Consumer Law

Scientists at FDA's Medical Device Center Claim Agency is Mismanaged and Bends to Manufacturers' Demands

By Brian Wolfman

CNN is reporting that nine scientists at the Food and Drug Administration's Center for Devices and Radiological Health have written a six-page letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk." Among the charges are that scientists have been threatened and told, on occasion, to ignore FDA regulations, that FDA managers have ignored serious safety and effectiveness concerns, and that FDA experts have been excluded from product meetings because manufacturers felt that they were "biased." An AP story provides additional details.

Full post as published by CL&P Blog on January 11, 2009 (boomark / email).