For The Defense, October 2010 - DRI Today

the drug continue to outweigh the risks.“New safety information” may developfrom adverse event reports, clinical trials,post- marketing monitoring systems, medicalliterature, or other appropriate scientificdata about a serious risk, whether previouslyknown or unknown.As with a patient package insert, theholder of a drug application may voluntarilypropose REMS and submit them tothe FDA. If the FDA approves the REMS,the manufacturer will have the same obligationsthat it would have had if the FDAhad initiated the REMS. If the FDA rejectsthe REMS, which essentially means thatthe drug does not require heightened safeguards,the manufacturer may still pursuethe strategies but without the formal obligationsof a FDA- mandated REMS. Themanufacturer may propose modificationsto approved REMS at any time.REMS include patient package insertsand medication guides. Among the currentlyapproved REMS, medication guidesand preferred package inserts are the predominantcomponents. Sometimes, adrug’s REMS may require both a patientpackage insert and a medication guide,although the FDA expects that rarely. TheFDA will regulate products with formerlyapproved patient package inserts or medicationguides that meet the REMS programstandards under the REMS provisions andrequirements from this point forward. Andthe FDA may require a manufacturer todevelop a communication plan as part ofa drug’s REMS, which can include a DearHealthcare Professional letter, web-basedproduct support, and educational materialsthat it will provide to prescribers throughprofessional associations and meetings, orthe FDA can require the communicationsplan instead of something else.The FDA may also require additionalmeasures or interventions, termed “elementsto ensure safe use,” abbreviated as“ETASU” in the REMS draft guidance, fordrugs with demonstrated efficacy, albeit“with known serious risks that would otherwisebe unavailable.” The draft guidancementions that these elements to ensure safeuse may include one or more of the following:requiring prescribers to have specialcertification, training, or experience;requiring drug dispensers, such as pharmaciesor hospitals, to have special certificationand training to dispense the drug;restricting the locations where a drug maybe dispensed, such restricting dispensingprivileges to hospitals; requiring laboratorytesting to confirm that the patients’ conditionwill allow them to use the drug safely;asking patients sign acknowledgements ofunderstanding concerning the drug’s risks;requiring periodic testing of patients tomitigate serious risk; and enrolling patientsin a drug-use registry.For example, the FDA recently approvedREMS for Onsolis, an opioid indicated forbreakthrough cancer pain, under whichOnsolis can be distributed only throughpharmacies participating in a special regis-For The Defense n October 2010 n 41