For the second phase of FDA’s transparency initiative, the agency unveiled 21 draft guidance proposals dealing with increased public disclosure of adverse events reports, drug evaluation procedures and manufacturing inspections, among several other proposals.
Draft guidance pertaining to adverse events (AE) reporting states that AE reports should be made available “in a format that is searchable and allows users to generate summary reports,” including a drug’s “trade name, dosage, route of administration, description of the adverse event and the health outcome.”
In a New England Journal of Medicine article published yesterday, Afia Asamoah, director of the FDA transparency initiative, and Joshua Sharfstein, principal deputy commissioner and chair of the transparency task force, discussed various pieces of the initiative, adding that “Not all [of] these proposals will necessarily be implemented. Some may require changes in law or regulation, and some may require substantial amounts of resources.”
Ten of the 21 draft guidance proposals deal with drug evaluation disclosures during the drug approval, or rejection, process. Complete response letters, not approvable letters and other FDA communique should be disclosed to the public, including the underlying reasons for these letters, which could include safety concerns, according to the draft guidance.
FDA will also begin posting responses to untitled letters sent to companies that run afoul of the agency’s marketing and communications rules, if the letter’s recipient gives the okay. FDA will begin posting inspection results for specific manufacturing facilities as well, a disclosure not currently posted on its website, should the draft guidance proposals be implemented. Public comment on the proposals is open until July 20.
The transparency initiative was first announced last June, and the third phase of the project, which addresses FDA transparency toward regulated industry, will be issued in a third round of draft guidance slated for this summer, according to an FDA statement. The full document containing all phase two draft guidance can be found here, in PDF.
