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Product Applications (including Investigational Applications) - Draft Proposal 16

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


Average Rating for this Proposal (Based on 1 Rating):  

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Draft Proposal

FDA should disclose relevant summary safety and effectiveness information from an investigational application, or from a pending marketing application, if the Agency concludes that disclosure is in the interest of the public health, which includes when FDA believes it is necessary to correct misleading information about the product that is the subject of the application.

Reasoning: Many stakeholders have an interest in whether safety and effectiveness data is made available to the public.  Sponsors and developers of that data have an interest in recouping the significant investment of resources that was required to develop the data before it becomes available to competitors.  Medical researchers have an interest in accessing this information to develop significant medical treatments more quickly.  Health care providers may use the information to inform prescribing decisions.  And investors may be better able to direct resources towards promising treatments based on an assessment of that data.

A balance must be struck between these competing interests in a manner that advances the public interest while maintaining the incentive for companies to develop new products for life-saving diseases. 

The disclosure of all data from ongoing trials or from pending marketing applications, before the company has had an opportunity to use those data to obtain approval of the product, may negatively affect product development.  Disclosure of certain information, at the wrong time, may have the unintended consequence of slowing, or even stifling, product development. 

Blanket protection of all information in pending product applications, however, has not been shown by industry to be economically necessary, in light of other legal protections provided for innovative research (e.g., patent and unfair competition laws, exclusivity periods provided innovator drugs).  Further, the impact on a company’s competitive position may cut both ways—disadvantages to one product line may be more than compensated for by the overall benefits to a company.  And there are public benefits to be gained by the disclosure of safety and effectiveness information, including in the advancement of science, protection of patients that may use these products, and the efficient use of limited resources available for research.

After considering the competing interests in disclosing safety and effectiveness information from investigational and pending applications, the Task Force proposes that limited additional disclosure is warranted.  The correct balance is to allow FDA to disclose a summary of safety and efficacy information, when it determines the information is necessary to protect the public health.  Selective publication of clinical trials results has, in the past, created a misleading picture of the safety and efficacy of a product, with negative implications for the public health.  This is particularly pronounced when the product is used off-label (i.e., for indications that have not been approved by FDA). 

A blanket policy against disclosure of summary safety and effectiveness information from an investigational application or notice, or pending marketing application does not adequately account for the public health benefits that could result from disclosure.  Further, industry has not demonstrated that blanket protection of aggregate information is warranted to maintain incentives for innovation.


Comments for this proposal 

(Total Received: 2)

Comment: From the reasoning above: "The disclosure of all data from ongoing trials or from pending marketing applications, before the company has had an opportunity to use those data to obtain approval of the product, may negatively affect product development. Disclosure of certain information, at the wrong time, may have the unintended consequence of slowing, or even stifling, product development. "
Date Submitted: 7/20/2010

Comment: We have concern over data integrity - who will verify, "disclosure safety and and effectiveness information" - we assume this will follow already established FDA processes but this should be spelled out.
Date Submitted: 7/20/2010