News Tagged ‘GAO

FDA knew of tainted syringes two years before inspecting plant

The FDA received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press.

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Daschle likely to inherit agency rife with issues

President-elect Barack Obama has made no formal announcement as yet, but it appears likely that Sen. Tom Daschle will be appointed Obama’s choice for Health and Human Services secretary, according to The Federal Times.

If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from .

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FDA inspections of foreign drug facilities could take years

This year’s contaminated heparin scare that seriously harmed hundreds of Americans has taught us one thing – we need a better system of ensuring that drugs manufactured in foreign markets are safe for Americans.

The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants.

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