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Product Applications (including Investigational Applications) - Draft Proposal 11

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

FDA should disclose that an unapproved NDA, ANDA, NADA, ANADA, BLA, or PMA, or uncleared 510(k) has been withdrawn or, if FDA determines that the application was abandoned, abandoned by the sponsor.  If the drug, biological product, or device is associated with a significant safety concern, FDA should provide a brief description of the product, the use for which approval was sought or obtained, and the identified safety concern. 

Reasoning: Information in a withdrawn or abandoned application may still have competitive value to the sponsor.  But the European Medicines Agency (EMA) currently discloses that a marketing authorization application (i.e., marketing application) has been withdrawn and information about its evaluation of the product at issue.  Given the global nature of the pharmaceutical and medical device industries, we believe that most of the industries regulated by FDA are subject to the EMA’s disclosure policy.  As a result, there are situations where competitive harm can be mitigated to the point it is not significant, while providing the public with important information FDA knows and believes can help promote and protect public health.

There are significant interests that favor disclosing the fact that a pending application has been voluntarily withdrawn or abandoned by the sponsor.  Disclosure of the fact that an application has been voluntarily withdrawn or abandoned by the sponsor allows interested individuals and the investor community to provide funding or to seek other opportunities that will allow for continued development of the product, if that community believes the treatment is worthwhile.  Additionally, if the public is aware that an application has been submitted to FDA (as disclosed by the company and/or FDA), disclosure of when the application was withdrawn is likely equally important to patients who may be awaiting new treatments for their diseases. 

Further, it is important for FDA to inform the public when it is aware that an application has been withdrawn or abandoned by the sponsor due to a significant safety concern.  Under current law, FDA has authority to withdraw approval of an application in certain circumstances.  In those cases, FDA can disclose when approval has been withdrawn, and in the case of NDAs and ANDAs, FDA can explain to the public if the drug was withdrawn due to a safety concern, or was shown not to be effective for its intended use.  FDA also makes available a detailed summary of information about the safety and effectiveness of the device that is the subject of a PMA withdrawn by FDA.

But when a sponsor withdraws or abandons an application before approval (in other words, requests that FDA stop its review of the application) for a safety or efficacy reason, that information is not conveyed to the public.  Disclosure of when an application is withdrawn or abandoned by the sponsor for a significant safety reason may allow researchers studying the same molecule or device, or a closely related molecule or device, to use that information to protect patients from the identified and potential risks.  If the information concerns an unapproved (off-label) use of a marketed product, health care professionals and patients would have access to information that could influence decisions about whether to use the products for that off-label use, if such use is not otherwise prohibited. 

The right balance is to allow FDA to disclose when a marketing application has been withdrawn or abandoned by the sponsor and to allow FDA to communicate additional information about the application when there is a significant safety concern.  Continuing FDA’s current practice of not disclosing the fact that an application has been withdrawn or abandoned by the sponsor means that information that is prohibited from disclosure in the United States is disclosed in Europe.  This disparate treatment is not merited, given the global nature of the regulated industry, and does not further the Administration’s goal for more open government.


No Comments for this proposal were submitted