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Drug imports must meet standards, White House says
March 10, 2009 / 6:04 PM / 9 years ago

Drug imports must meet standards, White House says

WASHINGTON (Reuters) - Cheap drugs imported into the United States to bring costs down must meet Food and Drug Administration safety and efficacy standards, White House budget director Peter Orszag said on Tuesday.

President Barack Obama’s administration is pressing for Congress to allow people to buy inexpensive drugs from other countries to try and lower healthcare costs, but drug makers complain this could leave the country open to substandard products.

At a hearing of the Senate Finance Committee, Kansas Republican Pat Roberts asked whether the White House supported first installing some controls.

“Would you agree that, before we move forward with any proposal to allow Americans to buy drugs from other countries, we certainly also must demonstrate that we can do so safely without increasing the chances that Americans may get a contaminated or potentially dangerous or counterfeit medication?” Roberts asked Orszag.

“Would you also agree that, if such a proposal were to move forward, we should demand that any drug imported into the U.S. meet the same high safety and efficacy standards of our FDA including bioequivalency standards?” he continued.

“Yes,” Orszag answered simply.

The FDA started last year setting up inspection offices in other countries, including China, so that food and drug products could be checked before they ever enter the United States.

Concern about the FDA’s oversight of foreign drug manufacturers rose last year after contaminated batches of the blood-thinner heparin made with raw ingredients from China killed more than a dozen people. It prompted a recall by Baxter International Inc..

Reporting by Maggie Fox; Editing by Cynthia Osterman

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