Publications

2007
Article

Pharmacovigilance and the Missing Denominator: The Changing Context of Pharmaceutical Risk Mitigation

By: Arthur A. Daemmrich

In the wake of Vioxx, Avandia, and other recent prominent cases of drugs found to cause side effects after marketing, the safety of pharmaceuticals has come to the forefront of American public policy. Press attention, congressional investigations, and legislative... View Details

Keywords: Brands and Branding; Policy; Risk Management; Government Legislation; Risk and Uncertainty; Goals and Objectives; Customers; Pharmaceutical Industry; Health Industry; United States

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January 2020 (Revised December 2024)
Case

Governing PG&E

By: Lynn S. Paine and Will Hurwitz

The five commissioners of the California Public Utilities Commission (CPUC) listened intently at a public forum in April 2019 as PG&E Corporation’s out-going chairman Richard Kelly described the company’s proposed new board. PG&E, which provided electricity and natural... View Details

27 Nov 2006
Research & Ideas

Manly Men, Oil Platforms, and Breaking Stereotypes

interview, Ely discusses the origins of the research, her experiences aboard an oil platform, and how this research can improve safety at other job sites. Sarah Jane Gilbert: How do you define masculine identity and what led you to study... View Details

Keywords: by Sarah Jane Gilbert; Energy; Utilities

2024
Working Paper

Product Liability Litigation and Innovation: Evidence from Medical Devices

By: Alberto Galasso and Hong Luo

We examine the relationship between product liability litigation and innovation by systematically combining data on product liability lawsuits with data on new product introductions in a panel dataset of leading medical device firms. We first document a decline in... View Details

Keywords: Lawsuits and Litigation; Product Development; Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

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

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November 2013 (Revised June 2014)
Case

E-Cigarettes: Marketing Versus Public Health

By: John A. Quelch and Margaret L. Rodriguez

Electronic cigarettes (e-cigarettes) were heralded by some as a healthcare game changer, enabling smokers to switch to a new product which carried lower risk of cancer. However, there were concerns about the public health risk of e-cigarettes, particularly the chance... View Details

Keywords: Public Health; Tobacco; Smoking; Cigarettes; Electronic Cigarettes; Cancer; Lung; Lorillard; Philip Morris; Safety; Technological Innovation; Conflict of Interests; Market Entry and Exit; Marketing; Health; Advertising; Consumer Products Industry; Health Industry

24 Sep 2007
Research & Ideas

The FDA: What Will the Next 100 Years Bring?

and complicated than it is today. So I would say the primary impact of the FDA over the past century has been to make predictable the safety of food, drugs, cosmetics, and other products regulated by the... View Details

Keywords: by Sean Silverthorne; Biotechnology; Consumer Products; Food & Beverage; Health

June 2010 (Revised February 2013)
Background Note

The Precautionary Principle

By: Michael W. Toffel and Nazli Z. Uludere Aragon

This note describes the precautionary principle and its key tenets, highlights challenges associated with its use, and includes many examples of its application, primarily within the realm of regulating activities based on the risk of harm to human health and the... View Details

Keywords: Governing Rules, Regulations, and Reforms; Policy; Health Disorders; Business and Government Relations; Safety; Natural Environment; Pollutants; Agriculture and Agribusiness Industry; Chemical Industry; Pharmaceutical Industry

14 Dec 2020
Research & Ideas

What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?

Pharmaceutical regulators around the world tend to speed through drug applications in December and before major national holidays, according to new research that might raise questions about COVID-19 vaccines and other treatments under... View Details

Keywords: by Danielle Kost; Pharmaceutical; Health

September 2010 (Revised January 2012)
Case

BP's Macondo: Spill and Response

By: Julio J. Rotemberg

This case starts by reporting various factors that may have contributed to the massive Macondo oil spill, noting that BP, its partners and the government all made decisions that helped cause the accident. It then discusses the response to this spill by BP and the... View Details

Keywords: Safety; Metals and Minerals; Crisis Management; Infrastructure; Trade; Pollutants; Risk and Uncertainty; Business and Government Relations; Finance; Multinational Firms and Management; Governing Rules, Regulations, and Reforms; Technology Adoption; Energy Industry; Mining Industry; United Kingdom; United States

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

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January 2021
Supplement

What Went Wrong with Boeing’s 737 Max? (B)

By: William W. George and Amram Migdal

Following the March 10, 2019, crash of Ethiopian Airlines flight 302, en route to Nairobi, Kenya and the October 29, 2018, downing of Lion Air flight 610 as it took off from Jakarta, Indonesia, Boeing’s 737 Max jet, the model flown in both instances, was grounded by... View Details

Article

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

04 Jan 2012
First Look

First Look: January 4

halls, on the docks, and during casual social interactions. The emphasis in the shared language gradually shifts from safety and solidarity to safety, collaboration, and economic power. The newly developed language supports and shapes the... View Details

Keywords: Carmen Nobel

21 Jun 2011
First Look

First Look: June 21

Moreover, there is something resembling "intelligent design" in finance, whereby regulators and legislators act in a quasidivine capacity, putting dinosaurs on life support. The danger is that such interventions in the natural... View Details

Keywords: Sean Silverthorne

February 2006 (Revised March 2008)
Case

ChoicePoint (A)

By: Lynn S. Paine and Zack Phillips

The CEO of ChoicePoint, a leading company in the rapidly growing U.S. personal data industry, must reexamine the company's business model after a serious breach of data security affecting some 145,000 U.S. citizens. He must decide on steps to strengthen data protection... View Details

Keywords: Business Model; Safety; Rights; Analytics and Data Science; Ethics; Information Technology; Information Industry; United States

September 2019 (Revised May 2020)
Case

Keroche (A): Fighting for Share in the Kenyan Alcoholic Drinks Market

By: Ramon Casadesus-Masanell and Pippa Tubman Armerding

This case discusses the challenges faced by Kenyan alcoholic drinks producer Keroche Industries Limited in 2003, when the Kenyan government accused the company of manufacturing and selling substandard alcoholic drinks, revoked its liquor licenses, and shut down its... View Details

Keywords: Keroche; Alcohol; Wine; Manufacturing; Informal Market; Regulation; Illicit; Illegal; Shutdown; Factory; Low-income Consumers; Multinational; Local; Government; Allegations; Accusations; Negative Press; EABL; Tusker; Beer; SAB; Chang'aa; Naivasha; Rift Valley; East Africa; Lawsuit; Legal Battle; Business Ventures; Business Exit or Shutdown; Business Growth and Maturation; Business Startups; Production; Safety; Quality; Distribution; Small Business; Family Business; Crime and Corruption; Customer Focus and Relationships; Decisions; Income; Demographics; Geographic Scope; Geographic Location; Goods and Commodities; Government Legislation; Growth and Development; Business History; Lawsuits and Litigation; Laws and Statutes; Lawfulness; Goals and Objectives; Consumer Behavior; Market Entry and Exit; Problems and Challenges; Social Issues; Poverty; Strategy; Competition; Entrepreneurship; Manufacturing Industry; Food and Beverage Industry; Kenya; Nairobi; Africa