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Product Applications (including Investigational Applications) - Considerations

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


Summary of Public Comments

Transparency Report Arrow Considerations

View All Product Applications (including Investigational Applications) Draft Proposals  


The Task Force considered rationales articulated by FDA in the past about current Agency policies regarding disclosure of information about pending applications.  We took into account the principles underlying FDA’s product-specific disclosure regulations, 21 C.F.R. Part 20, and the statements of former FDA personnel, including former Commissioner Donald Kennedy and former Chief Counsel Peter Barton Hutt.

The Task Force considered whether the FDA’s current disclosure policy allows the public to understand the rationale behind FDA’s decisions about the approval of medical products.  In addition, the Task Force considered whether the FDA’s current disclosure policy provided all segments of industry, not just an individual product sponsor, with sufficient information about FDA’s application review process and expectations for product approval.
The Task Force considered whether additional disclosure would promote Agency accountability for its regulatory decisions. 

The Task Force took into account whether greater public scrutiny of medical product approval decisions would increase the credibility of those decisions.  Additional disclosure of information will allow others the ability to independently assess information about a medical product and may allow for new perspectives about the safety and efficacy of medical products. 

The Task Force considered whether additional disclosure about medical product applications may advance scientific knowledge about medical products and lead to potential treatments for more diseases.  The Task Force took into account the interest clinical trial participants have in not being exposed to unnecessary risks and the interest they may have in ensuring that the results of those clinical trials are available to advance science and help other patients.  The Task Force recognizes that additional disclosure of clinical data may prevent the unnecessary duplication of clinical trials and improve the design of future clinical trials.
The Task Force considered the public interest in finding out information about the progress of treatments for diseases. 

The Task Force took into account FDA’s experience with patients, family members, and patient groups that are awaiting the approval of a particular treatment.  Individuals are often frustrated when they do not receive information about the status of an application, particularly one that has been withdrawn.  

The Task Force considered the amount of information related to marketing applications that is available in the public domain, including the information that is proactively released by companies and the recent requirement for manufacturers to post information about clinical trials and the results of those trials.

The Task Force considered the potential impact of disclosure on incentives for innovation.  The Task Force considered how the disclosure of certain information from pending applications would give competitors a significant competitive advantage. 

The Task Force considered the different development models for FDA-regulated medical products and the potential impact disclosure may have in those markets.  The Task Force took into account industry’s comments that additional disclosure may decrease the investment in product development.  The Task Force also took into account comments by the investor community that information from FDA about its views about the strength of an application during the review process will better direct resources and may stimulate investment. 

The Task Force took into account the disclosure policies of other federal agencies, such as the National Institutes for Health, as well as foreign regulators, since many FDA-regulated companies operate in countries other than the United States.  The Task Force considered other protections that may be available to protect a company’s proprietary information.

The Task Force recognizes that a balance needs to be struck between the benefits of additional disclosure and the impact on product innovation.