A U.S. Food and Drug Administration Task Force has issued a draft report that calls on the agency to better explain why it declines to approve drugs by making its so-called complete response letters to companies seeking approval for new products public. That is among 21 proposed measures aimed at helping the agency do a better job of communicating to the public and industry about how it operates and makes decisions.

“Our goal is to facilitate transparency that promotes public health and innovation,” says Joshua Sharfstein, FDA principal deputy commissioner and chair of the Transparency Task Force. “These proposals reflect a careful balancing of the importance of transparency with the importance of protecting trade secrets and confidentiality.”

The FDA formed the task force in June 2009 in response to the Obama Administration’s efforts to achieve openness in government. The agency says the proposals reflect the review of more than 1,500 public comments received by the FDA after two public meetings held by the task force and extensive consideration and discussion within the agency.

The recommendations are intended to make available useful and understandable information about FDA activities and decision-making in a timely manner and in a user-friendly format, the agency says, while appropriately protecting confidential information. They cover a broad range of areas including adverse event reports, enforcement actions, recalls, and warnings, but focus on company information. Some think it falls short because it makes industry more transparent, but not necessarily the agency itself. The task force is made up of the FDA’s Sharfstein and five of the Agency’s center directors, the chief counsel, the associate commissioner for regulatory affairs, and the chief scientist.

“Transparency is a good thing, but it should mean more than the FDA asking industry to be transparent,” says Peter J. Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA. “They should include representatives from industry and from patient groups and make the process itself more transparent.”

The FDA is accepting comments on the draft report until July 20. The report can be downloaded here.