FDA plan aims to increase import safety

Jun 20, 2011 By MATTHEW PERRONE , AP Health Writer

(AP) -- U.S. food and drug regulators would share more information with their foreign counterparts as part of a multifaceted strategy to police the safety of millions of imported goods.

A report issued Monday lays out plans to deal with a flood of imports to the U.S., which have quadrupled over the past decade.

The FDA's plan recycles ideas that have been circulated by FDA officials for more than a decade: computerize systems for tracking imports and collaborate more closely with regulators in developing countries.

The FDA report paints a daunting picture for regulators tasked with assuring the safety of most foods, drugs, cosmetics and medical devices sold in the U.S. Nearly two-thirds of all consumed in the U.S. are imports, while 80 percent of pharmaceuticals ingredients are imported from abroad.

"The shift in global product flows will make it difficult to identify the `source' of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities," states the report.

The FDA has taken steps to increase foreign inspections in recent years. The agency opened its first inspection offices in China and India in 2008 and 2009. That initiative followed dozens of deaths and hundreds of in the U.S. to the blood thinner - which was primarily made from an ingredient made at a Chinese facility.

The FDA points out that it increased inspections of foreign drug-manufacturing sites by 27 percent between 2007 and 2009. But a 2010 report found that the agency is still inspecting less than 11 percent of the plants on its own list of high-priority sites.

Explore further: FDA approves Eli Lilly's injectable diabetes drug

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Safety concerns about adulterated drug ingredients

May 17, 2011

Government regulators and pharmaceutical companies are moving to address a major new risk for the global supply of medicines: The possibility that unsafe ingredients are entering the supply chain as pharmaceutical companies ...

FDA tells doctors new heparin formula less potent

Oct 01, 2009

(AP) -- The Food and Drug Administration is alerting doctors that a widely used blood thinner has been reformulated to improve its safety, though the change could open the door to dosing errors.

US FDA head says China improving food, drug safety

Aug 13, 2010

(AP) -- The head of the U.S. Food and Drug Administration says China is improving its oversight of its exporters following a slew of scandals over bogus or substandard drugs and foods ranging from vaccines ...

FDA should adopt risk-based approach to food safety: report

Jun 08, 2010

The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal ...

New concerns raised about tuna imports

Jul 12, 2006

A U.S. study released this week is raising new concerns about the safety of imported, canned tuna -- the most popular fish in the United States.

Recommended for you

Flu vaccine for expectant moms a top priority

17 hours ago

Only about half of all pregnant women in the U.S. get a flu shot each season, leaving thousands of moms-to-be and their babies at increased risk of serious illness.

Experts want restrictions on testosterone drug use (Update)

Sep 17, 2014

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans ...

User comments : 0