The FDA is further delaying the effective date of the final rule regarding amendments to the intended use regulation that was published on January 9, 2017. The final rule creates a new “totality of evidence” standard that blocks the exchange of all scientific communication that is not included in the approval of the intended use of a medical product. Although the FDA has issued draft guidance documents to address off-label communication, the new intended use rule would supersede any of these statements. Stakeholders submitted petitions raising questions about the amendments to the regulations regarding “intended uses” and requests that the FDA reconsider these amendments.
ASCRS opposes the FDA’s final rule amendments to the intended use regulation, as the language “totality of evidence” creates a new standard that would severely restrict the communication of scientifically valid information and negatively impact patient outcomes. ASCRS plans to submit comments.