SUBMISSIONS AND DENIALS
Even more significant are proposals to disclose when manufacturers seek FDA approval to launch clinical trials or to bring
to market a new drug, biologic, animal drug, or medical device. The FDA also wants to announce when such applications are
withdrawn, rejected, or delayed, and to release complete response (CR) letters that spell out why the agency is not approving
a submission and what the sponsor needs to do to get to market.
Sponsors often elect to announce when they file an investigational new drug application (IND) or a license application to
demonstrate that a development project is moving forward, and the FDA Amendments Act of 2007 requires manufacturers to post
information about ongoing clinical trials and their results on the ClinicalTrials.gov/ web site. But FDA regulations currently prohibit the release of most information on the status or substance of investigational
products.
The task force proposes that the FDA disclose IND filings, including sponsor name, date of application, and anticipated indication
and trade name. The agency also could indicate when an IND is placed on clinical hold, or is terminated or withdrawn.
The FDA would provide similar information on the status of market applications for new drugs, biologics, and medical products
under this plan. The agency now announces only when it approves a medical product for market, but not when a manufacturer
files such an application. Interested parties may glean such information from company financial reports and FDA advisory committee
review materials.
The agency now seeks the authority to disclose when a company files a market application or efficacy supplement, as well as
when such applications are withdrawn or abandoned. Related to this, the task force wants the FDA to be able to explain that
when a sponsor abandons or withdraws an application for an orphan drug for business reasons, as opposed to safety concerns,
that should not deter another party from continuing development of a needed therapy for a rare disease.
An important, and controversial, proposal is for the FDA to release refuse-to-file notices and CR or not-approvable letters.
Sponsors often issue a summary of a CR letter to acknowledge a delay in approval and outline a scenario for reaching the market
in the future. But the FDA wants to fully explain its non-approval decisions, and investors and consumers support access to
the agency's full statements.
However, the transparency panel decided not to seek disclosure of refusal or CR letters to generic drug manufacturers or for
manufacturing and labeling supplements. The hundreds of manufacturing supplements filed each year contain a great deal of
trade secret information that would be difficult to redact, and, the task force notes, "would provide little insight about
the rationale underlying the FDA's drug review process."
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