112. FDA Requirements for Labeling and Promotion of Investigational New Drugs (§312.6, 312.7)

FDA Requirements for Labeling Investigational New Drugs

University and affiliate investigators are responsible for verifying that the following FDA requirements for labeling of investigational new drugs are met:

·        The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug--Limited by Federal (or United States) law to investigational use."

·        The label or labeling of an investigational new drug shall not bear any statement that is false or misleading and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.

NOTE: The appropriate FDA Center Director (per §201.26 or §610.68), may grant an exception or alternative to the provision requiring the cautionary label noted above, unless said labeling is explicitly required by statute. University and affiliate requesting an exception for the FDA cautionary labeling requirement must provide the IRB with written documentation from the FDA Center Director.

FDA Prohibitions Against the Promotion of Investigational New Drugs

Sponsors, investigators, and any persons acting on their behalf shall not imply or state that an investigational new drug is safe or effective for the purposes for which it is under investigation, or otherwise promote the drug. The purpose of the FDA prohibition against promotion of an investigational new drug is to

·        restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and

·        preclude commercialization of the drug before it is approved for commercial distribution.

University and affiliate investigators are advised review recruitment materials, consent documents materials, and other information for participants to verify compliance with these prohibitions.

NOTE: These prohibitions do not limit the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.

Additional Prohibitions for Investigational Drugs

·        A sponsor or investigator shall not commercially distribute or test market an investigational new drug.

·        A sponsor shall not unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.

Take the next step...