Industry Communications With Payors: US FDA Okays Info On Investigational Drugs

Industry Communications With Payors: US FDA Okays Info On Investigational Drugs

January 19, 2017, The Pink Sheet

Michael Labson is quoted by The Pink Sheet in an article regarding FDA’s draft guidance on payor communications. According to Labson, the draft guidance is consistent with changes from the 21st Century Cures Act and evolving case law on the First Amendment, and "provides additional important flexibility for manufacturers to communicate science-based information to payors." He adds that the guidance "seems to articulate a relatively broad science-based standard," noting that it appears to recognize that health care economic information could include treatment comparisons in the absence of head-to-head comparisons.