Opposing Views on FDA Complete Response Letters

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Opposing Views on FDA Complete Response Letters

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved applications. As a result there is a public debate as to whether a common good for learning from the letters’ information should change this. We think change is in order—not only to advance patient care, but to improve clinical trial operations. Learn about how sponsors are taking the initiative to improve their trial operations.

There are several ways companies handle a CRL, ranging from full disclosure to no disclosure.  Unfortunately, only 93 of 687 (14%) FDA statements within these letters from August 2008 to June 2013 were publicly shared in press releases from the sponsoring company.

Not receiving approval for a new drug application is a challenging time for any pharmaceutical company.  These decisions should be made without pressure from competitors.  But valuable scientific and clinical information on a given drug class lies within the CRLs.  For instance, 341 of 687 (49.6%) statements pertained to issues of safety and efficacy. This information can be helpful not only to patients and prescribing physicians, but also to trial operations practitioners.  Of note, 32 of the 61 total (52.5%) letters called for a new clinical trial.

It’s easy for those of us outside the sponsor to list off the benefits to publishing this data: scientific understanding, patient and physician information access, and knowledge advancement for clinical trial operations to name a few. Of course, immediate publishing of such information has the potential to harm the individual pharmaceutical company working on a specific therapy.

So what’s to be done?  There is a third option to allow for delayed release of information within the Complete Response Letter, possibly 5 years following its issuance.  This would permit collective learning on any given pharmaceutical subject and provide clear insight into the FDA process, while protecting the individual drug company during the critical decisions that come following a non-approval.  Such an approach would also reduce hearsay common to clinical operations professionals about what actually affects approval outcomes, allowing them to make the right choices for their trials.

Learn more about how sponsors are making the trial process both more efficient and audit ready.


Lurie P, Chahal HS, Sigelman DW, Stacy S, Sclar J, Ddamulira B. Comparison of 
content of FDA letters not approving applications for new drugs and associated
public announcements from sponsors: cross sectional study. BMJ. 2015 Jun
Mike Kassin

Mike Kassin

Clinical Director at Florence
As a physician leader, Mike brings medical expertise focusing on clinical workflows. For fun, he listens to a ton of audiobooks on medicine, commerce, and biographies.

Trained at Emory University, Medical Degree from Emory School of Medicine, BS in Biochemistry and Molecular Biology with Minor in Leadership from University of Georgia
Mike Kassin

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