The US Food and Drug Administration has released a list of proposals designed to promote more openness, which includes making public the reasons why products are rejected and details about facility inspections.

The FDA’s Transparency Task Force has put out 21 draft proposals for public comment “aimed at helping consumers, stakeholders and others understand how the agency operates and makes decisions”. The proposals are the second part of a three-phase initiative and come after two public meetings and more than 1,500 comments were received.

The main suggestions include giving more information about adverse event reports, as well as when files are submitted for marketing authorisation, withdrawn or denied approval. This would include the release of complete response letters sent to drugmakers explaining why treatments have been rejected.

At present, those letters are now secret, and most companies only summarise their content while the FDA very rarely comments at all on products before approval. Joshua Sharfstein, FDA principal deputy commissioner and chair of the task force said that “our goal is to facilitate transparency that promotes public health and innovation”.

However, he added that these proposals “reflect a careful balancing of the importance of transparency with the importance of protecting trade secrets and confidentiality.” Those concerns were echoed by the Pharmaceutical Research and Manufacturers of America, which said that “any proposal to disclose information about medicines during the FDA review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health”.

The public will have 60 days to comment and the FDA will then look at the feasibility of implementing the proposals.