2022
Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
Gupta R, Morten CJ, Zhu AY, Ramachandran R, Shah ND, Ross JS. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021. JAMA Health Forum 2022, 3: e221096. PMID: 35977259, PMCID: PMC9123500, DOI: 10.1001/jamahealthforum.2022.1096.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDrug ApprovalDrugs, GenericHumansPrescription DrugsTabletsUnited StatesUnited States Food and Drug AdministrationConceptsCross-sectional studyNovel drugsTherapeutic valueUS FoodDrug AdministrationWorld Health Organization Model ListGeneric approvalCapsule formMultivariable analysisAccelerated approvalClinical usefulnessMAIN OUTCOMEPrescription drugsBrand-name drugsModel ListEssential medicinesDrugsApproval statusMedicine inclusionFDANovel tabletBlockbuster statusApprovalAdministrationDrug salesAssociation Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology
Duarte-García A, Crowson CS, McCoy RG, Herrin J, Lam V, Putman MS, Ross JS, Matteson EL, Shah ND. Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology. Mayo Clinic Proceedings 2022, 97: 250-260. PMID: 35120693, PMCID: PMC9013005, DOI: 10.1016/j.mayocp.2021.08.026.Peer-Reviewed Original ResearchAssessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019
Zhou T, Liu P, Dhruva SS, Shah ND, Ramachandran R, Berg KM, Ross JS. Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019. JAMA Internal Medicine 2022, 182: 185-195. PMID: 34982097, PMCID: PMC8728660, DOI: 10.1001/jamainternmed.2021.7457.Peer-Reviewed Original ResearchMeSH KeywordsAgedAtrial FibrillationChronic DiseaseCross-Sectional StudiesDiabetes Mellitus, Type 2Drug CostsHealth ExpendituresHeart FailureHumansHypercholesterolemiaHypertensionMedicare Part CMedicare Part DMultiple Chronic ConditionsOsteoarthritisOsteoporosisPrescription DrugsPulmonary Disease, Chronic ObstructiveRetrospective StudiesUnited StatesConceptsCommon chronic diseasesGuideline-recommended medicationsGuideline-recommended managementPrescription drug plansCross-sectional studyChronic conditionsChronic diseasesPocket costsOlder adultsOutpatient medicationsMedicare prescription drug plansInitial treatmentMedicare Advantage plansRetrospective cross-sectional studyMultiple chronic conditionsMedicare Part D plansPart D plansSubstantial financial burdenAtrial fibrillationMAIN OUTCOMEExclusion criteriaMedicare beneficiariesAnnual outHypothetical patientsMedications
2021
Levothyroxine Use in the United States, 2008-2018
Brito JP, Ross JS, Kawkgi O, Maraka S, Deng Y, Shah ND, Lipska KJ. Levothyroxine Use in the United States, 2008-2018. JAMA Internal Medicine 2021, 181: 1402-1405. PMID: 34152370, PMCID: PMC8218227, DOI: 10.1001/jamainternmed.2021.2686.Peer-Reviewed Original ResearchCharacteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Zhang AD, Puthumana J, Downing NS, Shah ND, Ross JS. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2021, 4: e2113224. PMID: 34110392, PMCID: PMC8193429, DOI: 10.1001/jamanetworkopen.2021.13224.Peer-Reviewed Original ResearchConceptsPrimary efficacy end pointEfficacy end pointPivotal trialsIndication approvalsActive comparatorClinical outcomesSupplemental indicationsUS FoodEnd pointOriginal approvalTherapeutic areasPivotal efficacy trialsCross-sectional studyAdditional clinical dataDrug Administration approvalNew indication approvalsStrength of evidenceAdministration approvalMonths durationClinical dataClinical studiesEfficacy trialsMedian numberCancer indicationsMAIN OUTCOME
2020
On-Label and Off-Label Clinical Studies of FDA–Approved Ophthalmic Therapeutics
Gopal AD, Wallach JD, Shah SA, Regillo C, Ross JS. On-Label and Off-Label Clinical Studies of FDA–Approved Ophthalmic Therapeutics. Ophthalmology 2020, 128: 332-334. PMID: 32682839, PMCID: PMC9900733, DOI: 10.1016/j.ophtha.2020.07.028.Peer-Reviewed Original ResearchProstaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017
Bartlett VL, Liu P, Dhruva SS, Shah ND, Bollinger KE, Ross JS. Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017. Journal Of Managed Care & Specialty Pharmacy 2020, 26: 10.18553/jmcp.2020.26.4.562. PMID: 32223594, PMCID: PMC10391193, DOI: 10.18553/jmcp.2020.26.4.562.Peer-Reviewed Original ResearchMedicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals
Solotke MT, Liu P, Dhruva SS, Gulanski B, Shah ND, Ross JS. Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals. LGBT Health 2020, 7: 137-145. PMID: 32267818, DOI: 10.1089/lgbt.2019.0306.Peer-Reviewed Original Research
2019
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary managementMedicare Formulary Coverage of Brand-Name Drugs and Therapeutically Interchangeable Generics
Vijay A, Gupta R, Liu P, Dhruva SS, Shah ND, Ross JS. Medicare Formulary Coverage of Brand-Name Drugs and Therapeutically Interchangeable Generics. Journal Of General Internal Medicine 2019, 35: 1928-1930. PMID: 31625043, PMCID: PMC7280368, DOI: 10.1007/s11606-019-05432-6.Peer-Reviewed Original ResearchMedicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors.
Egilman AC, Zhang AD, Wallach JD, Ross JS. Medicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors. Annals Of Internal Medicine 2019, 171: 521-523. PMID: 31404926, DOI: 10.7326/m19-1085.Peer-Reviewed Original ResearchKept in the dark: Scotland rejects “sunshine” legislation
Ross JS. Kept in the dark: Scotland rejects “sunshine” legislation. The BMJ 2019, 364: l1379. PMID: 30926587, DOI: 10.1136/bmj.l1379.Commentaries, Editorials and LettersGeneric Drugs in the United States: Policies to Address Pricing and Competition
Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clinical Pharmacology & Therapeutics 2019, 105: 329-337. PMID: 30471089, PMCID: PMC6355356, DOI: 10.1002/cpt.1314.Commentaries, Editorials and LettersConceptsPrice increasesDrug pricesPatent drugsGeneric drugsBrand-name manufacturersGeneric drug applicationsGeneric competitionGeneric versionsPricesPolicy solutionsUnited StatesCompetitionPolicySource of concernPrescription drugsCostPricingMarketAgency policiesPolicymakersCompetitorsPast decadeFDA's roleShortageManufacturers
2018
Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval
Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. Journal Of Managed Care & Specialty Pharmacy 2018, 24: 10.18553/jmcp.2018.24.12.1230. PMID: 30479199, PMCID: PMC10397592, DOI: 10.18553/jmcp.2018.24.12.1230.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsPrescription drug plansOrphan drug statusFDA approvalYear of approvalTherapeutic agentsNovel therapeuticsPrior authorizationNovel therapiesPriority reviewStep therapyMedicare prescription drug plansDrug plansDrug coverageNational InstituteDrug statusPart D prescription drug benefitMedicaid ServicesDrug characteristicsTherapeutic areasCross-sectional studyDrug benefit coverageHealth insurance payerBlue Cross Blue Shield AssociationPrescription drug benefitAffordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. The BMJ 2018, 360: k831. PMID: 29555641, PMCID: PMC5858606, DOI: 10.1136/bmj.k831.Peer-Reviewed Original ResearchConceptsOff-patent drugsObservational studyRare diseasePrescription drugsPatent drugsStudy drugTotal Medicaid spendingCardiovascular diseaseOrphan drug designationPsychiatric diseasesDrug AdministrationPatient accessInfectious diseasesDiseaseDrug characteristicsEssential medicinesDrugsGeneric versionsGeneric drugsMedicaid spendingNovel tabletRegulatory agenciesFDAUnited StatesTreatment areaDirect-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines
Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. Journal Of General Internal Medicine 2018, 33: 651-658. PMID: 29484575, PMCID: PMC5910340, DOI: 10.1007/s11606-017-4274-9.Peer-Reviewed Original ResearchConceptsDTC adsDiabetes medicationsPresentation of risksLabel promotionPrescription drugsBlood pressure reductionFDA guidelinesBladder dysfunctionDiabetic neuropathyResultsOur sampleChronic conditionsInflammatory conditionsAllergic reactionsLabel usesPrescribers' decisionsUnique drugDrug AdministrationDrug risksDrug efficacyPressure reductionOff-label promotionWeight lossAdvertisement claimsConsumer advertisementsDrugs
2017
High Costs of FDA Approval for Formerly Unapproved Marketed Drugs
Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA 2017, 318: 2181-2182. PMID: 29131905, DOI: 10.1001/jama.2017.16481.Commentaries, Editorials and LettersThe FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. Journal Of Managed Care & Specialty Pharmacy 2017, 23: 1066-1076. PMID: 28944731, PMCID: PMC10397719, DOI: 10.18553/jmcp.2017.23.10.1066.Peer-Reviewed Original ResearchConceptsUnapproved Drugs InitiativeClinical evidenceAverage wholesale priceFDA approvalPrescription drugsNew clinical trial evidenceMedian shortage durationClinical trial evidenceNew clinical evidenceDrug shortagesNumber of drugsEvidence of safetyUtah Drug Information ServiceHealth-System PharmacistsAssociation between FDA black box warnings and Medicare formulary coverage changes.
Dhruva SS, Karaca-Mandic P, Shah ND, Shaw DL, Ross JS. Association between FDA black box warnings and Medicare formulary coverage changes. The American Journal Of Managed Care 2017, 23: e310-e315. PMID: 29087169.Peer-Reviewed Original ResearchMeSH KeywordsFormularies as TopicHumansMedicarePrescription DrugsRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationConceptsFDA black box warningBlack box warningNew black box warningsBox warningCardiovascular riskDrug alternativesNew safety informationMajority of drugsFormulary changeRetrospective analysisFormulary coverageFormularyDrugsCapsule formulationSubstantial proportionMedicationsDeathRiskSafety informationFDAYearsUS drug marketing: how does promotion correspond with health value?
Greenway T, Ross JS. US drug marketing: how does promotion correspond with health value? The BMJ 2017, 357: j1855. PMID: 28465309, DOI: 10.1136/bmj.j1855.Peer-Reviewed Original ResearchMeSH KeywordsDrug IndustryDrug PrescriptionsHealth PromotionHumansMarketingMotivationPractice Patterns, Physicians'Prescription DrugsUnited States