A balanced strategy between sharing of clinical studies and promotion of off label use for patients who do not have any other choice of drugs. Improvement in quality of breath is not a privilege but a fundamental right and an obligation.

1. UseofOffLabelIndicationswithinScienceandwithDignity
Mrs.RoohiBanoObaid
DeputyDirector/CivilServiceOfficer,
DrugRegulatoryAuthority,GovernmentofPakistan
Alumni,CDERForumofInternationalRegulators,US-FDA,Maryland
Alumni,HPFBForumofInternationalRegulators,HealthCanada,Ottawa
MemberInternationalSocietyofPharmaceuticalEngineering(ISPE)
MemberParenteralDrugAssociation(PDA)
Painofpatient,evidencesandcuriosityofclinicianencourageuseofapproveddrugsin
unapprovedindications.Thefreedom tochoosethisdangerouspathgavealotofbenefitto
helpless and hopeless innocentpatients on one hand and atthe same time made
patients/consumersvictimofunreasonable/blindtherapyontheotherhand.Inbothscenarios,
commercialbenefitgoestothecompany(MarketAuthorizationHolder).Themisuseofthis
approachasabusinessstrategytriggeredmorestringentregulatoryoversighttokeeptheright
ofconsumersprotectedfortheirwellbeing.Companiesarenotallowedtopromoteorshare
anyclinicalstudiesthatmaydrivethemindofclinicianfortheuseofdruginanyother
indicationthatisnotapproved.Thiswayaccesstoinformationisdeniedthatmaygivebenefit
tothelifeofotherdeservingpatients.Approvalofnewindicationhasitssubstantialfinancial
burdenaswellasliabilitiesthatcertainlydonotattractthecompanytomoveforward.The
companyleavesitontheclinicianandneveroptstogoforapprovalofnew indicationfor
commercialreasons.Asamatteroffact,manipulationinclinicalstudiesandunderline
promotionofofflabelusebythecompanysurfacedanumberoftimesacrosstheworld.
Globallyleadingcompanieshavebeencaughtinexploitingthepatientsforanumberofyears
andsettledsuchmatterswithhighestcriminalfinesofbillionsofdollars.However,itisalso
writtenonstonethatanumberofnooptioncasesorrarediseasepatientsmaygetbenefitif
studiesaresharedwiththeclinicians.Inthisway,potentialhelptotakeclinicaldecisionis
killed.Alineinbetweenpromotionofofflabeluseandsharingofinformationfornooption
casesneedtobedrawn.Spacemayexpandinbetweenencouragementordiscouragementof
offlabelusetoaccommodateandnourishtheevolutionprocessofscience.Necessary
guidancetodiscourageblindofflabeluseincaseswhereknownoptionsareavailablemaybe
issuedtoMedicalandPharmacyCouncils.
Karachi,the09August2017