Aaron S Kesselheim

Aaron S Kesselheim

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Aaron S Kesselheim

Aaron S Kesselheim

Publications by authors named "Aaron S Kesselheim"

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Decision-making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the US and Europe.

Clin Pharmacol Ther 2020 Apr 1. Epub 2020 Apr 1.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, Massachusetts, USA, 02120.

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http://dx.doi.org/10.1002/cpt.1835DOI Listing
April 2020

New drug approvals in oncology.

Nat Rev Clin Oncol 2020 Mar 4;17(3):140-146. Epub 2020 Feb 4.

Friends of Cancer Research, Washington, DC, USA.

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http://dx.doi.org/10.1038/s41571-019-0313-2DOI Listing
March 2020

Federal Spending on Off-Patent Drugs That Lack Generic Competition.

J Gen Intern Med 2020 Mar 6. Epub 2020 Mar 6.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-020-05752-yDOI Listing
March 2020

Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018.

Drug Saf 2020 Mar 16. Epub 2020 Mar 16.

From the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA.

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http://dx.doi.org/10.1007/s40264-020-00923-6DOI Listing
March 2020

Using real-world safety data in regulatory approval decisions: Sotagliflozin and the risk of diabetic ketoacidosis.

Pharmacoepidemiol Drug Saf 2020 Mar 18. Epub 2020 Mar 18.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1002/pds.4994DOI Listing
March 2020

Generating comparative evidence on new drugs and devices before approval.

Lancet 2020 03;395(10228):986-997

Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.

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http://dx.doi.org/10.1016/S0140-6736(19)33178-2DOI Listing
March 2020

Insulin access and affordability in the USA: anticipating the first interchangeable insulin product.

Lancet Diabetes Endocrinol 2020 Mar 20. Epub 2020 Mar 20.

Program on Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1016/S2213-8587(20)30105-4DOI Listing
March 2020

Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study.

PLoS Med 2020 Mar 31;17(3):e1003058. Epub 2020 Mar 31.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1003058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7108689PMC
March 2020

Estimation of Medicare Part D Spending on Insulin for Patients With Diabetes Using Negotiated Prices and a Defined Formulary.

JAMA Intern Med 2020 Feb 3. Epub 2020 Feb 3.

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2019.7018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042836PMC
February 2020

Novelty of Active Ingredients in High-Cost Brand-Name Drugs.

J Gen Intern Med 2020 Jan 2. Epub 2020 Jan 2.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-019-05565-8DOI Listing
January 2020

Response Rates and Durations of Response for Biomarker-Based Cancer Drugs in Nonrandomized Versus Randomized Trials.

J Natl Compr Canc Netw 2020 01;18(1):36-43

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; and.

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http://dx.doi.org/10.6004/jnccn.2019.7345DOI Listing
January 2020

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

JAMA 2020 01;323(2):164-176

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2019.20288DOI Listing
January 2020

Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support.

Ann Intern Med 2020 Jan 28. Epub 2020 Jan 28.

Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (A.S., A.K.L., A.S.K.).

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http://dx.doi.org/10.7326/M19-2576DOI Listing
January 2020

Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?

Open Forum Infect Dis 2020 Jan 28;7(1):ofaa001. Epub 2020 Jan 28.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1093/ofid/ofaa001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6986775PMC
January 2020

Reply to Boucher, et al.

Clin Infect Dis 2020 Jan 30. Epub 2020 Jan 30.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

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http://dx.doi.org/10.1093/cid/ciaa095DOI Listing
January 2020

FDA and EMA Biosimilar Approvals.

J Gen Intern Med 2019 Dec 2. Epub 2019 Dec 2.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-019-05408-6DOI Listing
December 2019

Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications.

Mayo Clin Proc 2019 12 2;94(12):2437-2443. Epub 2019 Nov 2.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. Electronic address:

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http://dx.doi.org/10.1016/j.mayocp.2019.05.015DOI Listing
December 2019

Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.

JAMA Intern Med 2019 Dec 2. Epub 2019 Dec 2.

Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2019.5337DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902106PMC
December 2019

Correction to: FDA and EMA Biosimilar Approvals.

J Gen Intern Med 2019 Dec 5. Epub 2019 Dec 5.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-019-05558-7DOI Listing
December 2019

The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation.

J Law Med Ethics 2019 Dec;47(4):783-787

Christopher J. Morten, J.D., Ph.D., is a Fellow of the Engelberg Center on Innovation Law & Policy and the Teaching Fellow and Supervising Attorney in the Technology Law & Policy Clinic at New York University School of Law. He is also a Visiting Fellow of the Information Society Project at Yale Law School. He received his JD from NYU Law, a PhD in organic chemistry from the Massachusetts Institute of Technology, and a BA in chemistry from Columbia University. Aaron S. Kesselheim, M.D., J.D., M.P.H., is a Professor of Medicine at Harvard Medical School and Director of the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. His work is funded by Arnold Ventures, the Harvard-MIT Center for Regulatory Science, and the Engelberg Foundation. Joseph S. Ross, M.D., M.H.S., is a Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale School of Medicine, a member of the Center for Outcomes Research and Evaluation at Yale-New Haven Health System, and Co-Director of the National Clinician Scholars Program at Yale.

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http://dx.doi.org/10.1177/1073110519897793DOI Listing
December 2019

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Drug Saf 2019 11;42(11):1287-1295

US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

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http://dx.doi.org/10.1007/s40264-019-00849-8DOI Listing
November 2019

Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions.

J Gen Intern Med 2019 Nov;34(11):2339-2341

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-019-05150-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848320PMC
November 2019

Physician Perceptions of Step Therapy Prescribing Requirements.

J Manag Care Spec Pharm 2019 Nov;25(11):1210-1224

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.18553/jmcp.2019.25.11.1210DOI Listing
November 2019

The U.S. Insulin Crisis - Rationing a Lifesaving Medication Discovered in the 1920s.

N Engl J Med 2019 Nov;381(19):1793-1795

From Mount Sinai Hospital and the Division of General Internal Medicine, Department of Medicine, University of Toronto - both in Toronto (M.F.); and the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (A.K.).

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http://dx.doi.org/10.1056/NEJMp1909402DOI Listing
November 2019

Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.

Circ Cardiovasc Qual Outcomes 2019 Nov 11;12(11):e006073. Epub 2019 Nov 11.

Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).

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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006073DOI Listing
November 2019

US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.

JAMA Intern Med 2019 Nov 11. Epub 2019 Nov 11.

Department of Medicine, George Washington University School of Medicine, Rockville, Maryland.

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http://dx.doi.org/10.1001/jamainternmed.2019.5451DOI Listing
November 2019

Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.

JAMA 2019 Nov 22. Epub 2019 Nov 22.

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2019.16842DOI Listing
November 2019

Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act.

Ann Intern Med 2019 Oct 1. Epub 2019 Oct 1.

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (A.S.K.).

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http://dx.doi.org/10.7326/M19-1218DOI Listing
October 2019

Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study.

Ann Intern Med 2019 Oct 1. Epub 2019 Oct 1.

Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (J.L., M.K., A.S., A.P., A.S.K.).

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http://dx.doi.org/10.7326/M18-1138DOI Listing
October 2019

Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.

BMJ Open 2019 10 10;9(10):e028634. Epub 2019 Oct 10.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1136/bmjopen-2018-028634DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797305PMC
October 2019

Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.

Clin Infect Dis 2019 Oct 20. Epub 2019 Oct 20.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

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http://dx.doi.org/10.1093/cid/ciz1039DOI Listing
October 2019

Desmopressin and the risk of hyponatremia: A population-based cohort study.

PLoS Med 2019 10 21;16(10):e1002930. Epub 2019 Oct 21.

Division of Pharmacoepidemiology and Pharmacoeconomics, Program On Regulation, Therapeutics, And Law (PORTAL), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1002930DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802819PMC
October 2019

Public sector financial support for late stage discovery of new drugs in the United States: cohort study.

BMJ 2019 10 23;367:l5766. Epub 2019 Oct 23.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Boston, MA 02120, USA

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http://dx.doi.org/10.1136/bmj.l5766DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812612PMC
October 2019

A Systematic Review and Meta-analysis of Bevacizumab in First-line Metastatic Breast Cancer: Lessons for the Research and Regulatory Enterprises.

J Natl Cancer Inst 2019 Oct 25. Epub 2019 Oct 25.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1093/jnci/djz211DOI Listing
October 2019

Confidentiality Orders and Public Interest in Drug and Medical Device Litigation.

JAMA Intern Med 2019 Oct 28:1-8. Epub 2019 Oct 28.

Collaboration for Research Integrity and Transparency, Yale Law School, New Haven, Connecticut.

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http://dx.doi.org/10.1001/jamainternmed.2019.5161DOI Listing
October 2019

Changes in Price for Generic Drugs in the USA, 2008-2016.

J Gen Intern Med 2019 Sep;34(9):1677-1679

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-019-05033-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6712128PMC
September 2019

Challenges and Opportunities for Biomarker Validation.

J Law Med Ethics 2019 Sep;47(3):357-361

Spencer Phillips Hey, Ph.D., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. He is also affiliated with the Center for Bioethics at Harvard Medical School. Elvira D'Andrea, M.D., M.P.H., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Emily H. Jung, A.B., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Frazer Tessema, B.A., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Jing Luo, M.D., M.P.H., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Bishal Gyawali, M.D., Ph.D., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. He is also affiliated with the Center for Bioethics at Harvard Medical School, and serves as the Edited-in-Chief of the Journal of Law, Medicine & Ethics.

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http://dx.doi.org/10.1177/1073110519876162DOI Listing
September 2019

Lung Cancer Survival Gains: Contributions of Academia and Industry.

J Law Med Ethics 2019 Sep;47(3):465-467

Bishal Gyawali, M.D., Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA, the Anticancer Fund, Belgium, and the Department of Oncology and Division of Cancer Care and Epidemiology, Queen's University, Kingston, Canada. Gauthier Bouche, M.D., M.P.H., is with the Anticancer Fund, Belgium Pan Pantziarka, Ph.D.,is with the Anticancer Fund, Belgium. Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Ameet Sarpatwari, Ph.D., J.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1177/1073110519876182DOI Listing
September 2019

Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.

J Law Med Ethics 2019 Sep;47(3):381-387

Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.

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http://dx.doi.org/10.1177/1073110519876167DOI Listing
September 2019

Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.

J Law Med Ethics 2019 Sep;47(3):430-441

Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO.

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http://dx.doi.org/10.1177/1073110519876176DOI Listing
September 2019

Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs.

Health Policy 2019 Aug 12;123(8):721-727. Epub 2019 Jun 12.

Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1016/j.healthpol.2019.06.002DOI Listing
August 2019

Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.

JAMA Intern Med 2019 Aug 5. Epub 2019 Aug 5.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2019.3107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686978PMC
August 2019

Why Are Biosimilars Not Living up to Their Promise in the US?

AMA J Ethics 2019 08 1;21(8):E668-678. Epub 2019 Aug 1.

A professor of medicine at Harvard Medical School in Boston, Massachusetts, and the director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital.

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http://dx.doi.org/10.1001/amajethics.2019.668DOI Listing
August 2019

Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation.

N Engl J Med 2019 08;381(9):875-881

From the Pediatric Therapeutics and Regulatory Science Initiative and the Computational Health Informatics Program, Boston Children's Hospital, and the Department of Pediatrics, Harvard Medical School (F.T.B.), and the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (A.S.K.) - all in Boston.

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http://dx.doi.org/10.1056/NEJMhle1901265DOI Listing
August 2019

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.

JAMA Netw Open 2019 Aug 2;2(8):e199570. Epub 2019 Aug 2.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamanetworkopen.2019.9570DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724156PMC
August 2019

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.

JAMA Intern Med 2019 Jul;179(7):906-913

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jam
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http://dx.doi.org/10.1001/jamainternmed.2019.0462DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547118PMC
July 2019

Pre-market development times for biologic versus small-molecule drugs.

Nat Biotechnol 2019 07;37(7):708-711

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1038/s41587-019-0175-2DOI Listing
July 2019

The Impact Of Price Regulation On The Availability Of New Drugs In Germany.

Health Aff (Millwood) 2019 07;38(7):1182-1187

Ameet Sarpatwari is an instructor in medicine at Harvard Medical School and assistant director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School.

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http://dx.doi.org/10.1377/hlthaff.2018.05142DOI Listing
July 2019

Reforming the Orphan Drug Act for the 21st Century.

N Engl J Med 2019 Jul;381(2):106-108

From the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston.

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http://dx.doi.org/10.1056/NEJMp1902943DOI Listing
July 2019

Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis.

BMJ 2019 07 17;366:l4257. Epub 2019 Jul 17.

Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA

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http://dx.doi.org/10.1136/bmj.l4257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6635813PMC
July 2019

Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

JAMA Netw Open 2019 Jul 3;2(7):e197591. Epub 2019 Jul 3.

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamanetworkopen.2019.7591DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6659147PMC
July 2019

Competition and price among brand-name drugs in the same class: A systematic review of the evidence.

PLoS Med 2019 07 30;16(7):e1002872. Epub 2019 Jul 30.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1002872DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667132PMC
July 2019

Trust and transparency in medical device regulation.

BMJ 2019 06 18;365:l4166. Epub 2019 Jun 18.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.

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http://dx.doi.org/10.1136/bmj.l4166DOI Listing
June 2019

Orphan Drug Designation and Exclusivity for "Same Drugs".

J Law Med Ethics 2019 Jun;47(2):347-349

Phebe Hong is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, and a student at Harvard Law School. Ameet Sarpatwari, J.D., Ph.D., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., leads the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1177/1073110519857293DOI Listing
June 2019

Landscape of Cardiovascular Device Registries in the United States.

J Am Heart Assoc 2019 06 1;8(11):e012756. Epub 2019 Jun 1.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA.

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http://dx.doi.org/10.1161/JAHA.119.012756DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585371PMC
June 2019

Physicians' Perspectives on FDA Approval Standards and Off-label Drug Marketing.

JAMA Intern Med 2019 05;179(5):707-709

The Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.

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http://dx.doi.org/10.1001/jamainternmed.2018.8121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503563PMC
May 2019

Cost Implications of Escalating Intravenous Acetaminophen Use in Children.

JAMA Pediatr 2019 05;173(5):489-491

Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamapediatrics.2019.0101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503505PMC
May 2019

US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?

JAMA Oncol 2019 May;5(5):607-608

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamaoncol.2019.0093DOI Listing
May 2019

Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return?

N Engl J Med 2019 May 1;380(21):1993-1995. Epub 2019 May 1.

From the Council on Foreign Relations, Washington, DC (T.B.); and the Program on Regulation, Therapeutics, and Law (PORTAL), Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston (A.S.K.).

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http://dx.doi.org/10.1056/NEJMp1902240DOI Listing
May 2019

Experiences With and Challenges Afforded by Expedited Regulatory Pathways.

Clin Pharmacol Ther 2019 04;105(4):795-797

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1002/cpt.1365DOI Listing
April 2019

Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis.

JAMA Netw Open 2019 04 5;2(4):e192224. Epub 2019 Apr 5.

Program on Regulation, Therapeutics, and Law (PORTAL) Biomarker Research Consortium, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://jamanetworkopen.jamanetwork.com/article.aspx?doi=10.1
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http://dx.doi.org/10.1001/jamanetworkopen.2019.2224DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6481429PMC
April 2019

The promise of ESCAT: a new system for evaluating cancer drug-target pairs.

Nat Rev Clin Oncol 2019 03;16(3):147-148

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1038/s41571-018-0110-3DOI Listing
March 2019

A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.

J Gen Intern Med 2019 03 10;34(3):420-428. Epub 2019 Jan 10.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1007/s11606-018-4791-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6420535PMC
March 2019

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.

JAMA Intern Med 2019 03;179(3):374-380

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jam
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http://dx.doi.org/10.1001/jamainternmed.2018.6417DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439690PMC
March 2019

Tepid Steps on Drug Pricing.

JAMA Intern Med 2019 03;179(3):439-441

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jam
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http://dx.doi.org/10.1001/jamainternmed.2018.6593DOI Listing
March 2019

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.

PLoS Med 2019 03 13;16(3):e1002763. Epub 2019 Mar 13.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.

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http://dx.plos.org/10.1371/journal.pmed.1002763
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http://dx.doi.org/10.1371/journal.pmed.1002763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6415809PMC
March 2019

Major Events in the Life Course of New Drugs, 2000-2016.

N Engl J Med 2019 Mar;380(11):e12

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http://dx.doi.org/10.1056/NEJMp1806930DOI Listing
March 2019

Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead.

Issue Brief (Commonw Fund) 2019 Mar 1;2019:1-11. Epub 2019 Mar 1.

Brigham and Women’s Hospital/Harvard Medical School.

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March 2019

Approximating Future Generic Entry for New Drugs.

J Law Med Ethics 2019 Mar;47(1):177-182

Reed F. Beall, Ph.D., is an Assistant Professor at the Cummings School of Medicine and O'Brien Institute of Public Health, University of Calgary, Calgary, AB, Canada. He is also affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Jonathan J. Darrow, S.J.D., J.D., M.B.A., is affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Aaron S. Kesselheim, M.D., J.D., M.P.H., is affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1177/1073110519840499DOI Listing
March 2019

The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents.

Appl Health Econ Health Policy 2019 02;17(1):47-54

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA.

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http://dx.doi.org/10.1007/s40258-018-0420-8DOI Listing
February 2019

Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate.

J Gen Intern Med 2019 02;34(2):195-197

Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, USA.

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http://dx.doi.org/10.1007/s11606-018-4688-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6374246PMC
February 2019

Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.

JAMA Intern Med 2019 02;179(2):224-230

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2018.6112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439654PMC
February 2019

New Drug Formulations and Their Respective Generic Entry Dates.

J Manag Care Spec Pharm 2019 Feb;25(2):218-224

2 Program On Regulation, Therapeutics, And Law (PORTAL) and Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.18553/jmcp.2019.25.2.218DOI Listing
February 2019

Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.

Health Aff (Millwood) 2019 02;38(2):313-319

Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School.

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http://dx.doi.org/10.1377/hlthaff.2018.05330DOI Listing
February 2019

Patent term restoration for top-selling drugs in the United States.

Drug Discov Today 2019 01 25;24(1):20-25. Epub 2018 Jul 25.

Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham & Women's Hospital, Department of Medicine, Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA 02120, USA.

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http://dx.doi.org/10.1016/j.drudis.2018.07.006DOI Listing
January 2019

Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.

Drug Saf 2019 01;42(1):85-93

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.

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http://dx.doi.org/10.1007/s40264-018-0703-xDOI Listing
January 2019

Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality?

Int J Cancer 2019 01 26;144(2):411-412. Epub 2018 Oct 26.

Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1002/ijc.31772DOI Listing
January 2019

Changes in Drug Pricing After Drug Shortages in the United States.

Ann Intern Med 2019 01 18;170(1):74-76. Epub 2018 Sep 18.

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (W.H.S.).

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http://annals.org/article.aspx?doi=10.7326/M18-1137
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http://dx.doi.org/10.7326/M18-1137DOI Listing
January 2019

The US Biosimilar Market: Stunted Growth and Possible Reforms.

Clin Pharmacol Ther 2019 01 28;105(1):92-100. Epub 2018 Dec 28.

Program On Regulation, Therapeutics, And Law (PORTAL), Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

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http://doi.wiley.com/10.1002/cpt.1285
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http://dx.doi.org/10.1002/cpt.1285DOI Listing
January 2019

An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Nat Biotechnol 2019 01;37(1):21-22

Harvard Medical School and Brigham & Women's Hospital, Boston, Massachusetts, USA.

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http://www.nature.com/doifinder/10.1038/nbt.4324
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http://dx.doi.org/10.1038/nbt.4324DOI Listing
January 2019

Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes.

JAMA 2019 01;321(4):374-384

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2018.21364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439763PMC
January 2019

Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015.

Drug Saf 2018 12;41(12):1333-1342

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Suite #3030, 1620 Tremont Street, Boston, MA, 02120, USA.

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http://dx.doi.org/10.1007/s40264-018-0697-4DOI Listing
December 2018

A Method for Approximating Future Entry of Generic Drugs.

Value Health 2018 12 11;21(12):1382-1389. Epub 2018 Jun 11.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1016/j.jval.2018.04.1827DOI Listing
December 2018

Predictors of Drug Shortages and Association with Generic Drug Prices: A Retrospective Cohort Study.

Value Health 2018 11 18;21(11):1286-1290. Epub 2018 May 18.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.

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http://dx.doi.org/10.1016/j.jval.2018.04.1826DOI Listing
November 2018

Reinforcing the social compromise of accelerated approval.

Nat Rev Clin Oncol 2018 10;15(10):596-597

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1038/s41571-018-0066-3DOI Listing
October 2018

A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.

Health Aff (Millwood) 2018 10;37(10):1605-1614

Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.

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http://dx.doi.org/10.1377/hlthaff.2018.0501DOI Listing
October 2018

The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.

J Law Med Ethics 2018 09;46(3):806-808

Michael S. Sinha, M.D., J.D., M.P.H., is with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmaco-economics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate Professor of Medicine at Harvard Medical School and Director of the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital and a faculty member at the Harvard Center for Bioethics in Boston. He is also a faculty member at the Harvard Center for Bioethics.

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http://dx.doi.org/10.1177/1073110518804246DOI Listing
September 2018

Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents.

JAMA 2018 08;320(7):650-656

Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.20
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http://dx.doi.org/10.1001/jama.2018.11439DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6142946PMC
August 2018

The Shortage of Normal Saline in the Wake of Hurricane Maria.

JAMA Intern Med 2018 07;178(7):885-886

Program on Regulation, Therapeutics, and Law (PORTAL), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2018.1936DOI Listing
July 2018

An Incomplete Prescription: President Trump's Plan to Address High Drug Prices.

JAMA 2018 06;319(23):2373-2374

The Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2018.7424DOI Listing
June 2018

Defining "True and Non-Misleading" for Pharmaceutical Promotion.

J Law Med Ethics 2018 06;46(2):552-554

Spencer Phillips Hey, Ph.D., is a Research Scientist in the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital and a faculty member at the Harvard Center for Bioethics in Boston. Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate Professor of Medicine at Harvard Medical School and Director of the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital and a faculty member at the Harvard Center for Bioethics in Boston. He is also a faculty member at the Harvard Center for Bioethics.

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http://dx.doi.org/10.1177/1073110518782970DOI Listing
June 2018

Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio.

J Law Med Ethics 2018 06;46(2):472-484

Alex Wang is a J.D. candidate at Yale Law School. He holds a B.A. from NYU Abu Dhabi, and a second B.A. from the University of Oxford. Aaron S. Kesselheim, M.D., J.D., M.P.H., is an associate professor of medicine at Harvard Medical School and leads the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital. He serves as an Irving S. Ribicoff Visiting Associate Professor of Law at Yale Law School and as a Distinguished Visitor at the Solomon Center for Health Law & Policy.

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http://dx.doi.org/10.1177/1073110518782954DOI Listing
June 2018

A Comparison of Response Patterns for Progression-Free Survival and Overall Survival Following Treatment for Cancer With PD-1 Inhibitors: A Meta-analysis of Correlation and Differences in Effect Sizes.

JAMA Netw Open 2018 06 1;1(2):e180416. Epub 2018 Jun 1.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.

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http://jamanetworkopen.jamanetwork.com/article.aspx?doi=10.1
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http://dx.doi.org/10.1001/jamanetworkopen.2018.0416DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324401PMC
June 2018

The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.

PLoS Med 2018 05 8;15(5):e1002564. Epub 2018 May 8.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1002564DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5940176PMC
May 2018

Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem.

JAMA Intern Med 2018 05;178(5):721-722

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2018.0989DOI Listing
May 2018

Expansion of the Priority Review Voucher Program Under the 21 Century Cures Act: Implications for Innovation and Public Health.

Am J Law Med 2018 May;44(2-3):329-341

M.D., J.D., M.P.H., Associate Professor of Medicine, Harvard Medical School and Director, PORTAL, Brigham and Women's Hospital, Boston, MA. The work at PORTAL is supported by the Laura and John Arnold Foundation, with additional support from the Engelberg Foundation and the Harvard Program in Therapeutic Science.

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http://dx.doi.org/10.1177/0098858818789430DOI Listing
May 2018

Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016.

JNCI Cancer Spectr 2018 Apr 1;2(2):pky016. Epub 2018 Jun 1.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

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http://dx.doi.org/10.1093/jncics/pky016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649801PMC
April 2018