Open Access. Powered by Scholars. Published by Universities.®
Pharmacoeconomics and Pharmaceutical Economics Commons™
Open Access. Powered by Scholars. Published by Universities.®
- Institution
- Keyword
-
- FDA (3)
- Innovation (3)
- Pharmaceutical industry (3)
- Patents (2)
- Absurdity (1)
-
- Administrative Law (1)
- Agreement on Trade-Related Aspects of Intellectual Property Rights (1994) (1)
- Biomimicry (1)
- Clinical trials (1)
- Commerce Clause (1)
- Compulsory licensing of patents (1)
- Constitutional Law (1)
- Contracts (1)
- Cross-border trade (1)
- Drug exports (1)
- Drug makers (1)
- Drug manufacturing (1)
- Drug research and development (R&D) (1)
- Drugs (1)
- Drugs--Patents (1)
- Efficacy standards (1)
- Entropy (1)
- Food and Drug Law (1)
- Fulfilment (1)
- Generics (1)
- Government Contracts (1)
- Hatch-Waxman Act (1)
- Health Law and Policy (1)
- Imitative (1)
- In-service training (1)
- Publication Year
- Publication
- Publication Type
Articles 1 - 14 of 14
Full-Text Articles in Pharmacoeconomics and Pharmaceutical Economics
The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann
The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann
Notre Dame Journal on Emerging Technologies
This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …
The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich
The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich
Notre Dame Journal on Emerging Technologies
Pharmaceutical manufacturers can delay the generic entry for a blockbuster drug. In order to keep the generic system on track, it is critical to expose the various avenues of generic delay. Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through …
Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida
Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida
Honors Theses
This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.
The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite
The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite
Articles
On the thirty-fifth anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set …
Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender
Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender
Student Theses 2015-Present
This paper aims to shed light on the dissonance caused by the superimposition of Dominant Human Systems on Natural Systems. I highlight the synthetic nature of Dominant Human Systems as egoic and linguistic phenomenon manufactured by a mere portion of the human population, which renders them inherently oppressive unto peoples and landscapes whose wisdom were barred from the design process. In pursuing a radical pragmatic approach to mending the simultaneous oppression and destruction of the human being and the earth, I highlight the necessity of minimizing entropic chaos caused by excess energy expenditure, an essential feature of systems that aim …
Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith
Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith
Senior Theses and Projects
After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. …
The Effect Of Any Willing Provider And Freedom Of Choice Laws On Prescription Drug Expenditures, Jonathan Klick, Joshua D. Wright
The Effect Of Any Willing Provider And Freedom Of Choice Laws On Prescription Drug Expenditures, Jonathan Klick, Joshua D. Wright
All Faculty Scholarship
Any Willing Provider and Freedom of Choice laws restrict the ability of managed care entities, including pharmacy benefit managers, to selectively contract with providers. The managed care entities argue this limits their ability to generate cost savings, while proponents of the laws suggest that such selective contracts limit competition, leading to an increase in aggregate costs. We examine the effect of state adoption of such laws on total state healthcare spending, finding that any willing provider/freedom of choice laws are associated with cost increases of at least 3 percent. These results suggest that these laws are harmful from a spending …
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Law Faculty Scholarship
Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …
Flag On The Play: The Ninth Circuit’S End-Run Around Implied Rights Of Action Runs Afoul In County Of Santa Clara V. Astra, Usa Inc., Brooke Burns
Brooke Burns
In County of Santa Clara v. Astra, USA Inc., the Ninth Circuit held that a third party was entitled to bring a private right of action for breach of contract under federal common law, even though the governing statute neither expressly nor impliedly provides for this right. Because the Supreme Court has increasingly limited the ability of a third party to bring an implied right of action claim, private parties have pursued third party beneficiary claims instead. As a result, a considerable circuit split has resulted as to whether federal common law provides a private right of action to a …
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Faculty Scholarship
In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …
Oy Canada! Trade's Non-Solution To "The Problem" Of U.S. Drug Prices, Daniel Gilman
Oy Canada! Trade's Non-Solution To "The Problem" Of U.S. Drug Prices, Daniel Gilman
Faculty Scholarship
Price disparities—price “differentiation” or “discrimination”—in pharmaceuticals markets have, in recent years, been the subject of much discussion. Price sensitivity should come as no surprise: Medicines play an increasingly important role in healthcare, while pharmaceuticals prices continue to rise. When prices vary greatly within markets or between neighboring markets, the pressure towards arbitrage is clear. This paper considers the question whether the re-importation of medicines from Canada or the EU is well advised and argues that it is not. First, we might reasonably question the extent to which we wish, as a matter of policy, to manage pharmaceuticals pricing; among other …
The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain
The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain
Business and Economics Faculty Publications
As rising health care expenditures focus government attention on slowing the growth, the pharmaceutical industry comes under increasing pressure to curb prices of ethical drugs. Pharmaceutical price regulations have been implemented in many countries to control pharmaceutical expenditures. Yet, creating innovative drugs requires enormous R&D costs, which in turn require adequate expected economic returns. Since price controls reduce profits and expected returns, as countries invoke stricter price regulations, firms will either move their R&D process into less regulated markets or move out of innovative R&D. This paper assesses the impact of drug price regulations in Japan compared to market-priced drugs …
What Are The Elements Of A Successful Training Model, As Perceived By Global Corporate Security Heads Working In The Ethical Pharmaceutical Industry?, Kevin P. Schatzle
What Are The Elements Of A Successful Training Model, As Perceived By Global Corporate Security Heads Working In The Ethical Pharmaceutical Industry?, Kevin P. Schatzle
Seton Hall University Dissertations and Theses (ETDs)
.
Pharmaceuticals And Intellectual Property: Meeting Needs Throughout The World, Thomas G. Field Jr.
Pharmaceuticals And Intellectual Property: Meeting Needs Throughout The World, Thomas G. Field Jr.
Law Faculty Scholarship
To the extent that most people think about patents and other forms of intellectual property at all, they tend to be aware that the owners of such property may have the legal capacity to limit market entry--without fully appreciating the extent to which products or processes that can be easily copied might otherwise be unavailable. Focusing on their function in recouping risk capital, this article will survey the types and functions of intellectual property. Then it will attend to the situation in developing countries, particularly the role of intellectual property in meeting their needs for medical products.