Publications

28 Mar 2023
Research & Ideas

The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation

Early in the COVID-19 pandemic, the US Food and Drug Administration faced the task of convincing a skeptical public of the safety of new vaccines when the agency began authorizing them for emergency use less than a year after the pandemic... View Details

Keywords: by Kasandra Brabaw; Pharmaceutical

Research Summary

Physician vs. Patient Incentives in Prescription Drug Choice

The market for medical care involves interactions among patients, providers, and the insurers who pay for the care of their enrollees. The division of responsibilities creates scope for agency costs and moral hazard in the physician's treatment choice.... View Details

Web

Drug & Alcohol Policy | About

Drug & Alcohol Policy Overview of HBS Substance Abuse Policies and Procedures Harvard Business School’s policy on drugs and alcohol—adapted from and in accordance with other similar policies at Harvard... View Details

January 2015 (Revised July 2019)
Case

CVS Health: Promoting Drug Adherence

By: Leslie John, John Quelch and Robert Huckman

Email mking@hbs.edu for a courtesy copy.

The case describes a program that CVS Health recently implemented to improve medication adherence, an important problem from a societal, public policy, and firm... View Details

01 Mar 2011
News

Fixing What Ails the Drug Industry

echoed Hamburg’s call for improvements in regulation, but he also emphasized the innovation side of the balancing act between safety and product development. “Reinvent invention,” he told the audience. The industry must get smarter about developing View Details

Keywords: pharmaceutical research; Health, Social Assistance

October 2010 (Revised November 2010)
Background Note

Plavix: Drugs in the Age of Personalized Medicine

By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon

PIavix, one of the world's best selling drugs in 2010, appears to have a limited future. Its patent was due to expire soon, and recently new data had been discovered that indicated that a small subset of the population would be at risk for stroke, heart attack, or even... View Details

Keywords: Health Care and Treatment; Product Positioning; Business and Government Relations; Genetics; Competitive Strategy; Pharmaceutical Industry

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

Read Now

06 Sep 2022
Research & Ideas

Curbing an Unlikely Culprit of Rising Drug Prices: Pharmaceutical Donations

Prescription drug costs continue to climb in the United States, but tightening a loophole in a federal law may help curb rising expenses, according to research published this week in Health Affairs. Efforts to control US health care... View Details

Keywords: by Ben Rand; Insurance; Health; Pharmaceutical

April 1989 (Revised May 1993)
Case

Novel Combination of Two Drugs (A)

By: Regina E. Herzlinger

Keywords: Health; Health Care and Treatment; Pharmaceutical Industry

12 Dec 2022
Research & Ideas

Buy-In from Black Patients Suffers When Drug Trials Don’t Include Them

Black patients and their doctors may be more open to new medications if drug trials included more Black people, new research shows. Currently, Black Americans represent just 5 percent of drug trial... View Details

Keywords: by Scott Van Voorhis; Pharmaceutical; Health

April 1989
Supplement

Novel Combination of Two Drugs (C)

By: Regina E. Herzlinger

Keywords: Health; Health Care and Treatment; Pharmaceutical Industry; Health Industry

April 1989
Supplement

Novel Combination of Two Drugs (B)

By: Regina E. Herzlinger

Keywords: Health; Health Care and Treatment; Pharmaceutical Industry; Health Industry

12 Jun 2018
Research & Ideas

In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?

was invented as a treatment for chronic myelogenous leukemia, and by the study’s measures was quite a novel drug. Novartis shares jumped almost 7 percent the day Gleevec was approved by the FDA. The drug... View Details

Keywords: by Rachel Layne; Health; Pharmaceutical

November 2018
Case

David Hysong and SHEPHERD Therapeutics

By: Ananth Raman, John Masko and Aldo Sesia

In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his... View Details

Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges

April 2024 (Revised July 2024)
Case

Market Dynamics and Moral Dilemmas: Novo Nordisk’s Weight-Loss Drugs

By: Joseph L. Badaracco, Tom Quinn and John Schultz

Danish pharmaceutical company Novo Nordisk was owned by a charitable foundation, and since its founding in the 1920s had focused on producing insulin to treat diabetes. In 2017, however, it released Ozempic, a diabetes treatment with the revolutionary side effect of... View Details

Web

2.3.1 Drug & Alcohol Policy | MBA

2.3.1 Drug & Alcohol Policy Harvard Business School’s policy on drugs and alcohol—adapted from and in accordance with other similar policies at Harvard University—reflects our concern for the health and... View Details

October 2024
Article

Medicare Part D Protected-Class Policy Is Associated with Lower Drug Rebates

By: Pragya Kakani, Michael Anne Kyle, Amitabh Chandra and Luca Maini

Medicare Part D does not allow plans to exclude drugs in six protected classes from their formularies, which may limit plans’ ability to negotiate rebates and lead to higher spending. We estimated the association between protected-class status, US-level estimated... View Details

Keywords: Insurance; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States

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

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December 2005 (Revised August 2006)
Case

Amgen Inc.'s Epogen--Commercializing the First Biotech Blockbuster Drug

By: Felix Oberholzer-Gee and Dennis A. Yao

Amgen Inc.'s Epogen was the first biotech blockbuster drug. Epogen helped prevent anemia, a condition that leads to severe fatigue, increased risk of cardiovascular disease, and even death. At the time, the market for Epogen, which included dialysis patients and... View Details

Keywords: Health Care and Treatment; Strategic Planning; Competition; Patents; Innovation and Invention; Pharmaceutical Industry; Biotechnology Industry; United States