FDA Raises Important Confidentiality Warning in a New Guidance Document
(Thursday, January 7, 2021]​
In the first Guidance Document of 2021, FDA emphasized a very important procedural aspect of sponsor-FDA meetings arising from the sponsor inviting outside parties to such meetings. FDA warns that bringing an outside party to a sponsor-FDA meeting could potentially compromise the confidentiality of the information discussed at the meeting unless the sponsor took legal measures to protect their information prior to the meeting. The cautionary statement, and the suggested remedy, is buried in a new guidance on developing individualized drug products. Although the guidance refers to the development of a specific product, antisense oligonucleotides (ASOs), the policy described applies to all kinds of products. FDA expects that due to the small market and the specific application, most ASO drug products are being developed by academic investigators who may be less experienced with FDA’s processes, particularly related to meetings and other interactions with the FDA. The guidance describes several procedural aspects of product development such as IND requirements, CMC requirements, IRB review and informed consent. However, the bulk of the guidance discusses processes for interacting with FDA reviewers to discuss the development program such as the pre-IND meetings, other meetings, emails, faxes, phone calls, etc. It is common for sponsors, to invite trial participant(s), family member(s), or other advocates to their meetings with FDA and other interactions, particularly for rare diseases where the patient may be the only one able to effectively communicate his/her condition in a rare less-understood disease. However, FDA considers any non-employee or non-contractor of the sponsor to be an outside party. So, discussing with an outside party “may be considered public disclosure of the sponsor’s confidential information (confidential commercial information and/or trade secret information) which generally is available to all members of the public, including under the Freedom of Information Act.” To prevent that from happening, FDA expects the sponsor to certify in writing before the meeting that either (1) the sponsor has a confidentiality agreement with the outside party, or (2) that the sponsor is aware of the public disclosure created by the presence of such outside party and accepts the risks. This practice of confidentiality agreements is common in industry, but academic sponsor-investigators and new developers should be aware as well. 

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

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