Regulatory Science Publications


Luo, J., Kesselheim, A.S., Greene, J., and Lipska, K.J. (2017a). Strategies to improve the affordability of insulin in the USA. Lancet Diabetes Endocrinol 5, 158–159.

Kesselheim, A.S., McGraw, S.A., Dejene, S.Z., Rausch, P., Dal Pan, G.J., Lappin, B.M., Zhou, E.H., Avorn, J., and Campbell, E.G. (2017a). Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study. Drug Saf. ePub ahead of print

Fralick, M., and Kesselheim, A.S. (2017). Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available. Pharmacoepidemiol. Drug Saf. ePub ahead of print

Kesselheim, A.S., and Avorn, J. (2017). New “21st Century Cures” Legislation: Speed and Ease vs Science. JAMA 317, 581–582.

Gagne, J.J., Polinski, J.M., Jiang, W., Dutcher, S.K., Xie, J., Lii, J., Fulchino, L.A., and Kesselheim, A.S. (2017). Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. ePub ahead of print

Guo, E., Jacobs, D.B., and Kesselheim, A.S. (2017). Eliminating Coverage Discrimination Through the Essential Health Benefit’s Anti-Discrimination Provisions. Am. J. Public Health 107, 253–254.

Rathi, V.K., Wang, B., Ross, J.S., Downing, N.S., Kesselheim, A.S., and Gray, S.T. (2017a). Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014. Otolaryngol. Head Neck Surg. 156, 285–288.

Kesselheim, A.S., Rome, B.N., Sarpatwari, A., and Avorn, J. (2017a). Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff. 36, 362–370.

Sarpatwari, A., Gagne, J.J., Levidow, N.L., and Kesselheim, A.S. (2017). Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 40, 105–108.

Deak, D., Powers, J.H., Outterson, K., and Kesselheim, A.S. (2017). The Fight Against Multidrug-Resistant Bacteria. Ann. Intern. Med. 166, 79.

Luo, J., Gagne, J.J., Landon, J., Avorn, J., and Kesselheim, A.S. (2017b). Comparative effectiveness and safety of thalidomide and lenalidomide in patients with multiple myeloma in the United States of America: A population-based cohort study. Eur. J. Cancer 70, 22–33.

Gupta, R., Kesselheim, A.S., and Ross, J.S. (2017). Prioritization of Generic Drug Review-Reply. JAMA Intern. Med. 177, 141–142.

Kesselheim, A.S., Treasure, C.L., and Joffe, S. (2017b). Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 14, e1002190.

Rathi, V.K., Wang, B., Ross, J.S., Downing, N.S., Kesselheim, A.S., and Gray, S.T. (2017b). Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014. Otolaryngol. Head Neck Surg. 194599816689666.

Sinha, M.S., and Kesselheim, A.S. (2016). Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg. Med. Chem. 24, 6446–6451.

Robertson, C., and Kesselheim, A.S. (2016). Regulating Off-Label Promotion – A Critical Test. N. Engl. J. Med. 375, 2313–2315.

Kesselheim, A.S., and Avorn, J. (2016). Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy. JAMA 316, 2357–2358.

Sarpatwari, A., Avorn, J., and Kesselheim, A.S. (2016). Factors Influencing Prescription Drug Costs in the United States-Reply. JAMA 316, 2431–2432.

Hwang, T.J., Carpenter, D., Lauffenburger, J.C., Wang, B., Franklin, J.M., and Kesselheim, A.S. (2016a). Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA Intern. Med. 176, 1826–1833.

Hwang, T.J., and Kesselheim, A.S. (2016). Public referendum on drug prices in the US: will it bring relief? BMJ 355, i5657.

Kesselheim, A.S., Bykov, K., Gagne, J.J., Wang, S.V., and Choudhry, N.K. (2016a). Switching generic antiepileptic drug manufacturer not linked to seizures: A case-crossover study. Neurology 87, 1796–1801.

Kesselheim, A.S., Eddings, W., Raj, T., Campbell, E.G., Franklin, J.M., Ross, K.M., Fulchino, L.A., Avorn, J., and Gagne, J.J. (2016b). Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval. PLoS One 11, e0163339.

Kimmelman, J., and Kesselheim, A.S. (2016). Translational research and the U.S. federal elections. Sci. Transl. Med. 8, 361ed13.

Kesselheim, A.S., and Gagne, J.J. (2016). Prescription Trends-Brand-Name Drugs vs Generic-Reply. JAMA Intern. Med. 176, 1574–1575.

Cárdenas-González, M., Osorio-Yáñez, C., Gaspar-Ramírez, O., Pavković, M., Ochoa-Martínez, A., López-Ventura, D., Medeiros, M., Barbier, O.C., Pérez-Maldonado, I.N., Sabbisetti, V.S., et al. (2016a). Environmental exposure to arsenic and chromium in children is associated with kidney injury molecule-1. Environ. Res. 150, 653–662.

Yeh, J.S.-J., Franklin, J.M., and Kesselheim, A.S. (2016). Payments to Physicians, Prescribing Rates, and More Appropriate Conclusions-Reply. JAMA Intern. Med. 176, 1577.

Hey, S.P., and Kesselheim, A.S. (2016a). The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ 354, i4435.

Hey, S.P., and Kesselheim, A.S. (2016b). BIOMEDICAL RESEARCH. Countering imprecision in precision medicine. Science 353, 448–449.

Pavkovic, M., Robinson-Cohen, C., Chua, A.S., Nicoara, O., Cárdenas-González, M., Bijol, V., Ramachandran, K., Hampson, L., Pirmohamed, M., Antoine, D.J., et al. (2016). Detection of Drug-Induced Acute Kidney Injury in Humans Using Urinary KIM-1, miR-21, -200c, and -423. Toxicol. Sci. 152, 205–213.

Pavkovic, M., and Vaidya, V.S. (2016). MicroRNAs and drug-induced kidney injury. Pharmacol. Ther. 163, 48–57.

Hwang, T.J., Sokolov, E., Franklin, J.M., and Kesselheim, A.S. (2016b). Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ 353, i3323.

Kesselheim, A.S., and Hwang, T.J. (2016). Breakthrough Medical Devices and the 21st Century Cures Act. Ann. Intern. Med. 164, 500–502.

Capati, V.C., and Kesselheim, A.S. (2016). Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine. J Manag Care Spec Pharm 22, 339–344.

Cárdenas-González, M., Jacobo Estrada, T., Rodríguez-Muñoz, R., Barrera-Chimal, J., Bobadilla, N.A., Barbier, O.C., and Del Razo, L.M. (2016b). Sub-chronic exposure to fluoride impacts the response to a subsequent nephrotoxic treatment with gentamicin. J. Appl. Toxicol. 36, 309–319.

Luo, J., and Kesselheim, A.S. (2016). Insulin patents and market exclusivities: unresolved issues–Authors’ reply. Lancet Diabetes Endocrinol 4, 98–99.

Podolsky, S.H., and Kesselheim, A.S. (2016). Regulating Homeopathic Products – A Century of Dilute Interest. N. Engl. J. Med. 374, 201–203.

Kesselheim, A.S., Avorn, J., and Sarpatwari, A. (2016c). The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA 316, 858–871.

Pavkovic, M., Riefke, B., Frisk, A.-L., Gröticke, I., and Ellinger-Ziegelbauer, H. (2015). Glomerulonephritis-induced changes in kidney gene expression in rats. Genom Data 6, 81–82.

Sarpatwari, A., and Kesselheim, A.S. (2015). The 21st century cures act: Opportunities and challenges. Clin. Pharmacol. Ther. 98, 575–577.

Luo, J., and Kesselheim, A.S. (2015a). Cost-effectiveness of Statin Therapy for ASCVD. JAMA 314, 2191.

Luo, J., and Kesselheim, A.S. (2015b). Evolution of insulin patents and market exclusivities in the USA. Lancet Diabetes Endocrinol 3, 835–837.

Kesselheim, A.S., Maggs, L.R., and Sarpatwari, A. (2015a). Experience With the Priority Review Voucher Program for Drug Development. JAMA 314, 1687–1688.

Luo, J., and Kesselheim, A.S. (2015). The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA 314, 1563–1564.

Kesselheim, A.S., and Gagne, J.J. (2015). Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness. Drug Saf. 38, 849–853.

Luo, J., Avorn, J., and Kesselheim, A.S. (2015). Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014. JAMA Intern. Med. 175, 1681–1686.

Kesselheim, A.S., Wang, B., Franklin, J.M., and Darrow, J.J. (2015b). Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ 351, h4633.

Wang, B., and Kesselheim, A.S. (2015). Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ 351, h4679.

Ross, J.S., and Kesselheim, A.S. (2015). FDA Policy and Cardiovascular Medicine. Circulation 132, 1136–1145.

Avorn, J., Sarpatwari, A., and Kesselheim, A.S. (2015). Forbidden and Permitted Statements about Medications–Loosening the Rules. N. Engl. J. Med. 373, 967–973.

Bateman, B.T., and Kesselheim, A.S. (2015). Propofol as a transformative drug in anesthesia: insights from key early investigators. Drug Discov. Today 20, 1012–1017.

Avorn, J., and Kesselheim, A.S. (2015). The 21st Century Cures Act–Will It Take Us Back in Time? N. Engl. J. Med. 372, 2473–2475.

Wang, B., Liu, J., and Kesselheim, A.S. (2015a). Variations in time of market exclusivity among top-selling prescription drugs in the United States. JAMA Intern. Med. 175, 635–637.

Kesselheim, A.S., Connolly, J., Rogers, J., and Avorn, J. (2015c). Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues. Health Aff. 34, 438–446.

Wang, B., Choudhry, N.K., Gagne, J.J., Landon, J., and Kesselheim, A.S. (2015b). Availability and utilization of cardiovascular fixed-dose combination drugs in the United States. Am. Heart J. 169, 379–386.e1.

Sarpatwari, A., Choudhry, N.K., Avorn, J., and Kesselheim, A.S. (2015a). Paying physicians to prescribe generic drugs and follow-on biologics in the United States. PLoS Med. 12, e1001802.

Hwang, T.J., Carpenter, D., and Kesselheim, A.S. (2015). Paying for innovation: reimbursement incentives for antibiotics. Sci. Transl. Med. 7, 276fs9.

Sarpatwari, A., Franklin, J.M., Avorn, J., Seeger, J.D., Landon, J.E., and Kesselheim, A.S. (2015b). Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin. Pharmacol. Ther. 97, 186–193.

Kesselheim, A.S., McGraw, S., Thompson, L., O’Keefe, K., and Gagne, J.J. (2015d). Development and use of new therapeutics for rare diseases: views from patients, caregivers, and advocates. Patient 8, 75–84.

Kesselheim, A.S., Tan, Y.T., and Avorn, J. (2015e). The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff. 34, 286–293.

Darrow, J.J., and Kesselheim, A.S. (2015). A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges? Food Drug Law J. 70, 243–258, i.

Kesselheim, A.S., and Darrow, J.J. (2015). Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era? Yale J. Health Policy Law Ethics 15, 293–347.

Rajan, P.V., Kramer, D.B., and Kesselheim, A.S. (2015). Medical device postapproval safety monitoring: where does the United States stand? Circ. Cardiovasc. Qual. Outcomes 8, 124–131.

Sarpatwari, A., Kesselheim, A.S., Malin, B.A., Gagne, J.J., and Schneeweiss, S. (2014). Ensuring patient privacy in data sharing for postapproval research. N. Engl. J. Med. 371, 1644–1649.

Kesselheim, A.S., Tan, Y.T., Darrow, J.J., and Avorn, J. (2014a). Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff. 33, 1770–1778.

Kesselheim, A.S., and Rajan, P.V. (2014). Regulating incremental innovation in medical devices. BMJ 349, g5303.

Kesselheim, A.S., Bykov, K., Avorn, J., Tong, A., Doherty, M., and Choudhry, N.K. (2014b). Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies. Ann. Intern. Med. 161, 96–103.

Darrow, J.J., Avorn, J., and Kesselheim, A.S. (2014). New FDA breakthrough-drug category–implications for patients. N. Engl. J. Med. 371, 89–90.

Hwang, T.J., Carpenter, D., and Kesselheim, A.S. (2014). Target small firms for antibiotic innovation. Science 344, 967–969.

Treasure, C.L., Avorn, J., and Kesselheim, A.S. (2014). What is the public’s right to access medical discoveries based on federally funded research? JAMA 311, 907–908.

Gellad, W.F., Choi, P., Mizah, M., Good, C.B., and Kesselheim, A.S. (2014). Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011. Am. J. Manag. Care 20, e90–e97.

Xu, S., and Kesselheim, A.S. (2014). Medical innovation then and now: perspectives of innovators responsible for transformative drugs. J. Law Med. Ethics 42, 564–575.