Michael Sinha

Dr. Sinha is a Regulatory Science Fellow in the new Harvard-MIT Center for Regulatory Science, within the Harvard Program in Therapeutic Science (HiTS) at Harvard Medical School. He is also affiliated with the Program On Regulation, Therapeutics, And Law (PORTAL), within the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine at Brigham and Women’s Hospital. His legal scholarship includes articles in the American Journal of Legal Medicine, the American Journal of Law and Medicine, the Journal of Law, Medicine & Ethics, the Harvard Law & Policy Review, the Food and Drug Law Journal, the Stanford Law & Policy Review (forthcoming), and the Hastings Law Journal (forthcoming). Medical publications have appeared in JAMA, JAMA Internal Medicine, CHEST, PLOS Medicine, the American Journal of Bioethics, and the Health Affairs Blog.

Education

2003 B.A. (cum laude) Biophysical Chemistry (Honors) Dartmouth College, Hanover, NH

2012 M.D. Medicine Southern Illinois University School of Medicine, Springfield, IL

2012 J.D. (cum laude) Law Southern Illinois University School of Law, Carbondale, IL

2012-2014 Resident Internal Medicine / Preventive Medicine Griffin Hospital / Yale School of Public Health, Derby, CT 2015 M.P.H. Law and Public Health Harvard T.H. Chan School of Public Health, Boston, MA

2015-2016 Resident Internal Medicine Boston Medical Center, Boston University School of Medicine, Boston, MA

2016-2018 Research Fellow Pharmaceutical Law and Health Services Research Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

2018- Research Fellow Harvard-MIT Center for Regulatory Science Harvard Program in Therapeutic Science, Harvard Medical School, Boston, MA

Teaching

Teaching prior to start of current Harvard appointment:

2012-2014; 2015-2016

Core Medicine Clerkship; Third- and fourth-year medical students Griffin Hospital; Boston Medical Center and Boston University School of Medicine

Teaching during current Harvard appointment:

2016-

The FDA and Prescription Drugs: Current Controversies in Context (Co-Course Director) HarvardX massive open online course, edX platform

2018-

Writing, Publishing, and Social Media for Healthcare Professionals (invited faculty) Harvard Medical School Continuing Medical Education

2018-

Career Advancement and Leadership Skills for Women in Healthcare (invited faculty) Harvard Medical School Continuing Medical Education

Publications

Research investigations

• Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling Changes and Costs for Clinical Trials Performed under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Intern Med. 2018 Nov 1;178(11):1458-146.
• Sinha MS, Freifeld CC, Brownstein JS, Donneyong M, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Uptake of FDA Drug Safety Communication Messages about Zolpidem in Social Media. JMIR Public Health Surveill 2018; 4(1):e1.
• Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Internal Medicine. 2017 Nov 1;177(11):1658-166
• Sinha MS, Kesselheim AS.Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorganic & Medicinal Chemistry. 2016 Dec 15; 24(24): 6446-6451.
• Kesselheim AS, Sinha MS, Joffe S. Physicians and Insider Trading. JAMA Internal Medicine. 2015 Dec 1; 175(12):1955-9.
• Illingworth KD, Shaha SH, Tzeng TH, Sinha MS, Saleh KJ. The Impact of Tort Reform and Quality Improvements on Medical Liability Claims: A Tale of 2 States. American Journal of Medical Quality. 2015; 30(3):263-270.

Other peer-reviewed publications

• Silver JK, Sinha MS. Sexual Harassment in Medicine: Toward Legal Clarity and Institutional Accountability. EClinicalMedicine 2019; 7:3-4.
• Silver JK, Rowe M, Sinha MS, Molinares DM, Spector ND, Mukherjee D. Ethical Legal Feature: Micro-inequities in Medicine. PM R. 2018 Oct;10(10):1106-11
• Sinha MS, Curfman GD, Carrier MA. Viewpoint: Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry. JAMA. 2018 Jun 12;319(22):2271-2272.
• Darrow JJ, Sinha MS, Kesselheim AS. When Markets Fail: Patents and Infectious Disease Products. Food & Drug Law Journal. 2018;73(3):361- 382.
• Sinha MS, Jain N, Hwang TJ, Kesselheim AS. Expansion of the Priority Review Voucher Program under the 21st Century Cures Act: Implications for Innovation and Public Health. American Journal of Law & Medicine. 2018 May;44(2-3):329-341.
• Sarpatwari A, Sinha MS, Kesselheim AS. The Opioid Epidemic: Fixing a Broken Pharmaceutical Market. Harvard Law and Policy Review. 2017;11(2):463-484.
• Parmet WE, Sinha MS. A Panic Foretold: Ebola in the United States. Critical Public Health. 2017;27(1):148-155.
• Sinha MS, Parmet WE. The Perils of Panic Ebola, HIV, and the Intersection of Global Health and Law. American Journal of Law & Medicine. 2016;42(2-3):223-255.
• Ryan M, Mekel M, Sinha MS. 2016, updated 2018. Disclosure of Errors in Surgical Procedures. UpToDate.com.
• Ryan M, Sinha MS. 2011, updated 2018. Informed Procedural Consent. UpToDate.com.
• Sinha MS. Rousseau at the Roundtable – The Social Contract and the Physician’s Responsibility to Society. Virtual Mentor. 2011 Oct 1;13(10):703-706.
• Sinha MS. Barking Up the Wrong Tree: The FDA's Misguided Attempt to Waive Informed Consent in Public Health Emergencies. Journal of Legal Medicine. 2007; 28(3):397-417.

Reviews, Chapters, Monographs, and Editorials

• Sinha MS, Kesselheim AS. Editorial: The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry. J Law Med Ethics. 2018 Sep;46(3):806-808.
• Sinha MS, Kesselheim AS. Editorial: The Next Forum for Unraveling FDA Off-Label Marketing Rules: State and Federal Legislatures. PLoS Med. 2018 May 8;15(5):e1002564.
• Sinha MS, Kesselheim AS, Darrow JJ. Editorial: Pharmaceutical Advertising in Medical Journals: Revisiting an Old Relationship. Chest. 2018 Jan;153(1):9-11.
• Silverman RD, Sinha MS. Chapter 28 - Mental Health Issues (2011 Supplement). Illinois Practice Series, Vols. 21 & 22: The Law of Medical Practice in Illinois. Kane RJ, Silverman RD, Singer LE, Eds.
• Gribble GW, et al. Novel Indole Chemistry in the Synthesis of Heterocycles. Current Organic Chemistry. 2005;9(15):1493-1519.

Blogs

• Silver JK, Sinha MS. Overwhelming Support for Gender Equity at the AMA. Doximity op-(m)ed. June 14, 2018.
• Sinha MS, Kesselheim AS. The Future of American Science and Medicine. The Spoke (blog of the Albright Institute Faculty Scholar Initiative, Wellesley College). July 25, 2017.
  
• Sarpatwari A, Sinha MS. The Current 21st Century Cures Legislation Is Still A Bad Deal For Patients. Health Affairs Blog. November 30, 2016.
• Sinha MS, Graham DR. September 23, 2009. H1N1 Questions and Answers. Springfield State Journal-Register, BeHealthySpringfield.com, and Sangamon Medical News.

Newsletters

• Sarpatwari A, Sinha MS, Kesselheim AS. June 2017-Present. PORTAL Literature Scan: Monthly Round-Up of What to Read on Pharma Law and Policy.
• Sinha MS. 2010. The Massachusetts Health Insurance Program. Sangamon Medical News.
• Sinha MS. 2006 – 2007. Student Contributor. Vol. 15, No. 5 – Vol. 16, No. 3. Legal Medicine Perspectives (American College of Legal Medicine).
• Basanta WE, Roszak A, Sinha MS. 2006 – 2007. All the Latest Developments in Health Care Law. Vol. 23, No. 1 – Vol. 24, No. Health Care Lawyer (Illinois State Bar Association).

Federal Comments

• Public Health Law Watch. Comments on regulatory provisions: ‘Inadmissibility on Public Charge Grounds’ (USCIS-2010-0012). December 7, 2018.
• Public Health Law Watch. A Response to "Unintended Consequences: Medicaid and the Opioid Crisis." February 14, 2018.
• Sarpatwari A, Sinha MS, Kesselheim AS. Comments on public meeting: ‘Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access’ (FDA-2017-N-3615-0053). Nov 10, 2017.
• Sinha MS, Kesselheim AS. Comments on public workshop: ‘Generic Drug User Fee Amendment of 2012’ (FDA-2013-N-0402-0029). Jun 2, 2017.

Theses

• Sinha MS. Improving Healthcare Transitions for Releases from Boston-Area Jails. [MPH practicum project]. On file, Department of Health Policy and Management, Boston, MA: Harvard T.H. Chan School of Public Health, 2015.
• Sinha MS. Synthesis of Novel Anti-tumor Alkaloids. [Honors undergraduate thesis]. On file, Department of Chemistry, Hanover, NH: Dartmouth College, 2003.