The report contains draft proposals for 21 specific actions aimed at providing clinicians, healthcare-product manufacturers and the public with better insight into the FDA's decision-making process, according to an executive summary issued by the transparency task force. In a letter explaining the recommendations, task force chairman and FDA Principal Deputy Commissioner Joshua Sharfstein said the draft proposals would better explain FDA decisions, provide more data to doctors and patients, and illuminate enforcement efforts.
Among the task force's proposals are recommendations for the FDA to provide an explanation for denying approval of a medical product; release summaries of safety and efficacy data submitted in product-approval applications; and post the classification of enforcement inspections.
The draft proposals, which would go into effect later this year, are open for public comment until July 20. FDA officials expect to launch the third and final phase of the transparency initiative this summer.
The first phase involved the creation of FDA Basics, and the third phase involves recommending ways the agency can make its processes more transparent to industry.