Defining “True and Non-Misleading” for Pharmaceutical Promotion

Food and Drug Administration, Medical Product Communications That Are Consistent With FDA-Required Labeling—Questions And Answers, January 19, 2017, available at <https://www.federalregister.gov/documents/2017/01/19/2017-01012/medical-product-communications-that-are-consistent-with-the-food-and-drug-administration-required> (last visited May 24, 2018).

Food and Drug Administration, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unap-proved Uses of Approved or Cleared Medical Products, January 19, 2017, available at <https://www.federalregister.gov/documents/2017/01/19/2017-01013/manufacturer-communications-regarding-unapproved-uses-of-approved-or-cleared-medical-products> (last visited May 24, 2018).

C. Robertson and A.S. Kesselheim , “Regulating Off-Label Promotion—A Critical Test,” New England Journal of Medicine 375, no. 24 (2016): 2313-2315, doi: 10.1056/NEJMp1611755.

S. Gottlieb , “From FDA, A Good Framework For Distributing Information on Off-Label Uses,” Health Affairs Blog, April 23, 2008, available at <http://healthaffairs.org/blog/2008/04/23/from-fda-a-good-framework-for-distributing-information-on-off-label-uses/> (last visited May 24, 2018).

S.P. Hey and A.S. Kesselheim , “An Unin-formative Truth: The Logic of Amarin’s Off-Label Promotion,” PLoS Medicine 13, no. 3 (2016):e1001978.

Amarin Pharma v US FDA, No. 1:15:cv-03588-PAE, Southern District of New York, August 7, 2016.

Robertson and Kesselheim, supra note 3.

Hey and Kesselheim, supra note 5.

Hey and Kesselheim, supra note 5.

Medical Product Communications, supra note 1.