A Federal Register (FR) notice that appeared on today’s pre-publication page discusses a request for comments on a draft nondisclosure agreement (NDA) for federal employees. The notice (here) discusses the proposed NDA to affirm “[f]ederal employees’ acknowledgment of, and agreement to comply with, current legal obligations to safeguard non-public, confidential, or proprietary information, created or obtained through their official duties, while expressly preserving the right to make disclosures authorized by law.”
The document states that “[f]ederal employees are subject to longstanding legal requirements to safeguard nonpublic information obtained through their official duties. These obligations arise under multiple authorities, including the Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635), which prohibit the unauthorized disclosure of nonpublic information, implementing regulations of the Federal Records Act.”
While the FR notice discusses some high-profile disclosures (leaks) of information, the fact that the FDA has been publishing copies of Complete Response Letters (CRLs) seems somewhat antithetical to the intent of this proposal and request for comments. As a former high-level FDA employee, I was always told and understood that even an acknowledgement of the existence of a pending application in conversation outside the office prior to its approval violated FDA regulations, let alone releasing pre-decisional documents regarding the review of the application. These acts are expressly forbidden by FDA regulations unless the information regarding the existence of an unapproved application was made public by other means. However, even in such a situation, we were advised that we should never disclose the existence of a filing until such time as it was approved.
We have blogged previously about the propriety of release of CRLs (here, here, and here). Needless to say, interpreting how this FR request for comment on the proposed NDA could impact such disclosures of CRLs is challenging. Will the FDA have a carve-out for continued CRL releases or will it just continue to ignore the apparent regulatory prohibition against such releases? Is the FDA looking to cover itself after it was sued by a major law firm on behalf of a client regarding the release of CRLs? Now that Makary has left the Agency, is the so-called “radical transparency” associated with the release of CRLs likely to stop? What is the limit of the intent of the proposed NDA? Only time will tell.
