Publications

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

Article

Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-Five Years of Drug Lag Debate

By: Arthur A. Daemmrich

Keywords: Cost; Health; Governing Rules, Regulations, and Reforms; Communication

11 Sep 2007
First Look

First Look: September 11, 2007

and reveals how to recruit, nurture, and promote this special type of leader. With a healthy supply of qualified internal candidates, companies get the leadership they need—when they need it. Who Killed Health Care? America's $2 Trillion... View Details

Keywords: Martha Lagace

Article

The CMS New Rule on Ambulatory Surgical Centers Earns Only Partial Credit

By: Junaid Nabi and Robert S. Kaplan

The Centers of Medicare and Medicaid Services (CMS) recently announced that it will be removing more... View Details

Keywords: Ambulatory Care; Payment Policy; Health Care and Treatment; Governing Rules, Regulations, and Reforms

June 2023 (Revised July 2024)
Case

Biogen and the Aduhelm Melee

By: Amitabh Chandra and Lauren Gunasti

Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.

This... View Details

Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry

Educators

Purchase

2009
Working Paper

Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location

By: Arthur Daemmrich

A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Health Testing and Trials; Power and Influence; Competitive Strategy; Pharmaceutical Industry; European Union; Germany; United States

01 Jun 2005
News

One-on-One with Grover Norquist

twenty years at the forefront of tax reform advocacy, what achievements would you like to be known for? My single most important achievement was creating the Taxpayer Protection Pledge, a promise never to raise taxes. Since 1986, we have... View Details

Keywords: Government

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

06 Oct 2015
First Look

October 6, 2015

at the Narayana Health City Cardiac Hospital (NH) in India. The case discusses the factors driving the adoption of task shifting at NH and identifies the implications of task shifting for surgeon training, surgical capacity, and procedure... View Details

Keywords: Sean Silverthorne

November 2008 (Revised July 2009)
Background Note

A Managerial Perspective on Clinical Trials

By: Arthur A. Daemmrich

This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Safety; Biotechnology Industry; Pharmaceutical Industry

Educators

Purchase

September 2009 (Revised August 2012)
Case

Novasys Medical

By: Richard G. Hamermesh and Lauren Barley

Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the... View Details

Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Health Disorders; Product Development; Business and Government Relations; Medical Devices and Supplies Industry; United States

Educators

Purchase

01 Mar 2013
News

Opening the Door

For her innovative research and outspoken advocacy of US health-care reform, Professor Regina Herzlinger is known in some media circles as "the godmother of consumer-driven health care." At HBS, she holds the distinction of being the... View Details

Keywords: Deborah Blagg; Colleges, Universities, and Professional Schools; Educational Services; Social Assistance; Health, Social Assistance; Management

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

2023
Article

Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control

By: Susanna Gallani

Can managers use monetary incentives to elicit cooperation from workers they cannot reward for their efforts? I study “conduit incentives,” an innovative incentive design, whereby managers influence bonus-ineligible workers’ effort by offering bonus-eligible employees... View Details

Keywords: Organizational Behavior Modification; Peer Monitoring; Persistence Of Performance Improvements; Crowding Out; Implicit Incentives; Compensation; Healthcare; Social Pressure; Image Motivation; Incentives; Motivation; Performance; Behavior; Motivation and Incentives; Compensation and Benefits; Governing Rules, Regulations, and Reforms; Organizational Culture; Health Industry; California

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

2020
Working Paper

How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?

By: Michael Blank, Samuel G. Hanson, Jeremy C. Stein and Adi Sunderam

Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that... View Details

Keywords: COVID-19; Bank Regulation; Recapitalization; Health Pandemics; Banks and Banking; Governing Rules, Regulations, and Reforms; Strategy; Risk Management; United States