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      • Faculty Publications  (51)

      Prescription Drug PolicyRemove Prescription Drug Policy →

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      • January 2007 (Revised January 2007)
      • Background Note

      Note on the U.S. Food and Drug Administration

      By: Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller
      Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure. View Details
      Keywords: Health; Governance Compliance; Policy; Product Development; Government and Politics; Pharmaceutical Industry; Medical Devices and Supplies Industry; Biotechnology Industry; Public Administration Industry; United States
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      Higgins, Robert F., Richard G. Hamermesh, and Virginia Fuller. "Note on the U.S. Food and Drug Administration." Harvard Business School Background Note 807-050, January 2007. (Revised January 2007.)
      • 2006
      • Book

      Science Business: The Promise, the Reality, and the Future of Biotech

      By: Gary P. Pisano
      Why has the biotechnology industry failed to perform up to expectations—despite all its promise? In Science Business, Gary P. Pisano answers this question by providing an incisive critique of the industry. Pisano not only reveals the underlying causes of... View Details
      Keywords: Science; Business Ventures; Biotechnology Industry
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      Pisano, Gary P. Science Business: The Promise, the Reality, and the Future of Biotech. Boston: Harvard Business School Press, 2006.
      • February 2005 (Revised April 2006)
      • Case

      Rx Depot: Importing Drugs from Canada

      By: Debora L. Spar
      In 2002, a handful of entrepreneurs began to ship drugs from Canada into the United States, taking advantage of regulatory and price differentials across the neighboring countries. Using the Internet and a low-cost network of Canadian pharmacies, firms like Rx Depot... View Details
      Keywords: Courts and Trials; Entrepreneurship; Intellectual Property; Laws and Statutes; Pharmaceutical Industry; Canada; United States
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      Spar, Debora L., and Adam Day. "Rx Depot: Importing Drugs from Canada." Harvard Business School Case 705-010, February 2005. (Revised April 2006.)
      • August 2004 (Revised July 2006)
      • Case

      PROPECIA TM: Helping Make Hair Loss History

      By: Marta Wosinska and Youngme E. Moon
      In late 1997, Tom Casola, brand manager for Propecia, debates the best approach to market this breakthrough one-a-day pill for hair loss. This launch would be atypical for a prescription drug because of the key position of the consumer. As a result, the team's... View Details
      Keywords: Advertising; Communication Strategy; Customers; Marketing Communications; Marketing Strategy; Product Launch; Product; Performance Effectiveness; Problems and Challenges; Quality; Pharmaceutical Industry
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      Wosinska, Marta, and Youngme E. Moon. "PROPECIA TM: Helping Make Hair Loss History." Harvard Business School Case 505-035, August 2004. (Revised July 2006.)
      • December 1999 (Revised February 2001)
      • Case

      CVS: The Web Strategy

      By: John A. Deighton and Anjali C. Shah
      How should America's second-largest pharmacy chain respond to the challenge from online drugstores? What threat does the web pose to bricks and mortar distribution of prescription drugs and the other items that make up 50% of a drugstore's sales? This case describes... View Details
      Keywords: Leveraged Buyouts; Marketing Channels; Distribution Channels; Service Operations; Corporate Strategy; Pharmaceutical Industry; Web Services Industry
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      Deighton, John A., and Anjali C. Shah. "CVS: The Web Strategy." Harvard Business School Case 500-008, December 1999. (Revised February 2001.) (request a courtesy copy.)
      • 1997
      • Chapter

      Discussion of "Microeconomic Policy, Technological Change, and Small Business" by Edwin Mansfield

      By: Joshua Lerner
      Edwin Mansfield’s thoughtful review of the literature on the economics of technological change raises a variety of interesting issues, far too many to address in a few pages. Consequently I will focus my discussion on the section that I found most challenging and... View Details
      Keywords: Policy; Technological Innovation
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      Lerner, Joshua. Discussion of "Microeconomic Policy, Technological Change, and Small Business" by Edwin Mansfield. In Technology and Growth: Proceedings of the 40th Economic Conference, edited by Jeffrey C. Fuhrer and Jane Sneddon Little, 208–213. Boston: Federal Reserve Bank of Boston, 1997.
      • 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
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      Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
      • Teaching Interest

      Overview

      By: Leemore S. Dafny
      U.S. Healthcare Strategy

      The U.S. healthcare sector accounts for 17 percent of GDP, and encompasses a diverse set of industries with public, nonprofit, and for-profit buyers and sellers. There are significant concerns about high and rising spending, and... View Details
      Keywords: Healthcare; Health; Healthcare Reform; Life Sciences; Health Industry; United States
      • Research Summary

      Overview

      By: John Beshears
      In his research, Professor Beshears shows how managers can influence the behavior of customers and employees by changing the decision-making environment to call attention to a decision, to use psychological framing to shape assessments of options, or to help... View Details
      Keywords: Behavioral Economics; Consumer Finance; Household Finance; Health Care; Organizational Economics; Decision Making; Economics; Negotiation; Behavioral Finance
      • Research Summary

      Overview

      By: Joshua Lev Krieger
      In examining the competitive dynamics of R&D strategy, Josh has become particularly interested in how the introduction of new knowledge generated by rivals impacts the direction of R&D efforts. Understanding how new information alters project portfolio decisions is... View Details
      • Forthcoming
      • Article

      Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

      By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
      Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details
      Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry
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      Chandra, Amitabh, Jennifer Kao, Kathleen L. Miller, and Ariel Dora Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." Review of Economics and Statistics (forthcoming). (Pre-published online March 18, 2024.)
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