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Articles 1 - 22 of 22
Full-Text Articles in Law
Criminal Law And Procedure, Marla G. Decker, Stephen R. Mccullough
Criminal Law And Procedure, Marla G. Decker, Stephen R. Mccullough
University of Richmond Law Review
No abstract provided.
Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard
Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard
Vicki W Girard
This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …
Jesting Pilate, Carl E. Schneider
Jesting Pilate, Carl E. Schneider
Articles
I have two goals this month. First, to examine a case that's in the news. Second, to counsel skepticism in reading news accounts of cases. Recently, I was talking with an admirable scholar. He said that transplant surgeons sometimes kill potential donors to obtain their organs efficiently. He added, "This isn't just an urban legend - there's a real case in California." A little research turned up California v. Roozrokh. A little Googling found stories from several reputable news sources. Their headlines indeed intimated that a transplant surgeon had tried to kill a patient to get transplantable organs. CNN.com: …
Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon
Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon
Michigan Telecommunications & Technology Law Review
Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited …
Pushing Drugs Or Pushing The Envelope: The Prosecution Of Doctors In Connection With Over-Prescribing Of Opium-Based Drugs, Deborah Hellman
Pushing Drugs Or Pushing The Envelope: The Prosecution Of Doctors In Connection With Over-Prescribing Of Opium-Based Drugs, Deborah Hellman
Faculty Scholarship
No abstract provided.
Pathways Across The Valley Of Death: Novel Intellectual Property Strategies For Accelerated Drug Discovery, Arti K. Rai, Jerome H. Reichman, Paul F. Uhlir, Colin Crossman
Pathways Across The Valley Of Death: Novel Intellectual Property Strategies For Accelerated Drug Discovery, Arti K. Rai, Jerome H. Reichman, Paul F. Uhlir, Colin Crossman
Faculty Scholarship
Drug discovery is stagnating. Government agencies, industry analysts, and industry scientists have all noted that, despite significant increases in pharmaceutical R&D funding, the production of fundamentally new drugs - particularly drugs that work on new biological pathways and proteins - remains disappointingly low. To some extent, pharmaceutical firms are already embracing the prescription of new, more collaborative R&D organizational models suggested by industry analysts. In this Article, we build on collaborative strategies that firms are already employing by proposing a novel public-private collaboration that would help move upstream academic research across the valley of death that separates upstream research from …
Addressing Potential Drug Risks: The Limits Of Testing, Risk Signals, Preemption, And The Drug Reform Legislation, Margaret Gilhooley
Addressing Potential Drug Risks: The Limits Of Testing, Risk Signals, Preemption, And The Drug Reform Legislation, Margaret Gilhooley
South Carolina Law Review
No abstract provided.
Is Preemption Right For You - The Third Circuit Applies Preemption To A Misleading Drug Advertisement Claim In Pennsylvania Employee Benefit Trust Fund V. Zeneca, Inc., Diana Rabeh
Villanova Law Review
No abstract provided.
Building A Better Innovation System: Combining Facially Neutral Patent Standards Withtherapeutics Regulation, Arti K. Rai
Building A Better Innovation System: Combining Facially Neutral Patent Standards Withtherapeutics Regulation, Arti K. Rai
Faculty Scholarship
No abstract provided.
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Articles
This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …
Federal Labor Law Obstacles To Achieving A Completely Independent Drug Program In Major League Baseball, Robert D. Manfred Jr.
Federal Labor Law Obstacles To Achieving A Completely Independent Drug Program In Major League Baseball, Robert D. Manfred Jr.
Marquette Sports Law Review
No abstract provided.
The Immaculate Deception: How The Holy Grail Of Protectionism Led To The Great Steroid Era, Eldon L. Ham
The Immaculate Deception: How The Holy Grail Of Protectionism Led To The Great Steroid Era, Eldon L. Ham
Marquette Sports Law Review
No abstract provided.
Are We All Dopes? A Behavioral Law And Economics Approach To Legal Regulation Of Doping In Sports, Shayna M. Sigman
Are We All Dopes? A Behavioral Law And Economics Approach To Legal Regulation Of Doping In Sports, Shayna M. Sigman
Marquette Sports Law Review
No abstract provided.
Corruption: Its Impact On Fair Play, Richard H. Mclaren
Corruption: Its Impact On Fair Play, Richard H. Mclaren
Marquette Sports Law Review
No abstract provided.
A Call For Drug-Testing Of High School Student-Athletes, Scott A. Andresen
A Call For Drug-Testing Of High School Student-Athletes, Scott A. Andresen
Marquette Sports Law Review
No abstract provided.
From Medals To Morality: Sportive Nationalism And The Problem Of Doping In Sports, Dionne L. Koller
From Medals To Morality: Sportive Nationalism And The Problem Of Doping In Sports, Dionne L. Koller
Marquette Sports Law Review
No abstract provided.
Which Washington: Constitutions In Conflict?, Jonathan F. Duncan, Kristina V. Giddings
Which Washington: Constitutions In Conflict?, Jonathan F. Duncan, Kristina V. Giddings
Marquette Sports Law Review
No abstract provided.
Fall Of The Rocket: Steroids In Baseball And The Case Against Roger Clemens , Daniel Healey
Fall Of The Rocket: Steroids In Baseball And The Case Against Roger Clemens , Daniel Healey
Marquette Sports Law Review
No abstract provided.
Dopers Are Not Duped: Usada's Assistance To Federal Prosecutions Ultimately Protecting Clean Athletes Is Not State Action, Sarah L. Horvitz, Travis Tygart, Paul A. Turbow
Dopers Are Not Duped: Usada's Assistance To Federal Prosecutions Ultimately Protecting Clean Athletes Is Not State Action, Sarah L. Horvitz, Travis Tygart, Paul A. Turbow
Marquette Sports Law Review
No abstract provided.
The International Convention Against Doping In Sport: Is It The Missing Link To Usada Being A State Actor And Wadc Coverage Of U.S. Pro Athletes?, Michael Straubel
The International Convention Against Doping In Sport: Is It The Missing Link To Usada Being A State Actor And Wadc Coverage Of U.S. Pro Athletes?, Michael Straubel
Marquette Sports Law Review
No abstract provided.
The Body And The Law: How Physiological And Legal Obstacles Combine To Create Barriers To Accurate Drug Testing , Genevieve F.E. Birren, Jeremy C. Fransen
The Body And The Law: How Physiological And Legal Obstacles Combine To Create Barriers To Accurate Drug Testing , Genevieve F.E. Birren, Jeremy C. Fransen
Marquette Sports Law Review
No abstract provided.
Are We All Dopes? A Behavioral Law & Economics Approach To Legal Regulation Of Doping In Sports, Shawn Crincoli
Are We All Dopes? A Behavioral Law & Economics Approach To Legal Regulation Of Doping In Sports, Shawn Crincoli
Scholarly Works
No abstract provided.