Letter Addresses FDA ‘Timeliness’ in Draft Guidances

Four Senate GOP HELP committee members have penned a letter to FDA Commissioner Robert Califf complaining about the agency’s handling of draft guidances.

HELP Committee Chairman Lamar Alexander (R-Tenn.), along with Sens. Richard Burr (R-Va.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah) wrote last week that the agency needs to finalize, revise and withdraw draft guidances in a more timely fashion.

Because guidances can remain in draft form for years, drugmakers believe they have no choice but to treat draft guidances as if they were final, even if the most up-to-date science suggests an alternative path, the senators complained.