May your drug price be evergreen.

@article{Feldman2018MayYD,
  title={May your drug price be evergreen.},
  author={Robin C. Feldman},
  journal={Journal of Leukocyte Biology},
  year={2018},
  volume={5},
  pages={590-647}
}
  • Robin C. Feldman
  • Published 7 December 2018
  • Political Science
  • Journal of Leukocyte Biology
Presenting the first comprehensive study of evergreening, this article examines the extent to which evergreening behavior—which can be defined as artificially extending the protection cliff—may contribute to the problem. The author analyses all drugs on the market between 2005 and 2015, combing through 60,000 data points to examine every instance in which a company added a new patent or exclusivity. The results show a startling departure from the classic conceptualization of intellectual… 

The Effect of Medicare Part D on Evergreening, Generic Entry, and Drug Prices

The results show that Part D increased evergreening and reduced generic entry, and suggest that these effects are associated with higher prices, while Part D’s overall effect on drug prices is still negative.

Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity

EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new

Patent Cliffs in the Era of Complex Therapies and Biologics

This research looks to analyze the ‘patent cliff’ across varying product classes and, in doing so, understand the drivers behind the different market dynamics post-LoE for traditional molecules, complex molecules and biologics.

Viral Licensing: Ensuring the Public Interest When Taxpayers Fund Pharmaceutical Research

In recent years, the nation’s drug development and delivery system has loomed in the forefront of pressing policy concerns. This piece suggests a relatively simple pathway that could provide

The Medicare Innovation Subsidy

It is important for policymakers to understand how access policies like Medicare also serve as innovation incentives, and this extra innovation subsidy may open the policy space for hybrid proposals that combine expanded government insurance like Medicare for All with lower drug prices while preserving or even increasing current returns to innovation.

Pharmaceutical drug development: high drug prices and the hidden role of public funding

Issues surrounding the current patent-based drug development model, public funding of research and pharmaceutical lobbying will be addressed, and innovations in drug development to improve public health needs and guaranteeing medication access to patients will be explored.

Rising Drug Costs for Neurologic Diseases.

Clinicians should discuss the drug's value and the associated opportunity cost with patients and have an open discussion about patients' ability to financially tolerate the treatment, and clinical- and economic-based analyses from independent groups such as the Institute for Clinical and Economic Review can help physicians understand the value of drugs.

Generics and Biosimilars: Barriers and Opportunities.

Global secular stagnation and the rise of intellectual property monopoly

  • H. Schwartz
  • Economics
    Review of International Political Economy
  • 2021
Abstract Explanations for slow global growth (secular stagnation) correctly focus on income inequality and wage formation but are incomplete. They ignore the source of wages and fail to ask why a

New Drug Formulations and Their Respective Generic Entry Dates.

The results suggest that the introduction of new formulations of brand-name drugs occurs in about half of cases and sometimes provides manufacturers with a lengthy period of additional market exclusivity beyond that of the original product.

References

SHOWING 1-10 OF 23 REFERENCES

The Orphan Drug Act: Restoring the Mission to Rare Diseases

It is suggested that patients with rare cancers and other diseases may suffer due to dilution of the incentives and benefits and proposed reform to increase submission scrutiny, decrease benefits based on off-label use, and increase price transparency is proposed.

Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development is considered.

Off‐label use of medicines: consensus recommendations for evaluating appropriateness

The development of a guide for clinicians, policymakers and funders of health care in evaluating the appropriateness of medicines proposed for off‐label use is described and three broad categories of appropriate off-label use are identified.

Editorial by concerned physicians: Unintended effect of the orphan drug act on the potential cost of 3,4‐diaminopyridine

This book aims to provide a history of web exceptionalism from 1989 to 2002, a period chosen in order to explore its roots as well as specific cases up to and including the year in which descriptions of “Web 2.0” began to circulate.

When Everyone Is an Orphan: Against Adopting a U.S.-Styled Orphan Drug Policy in Canada

  • M. Herder
  • Medicine, Political Science
    Accountability in research
  • 2013
It is argued that Canada, which recently announced plans to develop its own “orphan drug framework” should not follow the United States' orphan drug model, given the biopharmaceutical industries' growing interest in orphan diseases.

supra note 31; see supra notes 78-80 and accompanying text; see infra note 173 and accompanying text

    To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries

      describing examples of the complex second generation of pay-for-delay settlements, taking place even after courts try to shut down pay-for-delay settlements of the first generation

        Patients Fear Spike in Price of Old Drugs

        • NEW YORK TIMES

        Outlook to 2022