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Product Applications (including Investigational Applications) - Draft Proposal 12

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


Background

Summary of Public Comments

Considerations

View All Product Applications (including Investigational Applications) Draft Proposals

View Comments for this Proposal


Draft Proposal

When an application for a designated orphan drug or a designated minor use/minor species animal drug has been withdrawn, terminated, or abandoned, FDA should disclose, if it determines, based on its review, that the application was not withdrawn, terminated, or abandoned for safety reasons and the product, if approved, could represent a significant therapeutic advance for a rare disease or for a minor animal species.  A disclaimer that provides that FDA’s expressed views about the product do not reflect whether a subsequent application involving the product will be accepted for filing or will be approved by FDA should accompany the disclosure of this information.

Reasoning: Applications for products for rare diseases and minor animal species are sometimes abandoned before approval, solely for business reasons.  In those circumstances, disclosure of FDA’s view that a certain product may represent a significant therapeutic advance for a rare disease or for a small population of animals may foster development of promising products for that disease.  Disclosure of FDA’s view that a product holds promise may provide encouragement to the private sector to continue development of a promising product.  Disclosure may also allow the community affected by this disease to seek funding, or other opportunities that will allow for continued development of the product. 

Disclosure of FDA’s views about the product does not equate to disclosure of the information in the actual application.  FDA’s announcement should not negatively impact companies planning to continue development of the product once it is economically feasible to do so.  Indeed, FDA’s announcement may help such companies obtain funding to continue development of the product, or may support efforts to find another company that is interested in doing so.

FDA should disclose its determination that a certain product may represent a significant therapeutic advance for a rare disease or a minor animal species if the application is withdrawn, terminated, or abandoned for other than a safety reason.  Any such announcement by FDA must make clear that the Agency’s view about the product is no indication that a subsequent marketing application submitted to FDA would be accepted for filing or approved by FDA.


No Comments for this proposal were submitted