Nathan Brown Quoted in Medtech Insight on FDA’s Rulemaking Authority on the VALID Act
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Medtech Insight has quoted Akin Gump health care and life sciences partner Nathan Brown in the article “Diagnostics Have Evolved, So Too Has the VALID Act, Says FDA's Hillebrenner.”
Brown, who leads the FDA practice at Akin Gump, moderated a panel titled “Diagnostics Reform at a Crossroads: Navigating Through a Pivotal Time” at the MedTech Conference earlier this week in Boston, to speak on navigating diagnostics reform.
The panel discussed the VALID [Verifying Accurate Leading-edge IVCT Development] Act regulating in vitro clinical tests, potential regulatory reforms and developments relating to point of care testing and collection models, personalized medicine, testing for public health emergencies, test validation methods and what the new MDUFA user fee agreement mean for IVDs.
Brown commented on remarks by FDA Commissioner Robert Califf that the FDA might resort to its rulemaking authority if Congress fails to pass the diagnostic reforms laid out in VALID. The article states that Brown said that these remarks were open to interpretation and more along the lines of what the agency “could do, not what it planned on doing.”
