Recently, the British Medical Journal published analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, specifically the center for drug evaluation and research (CEDR). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with Complete Response Letters because of privacy rules around unapproved applications. As a result there is a public debate as to whether there is a common good for learning from the information should change this. We think change is in order—not only to advance patient care, but to improve clinical trial operations.
There are several ways companies handle a complete response letter, ranging from full disclosure to no disclosure. Unfortunately, only 93 of 687 (14%) FDA statements within complete response 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 complete response letters. For instance, 341 of 687 (49.6%) statements within complete response letters 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%) complete response 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 companies working on a specific cure.
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 the issuing of a CRL. 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 an 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.
Reference:
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 10;350:h2758. Learn more at florencehc.com
