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."
"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 Draft guidances state that the ‘guidance document is being distributed for comment purposes only.’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Another concern is that "these draft guidances are not being revised, finalized, or withdrawn in a timely manner," according to the letter.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care providers, consumers, and patients not only will help shed light on any unintended consequences of the agency’s draft guidance, but better inform and , ultimately, improve that guidance.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.
The senators also said they’re worried that some of the draft guidances don’t seem to take into account, or even conflict with, current scientific thinking. They want Hamburg to send them a list of all Level 1 draft guidances, their date of issue and the timeline for withdrawal, revision or finalization of each one. Alexander, Burr, Isakson and Hatch also want an update on the FDA’s implementation of the best practices recommended in a 2011 report, "Food & Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency."
They also want Hamburg to tell them whether her agency has implemented a recommendation from President Barack Obama’s Council of Advisors on Science & Technology "to rely more on the biomedical community in help [sic] developing and revising guidances." The senators asked Hamburg how she ensures that FDA staffers don’t rely on draft guidance "in the absence of any other policy or final guidance;" they also want to know the average time it took the FDA to finalize draft guidances issued over the last 5 years, according to the letter.