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 ResearchConceptsCross-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 sales
2019
Generic 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
Affordability 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
The 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 PharmacistsClinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014. Otolaryngology 2017, 156: 683-692. PMID: 28116974, DOI: 10.1177/0194599816689666.Peer-Reviewed Original ResearchConceptsPivotal studiesOriginal indicationPrimary endpointClinical evidenceDrug indicationsSupplemental indicationsUS FoodFDA approvalAvailable FDA documentsDouble-blinded studyDrug Administration approvalInformed treatment decisionsPivotal clinical studiesPremarket evidenceOtolaryngologic diseaseMedian enrollmentSurrogate markerAdministration approvalClinical studiesTreatment decisionsMost indicationsDrug AdministrationInitial approvalMultidisciplinary teamPrescription drugs
2011
Generic Atorvastatin and Health Care Costs
Jackevicius CA, Chou MM, Ross JS, Shah ND, Krumholz HM. Generic Atorvastatin and Health Care Costs. New England Journal Of Medicine 2011, 366: 201-204. PMID: 22149736, PMCID: PMC3319770, DOI: 10.1056/nejmp1113112.Peer-Reviewed Original Research