Publications

Educators

August 2008 (Revised September 2008)
Supplement

The Flaxil Label (C): Debrief and Endnotes

This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details

Keywords: Safety; Value Creation; Negotiation; Health Care and Treatment; Sales; Pharmaceutical Industry

April 2020
Article

Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning

By: Ariel Dora Stern and W. Nicholson Price, II

In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging... View Details

Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms

2023
Working Paper

Market Exclusivity and Innovation: Evidence From Antibiotics

By: Edward Kong and Olivia Zhao

The US incentivizes drug innovation via patents as well as market exclusivity periods awarded by the US Food and Drug Administration. We estimate the causal effects of extending market exclusivity for an important drug class: antibiotics. Using a... View Details

Keywords: Health Testing and Trials; Innovation and Invention; Motivation and Incentives; Government Administration; Government Legislation; Pharmaceutical Industry; United States

SSRN

2007
Book

Perspectives on Risk and Regulation: The FDA at 100

By: Arthur A. Daemmrich and Joanna Radin

Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific... View Details

Keywords: Private Sector; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Business and Government Relations; Risk and Uncertainty; Cooperation

2024
Working Paper

Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances

By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins

This case history describes how Magnetic Resource Imaging (MRI) came to complement – and partially replace -- computed tomography (CT) imaging of soft tissue. Specifically, we chronicle 1) the development of foundational techniques and prototypes (through the 1970s);... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms

SSRN

15 Jan 2019
First Look

New Research and Ideas, January 15, 2019

forthcoming American Journal of Therapeutics Food and Drug Administration Guidance Documents and New Medical... View Details

Keywords: Dina Gerdeman

May 2021
Case

The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease

By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra

This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory... View Details

Keywords: Innovation and Invention; Strategy; Business or Company Management; Society; Health; Public Administration Industry; Public Administration Industry; United States

Educators

2010
Chapter

From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance

By: Arthur A. Daemmrich

Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States

August 2022
Article

Availability of New Medicines in the U.S. and Germany From 2004 to 2018

By: Katharina Blankart, Huseyin Naci and Amitabh Chandra

Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial... View Details

Keywords: Market Entry and Exit; Price; Market Timing; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States; Germany

Register to Read

14 Nov 2017
First Look

New Research and Ideas: November 14, 2017

authors provide numerous examples of health care organizations that are taking these steps—and seeing impressive results. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53460 forthcoming JAMA Cardiology The Central and... View Details

Keywords: Carmen Nobel

November 1993 (Revised January 2006)
Supplement

Beech-Nut Nutrition Corporation (B)

By: Lynn S. Paine

Officials of the U.S. Food and Drug Administration (FDA) must decide whether to refer the Beech-Nut apple juice case to the Justice Department for criminal prosecution, and if so, whether to recommend prosecution of individual executives or of the company only. View Details

Keywords: Crime and Corruption; Decisions; Cases; Law; Management; Food and Beverage Industry

2021
Working Paper

Regulatory Approval and Expanded Market Size

By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite

Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details

Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry

18 Dec 2018
First Look

New Research and Ideas, December 18, 2018

2018 Innovation Policy and the Economy The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century By: Bagley, Nicholas, Benjamin Berger, Amitabh... View Details

Keywords: Dina Gerdeman

2024
Working Paper

Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational Advances

By: Amar Bhidé and Srikant M. Datar

In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works, 2) the foundational advances and discoveries, 3) the... View Details

Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms

SSRN