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Michael Labson is quoted by The Pink Sheet in an article regarding FDA’s draft guidance on payor communications. According to Labson, the draft guidance is consistent with changes from the 21st Century Cures Act and evolving case law on the First Amendment, and "provides additional important flexibility for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 ...

November 11, 2016, FDA Week

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America where he laid out a stepwise approach PhRMA believes FDA should take regarding off-label communication, and is quoted in an FDA Week article. According to Labson, FDA should create three safe harbors for different types of communication: first, ...

November 4, 2016, FDA Week

Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...