DRUG DEVELOPMENT

Drug Development

Abstract

This study tries to explore the concept of Drug Development in a holistic context. The main focus of the research is on Drug Development and its relation with Stakeholders. The research also analyzes many aspects of Drug Development and tries to gauge its effect on Stakeholders.

Table of Contents

Abstract2

Outline4

Background6

Thesis Statement9

Arguments9

Evidence, Explanations, Rebuttals11

Indicators of Public-Sector Involvement11

Policy implications11

Conclusions12

References14

Outline

I. Background

The US public and private sectors are both involved in producing innovative drug products. Although industry supplies the bulk of the funds devoted to research and development, the public sector- primarily the National Institutes of Health (NIH) - supports most of the nation's basic biomedical research.

II. Thesis Statement

This paper presents new data to assist policy makers who are considering expanding recoupment or march-in measures. It also analyzes whether the drug development is a speedy or safety measure.

III. Arguments: Pro and Con

The unstated tradeoff for drug makers' increased investment in post approval drug-safety monitoring is supposed to be greater US Food and Drug Administration flexibility in approving new drugs for market.

A major challenge for sponsors and for FDA is to determine how best to measure whether a REMS is effective. FDA suggests that sponsors conduct surveys, collect prescriber information, or establish active systems to assess these programs.

IV. Evidence, Explanations, Rebuttals

Public-sector patents are defined as all of those that were assigned to a government agency and all of those with government interest statements.

Using patent and bibliometric data, it was found that the indirect influence of the public sector in drug development was much larger than the direct effect. Both effects were much greater for priority-review than for standard-review drugs.

V. Conclusion

Government support, through publicly funded research, had a large indirect impact on pharmaceutical innovation. The direct effect of government support- that is, cases where the government owns the patents outright or has claims on the intellectual property involved in the drugs' development- is more limited, but still large for the most innovative drugs, those whose applications received priority review by the FDA.

Drug Development

Background

The US public and private sectors are both involved in producing innovative drug products. Although industry supplies the bulk of the funds devoted to research and development, the public sector- primarily the National Institutes of Health (NIH) - supports most of the nation's basic biomedical research.

The question of what roles the different sectors play has recently become central to discussions of pharmaceutical policy. Several recent books and articles argue that the public sector is the main source of innovative drugs. The issue had been the subject of congressional debate and even made an appearance as a talking point during the 2008 presidential campaign, when then candidate Hillary Clinton argued that various proposals for regulating drug prices were reasonable "because ultimately, the American tax payer pays for the development of a lot of these drugs through NIH grants and other kinds of research grants (Walsh, 2002)."

In addition to proposing recoupment of royalties, some advocates have urged the public sector to exercise its "march-in" rights to reduce ...