Pharmaceutical Industry : Innovation and Developments.
David A. Mancuso
Bok Engelsk 2011 · Electronic books.
| Omfang | 1 online resource (194 pages)
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| Utgave | 1st ed.
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| Opplysninger | Intro -- PHARMACEUTICAL INDUSTRY: INNOVATION AND DEVELOPMENTS -- PHARMACEUTICAL INDUSTRY: INNOVATION AND DEVELOPMENTS -- CONTENTS -- PREFACE -- AUTHORIZED GENERIC PHARMACEUTICALS: EFFECTS ON INNOVATION -- SUMMARY -- MARKETING APPROVAL AND PATENT ISSUES FOR GENERIC DRUGS -- FDA Approval Procedures -- Resolution of Patent Disputes -- Generic Marketing Exclusivity -- THE CONCEPT OF AUTHORIZED GENERICS -- Authorized Generics Practice -- Authorized Generics within the Hatch-Waxman Framework -- Legality of Authorized Generics -- CONCLUDING OBSERVATIONS -- End Notes -- AUTHORIZED GENERICS: AN INTERIM REPORT -- EXECUTIVE SUMMARY -- 1. PRELIMINARY FINDINGS ON THE SHORT-TERM IMPACTS OF AUTHORIZED GENERICS -- I. Introduction -- II. Preliminary Empirical Results -- A. Description of the Data -- B. Empirical Analysis of Market Outcomes During Exclusivity Periods -- 1. Price Discounts -- a. Retail Generic Discounts -- b. Wholesale Price Discounts -- 2. Wholesale Expenditures -- 3. Retail Quantities -- CONCLUSION -- 2. THE USE OF AUTHORIZED GENERICS IN PATENT SETTLEMENT AGREEMENTS -- I. The Problem of Anticompetitive Brand-Generic Patent Settlement Agreements -- II. The Possible Use of AGs to Compensate Generics for Deferring Generic Entry -- A. Agreements Involving AGs -- A. Type (1) Agreements: Explicit Commitments Not to Compete with an AG. -- A. Type (2) Agreements: Other Promises by Brand Not to Compete with AG on Litigated Product -- C Type (3) Agreements: Brand Appoints Subsequent Filer as AG on Litigated Product -- D Type (4): Brand Appoints Generic as AG on Another Product -- III. More Complex Possible Strategies to Forestall Generic Entry through Agreements Involving Authorized Generics -- A. Multiple Dosage Forms/Products and Exclusive Agreements Relating to AGs -- B. Strategic Information Disclosures -- CONCLUSION -- APPENDIX : DESCRIPTION OF DATA.. - 1. IMS Health Inc -- 2. FDA and Company Data -- End Notes -- REMARKS OF J. THOMAS ROSCH, COMMISSIONER, FEDERAL TRADE COMMISSION, BEFORE THE WORLD GENERIC MEDICINE CONGRESS, HEARING ON "PAY-FOR-DELAY SETTLEMENTS, AUTHORIZED GENERICS, AND FOLLOW-ON BIOLOGIES: THOUGHTS ON THE HOW COMPETITION LAW CAN BEST PROTECT CONSUMER WELFARE IN THE PHARMACEUTICAL CONTEXT" -- I. -- II. -- III. -- End Notes -- FEDERAL R& -- D, DRUG DISCOVERY, AND PRICING: INSIGHTS FROM THE NIH-UNIVERSITY-INDUSTRY RELATIONSHIP -- SUMMARY -- OVERVIEW -- GOVERNMENT SUPPORT FOR R& -- D -- INDUSTRIAL R& -- D -- PATENTS -- LEGISLATIVE INITIATIVES -- The Stevenson-Wydler Technology Innovation Act -- The Bayh-Dole Act -- NIH-UNIVERSITY-INDUSTRY COLLABORATION: THE RESULTS -- Intramural Research -- Policies -- Fair Pricing Clause -- Extramural Research -- ISSUES AND OPTIONS -- Pricing Decisions and Recoupment -- Research Tools -- Government Rights: Royalty Free Licenses and Reporting Requirements -- CONCLUDING OBSERVATIONS -- End Notes -- PHARMACEUTICAL R& -- D AND THE EVOLVING MARKET FOR PRESCRIPTION DRUGS -- The Rate of New-Drug Development -- Investment in R& -- D -- THE ROLE OF HEALTH INSURANCE IN THE DEMAND FOR PRESCRIPTION DRUGS AND DRUG R& -- D -- POLICY OPTIONS AND THEIR IMPLICATIONS FOR R& -- D -- Expand Prescription Drug Coverage -- Expand the Medicaid Rebate Paid by Manufacturers of Brand-Name Drugs -- Require Drugmakers to Pay a Minimum Rebate on Drugs Covered by Medicare Part D -- Increase the Availability and Use of Follow-On Biologic Drug Products -- Incorporate Findings on Comparative Effectiveness into Decisions about Insurance Coverage -- End Notes -- FEDERAL TAXATION OF THE DRUG INDUSTRY AND ITS EFFECTS ON NEW DRUG DEVELOPMENT -- SUMMARY -- DISTINGUISHING CHARACTERISTICS OF THE DRUG INDUSTRY RELEVANT TO ITS FEDERAL TAX BURDEN -- Heavy Spending on R&.. - D Relative to Sales -- Substantial Investment in Advertising and Product Promotion -- Fragmented Competitive Structure -- Strong Reliance on Patent Protection under Regulatory Oversight by the Food and Drug Administration -- Extensive Foreign Operations -- FEDERAL INCOME TAXES PAID BY THE DRUG INDUSTRY BETWEEN 1990 AND 2006 -- Foreign Tax Credit -- Possessions and Puerto Rican Economic Activity Tax Credit -- Prior-Year Minimum Tax Credit -- General Business Credit -- Research Tax Credit -- Orphan Drug Credit -- FEDERAL TAX BURDEN ON THE DRUG INDUSTRY AND MAJOR U.S. INDUSTRIES FROM 2000 TO 2006 -- Deferral of Federal Income Taxes on Foreign-Source Income -- Temporary Dividends Received Deduction under IRC Section 965 -- Transfer of Intangible Assets Like Drug Patents to Low-Tax Countries -- Expensing of Qualified Research Spending -- Expensing of Advertising Spending -- FEDERAL TAX POLICY AND INVESTMENT IN NEW DRUG DEVELOPMENT -- End Notes -- PHARMACEUTICAL PATENT LITIGATION SETTLEMENTS: IMPLICATIONS FOR COMPETITION AND INNOVATION -- SUMMARY -- PATENT DISPUTES UNDER THE HATCH-WAXMAN ACT -- Patent Fundamentals -- FDA Approval Procedures -- Resolution of Patent Disputes -- Generic Exclusivity -- FUNDAMENTALS OF REVERSE PAYMENT SETTLEMENTS -- ANTITRUST IMPLICATIONS OF REVERSE PAYMENT SETTLEMENTS -- Sixth Circuit -- Eleventh Circuit -- Second Circuit -- Federal Circuit -- ISSUES AND OBSERVATIONS -- End Notes -- FDA'S AUTHORITY TO REGULATE DRUG COMPOUNDING: A LEGAL ANALYSIS -- SUMMARY -- BACKGROUND -- THOMPSON V. WESTERN STATES MEDICAL CENTER24 -- 2002 FDA COMPLIANCE POLICY GUIDE -- MEDICAL CENTER PHARMACY V. MUKASEY -- ISSUES WITH CURRENT FDA AUTHORITY TO REGULATE DRUG COMPOUNDING AND POSSIBLE FUTURE DEVELOPMENTS -- End Notes -- PROMOTIONAL SPENDING FOR PRESCRIPTION DRUGS -- Marketing to Physicians and Consumers -- Overall Marketing Trends.. - Direct-to-Consumer Marketing -- Different Marketing Strategies for Different Drugs -- MARKET CHARACTERISTICS THAT INFLUENCE PROMOTIONAL STRATEGIES -- Market Size -- Competing Drugs -- Years since FDA Approval -- End Notes -- CHAPTER SOURCES -- INDEX.
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| Emner | |
| Sjanger | |
| Dewey | |
| ISBN | 9781621004394
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