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First Amendment, FDA, food and drug, commercial speech, off-label, enduring materials


Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think that such materials deserve a very high level of protection; 3) FDA restrictions on enduring materials are liable to be both constitutionally suspect and futile; and 4) FDA ought, therefore, to repudiate its prior restrictions on the dissemination of enduring materials.

Publication Citation

58 Food and Drug Law Journal 463 (2003).


Food and Drug Law