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- July 2019
- Article
The Impact of Price Regulation on the Availability of New Drugs in Germany
By: Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari
The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate... View Details
Keywords: Regulation; Pharmaceuticals; Healthcare; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Germany
Stern, Ariel Dora, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim, and Ameet Sarpatwari. "The Impact of Price Regulation on the Availability of New Drugs in Germany." Health Affairs 38, no. 7 (July 2019): 1182–1187.
- July 2020
- Article
Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany
By: Victoria D. Lauenroth, Aaron S. Kesselheim, Ameet Sarpatwari and Ariel Dora Stern
Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the U.S., it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been... View Details
Keywords: Pharmaceuticals; Prescription Drug Costs; Drug Pricing; Access To Care; Cost Reduction; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Cost Management; Germany
Lauenroth, Victoria D., Aaron S. Kesselheim, Ameet Sarpatwari, and Ariel Dora Stern. "Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany." Health Affairs 39, no. 7 (July 2020): 1185–1193.
- 2004
- Book
Pharmacopolitics: Drug Regulation in the United States and Germany
By: Arthur A. Daemmrich
Keywords: Health; Governing Rules, Regulations, and Reforms; Government and Politics; United States; Germany
Daemmrich, Arthur A. Pharmacopolitics: Drug Regulation in the United States and Germany. University of North Carolina Press, 2004. (Winner of Edward Kremers Award of the American Institute of the History of Pharmacy For best book in pharmaco-historical writing published in the previous two years presented by American Institute of the History of Pharmacy.)
- December 2000
- Article
Risk versus Risk: Tragic Choices in Drug Regulation in the United States and Germany
By: Arthur A. Daemmrich
Daemmrich, Arthur A. "Risk versus Risk: Tragic Choices in Drug Regulation in the United States and Germany." Science as Culture 9, no. 4 (December 2000): 505–534.
- 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
Keywords: Health; Economics; Government and Politics; Innovation and Invention; Research; Science; Biotechnology Industry; Health Industry; Pharmaceutical Industry
Cohen, Lauren, Umit Gurun, and Danielle Li. "Internal Deadlines, Drug Approvals, and Safety Problems." American Economic Review: Insights 3, no. 1 (March 2021): 67–82.
- September 1991 (Revised August 1994)
- Background Note
Note on Pharmaceutical Industry Regulation
Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,... View Details
Keywords: Safety; Industry Growth; Marketing; Research and Development; Health Testing and Trials; Economics; Pharmaceutical Industry; United States
Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous... View Details
Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- December 2008 (Revised October 2013)
- Case
Amylin Pharmaceuticals: Diabetes and Beyond (A)
By: Richard G. Hamermesh and Rachel Gordon
Ginger Graham, CEO of Amylin Pharmaceuticals, joined the company with the expectation of taking the company's signature drug, Symlin, to market. However, unforeseen regulatory challenges have put the approval process in jeopardy. At the same time, the company has a... View Details
Keywords: Regulations; Drug Regulations; Symlin; Negotiation; Governing Rules, Regulations, and Reforms; Resource Allocation; Negotiation Deal; Product Development; Research and Development; Commercialization; Pharmaceutical Industry; United States
Hamermesh, Richard G., and Rachel Gordon. "Amylin Pharmaceuticals: Diabetes and Beyond (A)." Harvard Business School Case 809-011, December 2008. (Revised October 2013.)
- September 2022
- Article
Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities
By: Leemore Dafny, Christopher Ody and Teresa Rokos
The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations... View Details
Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
policy and regulatory policy innovation allowing us to do more with what we have,” she says. A quicker process could save millions—per drug The FDA didn’t receive additional funding for the BTD program; instead, the agency shifted the... View Details
- 11 Sep 2019
- Research & Ideas
Germany May Have the Answer for Reducing Drug Prices
the Poronui Associate Professor of Business Administration. Pharmaceutical companies have long opposed efforts to regulate drug prices, arguing that prices reflect the companies’ massive research... 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
Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- Research Summary
Regulatory Change/Business-Government Relations
“Sources of Learning Heterogeneity: Discontinuous Regulatory Shock and its Impact on Organizational Search Behaviors”
Co-authoring with Jerry Kim, in this study I look at how discontinuous regulatory shock shapes organizational... View Details
- 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... View Details
- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S.... View Details
Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London
Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
- Research Summary
Regulatory negotiations and risk communication
In the pharmaceutical industry a drugs benefits and risks are constantly being weighed by companies, regulators, physicians and drug consumers. While companies and regulators must make decisions based on population statistics about drug outcomes, physicians and drug... View Details
- 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
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details
Keywords: Public Health; Genome Testing; Health Care; Ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States
Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
- 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
Daemmrich, Arthur A., and Joanna Radin, eds. Perspectives on Risk and Regulation: The FDA at 100. Chemical Heritage Foundation, 2007. (Fulltext.)