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Generic drugs

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Articles 31 - 38 of 38

Full-Text Articles in Food and Drug Law

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm Jan 2007

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm

Michigan Telecommunications & Technology Law Review

Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …

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Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher Jan 2007

Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher

Michigan Telecommunications & Technology Law Review

Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …

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Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak Jan 2005

Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak

Michigan Journal of International Law

This Note argues that the Panel in Canada-Generic Medicines correctly decided that the non-discrimination clause in Article 27 applies to the exceptions of Articles 30 and 31. Because Article 27 is the guiding force of Section 5, any exceptions to the rights granted under Section 5 must comply with the requirements set forth in Article 27. Although extreme applications of the non-discrimination clause could be limiting upon some exceptions, Articles 30 and 31 were not placed into TRIPs as complete escape clauses from the framework of Section 5. Additionally, the application of the non-discrimination clause to Articles 30 and 31 …

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2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan Jan 2004

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.

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The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox Apr 1986

The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox

University of Michigan Journal of Law Reform

This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.

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Consumer Protection And Prescription Drugs: The Generic Drug Substitution Laws, Jillena A. Warner Jan 1978

Consumer Protection And Prescription Drugs: The Generic Drug Substitution Laws, Jillena A. Warner

Kentucky Law Journal

No abstract provided.

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Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof Jan 1976

Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof

University of Michigan Journal of Law Reform

This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.

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The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig Jan 1972

The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig

University of Michigan Journal of Law Reform

This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.

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