The FDA responds to numerous petitions each year asking for determinations as to whether products that have been withdrawn or discontinued from marketing have been so removed for safety or efficacy reasons. Such determination is necessary to permit the continued marketing of other approved ANDAs that cite a Reference Listed Drug (RLD) as their basis for submission, and whether the FDA will continue to accept ANDAs for generic versions of the subject RLD.
Most petition responses and FDA determinations are pretty straightforward, where the FDA says either that there are no safety or efficacy issues (as it does for most requests) or that there are, which would result in products coming off the market or that generic copies of the RLD product are no longer eligible for submission or approval. Today’s Federal Register announces an unusual response from the Agency for a drug called Danocrine.
The FDA determined that Danocrine capsules “were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness.” The notice goes on to say that “DANOCRINE is indicated for the treatment of endometriosis amenable to hormonal management, prevention of attacks of angioedema of all types (cutaneous, abdominal, and laryngeal) in males and females, and fibrocystic breast disease.” Upon the Agency’s risk-benefit review of the various approved indications, given the potential significant side-effect profile of the drug, and considering the fact that there are other treatments now available with a more favorable side-effect profile for the treatment of fibrocystic breast disease, the FDA no longer considers this indication to have an acceptable risk-benefit profile. As such, the FDA noted that it will not commence regulatory action against approved ANDA holders that remove the fibrocystic breast disease indication from labeling and will permit ANDAs to be received as long as they do not contain this indication in their proposed labeling.
This half-and-half response is one of the few I have seen over my career and is an example of the FDA not throwing the baby out with the bath water. A reasoned approach such as this will permit patients to benefit from the drug for its other approved indications. A full copy of the pre-publication notice can be found here.
