These data have important implications for patient care . Special regulatory designations allow drugs to be approved at earlier stages based on less rigorous clinical testing ; for example , one review showed drugs with orphan designations or granted accelerated approval are also more likely than drugs without these designa- tions to be tested in single arm studies without placebo or active comparators . 4 While many physicians and patients trust that FDA approved products are effective and safe for use , products approved on the basis of more limited data are at greater risk for later changes to their effectiveness or safety profiles . 31 Ponatinib ( Iclusig , Ariad Pharmaceuticals , Cambridge , MA)-designated for priority review and orphan status , and granted accelerated approval - was approved for refractory chronic myeloid leukemia in 2012 and its approval was suspended a year later as emerging data showed it to be less safe than it originally appeared . The suspension was lifted a few months later , with a stronger warning label and limitations to prescribing . 32 Given the increased likelihood of post - approval changes in the prescribing information for these therapeutics , regulators may want to ensure that the provisional nature of these drugs is well communicated to patients and physicians . Currently , only drugs approved through accelerated approval have this information integrated into their official labels . In addition , the FDA may want to consider new guidance on advertising practices to ensure that all advertisements prominently feature the limited nature of the data supporting agents approved through these pathways .