Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “Stakeholders Float Ways to Speed FDA Development of Final Guidance,” by Erin Durkin.
Following is an excerpt:
Bradley Thompson, an attorney at Epstein Becker & Green, said that FDA allegedly uses guidance documents as a less onerous form of rulemaking, and knowledge transfer, but he says the agency “is failing in both cases.”
“It has gotten so complicated and bureaucratic and constipated that it takes years to write a draft guidance, a draft that lacks public input and that frankly never gets substantially revised if it ever gets finalized,” said Thompson. “Further, these guidances ossify—stagnating because the process of updating them is so burdensome and time-consuming. Basically the flow of information—both high-level important policy and low-level but still important data points—has slowed to a trickle.”
He further states that FDA is putting stakeholders in a position where if they want more guidance in an area, they have to accept that more guidance will likely not be finalized, adding that in order for the agency to do more would require FDA getting more resources.
Thompson described a legislative solution that leverages digital tools, such as: help pages, frequently asked questions, searchable knowledge bases and community forums, along with live chat and phone support.