“I have reviewed and questioned how the FDA handles the pre-market review and postmarket surveillance of drugs, biologics, devices and veterinary medicines to assess whether or not the agency is fulfilling its mission to protect the public health. Additionally, I have worked to give voice to the concerns of a number of rank-and-file scientists and FDA managers who share a common complaint: a deep-seated cultural divide exists within the FDA, and it has led to systemic problems that plague the agency. Together we have shed sunlight on how frequently differences of scientific opinion are quashed, the nature of the cozy relationship between the FDA and the industries it is supposed to regulate, and the failure of the agency to be adequately transparent and accountable to the public. Others also have identified serious leadership problems at the FDA. Editorial pages of publications across the nation, including a number of the most esteemed scientific journals, have recognized and expressed outrage at the FDA’s failures in recent years. The Government Accountability Office (GAO), the independent and non-partisan agency that works on behalf of Congress and the American people, has also identified serious and systemic problems at the FDA.”
Related government resources:
Databases on the FDA Website: “The search engine on the FDA Website will not find information that is in the databases that make up a large part of the site. Those databases can be accessed separately, using the links below. Following each link is a brief description of the database.”
Sabrina is the also the solo Editor/Publisher and Founder of LLRX.com® – Legal, technology and knowledge discovery resources on the “moving edge” for Librarians, Lawyers, Researchers, Academic and Public Interest Communities – launched in 1996.