Medtech Insight Quotes Nathan Brown on FDA Facility Inspections
Medtech Insight has quoted Akin Gump health partner Nathan Brown in the article “US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say,” discussing the new FDA Reauthorization Act (FDARA). Signed by President Trump last month, the article notes that the law aims to smooth out the FDA inspection process of U.S. medical device manufacturers, including putting a stop to arbitrary audits.
One section of the law, discussed by Brown and fellow partner Howard Sklamberg in an earlier article they wrote for the publication, would permit manufacturers to request informal feedback on proposed corrective actions to address deficiencies found by investigators. Brown said the feedback requirement is a win for device makers, since there can be situations “in which a company very much wants to address an observation as quickly as possible, but may not be confident that whatever changes they invest in will be ones that FDA subsequently agrees were what the agency was looking for.” It’s important, he pointed out, for companies to get that quick feedback so they can save time and money.
Brown added there may also be a situation in which an observation raises “new issues or may implicate a scope of changes that are time-consuming and costly to undertake, and may involve making systemic changes that cross different plants.” Before proceeding, he said he thinks some companies might prefer “some opportunity for informal dialogue with FDA that they’re on the right track … to know that what they’re proposing to do has a high degree of likelihood of addressing the concern that FDA had.”
Finally, Brown said that as device-specific inspections teams are developed over time, more meaningful dialogue about inspections will be possible. As a result, the FDA will be “better positioned to provide feedback to establishments that are working to respond effectively to inspections observations.” In the end, he added, this will allow “for quicker and more consistent resolution of challenging issues.”