Law Commons^™

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 Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch

Journal of Health Care Law and Policy

No abstract provided.

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

The Breast Implant Controversy: A Prism For Reform, Benson Yang

RISK: Health, Safety & Environment (1990-2002)

The author argues that regulatory blunders and the litigation explosion pertaining to breast implants highlight defects in U.S. administrative and tort law systems.

Identifying Chemical Hazards For Regulation: The Scientific Basis And Regulatory Scope Of California's Proposition 65 List Of Carcinogens And Reproductive Toxicants, William S. Pease

RISK: Health, Safety & Environment (1990-2002)

Noting that the Proposition 65 list has become an authoritative source for hazard identification, Dr. Pease examines its legislative, regulatory and scientific origins. After analyzing the California approach, he offers suggestions for better selection of future regulatory targets.

Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton

RISK: Health, Safety & Environment (1990-2002)

Mr. Hilton attempts to show why important choices presented in current proposals to amend child-resistant packaging regulations are fundamentally normative. He then argues that these choices should not be obscured by the technical issues.