Product Applications (including Investigational Applications) - Draft Proposal 8
FDA should disclose the existence and, when asked, confirm the existence or non-existence of investigational applications. For investigational applications, the disclosure should include the name of the application sponsor, the date the application was received, the proposed indication(s) or intended use(s) of the product, and the proposed proper and/or trade name of the product, if available.
Reasoning: There are important public benefits to disclosing the existence of investigational applications received by FDA. Investigational applications inform FDA that a company plans to start a clinical trial in humans or animals. FDA receives questions from the public about planned clinical trials. If FDA could disclose when an investigational application has been received, it may encourage patient enrollment in clinical trials that are underway or are likely to be started, particularly those trials that may not be posted on ClinicalTrials.gov. Public availability of this information may reduce the potential for public confusion about the development of a particular product.
Most clinical trials conducted in the United States that are used to support approval of a new drug or device, or a new use of an existing drug or device, are conducted pursuant to an investigational application submitted to and reviewed by FDA. The public is provided information about clinical trials that are underway to develop new medical products, in large part due to federal requirements requiring public registration and results reporting for certain clinical trials, guidelines set forth by other public entities encouraging disclosure of clinical trials and results, and proactive disclosures by companies themselves about new products in development. Disclosure of an ongoing clinical trial in the U.S. in many cases means that an investigational application has been submitted to FDA.
The public benefits of disclosure apply to all clinical investigations conducted with FDA-regulated products. Disclosing the fact that FDA has received an investigational application will not allow a competitor to copy the formulation of a product or reverse engineer a device. The potential availability of a new product on the market is not the only basis on which products compete; for example, improved effectiveness of the product, fewer side effects, and easier use by the patient are among factors that differentiate products on the market.
As a result, the right balance is for FDA to disclose the existence of investigational applications to the public and answer questions from the public about the existence of these applications.
(Total Received: 3)
Comment: A mechanism already exists to inform physicians and the public on the existance of clinical trials and that is ClinicalTrials.gov. Clinicaltrials.gov also posts more information regarding the where, when, how and who of the study so an individual or a physician can make an educated decision on whether to approach the investigators or not. Disclosures of investigational applications would only benefit competitors. Drug and Device companies should be able to conduct development activies in confidence and make their own decisions on when that information is released.
Comment: MRA supports efforts to speed research and development aimed at providing better options for patients. In the interest of optimizing new drug development, MRA supports the Task Force’s recommendations to disclose more information about the drug development process, including the submission or withdrawal of applications for new drugs or devices, significant safety concerns causing a sponsor to withdraw an application, and the Agency’s rationale for declining to approve an application. The availability of this type of information has the potential to accelerate the development of new drugs and devices by allowing other researchers to learn from the outcomes of successful or unsuccessful applications. At the same time, disclosures should be made in a manner that takes into consideration the potential impact on sponsors and their incentives for innovation in research and development. Consideration should be given to evaluating the effects of the implemented proposals on innovation an
Comment: The products undergoing these investigations may never be commercialized. In addition, the companies have disclosed everything required under statute to FDA, much of it proprietary. What benefit does it serve the public to know there is an investigation underway?