Should FDA Disclose Submission of NDA and BLA Applications?
[Thursday, June 13, 2019]

FDA is not allowed by law to report submission of NDA and BLA applications or when it rejects these applications, but submitters do. In more than 97% of the times, companies announce via news releases, SEC filings or both, the submission of their market approval applications. A publication by FDA officials in JAMA this week argues if it is time for FDA too to disclose such submissions as well. However, it is not clear what benefit does the FDA believe it would get from such disclosure. Since the submission information is already publicized by the submitters, FDA disclosure of the same seems to be a zero-sum situation. Application information is confidential and should be kept that way. It is similar to the situation with clinical trial information where companies chose to announce submission of their applications at their discretion without having to worry about FDA preempting them. It is not about transparency but about control of information and the owners of the information, namely the submitters should control when it is publicized.