleigh.

The report also recommends developing low-cost technologies to prevent fraud and looking into whether the FDA pilot program, Secure Supply Chain, can be expanded. It rewards drug firms that track their products from manufacture to market by speeding entry of their products into the U.S. market.

The report also called for investing in safe food and drug programs in developing countries. Various U.S. agencies could provide technical expertise, training and tools to improve the surveillance systems in these countries, the report said, and provide this assistance directly or through international organizations such as the World Health Organization.

But, it's not as if food safety in the United States is all that good, Hanson said. "There is a need for better food safety inspection all along the way. We have folks who have not been able to get salmonella out of turkeys in the U.S.," he said.

The report said the FDA and the U.S. Department of Agriculture should provide incentives to businesses and academics to develop inexpensive technologies that can be used in developing nations to prevent and detect fraud and provide tracking and verification of products.

But, Hanson said, the government needs to be able to prosecute importers of bad food and drugs and cut off imports from countries where these problems are endemic. "One of the things that got cut from the Food Safety Modernization Act was real criminal penalties," he added.

Moreover, the FDA needs to be more transparent and post violations on the Internet, something the report doesn't call for, Hanson said.

More information

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SOURCES: Jaydee Hanson, senior policy analyst, Center for Food Safety, Washington, D.C.; February 2012, Associated Press; April 4, 2012, report, Institute of Medicine, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
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