Senators want info on FDA's use of draft guidances

Four members of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee sent a letter to FDA Commissioner Margaret Hamburg expressing concerns with the agency's use of draft guidances to "make substantive policy changes." The senators said stakeholders have said draft guidances are "increasingly becoming default FDA policy." The lawmakers expressed concern that the agency is giving equal weight to draft and final guidances, which they said undercuts the purpose of soliciting public comment. The senators also noted that draft guidances are not being revised, finalized or withdrawn in a "timely manner."

The senators asked FDA to provide a list of all issued draft guidances, including the date issued and a timeline to withdraw, revise or finalize the guidance, as well as information on the average amount of time FDA took to finalize draft guidances over the past five years. The letter does not include a timeline for FDA to respond. ...