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How Should the Government Negotiate Medicare Drug Prices? A Guide for the Perplexed

Fred D. Ledley | March 4, 2024

INET Blog
/iStock, Abscent84

Now, at last, thanks to the Inflation Reduction Act (IRA), the federal government will be allowed to negotiate a "maximum fair price" for drugs covered by Medicare Part D. This historical change, taking place in the face of intense industry opposition, incrementally reverses policies that have prohibited the government from engaging in price negotiations since Medicare Part D was first established in 2003. While only ten drugs will be subject to negotiation in the first year of the IRA and 90 over the first five years, negotiations are now ongoing. 

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Opinion: Who Really Pays for Drug Development? Both Government and Industry

Fred D. Ledley | July 17, 2023

Pictured: Illustration of scientists working on biomedical research/iStock, Olga Kurbatova
/iStock, Olga Kurbatova

There is a stark divide in public depictions of pharmaceutical innovation. The biopharma industry proudly advertises its accomplishments in launching new drugs for cancer, neurodegenerative disease, diabetes, weight loss and more without acknowledging the billions of dollars of government funding for basic and applied biomedical science that enabled these advances. Industry critics, meanwhile, argue that this government funding is responsible for pharmaceutical innovation, going as far as to propose that patients “pay twice” for medicines, once in the form of taxes that underwrite government research and again in purchasing these products.

Two recent papers published by my colleagues and me in the Journal of the American Medical Association’s Health Forum suggest that neither view is accurate. Our research illustrates the essential complementarity of government and industry spending on new medicines.

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Why the big questions about drug prices are rarely asked: It’s hard to do

Fred D. Ledley | December 16, 2021

Adobe Image
/Adobe, anko_ter

Do pharmaceutical companies have a responsibility to provide medicines to those in need, or is their primary purpose as corporations to maximize value for shareholders? Does government have a responsibility to provide medicines to the public, or is its role to incentivize companies to make medicines available by linking increased profits to the provision of important products?

Why don’t these questions get asked, so they can be answered?

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Returns to Public Investment in Drug Discovery: Some Fundamental Questions

Fred D. Ledley, Ekaterina Galkina Cleary, Matthew Jackson | September 3, 2020

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/Adobe, rabbitti

The COVID-19 pandemic has transformed longstanding debates about the role of the public and private sectors in drug discovery and development from questions of optimal policy to questions of life and death. On one hand, it has dramatically demonstrated the public’s dependence on biopharmaceutical companies for the discovery, development, manufacture, and distribution of drugs and vaccines that may quell the pandemic. On the other hand, the billions of dollars of public funding demanded by the private sector to pursue these products vividly illustrates the industry’s reliance on public funding for the development of products that address the public’s most pressing needs.

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US Tax Dollars Funded Every New Pharmaceutical in the Last Decade

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/iStock, lisegagne

Fred D. Ledley, Ekaterina Galkina Cleary, Matthew Jackson | September 2, 2020

The escalating controversies and divisive commentaries over drug pricing and the prioritization of products that benefit from federal funding also highlight deep divides between the precepts of the public and private sectors concerning the mission of the corporation as well as the role of government in value creation and markets. These conflicts also highlight the lack of coherent policies designed to maximize the public return on taxpayer investments and ensure that the public's needs are met.

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Big Pharma Wants to Pocket the Profits From a COVID Treatment You Already Paid For

Fred D. Ledley, Ekaterina Galkina Cleary, Zoë Folchman-Wagner, Matthew Jackson | July 7, 2020

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/Depositphotos, terovesalainen

Our data suggests that Gilead's considerable accomplishment in securing authorization for use of remdesivir in treating COVID-19 represents only the culminating step in a cumulative process of innovation that involved the collective action of public, as well as private, enterprise. While Gilead will likely invest several billion dollars in bringing remdesivir to market, our data suggests that the public sector, in aggregate, has already invested much more. 

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The Fleming Myth and the Public Sector Contribution to Discovery and Development of New Cancer Drugs

Ekaterina Galkina Cleary, Fred D. Ledley | June 2, 2020

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/Flickr, ERP

When people think about the process of drug discovery, they often recall the "Fleming myth." The myth recounts how a solitary English physician-scientist, "tired and shaken" by witnessing soldiers dying of wound infections during World War I, discovered penicillin when a plate of bacteria in his laboratory became contaminated with a Penicillium fungus that killed the bacteria. The story continues that Alexander Fleming then used his discovery to save young Winston Churchill's life.
 
The story, of course, is apocryphal, and so is this simplistic allegory of drug discovery.

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Op Ed: Meeting the needs of the life science industry isn't just about teaching science

Fred D. Ledley, Naomi Wernick | February 7, 2020Fred Ledley

The workforce needs of the life science industry are not being met by initiatives that focus solely on promoting science education. Writing in the Boston Business Journal, Drs. Naomi Wernick, associate teaching professor in biology at the University of Massachusetts, Lowell, and Dr. Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University argues that such strategies need to focus on attracting and retaining students with interests that span both science and business.

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30 Years is Too Long to Wait for New Medicines. There are Ways to Speed Up Drug Development

Fred D. Ledley | June 6, 2020

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/Getty Images, General Photographic Agency

Have you heard the oft-repeated “fact” that it takes at least 10 years from initial discovery for a new drug to enter the marketplace? Take it with a grain of salt. The drug development journey is closer to 30 years.

I’ve experienced the lag time between discovery and commercial success as the co-founder of a biotech startup, and now I study it at the Center for Integration of Science and Industry at Bentley University.

In the early 1990s, I co-founded GeneMedicine Inc., one of the first gene therapy companies. It had a successful startup, raised hundreds of millions of dollars, pioneered new product and business opportunities, and completed an initial public offering, which gave our initial investors a substantial profit.

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Why a 'Moonshot' to Cure Cancer Might Just Work

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/Ben McKeown

Fred D. Ledley | April 29, 2016

Expectations are building for major breakthroughs in cancer treatment. Philanthropists Sean Parker, Michael Bloomberg and Sidney Kimmell have collectively contributed half a billion dollars for new initiatives in immunotherapy, and President Obama has pledged a billion dollars for Vice President Joe Biden’s “moonshot” cancer initiative. Is this the time to be reaching for the moon in cancer therapy?

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Careers of the Future: Will You Be Able to Recognize the Next Big Thing?

Fred D. Ledley | 2014

In this final installment of our seven-week Careers of the Future Series, Fred Ledley, professor of Natural and Applied Sciences and Management as well as director of the Bentley Center for Integration of Science and Industry, explores what exactly it takes for millennial students to prepare for tomorrow's careers — including those can't even be imagined today. 

College graduates in 2014 will have more than a dozen different jobs during their lifetimes, many in industries and positions that haven’t even been created today.

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Biotech: Not Just for Geeks

Fred D. Ledley | 2013

Business students get high marks for scientific literacy

In a down economy, biotechnology jobs are growing faster than the overall Massachusetts state economy. The numbers don’t lie, says a recent industry study:

  • More than 53,000 people in the Bay State are employed in the biopharmaceutical industry
  • More than 28,000 people in biotechnology collectively earn more than $6 billion per year

These are big numbers. They reflect the state’s leading role in an industry that comprises more than 70,000 establishments, employs more than 1.5 million people nationwide, and continues to grow, according to the Massachusetts Biotechnology Council.

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Making the Case for Science

Businesses demand science literacy from management students. Here's why. 

David Szymanski | 2013

On March 14 in Washington, D.C., a group of business school educators and administrators gathered at the National Academy of Sciences to meet with leaders from the private and public sectors and have a conversation on an unlikely topic: climate change education for future business leaders.

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Learning in unexpected places

Fred D. Ledley | 2013
 
I only remember two of the courses I took in college, and neither was in my major. I went to college in the 1970s as a pre-medical student, and my college curriculum was dominated by courses that were pre-requisite for medical school. None of those courses matter now. By the time I began my professional career, everything I learned in those courses was obsolete, and the textbooks I used are now yellowed museum pieces in my library.
 

Why Innovation is Stuck in Slow Motion

Fred D. Ledley | 2013

Creating economic growth from the third industrial revolution

Business innovation has a problem. A recent working paper by Robert Gorden titled “Is US Economic Growth Over? Faltering Innovation Confronts the Six Headwinds” suggests that “innovation does not have the same potential to create growth in the future as in the past.”

Want a good example? Consider the most talked-about advertisement “teaser” leading up to this year’s Super Bowl titled “Kate Upton Washes the All-New Mercedes-Benz CLA in Slow Motion.” It is impossible to watch this advertisement without asking: “what’s new?” 

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Academia should heed industry’s scientific plea

David Szymanski | September 29, 2013

Creative problem solving demands critical thinking and science literacy

Business school educators and administrators assembled at the National Academy of Sciences to meet leaders from the private and public sectors and discuss a somewhat unlikely topic: climate-change education for future business leaders.

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An entrepreneur’s view on the effects of GDP revisions on R&D investment and the economy

Fred D. Ledley | 2013

Entrepreneurs should pay attention to recent changes in the way the U.S. calculates Gross Domestic Product (GDP). The revision, which shifts research and development (R&D) from an operating expense to a fixed investment, could stimulate greater R&D spending and promote much-needed technological innovation.

Calculating the GDP has become more complex as the U.S. shifts from a manufacturing economy to a knowledge economy more dependent on the often-abstract products of innovation. The Bureau of Economic Analysis’ (BEA) definition of GDP — “the market value of final goods and services produced by labor and property within the United States during a given period” — can be problematic for entrepreneurship. This is particularly true for enterprises focused on translating emerging scientific discoveries into new products and businesses.

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