Senate Bill Aims to Increase Drug Import Safety

Publication: The Associated Press

Author: Matthew Perrone


05/24/2012 - U.S. regulators would inspect more drug manufacturing facilities in China, India and other foreign countries as part of legislation approved Thursday that aims to step up oversight of the nation's imported pharmaceutical supply.

The Senate bill, approved by an overwhelming 96-1 vote, addresses a number of concerns about the safety and quality of imported medicines. It also gives regulators new tools to combat drug counterfeiting and shortages.

The legislation represents a major shift in how the government oversees the pharmaceutical industry. For more than 70 years, the Food and Drug Administration has focused its inspections on U.S. factories. But over time, most companies have moved their operations overseas to take advantage of cheaper labor and materials. Between 2001 and 2008 the number of U.S. drugs made outside of the country doubled, according FDA figures. Today roughly 80 percent of the ingredients used in U.S. medicines are made overseas.

The Senate bill would do away with a requirement that FDA inspect all U.S. factories every two years, and give the agency more discretion to focus on foreign facilities. Currently, the FDA inspects the average foreign manufacturing facility just once every nine years. Under the bill, FDA inspectors would be instructed to target the most problematic manufacturing sites, regardless of location.

"This puts domestic and international facilities on an even playing field for the first time," said Allen Coukell of the Pew Charitable Trusts, which has advocated for increased drug safety. "It says to FDA, 'you should inspect the highest risk facilities first, no matter where they are in the world."

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Read the full Associated Press article, Senate Bill Aims to Increase Drug Import Safety, on the Boston Globe's website.

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