Publications

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

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

December 2000
Article

Risk versus Risk: Tragic Choices in Drug Regulation in the United States and Germany

By: Arthur A. Daemmrich

Keywords: Risk and Uncertainty; Decision Choices and Conditions; Health; United States; Germany

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

SSRN

September 1991 (Revised August 1994)
Background Note

Note on Pharmaceutical Industry Regulation

By: Willis M. Emmons III

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

01 Apr 2014
News

FDA Moves to Regulate E-Cigarettes

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

01 Mar 2011
News

Fixing What Ails the Drug Industry

presentation to upwards of 280 HBS alumni who gathered on the Harvard Medical School campus, is better regulatory science. That translates into faster decision-making and a better balance between safety and innovation with respect to drugs, food, and other View Details

Keywords: pharmaceutical research; Health, Social Assistance

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

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Web

Regulation and Compliance | Working Knowledge

Regulation and Compliance Explore complex global issues in this collection on regulation and compliance, from navigating Asia's authoritarian regimes and political influence on voting to ethical dilemmas in... View Details

08 Jul 2019
News

What the U.S. can learn from Germany on drug prices

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

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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

Keywords: by Kasandra Brabaw; Pharmaceutical

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

Keywords: by Danielle Kost; Health

Web

Understanding Health Systems, Payors, and Regulation - Health Care

Impact Understanding Health Systems, Payors, and Regulation Health Minute: The Real Impact of Coupons on Drug Pricing Nabihah Sachedina Joint Degree 2013 More “Health Systems” stories Faculty Focus... 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

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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