Case Detail

In re: FDA “Intended Uses” Regulations
On November 24, 2015, WLF filed formal comments with the Food and Drug Administration (FDA), calling on FDA to substantially modify its proposed regulations regarding “intended uses”—i.e., the circumstances under which a drug or device manufacturer will be deemed to intend that its product be used for a specified use. The issue is of critical importance whenever an FDA-approved product is regularly prescribed for off-label uses (i.e., a use not approved by FDA). WLF argued that FDA’s proposed “intended uses” regulations do not adequately reflect recent First Amendment case law, which has significantly curtailed FDA authority to ascribe to a manufacturer an intent to engage in off-label distribution and sales based solely on truthful statements regarding its product’s qualities. WLF urged FDA to revise the regulations to reassure manufacturers of their right to speak truthfully without fear that the statements will be used to create new “intended uses” for their products.
Case Status:
Awaiting FDA response.
More Information and Downloads:
11/24/2015: Download the Comments

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