Better Safeguards Needed for Imported Food, Drugs:
WEDNESDAY, April 4 (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
"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
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,
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