January 30, 2017 - The article, "FDA Memo Does Not Simplify 1st Amendment Considerations" was published in Law360.

On Jan. 18, 2017, just two days before a new administration was set to take over, the U.S. Food and Drug Administration issued a memorandum purporting to address First Amendment and other considerations as part of its reexamination of FDA rules and policies relating to company communications of truthful nonmisleading information regarding unapproved uses of approved/cleared drugs and medical devices.[1] Those hoping the FDA might acknowledge directly that the sharing of such information constitutes protected free speech under the First Amendment, or less drastically, at least might simplify the universe of FDA guidances and good practice documents addressing its positions on the issue, will be disappointed. The FDA memorandum does little more than set out information about its positions that was already available in the public domain — including the FDA’s position that it is not constrained by the First Amendment to penalize only company communications promoting unapproved uses of approved/cleared drugs and medical devices that are false and misleading.

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