Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Industry Protests FDA Plan to Clear Guidance Backlog by Skipping Comments,” by Jessica Karins. (Read the full version – subscription required.)
Following is an excerpt:
Key industry groups are objecting to FDA’s plan to tackle its decades-old backlog of draft guidance documents by sometimes skipping opportunities for public comment, and they offer a number of other ways the agency could overhaul its guidance procedures. While it made sense to sidestep public comments to expedite guidance during the COVID-19 pandemic, industry says, the practice shouldn’t carry over post-pandemic. Instead, stakeholders say the agency should overhaul its guidance practices by having the commissioner address intra-agency differences that ...
Bradley Merrill Thompson, an attorney at the law firm Epstein Becker Green who has been a longtime advocate for good guidance practices, told Inside Health Policy he was skeptical the policies would bring about the necessary change. Thompson also published a blog post analyzing FDA’s practices in finalizing guidance documents, noting that there is wide variability among the agency’s centers in how long guidances take to finalize.
Related reading: Health Law Advisor, “Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents,” by Bradley Merrill Thompson.
