The Food and Drug Administration (FDA) today began a public comment period for 21 transparency proposals the agency is considering. The proposals are part of a larger report the FDA issued on Wednesday. From the FDA:

If the proposals were to be adopted and implemented, the FDA would make substantially more information about the regulatory process available to the public. The agency would disclose, among other things, when a drug or device is being studied and for what indication, when an application for a new drug or device has been submitted or withdrawn by the sponsor, whether there was a significant safety concern associated with the drug or device that caused the sponsor to withdraw an application, and why the agency did not approve an application. 

Currently, this type of information is not usually disclosed.

The proposals are a part of FDA’s Transparency Initiative, which commissioner Margaret Hamburg launched in June 2009 to find ways to provide the public with more information about the agency’s activities. The initiative is consistent with President Obama’s pledges to improve government transparency, FDA says.

The proposals were in part generated during an open process that included a public comment period and two public meetings. FDA received more than 1,500 comments, according to the report.

OMB Watch’s comments addressed several regulatory issues. We urged FDA to expand and improve its online rulemaking docket, provide more details on its budget and staffing, and disclose more information on product approvals and disapprovals (some of which could be addressed, as mentioned above). The comments also listed several enforcement metrics the public could use to better assess FDA’s regulatory performance.

I am encouraged to see that some of OMB Watch’s comments (which surely overlapped with the comments of others) were taken to heart. For example, under one proposal, FDA would disclose its final safety determination on all the facilities it inspects. In the current regulatory environment, where disasters like the BP oil spill and WV mine explosion have been linked to inspection and enforcement failures, this is no small issue, and I applaud FDA for handling it.

Another proposal would expand the amount of information FDA includes in its online rulemaking docket to include all public comments. This is another good step, though it does not go quite as far as OMB Watch recommended.

FDA will use the ensuing public comment period to determine how to triage its 21 proposals. The agency may not implement all the reforms, the report says. The comment period for the proposals is open until July 20.