FDA Seeks Transparency in Data and Decisions - More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies. - BioPharm International

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FDA Seeks Transparency in Data and Decisions
More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.


BioPharm International
Volume 23, Issue 7

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 The FDA also wants to announce when such applications are withdrawn, rejected, or delayed, and to release complete response (CR) letters that spell out why the agency is not approving a submission and what the sponsor needs to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 The agency also could indicate when an IND is placed on clinical hold, or is terminated or withdrawn.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to disclose when a company files a market application or efficacy supplement, as well as when such applications are withdrawn or abandoned.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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