The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance documents, which were originally promised by the FDA in 2010, represent its latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media.

Background -

Drug and device labelling and promotion are highly regulated activities, subject to onerous approval requirements enforced by the FDA under the Federal Food, Drug and Cosmetic Act . Under the act, 'labelling' includes "all labels and other written, printed, or graphic matter" that "accompany" a drug or device. This definition has been broadly interpreted by the courts to include materials that supplement or explain a drug or device, even when there is no physical attachment to the drug.

Originally published in International Law Office on July 17, 2014.