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- October 2023
- Article
Improving Regulatory Effectiveness Through Better Targeting: Evidence from OSHA
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
We study how a regulator can best target inspections. Our case study is a U.S. Occupational Safety and Health Administration (OSHA) program that randomly allocated some inspections. On average, each inspection averted 2.4 serious injuries (9%) over the next five years.... View Details
- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to... View Details
- Article
Internal Deadlines, Drug Approvals, and Safety Problems
By: Lauren Cohen, Umit Gurun and Danielle Li
Absent explicit quotas, incentives, reporting, or fiscal year-end motives, drug approvals around the world surge in December, at month-ends, and before respective major national holidays. Drugs approved before these informal deadlines are associated with significantly... View Details
- June 2020
- Article
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Accuracy and consistency are critical for inspections to be an effective, fair, and useful tool for assessing risks, quality, and suppliers—and for making decisions based on those assessments. We examine how inspector schedules could introduce bias that erodes... View Details
- 2021
- Working Paper
Elusive Safety: The New Geography of Capital Flows and Risk
By: Laura Alfaro, Ester Faia, Ruth Judson and Tim Schmidt-Eisenlohr
A confidential dataset with industry-level disaggregation of U.S. cross-border claims and liabilities, shows U.S. securities to be increasingly intermediated by tax-haven-financial-centers (THFC) and less regulated funds. These securities are risky, in... View Details
- January 2020 (Revised October 2023)
- 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
Keywords: Bankruptcy; Board Of Directors; Board Dynamics; Business Ethics; Business Model Innovation; Corporate Boards; Energy Efficiency; Environmental And Social Sustainability; Government And Business; Hedge Funds; Institutional Investors; Legal Aspects Of Business; Regulated Monopolies; Regulation; Shareholders; Stakeholder Management; Strategy And Execution; Utilities; Insolvency and Bankruptcy; Governing and Advisory Boards; Ethics; Capital Structure; Climate Change; Corporate Accountability; Corporate Governance; Environmental Sustainability; Executive Compensation; Leadership; Management; Safety; Business and Government Relations; Energy Industry; Utilities Industry; California; 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
- September 2019
- Supplement
Keroche (B): Considering Entry into the Kenyan Beer Market
By: Ramon Casadesus-Masanell and Pippa Tubman Armerding
This case discusses the situation of the Kenyan alcoholic drinks producer Keroche in July 2004, when co-founder Tabitha Karanja was debating whether to enter the Kenyan beer market. Doing so would mean direct competition with the multinational EABL in an industry and... View Details
Keywords: Keroche; Alcohol; Alcoholic Drinks; Alcoholic Beverages; Beverages; Drinks; Wine Industry; Wine; Fortified Wine; Viena; Beer; Beer Market; Manufacturing; Production Capacity; Capacity; Growth; Regulated; Unregulated; Informal; Informal Market; Regulation; Illicit; Illegal; Substandard; Dangerous; Shutdown; Factory; Safe; Affordable; Low-income Consumers; Business Growth and Maturation; Business Startups; Production; Investment; Safety; Quality; 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; Marketing; Manufacturing Industry; Food and Beverage Industry; Kenya; Nairobi; Africa
- 2020
- Working Paper
Improving Regulatory Effectiveness Through Better Targeting: Evidence from OSHA
By: Matthew S. Johnson, David I. Levine and Michael W. Toffel
We study how a regulator can best target inspections. Our case study is a US Occupational Safety and Health Administration (OSHA) program that randomly allocated some inspections. On average, each inspection averted 2.4 serious injuries (9%) over the next five years.... View Details
- August 2019 (Revised February 2020)
- Teaching Note
Sidewalk Labs: Privacy in a City Built from the Internet Up
By: Leslie John and Mitch Weiss
Email mking@hbs.edu for a courtesy copy.
The case serves as a microcosm of issues of digital privacy: the availability of data – personal data in particular – has tremendous potential to improve people’s lives... View Details
The case serves as a microcosm of issues of digital privacy: the availability of data – personal data in particular – has tremendous potential to improve people’s lives... View Details
- November 2017
- Case
The 'Wonder Drug' That Killed Babies
By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children... View Details
Keywords: Regulation; Business and Government Relations; Business and Community Relations; Business and Stakeholder Relations; Product Marketing; Corporate Social Responsibility and Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe
- October 2017 (Revised April 2018)
- Case
Improving Worker Safety in the Era of Machine Learning (A)
By: Michael W. Toffel, Dan Levy, Jose Ramon Morales Arilla and Matthew S. Johnson
Managers make predictions all the time: How fast will my markets grow? How much inventory do I need? How intensively should I monitor my suppliers? Which potential customers will be most responsive to a particular marketing campaign? Which job candidates should I... View Details
- 2018
- Working Paper
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Many production processes are subject to inspection to ensure they meet quality, safety, and environmental standards imposed by companies and regulators. Inspection accuracy is critical to inspections being a useful input to assessing risks, allocating quality... View Details
- Fall 2016
- Article
The Integrity of Private Third-party Compliance Monitoring
By: Jodi L. Short and Michael W. Toffel
Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators.... View Details
Keywords: Regulation; Compliance; Compliance Policies; Conflict Of Interest; Independent Third Party; Inspection; Audit Quality; Auditor; Audit; Environment; Safety; Conflict of Interests; Working Conditions; Labor; Corporate Social Responsibility and Impact; Governance Compliance; Accounting Audits
- 2015
- Working Paper
The Integrity of Private Third-party Compliance Monitoring
By: Jodi L. Short and Michael W. Toffel
Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators.... View Details
Keywords: Regulation; Compliance; Compliance Policies; Conflict Of Interest; Independent Third Party; Inspection; Audit Quality; Auditor; Audit; Environment; Production; Supply Chain; Quality; Government Administration; Working Conditions; Safety; Labor; Governing Rules, Regulations, and Reforms; Governance Compliance; Manufacturing Industry; Public Administration Industry; Accounting Industry; Service Industry; United States
- January 2015 (Revised March 2015)
- Case
Wegmans and Listeria: Developing a Proactive Food Safety System for Produce
By: Ray A. Goldberg and Christine Snively
In July 2014, supermarket chain Wegmans received notification from supplier Wawona Packing Co. that its peaches arrived in Australia with a small trace of Listeria monocytogenes. While some countries such as Australia allowed low-levels of listeria to be present in... View Details
- March 2014
- Module Note
Implementing Environmentally Sustainable Operations
Keywords: Sustainability; Sustainability Management; Sustainability Reporting; Sustainable Supply Chains; Sustainable Operations; Environment; Environmental And Social Sustainability; Environmental Management; Environmental Operations; Environmental Performance; Environmental Policy; Environmental Protection; Environmental Strategy; Environmental Regulation; Operations Management; Operations Strategy; Supply Chain Management; Operations; Supply Chain; Business Processes; Corporate Social Responsibility and Impact; Performance Evaluation; Performance Improvement; Safety; Social Enterprise; Quality; Production; Working Conditions; Animal-Based Agribusiness; Buildings and Facilities; Agriculture and Agribusiness Industry; Apparel and Accessories Industry; Biotechnology Industry; Construction Industry; Manufacturing Industry
- 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
- May–June 2013
- Article
Can Global Brands Create Just Supply Chains? Response: Promoting Political Mobilization
By: Jodi L. Short and Michael W. Toffel
Codes of conduct indicate that working conditions are improving overall at the factories being monitored by multinational corporations, and that these codes of conduct also create possibilities for political mobilization that can improve labor conditions more broadly. View Details
Keywords: Regulation; Auditing; Labor Relations; Occupational Safety; Environmental Operations; Environmental Regulation; Employees; Labor; Labor and Management Relations; Governing Rules, Regulations, and Reforms; Manufacturing Industry; China; Bangladesh; India; Honduras; Nicaragua; Pakistan; Guatemala; Malaysia; Viet Nam
- February 2013
- Article
An Activity-Generating Theory of Regulation
By: Joshua Schwartzstein and Andrei Shleifer
We propose an activity-generating theory of regulation. When courts make errors, tort litigation becomes unpredictable and as such imposes risk on firms, thereby discouraging entry, innovation, and other socially desirable activity. When social returns to activity are... View Details