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Fall 2017

ISSN 0890-913X

Volume 32, Number 3

Categories: Fall 2017 | Entrepreneurship

Entrepreneurship in Off-Label Drug Prescription: Just What the Doctor Ordered!

Raymond J. March, Texas Tech University

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TheJournalofPrivateEnterprise32(3),2017,75–92EntrepreneurshipinOff-LabelDrugPrescription:JustWhattheDoctorOrdered!RaymondJ.MarchTexasTechUniversity______________________________________________________AbstractThispaperfindsthatphysiciansandpharmaceuticalcompaniesworkingasentrepreneurialactorswereabletobetterservepatientsbyfindingeffectivealternativeusesofthreedrugs.Iexamineoff-labeldrugprescriptionwithinanentrepreneurialframeworkbyexaminingthedevelopmentprocessesofaspirin,Viagra,andminoxidil.Ineachcase,themedicalcommunityreachedresearchandtreatmentconclusionsquickerthantheFDAdid.Theseexamplesprovidecounterevidencetotheviewthatoff-labelprescriptionisrecklessandrequiresadditionalgovernmentaloversightduetoalackofsufficienttesting.______________________________________________________JELCodes:I18,I12,K23Keywords:healtheconomics,off-labeldrugprescription,entrepreneurship,FDAI.IntroductionAnylegallyprescribeddrugintheUnitedStatesmustundergoalengthy,costly,anduncertainprocessenforcedbytheFoodandDrugAdministration(FDA).Thetimebetweendrugdiscoveryandapprovalaveragessixteenyears,andtheprobabilityofapprovalforhumanuseisapproximately10percent(Stossel2015).Completingthisapprovalprocessrequiresanaverageinvestmentof$403million(Demasi,Hansen,andGrabowoski2003).1ThehighcostofFDAdrugapprovalcreatessignificantbarrierstoentryandreducesthenumberofpharmaceuticalsavailabletoconsumers(Tabarrok2000,2009).Physiciansareleftwithfewoptionstoservepatients(Benson2004).Despitethesehighbarrierstoentry,physicianscanexerciseanentrepreneurialroleintheirpracticesbyprescribingandrecommendingpharmaceuticalsoff-label.AsnotedbySalbu(1999),1Theauthorsprovidethisestimatein2000dollars.In2016dollars,$403millionisapproximately$560million.

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Title	Entrepreneurship in Off-Label Drug Prescription: Just What the Doctor Ordered!
Authors/Creators:	Raymond J. March, Texas Tech University
Year:	2017
Volume:	32
Number:	3
Pages:	75 - 92
Publisher:	The Association of Private Enterprise Education
ISSN:	0890-913X
Document Type:	Articles
Keywords:	health economics, off-label drug prescription, entrepreneurship, FDA

Citation:
March, Raymond J. / 2017. "Entrepreneurship in Off-Label Drug Prescription: Just What the Doctor Ordered!." The Journal of Private Enterprise, 32(3): 75-92.