"FDA lacks clear and effective processes for making decisions about, and('Postmarket' means after a drug has been given a license and is being sold to consumers, in contrast to the process of establishing safety of the drug in order to license it, for which FDA's process is generally more standardized.)
providing management oversight of, postmarket safety issues. The process
has been limited by a lack of clarity about how decisions are made and about
organizational roles, insufficient oversight by management, and data
constraints. GAO observed that there is a lack of criteria for determining
what safety actions to take and when to take them."
The bottom line is that FDA is totally politicized, and several doctors and scientists concerned about safety have been attacked by their superiors, as well as being prevented from giving talks and publishing papers. There has been ample evidence of this in the media and medical journals over the past several years.