Product Applications (including Investigational Applications) - Summary of Public Comments
Summary of Public Comments
Summary of Public Comments
Comments from patient groups, consumer groups, healthcare practitioners and individuals supported additional disclosure of information about the status and contents of applications. Comments from patient groups, consumer groups, and individuals stated that disclosure of emerging safety data and information about the status of products in development increases the credibility of FDA decisions, promotes better public understanding of the rationale for regulatory decisions, helps patients track the progress of unapproved treatments for their diseases and make decisions about management of their diseases, and prevents wasted scientific resources and unnecessary human suffering. A patient group stated that transparency was important to avoid and to address public mistrust of regulatory decisions.
In general, industry comments stated that the protections set forth in current law represent the correct balance between disclosure of information and maintaining the confidentiality necessary to foster innovation. Comments from manufacturers and industry trade groups contended that early release of information about the status of, or safety and effectiveness information on, products in development could give competitors an advantage by providing access to previously unavailable insights into the development process and harm incentives for innovation. These comments stated that the FDA’s current policies regarding information about product applications are necessary to encourage innovation and that FDA’s current policies provide adequate transparency.
Investors stated, however, that disclosure of more information during FDA’s product review process about the status of the application, along with the FDA’s views about the strength of an application, will foster innovation by directing resources towards research for products that can meet the Agency’s standards of approval. One industry commenter stated that:
Moreover, it is our view that the majority of applicants disclose to the public—usually via press releases and annual financial reports—when an application for a new product or significant new indication has been submitted, approved or withdrawn. This is especially common practice for products that are new molecular entities.
Comments argued that in order to protect patients in trials of related compounds, additional disclosure of information about investigational applications is particularly important when research is stopped due to safety reasons. Comments stated that product sponsors do not publish negative results from clinical trials conducted on investigational and marketed products, and thus, other companies may expose patients to closely-related products without knowledge that another study of a similar compound revealed significant harm.
One industry comment stated that additional disclosure of information about clinical trials is not needed to protect subjects participating in clinical trials that are testing similar medical products because FDA oversees clinical trials and will prevent any unnecessary risks to subjects. Another industry comment stated that “disseminating certain additional trial information may reduce duplicative studies which divert industry resources that could be used to undertake innovative research,” but transparency objectives must be balanced by the need to protect proprietary information. Other comments stated that greater disclosure may encourage rather than discourage medical breakthroughs by allowing scientists to avoid repeating past failures.
One comment from industry stated that FDA should await implementation of the clinical trial registry and results data bank before changing its disclosure policies. One comment stated that industry compliance with ClinicalTrials.gov has been “uneven.”
Comments stated that FDA should disclose letters sent to applicants when FDA does not approve an NDA, NADA, BLA, or PMA or clear a 510(k). One comment noted that disclosure of these letters would “make it more difficult, if not impossible, to promote the drug off-label” for indications that were included in the marketing application and were not approved by FDA. Industry comments stated, however, that information in these letters would provide competitors with information they can use to gain an unfair competitive advantage and decrease the incentive to invest in the development of new medicines.
Comments suggested that FDA make publicly available summaries of the data in the product application prior to approval or clearance; other comments urged that FDA make publicly available non-summary safety and efficacy data (or require companies to do so). Industry comments stated that providing information found in product applications, such as raw safety and effectiveness data, clinical study protocols, and proposed indications and warnings for the product may provide competitors with insights into the development process and hinder product innovation.
Comments stated that the information in product applications that are withdrawn, terminated, or abandoned before approval may provide valuable information to health care professionals, patients, researchers, and others and should be disclosed. Some industry comments stated that information in such applications may still have commercial value to the sponsor and should not be disclosed. An industry comment stated support for the disclosure of clinical trial results if studies for certain products were stopped for safety issues prior to approval or clearance. Industry comments generally requested consultation with the sponsor before any information is disclosed.
Comments stated that the European Medicines Agency (EMA) releases information about product applications but that same information is not disclosed by FDA. Comments also stated that companies publicly disclose information about product applications but that same information is not disclosed by FDA.