WASHINGTON — The nation’s top drug regulator proposed Wednesday to disclose more information about safety problems with the medicines and devices it rejects.
The effort is part of a broader plan to remake the image of the Food and Drug Administration, which has come under fire for being too secretive.
An agency task force is suggesting 21 ways the FDA could release more information to the public in areas such as drug evaluation and in food-manufacturing inspections, another area in which it has oversight responsibility.
Agency leaders stressed that the FDA is merely considering the changes and that some would require legal changes by Congress to implement.
The FDA has long operated under strict confidentiality rules because its scientists handle reams of proprietary information from food, drug and device companies. But that operating style has come under fire in recent years from critics who have charged that the agency is too slow to disclose drug-safety issues.
The changes suggested in the 67-page report would mark an about-face from current policies that allow manufacturers to control most public information about products in development.
Deputy Commissioner Joshua Sharfstein said greater transparency would benefit consumers and companies, who will be able to learn from the success and failures of competitors.
