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U.S. lawmaker questions FDA, cites industry tiesThe head of the U.S. House of Representatives Oversight and Government Reform Committee questioned how the FDA set its priorities given recent controversies over its handling of safety issues, including tracking tainted foods and inspecting drug manufacturers.
A 2007 FDA list of top projects includes plans to offer advice to companies on promoting products, as well as guidance on offering reprints of journal articles to physicians, California Democrat Henry Waxman said in a letter to FDA Commissioner Andrew von Eschenbach.
The agency also planned to change its regulations to protect device makers from lawsuits as long as their products are FDA-approved.
"All appear to prioritize industry desires over consumer protection," Waxman wrote. The initiatives also appear to have bypassed normal regulatory channels so they could be implemented sooner.
The FDA has come under fire in recent years following a string of highly-publicized safety scares, starting with the 2004 withdrawal of Merck & Co Inc's painkiller Vioxx after it was linked to heart problems.
The risk of suicide with antidepressants and other drugs, as well as tainted batches of blood-thinner heparin and bacteria-laced produce such as spinach and hot peppers have also fueled concerns.
In Waxman's letter, he said a June 15, 2007 e-mail from then FDA Chief Counsel Sheldon Bradshaw showed Bradshaw planned to forward a list of agency priorities to the deputy secretary at the U.S. Department of Health and Human Services.
