The US Food and Drug Administration (FDA) has announced the publication of more than 200 complete response letters (CRLs), representing a significant step in its aim to improve transparency.
The “initial batch” of published letters, issued in response to applications submitted to the FDA between 2020 and 2024, is now accessible to the public, and the regulator said it is “in the process” of publishing additional CRLs from its archives.
The FDA issues CRLs to sponsors of drugs or biological products when it determines that it cannot grant an approval of an application in its current form. This is due to a range of reasons, including safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues.
Deficiencies are detailed in the letters; however, because the FDA has not previously published CRLs for pending applications, sponsors can misrepresent the rationale behind the decision to their stakeholders and the public.
A 2015 analysis carried out by FDA researchers showed that sponsors avoided mentioning 85% of concerns surrounding safety and efficacy when announcing that their application was not approved.
The analysis also found that, when the FDA requests a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time, while lessons learned from non-approvals are also not shared within the industry.
It is hoped that making CRLs available will offer the public a greater insight into the FDA’s decision-making and highlight the most common deficiencies that sponsors must address before their application is approved.
FDA commissioner Marty Makary, said: “For far too long, drug developers have been playing a guessing game when navigating the FDA.
“Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”
The CRL publication is the latest in a series of initiatives recently introduced by the FDA. Last month, the regulator unveiled a new programme that will aim reduce its review time for certain drug applications from around ten to 12 months to just one to two months.
It also announced in May that all its centres will operate on a common generative artificial intelligence (AI) system by 30 June this year.