Drug, Food Risks Stay Secret as Inquiries to U.S. FDA Pile Up

[Purveyor]

Source: Bloomberg

June 19 (Bloomberg) -- Claudia Krcmarik can't get documents about her father-in-law's death during a medical study. Meryl Nass keeps asking for records she thinks will show an anthrax vaccine is dangerous. The American Bakers Association's request for a paper on the safety of imported honey has languished.

All filed public information requests with the U.S. Food and Drug Administration at least four years ago and have yet to receive what they asked for -- even though American law says agencies must release records ``promptly.''

The FDA's 20,365 unfilled requests for information exceed the totals for the departments of Defense and Justice. One company, FOI Services Inc., accounts for 44 percent of the backlog, according to the agency. Researchers, consumer groups and individuals say the delays limit their ability to alert the public to food and drug dangers and to hold the FDA accountable.

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The FDA's oversight of food and drug safety has come under criticism by advocacy groups and lawmakers. They say the agency failed to act effectively before Vioxx, a Merck & Co. painkiller, was withdrawn in 2004 because of a link to heart attacks and strokes and didn't alert the public more recently to heart risks associated with GlaxoSmithKline Plc's diabetes drug Avandia. They also fault the FDA for failing to prevent contamination of peanut butter, spinach and pet food.



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[OneBlueSky]

1. simple solution . . . if it can't be inspected and certified as safe, it doesn't get in . . .

the effect will initially be to increase prices, but in the long run, banning a any number of currently imported products could be a shot in the arm to the U.S. manufacturing sector -- what's left of it . . .