Drug is finally approved? It’s not over yet.
Successful approval does not always guarantee unconditional and easy profit for pharma industry. US FDA approved 222 novel therapeutics through 2001 to 2010. Among them, 183 (82,4%) were pharmaceuticals and 39 (17,6%) were biologics. But many of those approvals faced safety issues during the postmarket period.
A cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, (followed up through February 28, 2017) revealed that among these novel therapeutics 71 (32,0%) were affected by postmarket safety events.
Downing et al. (article published in JAMA) conducted a study to examine risk factors for postmarket safety events occurrence among novel therapeutics and frequency of such events.
During the median follow-up of 11,7 years, there were 3 withdrawals due to safety concerns: Pimecrolimus (calcineurin inhibitor) for atopic dermatitis due to skin cancer risk, Efalizumab – (monoclonal antibody against lymphocyte receptor CD11a) for psoriasis due to high risk of systemic infection and Tegaserod (5-HT4 agonist) for management of irritable bowel syndrome due to high cardiovascular events risk.
FDA issuance of incremental boxed warnings added in the postmarket period – a measure used to indicate that potentially life-threatening or preventable safety events had been observed in the postmarket period affected 43 novel therapeutics during the follow-up.
Also, there were 59 FDA safety communications during the study period.
Study identified several risk factors associated with increased frequency of postmarket safety events. Biologics were at higher risk compared with pharmaceuticals. Psychiatric Therapeutics were at the highest risk for safety events occurrence. Several other patterns were identified in the study.
The authors came to an obvious conclusion that postmarket safety monitoring should be continued at least to the same extent. The results that are most important for industry concern special regulatory approval pathways. Most interestingly, priority review and orphan status were not associated with postmarket safety events. Even though, accelerated approval and near-regulatory deadline approval were significant risk factors for safety event occurrence.
Thus, some special regulatory pathways turned out to be safer than others. The pharmaceutical industry should keep this exact conclusion in mind to maximize the cost-effectiveness of drug development and manufacturing.
