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Product Applications (including Investigational Applications) - Draft Proposal 9

View PDF of the Product Applications (including Investigational Applications) Section (142 KB)


Background

Summary of Public Comments

Considerations

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Draft Proposal

FDA should disclose: (1) whether an investigational new drug application (IND) has been placed on hold, terminated, or withdrawn, whether an investigational device exemption (IDE) has been terminated or withdrawn, or whether an investigational exemption for a new animal drug has been terminated and (2) if an IND has previously been placed on hold, whether and when the hold is lifted.  A statement should be included that such actions may be taken for various reasons, only some of which relate to safety or effectiveness. 

Reasoning: The public has an interest in knowing the status of clinical trials, namely whether FDA has concluded that a clinical trial should not be started, or should not be continued and when a previously stopped human clinical trial is permitted to begin again.  Although companies may disclose when a clinical hold has been “lifted” by the FDA, it is equally, if not more important, to inform the public when a clinical hold has been imposed or when FDA has decided to terminate an exemption which permits the use of unapproved new animal drugs in clinical investigations.  That way, individuals that are interested in enrolling in the clinical trial, or already are enrolled, and owners of animals that may be participating in the clinical trial are aware of FDA’s action and can take steps to limit exposure to unnecessary risks.   
Providing the status of the clinical trial does not disclose information that could be used by competitors to “free-ride” off of the sponsor’s innovative effort.  In some cases, the existence of human clinical trials is already public. 

Disclosing the status of an investigational application or exemption yields significant public benefits, mainly in the protection of human and animal subjects, while furthering the Administration’s goals of more transparent government.  All disclosures should be accompanied with a clear disclaimer about the limits of the information.


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