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.
``It is important information that we need to tell this story,'' said Krcmarik, of Ann Arbor, Michigan, who wants to know how her father-in-law was given an overdose in an FDA- regulated clinical trial before he died in 2002. ``That information should be available, and it should be timely. What we wanted to avoid is this happening to anyone else.''
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 They say the agency failed to act effectively before Vioxx, a Merck & Co. painkiller, was withdrawn in 2004 because of a link to heart attacks and strokes and didn't alert the public more recently to heart risks associated with GlaxoSmithKline Plc's diabetes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.