“Radical Transparency” or Not? FDA Releases Hundreds of Decision Letters to the Public
FDA publishes drug approval decision letters for the first time, aiming to clarify decision-making.
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In a bid to “embrace radical transparency”, the US Food and Drug Administration (FDA) has made over 200 complete response letters (CRLs) – also known as decision letters – public. Accessible at openFDA, the CRLs have been edited to remove trade secrets and confidential commercial information, the agency said.
A CRL is a notice issued by the FDA in response to either a new drug application, an amended new drug application or a biologics license application, which informs the submitter that the application will not be approved in its current form. The approach was first introduced in 2008, and this is the first time the FDA has made such decision letters publicly available.
“The FDA issues CRLs for various reasons, most related to safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues. These deficiencies are detailed in the letter and may also include recommendations for addressing them,” an FDA statement reads.
FDA Commissioner Dr. Marty Makary said that drug developers have been “playing a guessing game when navigating the FDA” for too long: “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 agency also said that some companies receiving CRLs “misinterpret the rationale behind FDA’s decision to their stakeholders and the public”, implying that publishing the CRLs would help overcome any issues with said companies failing to disclose FDA concerns about products. “By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved,” the FDA’s statement reads.
How transparent is the FDA’s CRL disclosure, really?
Some critics are challenging the claim that this is “radical transparency”. It appears the list of CRLs isn’t exhaustive and only includes letters relating to products that have since been approved for marketing. Such letters would have been available for the public to access as they are included in a product’s approval packages – the person wanting access would simply need to know where to look.
The FDA also said this initial batch of published decision letters was issued in response to applications submitted to the FDA between 2020–2024. Upon accessing and reviewing the CRLs, Technology Networks noted that there are letters dated outside of this range. For example, a CRL addressed to AB pharmaceuticals for the product efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400 mg/300 mg/300 mg, is dated 2018. To date, the FDA has not publicly responded to questions about the timeframe discrepancies.
Additional CRLs are expected in the future, as the agency has stated it is in the process of releasing more from its archives. However, it remains unclear whether it will address the timeline discrepancies identified or publish CRLs for products that were ultimately rejected.
