I opened my browser this morning at 6AM PST and the first thing I saw was an FDA notice I never thought I would see. Right there on my computer, the Notice (here) said “FDA Embraces Radical Transparency by Publishing Complete Response Letters”. Yes, that’s right – CRLs are now being posted! According to the Notice, the “U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transparency.”
The Agency notes that “[T]his initial batch of published decision letters associated with since-approved applications is now accessible to the public at openFDA. The CRLs were redacted for trade secrets and confidential commercial information. The Agency is in the process of publishing additional CRLs from its archives and is continuously exploring ways of providing the public with greater transparency into its decision-making process.”
The letters have been redacted to protect confidential commercial and trade secret information. In addition, it does not appear that FDA will be releasing any CRLs until after an application is approved. This protects both the firm’s and FDA’s confidentiality of the long-held FDA policy that they will not acknowledge the existence of an application until it is approved, so don’t expect to see any CRLs for pending applications.
The website to view the published CRLs is called openFDA and can be found here. The website has extensive search capability but there is one thing to note for novice database users. The term “API” is used extensively throughout the document. For most of us in the drug industry, API refers to active pharmaceutical ingredient, however, in openFDA that acronym refers to Application Programming Interface (API). It took me a while to figure that out so don’t fall into the same trap I did!
Enjoy this website as it is designed, as noted above to increase transparency into the FDA decision making process. At this time, records include only Complete Response Letters (CRL) issued in response to approved new drug applications (NDAs) and biologics license applications (BLAs) between 2020 and 2024 but maybe one day it will cover ANDAs and other FDA approved applications as well.
