The Minneapolis Star Tribune
By Michael Carome
Dr. Michael Carome, director of Public Citizen’s health research group, said the FDA should never have created the program. He said allowing summaries gave the appearance that the FDA was serving the device industry, not the public.
“It was easier for the industry to file these reports” rather than individual adverse event reports, Carome said. “But [summaries] hid information. Important safety information was not available to the public. What we need now is for the hidden information to be available and easily searchable.”