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Product Applications (Including Investigational Applications) - Draft Proposal 10

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 3 Ratings):

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Draft Proposal

FDA should disclose the fact that an NDA, NADA, ANDA, ANADA, BLA, PMA, or 510(k) application or supplement was submitted (or resubmitted) to the Agency at the time the application is received by FDA.  The disclosure should include the name of the application sponsor, the date the application was received, the proposed indications or intended use of the product, and the proposed proper and/or trade name of the product, if available.

Reasoning: There are strong public interests that favor Agency disclosure of whether a marketing application has been submitted to FDA for review.   

FDA receives questions from interested members of the public, including patients suffering from a specific disease, or family members of those patients, about whether an application for a new product is being reviewed by the Agency.  The majority of the questions FDA receives request information about new products or new uses for existing products.  Oftentimes, the person asking is eagerly awaiting a treatment for a particular disease and wants to know when that treatment may be available.  Disclosing whether, and when, a marketing application has been submitted for a specific use will provide helpful information to these individuals, and ease some of the current frustration that stems from the FDA’s restrictions on providing this type of information.

Not only will greater disclosure alleviate the frustration of individuals who call FDA now, and receive no response, but greater disclosure may also increase Agency accountability.  Disclosing whether an application for a new product, or new use of an existing product, has been submitted, and when, may provide greater insight into the application review process, i.e., when FDA action is expected on a specific application.

Further, the public is at times currently provided information about whether an application has been submitted to FDA for review.  Often, this information is proactively provided by sponsors themselves, or provided pursuant to other legal requirements. 

FDA should disclose whether marketing applications seeking approval of a new product, or a new use for an existing product, have been submitted to FDA, and if so, when.  The public health benefits associated with disclosing the existence of marketing applications are strongest in the case of such marketing applications.  While members of the public may be interested in other applications, such as labeling changes, the public health interests does not warrant the significant resources entailed in proactive disclosure of this information.


Comments for this proposal 

(Total Received: 3)

Comment: Disagree with this proposal. Can raise false hopes, since submissions often do not make it to approval or clearance, intended use/indications for use/claims often change over the course of FDA review, and times can very GREATLY from product to product for approval/clearance. Desperate patients may hang all their hopes on a technology that could be years away, but had an early submission, or, worse, hold off on conventional treatment, while waiting for the 'next big thing' - despite what regulators or companies might tell them. People hear what they want to hear. Also, don't put it past companies to file submissions that they know will fail, if they know that they will become public knowledge. This could be done for a funding milestone or even to throw off the competition. It just seems that early disclosure can open a can of worms.
Date Submitted: 7/09/2010

Comment: The previous commenter makes some valid points in my opinion. However, the proposal is ill-advised from another perspective as well. And that is from the perspective of disclosure of ANDA submissions. These submissions are not for new treatment modalities and therefore their disclosure would not add to current scientific or medical knowledge. Conversely, mandatory disclosure of ANDA filings could negatively impact generic drug market dynamics (brands could file citizen petitions and engage in other means of slowing approval)which negatively impacts patients. There does not appear to be an upside to this disclosure.
Date Submitted: 7/20/2010

Comment: For most of these submissions, the suffering patient's knowledge of a premarket application will only offer false hope or disappointment, as the approval process can take a very long time. These disclosures are not helpful to the public but only to competitors.
Date Submitted: 7/20/2010