- A study published in the British Medical Journal shows that 48% of Complete Response Letters (CRLs) issued by the FDA during a 5-year period were related to efficacy and safety concerns. Yet, pharma companies tend to omit many of the details listed in these letters in issued press releases, particularly after rejections and other negative feedback.
- Only 13% of CRLs cited neither safety nor efficacy.
- 59% of CRLs called for a new clinical trial.
The gist of the reseach published in BMJ focused on 61 CRLs and found that most of the letters were issued for safety/efficacy-related substantive reasons. However, researchers also found that most of the press releases issued about the CRLs were incomplete and did not include all of the reasons for the lack of FDA approval. In fact, only 14% of the press release statements matched the CRL completely.
It is best to go directly to the source to find out why a company received a CRL for a specific drug. That information can be found at the FDA's Center for Drug Evalaution and Research Web site.