Opening the Black Box
Much more substantive is phase two, which was published May 21, 2010, and offers 21 proposals for disclosing regulatory documents and actions. Some are quite far-reaching and will require Congressional action to implement.
Most controversial is whether FDA should drop its long-held policy against releasing information on the status and substance of investigational products. The task force proposes that FDA disclose when a company seeks permission to launch clinical trials or to bring to market a new drug, biologic, animal drug, or medical device. FDA also wants to announce when such applications are withdrawn, rejected, or delayed. The agency also wants to release Complete Response (CR) letters explaining why it is not approving a product, as well as what the sponsor needs to do to get to market.
Pharma companies often elect to announce when they file an IND (investigational new drug application) or a license application to demonstrate that a development project is moving forward or to comply with financial reporting rules. The FDA Amendments Act, moreover, requires manufacturers to post information about ongoing clinical trials and their results on ClinicalTrials.gov/, and dossiers on some products are posted as part of FDA advisory committee deliberations. But FDA itself only announces when it approves a new product.
That would change considerably under the task force proposal for FDA to disclose IND filings, including name of sponsor, date of application and anticipated indication and trade name. The agency also would indicate when an IND is placed on clinical hold or is terminated or withdrawn. Similarly, FDA would indicate when a company files a market application or efficacy supplement, as well as when such applications are withdrawn or abandoned.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 FDA to be able to explain that when a sponsor abandons or withdraws an application for an orphan drug due to internal business reasons, safety concerns, or regulatory issues should not deter another party from developing that needed therapy.
A significant, and controversial, proposal is for FDA to release refuse-to-file notices and CR or not-approvable letters. Sponsors often will issue a summary of a CR letter and a scenario for reaching the market in the future. But FDA wants to provide full explanations of its delay decisions, and investors and consumers want to see those statements.
However, the transparency panel decided not to seek disclosure of refusal or CR letters to generics drug manufacturers, or for manufacturing and labeling supplements; these contain considerable trade secret information that is considered less crucial to drug development.