Senate Republicans want answers from FDA commish Hamburg on draft guidances

May 8, 2014 by Brad Perriello

A quartet of Senate Republicans want some answers from FDA commissioner Dr. Margaret Hamburg about the watchdog agency's practice of issuing draft guidance documents.

Senate Republicans want answers from FDA commish Hamburg on draft guidances

Four Republican senators are asking FDA commissioner Dr. Margaret Hamburg for some answers on the federal watchdog agency's practice of issuing draft guidances to cover medical device and drug review policies.

In the May 6 letter the legislators – Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah) – say they're concerned that the draft guidances are being used by the FDA "to make substantive policy changes."

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"Stakeholders tell us that draft guidances are increasingly becoming default FDA policy and position. Draft guidances state that the 'guidance document is being distributed for comment purposes only.' However, in the absence of finalized guidance, drafts are the only information that FDA review staff, patients, clinicians, and FDA-regulated entities have on the agency's most current thinking on important issues," the senators wrote.

Another concern is that "these draft guidances are not being revised, finalized, or withdrawn in a timely manner," according to the letter.

"We believe that public comment from FDA-regulated entities, health care providers, consumers, and patients not only will help shed light on any unintended consequences of the agency's draft guidance, but better inform and , ultimately, improve that guidance. It is integral that those improvements are reflected in updated guidance documents and the guidance is being appropriately and consistently applied by product reviewers," according to the letter.

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